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ANNUAL REPORT2016-17

NATIONAL INSTITUTE OF BIOLOGICALSMinistry of Health and Family Welfare

Government of IndiaNOIDA

Contents1. Report from the Desk of Director i

2. Introduction iv

3. ScientificProgress 1

3.1 Immunodiagnostic Kit Laboratory 3

3.2 Molecular Diagnostic Laboratory 15

3.3 Blood Grouping Reagent Laboratory 19

3.4 Biochemical Kit Laboratory 27

3.5 Bacterial Vaccine Laboratory 35

3.6 Viral Vaccine Laboratory 39

3.7 Blood Products Laboratory 43

3.8 Recombinant Product Laboratory 48

3.9 Enzyme and Hormone Laboratory 55

3.10 Therapeutic Monoclonal Antibody Laboratory 62

3.11 Allergen Testing Laboratory 68

3.12 Animal Facility 77

3.13 Support Services 85

3.13.1 Quality Management Unit 87

3.13.2 Sample Receipt and Report Dispatch Unit 94

3.13.3 Training Unit 98

3.14 Haemovigilance Programme of India (HvPI) 102

3.15 Information Technology Cell 107

3.16 International Cooperation 108

3.17 Electrical and Mechanical Engineering Works 110

3.18 National Drug Survey 112

4. Trainings,WorkshopsandMeetings 131

5. Report ofAdministrativeWork 151

6. Rajbhasha (Hindi) 156

7. Personnel 158

8. EmpoweringConsumers:Right to InformationAct, 2005 161

9. Auditor’s Reports 163

Annual Report 2016-17 i

SCIENTIFIC PROGRESS

Safe and quality biologicals are necessary for promoting and protecting human health. NIB has been committed, and successfully contributing to this endeavour for the last 25 years. The mandate of the Institute includes ensuring quality of biological drugs including therapeutic monoclonal antibodies used by patients suffering from cancer and autoimmune diseases by undertaking high end science based testing with Research and Development interface for application of science. One of the main functions of the Institute is to undertake research, establish linkages and exchange personnel with different institutions in India and abroad for furtherance of its mandate. Other subjects forming part of its mandate are (i) developing and validating standards for quality control testing; (ii) developing linkages with other National/International institutions and keep abreast with worldwide scientific research and technological developments; (iii) providing training facilities in quality control of biologicals; (iv) assessing from time to time the availability of qualified manpower; and (v) implementing and coordinating activities of Haemovigilance Programme of India (HvPI). Majority of the NIB Laboratories are accredited as per ISO 17025: 2005 by NABL and eight laboratories of NIB have been declared as the Central Drugs Laboratory (CDL) viz. Blood Grouping Reagents, Immunodiagnostic Kits, Blood Products, Recombinant Products, Biochemical Kits, Enzyme and Hormones, Bacterial Vaccines and Viral Vaccines vide Extraordinary Gazette Notification G.S.R.908 (E) dated 22.12.2014 and G.S.R250 (E) Dated 15.03.2017. Five Scientists of the Institute have been declared as Government Analysts vide Extraordinary Gazette Notification S.O. 2393 (E) dated 02.09.2015 and G.S.R. 250 (E) - Part-II -

REPORT FROM THE DESK OF DIRECTOR

Section 3 - Sub-Section (i) dated 15th March, 2017. One NIB scientist is also a GLP inspector in the National GLP Compliance Monitoring Authority (NGCMA) under the Department of Science & Technology who is regularly inspecting the facilities, as and when required in the country. One of the scientist of NIB has been declared as Board Member of International Haemovigilance Network (IHN).

NIB has developed capacity to test 185 different types of biologicals and during the said period performed Quality evaluation of 1900 batches. Out of these 15 batches were identified as Not of Standard Quality (NSQ) thus highlighting the role of Institute in protection and capital promotion of public health.

NIB carried out “Survey of Extent of Problems of Spurious and Not of Standard Quality Drugs in the Country 2014-16” for Ministry of Health and Family Welfare, Govt. Of India. The report of above said drug survey was submitted to the Ministry, this year. According to the report out of about 47000 samples tested, 13 samples were found as Spurious and 1850 were found as not of Standard Quality (NSQ). Therefore, the estimated percentage of NSQ drugs in India was found as 3.16% and of Spurious drugs was 0.0245%

Under “Pradhan Mantri Kaushal VikasYojna”, the Institute conducted training programs on ‘National Skill Development and Hands–on training on Quality Control of Biologicals’. A total number of 691 trainees were trained during the said period which included 89 Students of Biotechnology, Microbiology and Biochemistry

Annual Report 2016-17ii

National Institute of Biologicals

from Universities of Jammu, Kashmir, Himachal Pradesh, Uttarakhand and North-Eastern Universities of Silchar, Guwahati and Dibrugarh, 117 M.Pharma students from various NIPERs and JSS College of Pharmacy-Ooty, 271 CPCSEA Officials, 120 Blood Bank Officials, 3 Food and Drug Analysts. Also, 91 technical persons including Quality Control and Quality Assurance Officials from manufacturers, Regulators and Pharmacopeial Body in collaboration with Clinical Development Service Agency (CDSA), DBT. NIB also provided infrastructure facilities and logistics support in its campus to CDSCO for organizing advanced training programs for 493 Drug regulators and Govt. Analysts from Center and States.

NIB organized trainings under the Haemovigilance Programme of India (HvPI) through 4 Continual Medical Education (CMEs) and 2 National workshops all over India wherein 870 health care professionals including Blood bank officials, clinicians, nurses & blood bank technical staff were trained.

Dr. Ute Rosskopf, Scientist WHO and Dr. Christina Von Hunolstein, Director, Bacterial Vaccine Unit CRIVIV-ISS Rome, Italy, visited NIB in February 2017, to discuss, oversee and finalize the arrangements for the forthcoming 1st WHO Global Network of National Vaccine Control Laboratories (GNNVCL) meeting and training workshop for potency testing of Hib Vaccine to be held at NIB in collaboration with WHO and CRIVIV-ISS Rome in the month of October-November 2017. One of the NIB scientist will be a resource person for facilitating the training program.

Institute extended its services to Bhutan for establishment of their Haemovigilance system. A 13 member delegation of Blood Technical Advisory Committee (BTAC) Members, Blood

Bank and Nursing Staff of Bhutan visited NIB, India from 19th to 21st October, 2016 for 3 days workshop to study Haemovigilance Programme of India & establishment of Haemovigilance system in Bhutan. Subsequently, NIB Officials visited Bhutan from 07th to 11th November, 2016 with regard to INDO-BHUTAN CME on Haemovigilance for establishment of Haemovigilance System in Bhutan. IT Cell of HvPI developed a dedicated Haemo-Vigil Software for Bhutan and provided hands on training on Haemo-Vigil Software developed for Bhutan to the Blood Bank officials of Bhutan. Subsequently, a software manual for the usage of this software was developed by NIB and handed over to Bhutan.

Upon the request received from Ethiopia to extend NIB’s support for Haemovigilance System in their country, the Institute forwarded documents to them which would aid in establishing their Haemovigilance System. The Ethiopian Counterpart is in constant touch with officer In-charge of Haemovigilance Programme of India in this regard.

Further, Hon’ble High Commissioner of Embassy of Zambia also visited NIB to identify the areas of cooperation between Health agencies in Zambia and NIB.

In pursuit of its functions to undertake research, develop reference materials for biologicals and to prepare monographs for incorporation in Indian Pharmacopeia, NIB has proposed to develop “Institutional Development Plan” for preparation of 44 Reference Standards and 34 Monographs and for fulfilling its mandate to provide training facilities in quality control. Projects for development of new test/analysis methods including alternate testing methods and preparation of new monographs for inclusion in Indian Pharmacopoeia (IP) have also been

Annual Report 2016-17 iii

SCIENTIFIC PROGRESS

proposed. Institute has also published 18 research articles on quality evaluation of biologicals in various National and International Indexed Journals. NIB is fulfilling its mandate of assuring the quality of Biologicals, keeping abreast with the Goal of Ministry of Health and Family Welfare to provide reliable and accessible healthcare. NIB is continuously Contributing in the talent

pool of trained human resource for industry and regulatory bodies, in line with “Skill India development”. The Institute in its endeavor of effective and uniform quality control of Biologicals is collaborating with National and International research and regulatory Institutes for development of Reference Standards and new Monographs, thus facilitating “Make in India” program of Government of India.

Annual Report 2016-17iv


INTRODUCTION

National Institute of Biologicals (NIB) had been set up in 1992 as an autonomous Institute under the administrative control of the Ministry of Health & Family Welfare, Government of India. The Institute is located on the outskirts of Delhi at A-32, Sector-62, Institutional Area, NOIDA (UP). The Institute is committed for ensuring the quality of biological drugs and diagnostics used by patients suffering from infectious diseases, cancer and autoimmune diseases etc. Institute is also running Heamovigilance Programme of India (HvPI) to track adverse reactions associated with Blood Transfusion and Blood donation. Furthermore, Institute is organizing training programmes for development of skilled manpower in the field of biologicals in accordance to the Pradhan Mantri Kaushal Vikas Yojna. For the pursuance of its functions NIB is striving towards establishing the linkages with various National and International regulatory and research institutes for development of Reference Standards and Monographs on Biologicals so as to ensure the uniformity in the quality evaluation of Biologicals. The Institute is providing technical expertise to Central Drugs Standard Control Organization (CDSCO) and participate in joint inspections carried out at manufacturers premises by the team constituted by CDSCO. Institute is also extending the support on International platform by facilitating the establishment of Haemovigilance Programme in Bhutan and Ethiopia. NIB is equipped with State

of the Art Laboratory, committed scientists, IT facility, Animal House infrastructure, classrooms, cafeteria and Hostel facility. All Laboratories have been designed according to the technical requirements necessary for the testing of biological products. Laboratories are equipped with high end equipments like Fast Protein Liquid Chromatography (FPLC), Capillary Zone Electrophoresis (CZE), Fluorecence-activated Cell Sorter (FACS), High Performance Liquid Chromatography (HPLC), High Performance anion Exchange with Pulsed Amperometric Detection (HPAEC-PAD) and Atomic Absorption Spectrophotometer (AAS) etc. for quality evaluation of biologicals. Eight laboratories of NIB are CDL notified and five of NIB scientists have been notified as Government Analysts. One of the scientist of NIB is also a Good Laboratory Practices (GLP) inspector in the National GLP Compliance Monitoring Authority (NGCMA). Another scientist of NIB has been declared as Board Member of International Haemovigilance Network (IHN). The expenditure on salaries, maintenance, procurement of reagents, chemicals and scientific equipment etc. is met from the grant given by the Ministry of Health & Family Welfare, Govt. of India. The revenue generated from the Quality Control Testing of biologicals is deposited to the consolidated fund of Government of India with Ministry of Health & Family Welfare.

SCIENTIFICPROGRESS

Annual Report 2016-17 3

SCIENTIFIC PROGRESS

1. Lab/Division ImmunodiagnosticKitLaboratory

2. NameofHead Dr.R.K.Sharma,ScientistGr.-III

3. Manpower in theLab/Division: I. NameofScientificStaff Mr. Pankaj Kumar Sharma,

Scientist Gr.-III Mr. Sanjeev Kumar Sharma,

Junior Scientist Mr. Rajeev Kumar, Junior Scientist

II. NameofTechnicalStaff Mr. Brij Bhushan, Lab Technician Ms. Sweeti Dalal, Lab Technician,

NRL, NACO

III. No.(s) ofContractualStaff:Eight

IMMuNODIAGNOSTICKITLAbORATORy

4. ScientificActivitiesundertaken: a) Collaboration with other

organizations:

Networking with blood banks/hospitalsof Delhi/National Capital Region (NCR)and different geographical region of thecountryforcollectionofplasmabags:

DCG (I) has directed various blood banks/hospitals of Delhi/NCR and different geographical regions of the country to provide non-usable plasma bags for preparing performance panels of HIV, HBV, HCV and Syphilis to NIB.

During the year 2016-17 a total of 745 plasma donor units were collected out of which 405 were characterized as reactive for HIV, HCV, HBV & Syphilis and 340 as non-reactive. (Table 1).

Table1:NumberofPlasmabagsCollected

TotalNumberofPlasmabagsCollected in theyear2016-17 fromDifferentGeographicalRegionsNameofHospital/bloodbank Marker

HIV HbsAg HCV Syphilis Non-Reactive

Total

I.R.C.S,Delhi 0 0 0 0 340 340KailashHospital,Delhi 3 72 42 7 0 124FortisHospital,Gurgaon 7 31 27 15 0 80G.T.b.Hospital,Delhi 7 33 9 5 0 54G.b.PantHospital,Delhi 0 1 2 1 0 4MoolchandHospital,Delhi 1 14 2 0 0 17MedantaHospital,Gurgaon 0 9 1 0 0 10ApolloHospital,Delhi 1 4 2 0 0 7Rotarybloodbank,Delhi 10 0 49 8 0 67Prathmabloodbank,Gujarat 4 9 3 0 0 16b.I.M.R.Hospital,MadhyaPradesh 0 26 0 0 0 26

Total 33 199 137 36 340 745

Annual Report 2016-174


b) CDLNotification:

The Immunodiagnostic Kit Laboratory is a notified Central Drugs Laboratory (CDL) by Government of India since 2002 for diagnostic kits of HIV-Ab, HCV-Ab and HBsAg. It is also a NABL Accredited Laboratory in accordance with ISO/IEC 17025:2005 for the testing of HIV 1&2 Antibody, HCV Antibody & HBsAg (Rapid, ELISA) and Syphilis Rapid test kit.

Laboratory has established Quality

Management System (QMS) for conducting Quality Evaluation of indigenous and imported kits (Rapid, ELISA, CLIA, ELFA, Confirmatory, Ag/Ab & Combo kits) for HIV, HCV, HBsAg & syphilis forwarded by offices of Central Drugs Standard Control Organization (CDSCO), various State Drugs Control Organizations and procurement division of NACO. Overall laboratory ensures the supply of immunodiagnostic kits of standard quality for safeguarding the public health.

c) NotificationofGovernmentAnalyst:

S.no. Nameof theStaffGazetteNotificationNo.&Date

ImmunodiagnosticKitMarkers

1. Dr. Reba Chhabra , Scientist Grade - I

Gazette Notification No. S.O. 2393 (E) published on 2nd September 2015

1. Human Immunodeficiency Virus.

2. Hepatitis B Surface Antigen.

3. Hepatitis C Virus.

d) DevelopmentofMonograph:N/A

e) Publication(s): NIL

5. Testingofbiologicals:5.1 In the year 2016-17 a total of 391 RAPID, ELISA, ELFA, CLIA, Confirmatory & Combo kits for

HIV, HCV, HBV and Syphilis were received. These kits were forwarded by offices of CDSCO and various State Drugs Control Organizations for Quality Control Testing from the following manufactures (Table 2).

Table 2:List of indigenous and foreignmanufacturerswhose kits have been received forQualityControl evaluationatNIb.

LISTOFMANuFACTuRER’SINDIGENOuS IMPORTED

M/s. Bhat Biotech India (P) Ltd., Karnataka M/s. Roche Diagnostics Gmbh, Germany

M/s. Avantor Performance Materials India Limited , Dehradun

M/s. Siemens Healthcare Diagnostics Inc, USA

M/s. Meril Diagnostics Pvt. Ltd., Gujarat M/s. Orhtho Clinical Diagnostics, USA

M/s. Transasia Biomediacals Ltd. Daman M/s. Abbott Gmbh & Co., Germany

M/s. Beacon Diagnostics Pvt. Ltd., Gujarat M/s. Beckman Coulter, Inc, USA


SCIENTIFIC PROGRESS

M/s. Medsource Ozone Biomedicals Pvt. Ltd., Haryana.

M/s. Standard Diagnostics Inc, Korea.

M/s. Trivitron Healthcare Pvt. Ltd. Chennai, Tamil Nadu.

M/s. Biokit, S.A.- Spain.

M/s. Arkray Healthcare Pvt. Ltd., Surat, Gujarat. M/s. Green Cross Medical Science, Korea.

M/s. Athenese -Dx Pvt. Ltd. ,Chennai, Tamil Nadu.M/s. DiaSorin South Africa, (PTY) Ltd., South Africa.

M/s. SD Biostandard Diagnostics, Haryana. M/s. Biomerieux, S.A. France.

M/s. Diagnocure (India) Solan, H.P. M/s. Alere Medical Co., Ltd., Japan.

M/s. Sidak Lifecare Pvt. Ltd., Haryana. M/s. Diasorin S.P.A., UK.M/s. Biorad, France.M/s. Generals Biologicals Corp. , Taiwan.M/s. Lab 21 Healthcare Ltd., UK.

M/s. Abon Biopharm Co., Ltd.,China.

M/s. Sd Biosensor, Korea.

5.2QualityControlTest/Evaluationofin-vitroDiagnosticsKits:

During the year 2016-17, a total of 375 Immunodiagnostic Kits including RAPID, ELISA, ELFA, CLIA, Confirmatory and Combo Kits for HIV, HCV, HBV and Syphilis were evaluated in the laboratory (Table 3). Out of 375 kits, 105 (28%) of HIV, 93 (24.8%) of HCV, 158 (42.14%) of HBV and 19 (5.06%) of Syphilis were evaluated (Figure 1).

Table3:Marker-wisedistributionofevaluatedindigenousandimportedkitsforwardedbyCDSCOintheyear2016-17.

biologicalsTested

Typeofbiologicals

NumberofbatchesEvaluated

No. ofbatches found

to be of Standard Quality

No. ofbatches found to be not of Standard Quality

Rem

arks

Imported Indigenous

HIV

RAPID 22 19 41 NIL -ELISA 11 10 21 NIL -CLIA 32 NIL 32 NIL -ELFA 8 NIL 8 NIL -CONFIRMATORY 3 NIL 3 NIL -

HbV

RAPID 4 16 20 NIL -ELISA 30 17 47 NIL -CLIA 58 3 61 NIL -ELFA 21 NIL 21 NIL -CONFIRMATORY 9 NIL 9 NIL -



HCV

RAPID 6 21 27 NIL -ELISA 22 10 32 NIL -CLIA 26 NIL 26 NIL -ELFA 7 NIL 7 NIL -CONFIRMATORY 1 NIL 1 NIL -

SYPHILISRAPID 6 10 16 NIL -CLIA 3 NIL 3 NIL -

28%

42.14%

24.8%

5.06%

375

0

50

100

150

200

250

300

350

400

HIV HBV HCV SYPHILIS TOTAL

Nu

mb

er o

f B

atc

hes

Figure 1: Number and corresponding percentage of Immunodiagnostics Kits evaluated for the four markers (HIV, HCV, HBV, Syphilis) in the year 2016-17

5.3ListofHbVmarkerskitsevaluatedintheyear2016-17:

Out of 375 kits evaluated during the financial year 2016-17, 158 kits were evaluated for following markers of HBV (Table 4).

Table4:ListofHbVmarkersreceivedduringtheyear2016-17.

S.No.NAMEOFPRODuCT/

MARKER

NO.OFbATCHES

EVALuATED

STANDARDQuALITy

NOTOFSTANDARDQuALITy

1. Anti- HBs Ab 14 14 02. HBc IgM 13 13 03. Anti-HBc 22 22 04. HBsAg Quantification 3 3 05. Anti- HBe 10 10 06. HBeAg 8 8 07. HBsAg 88 88 0 TOTAL 158 158 0


SCIENTIFIC PROGRESS

Table5:CountryWiseDistributionofNumberofHIV,HbV,HCVandSyphilisImmunodiagnostickitsevaluatedduringtheFy2016-17.

S.No. COuNTRyMARKER

TOTALHIV HbV HCV SyPHILIS

1 India 29 38 31 10 108

2 Germany 11 27 9 3 50

3 USA 20 32 13 0 65

4 Ireland 2 8 2 0 12

5 Korea 11 3 4 3 21

6 Spain 0 2 1 0 3

7 South Africa 0 0 1 0 1

8 Japan 11 2 0 0 13

9 UK 1 1 6 3 11

10 France 16 38 20 0 74

11 Taiwan 4 16 4 0 24

12 China 3 3 3 0 9

TOTAL 108 170 94 19 391

5.4CountrywisedistributionofreceivedHIV,HCV,HbV&SyphilisELISAandRapidkitsintheyear2016-17:

Out of 391 received kits, 108 (27.62%) were indigenous & 283 (72.38%) were imported. Among HIV Immunodiagnostic Kits, 29 (26.85%)were indigenous and 79 (73.14%)wereimported. Out of 170 HbV

kits, 38 (22.35%) were indigenous and132 (77.64%) were imported. In case of HCV Immunodiagnostic kits, 31 (32.97%)were indigenous and 63 (67.02%) wereimported. For Syphilis, 10 (52.63%)wereindigenousand09(47.36%)importedkits were received (Table 5).

5.5Inter-laboratorytestingofbiologicalsandbiotherapeuticSamples:

In the year 2016-17, laboratory has tested 584 lots/batches of biologicals & biotherapeutics samples for infectivity of HIV-Ab, HCV-Ab & HBsAg received from Blood Products

Laboratory, Enzyme & Hormones Laboratory, Recombinant Product Laboratory and Viral Vaccine Laboratory (Figure 2).



0

500

1000

1500

2000

2500

3000

3500

4000

RPL EHL VVL BPL Total TotalTests forHIV-Ab,

HCV-Ab &HBsAg

3 13 24

544 584

3504Nu

mbe

r of T

hera

peut

ics

Figure 2: Number of inter-laboratory biologicals & biotherapeutic products tested during April, 2016-March, 2017 for Viral Marker testing. RPL: Recombinant Product Laboratory; EHL; Enzyme and Hormone

Laboratory; VVL: Viral Vaccine Laboratory, BPL: Blood Product Laboratory.

6. PreparationandSupplyofNationalstandards,SeraPanel etc.:

In the year 2016-17, the laboratory supplied total volume of ~8.8 Liters (3.2 Liters ofHIV, 2.8 liters of HCV and 2.8 liters ofHbsAg) Performance Panel to 8 indigenous

manufacturers (Table 6), each comprising of 100 Positive & 300 Negative Panels. The total revenue of ~ 10,03,200INR(Tenlakhs, three thousand and two hundredrupees) has been generated.

Table6:ListofindigenousmanufacturerswhopurchasedperformancepanelsfromNIb

S.No. NameofManufacturer

1. Avantor Performance Materials India Limited, Dehradun

2. Karwa Enterprises, Delhi

3. Alere Medical Pvt. Ltd., Gurgaon

4. Transasia Biomedicals Ltd., Daman, Gujarat

5. Bhat Biotech India (P) Ltd. Bangalore

6. Meril Diagnostics Pvt. Ltd., Gujarat


SCIENTIFIC PROGRESS

HIV HBV HCV SYPHILIS TOTAL

2015-2016 84 135 76 47 342

2016-2017 105 158 93 19 375

11.1%

7.84%

10.06%

- 42.42%

4.6%

0

50

100

150

200

250

300

350

400

No

. o

f B

atc

hes E

valu

ate

d

2015-2016 2016-2017

Figure 3: Trend in volume of Immunodiagnostic kits evaluated during April, 2016 to March, 2017 as compared to previous years (2015-2016).

7. Trend in volume of work ascompared to previous year (2015-2016):

7.1 Trend in volume of work as comparedto the previous year for Quality ControlTestingofImmunodiagnosticKits:

A total of 375 batches of Immunodiagnostic

Kits of HIV, HCV, HBV & Syphilis were evaluated in the year 2016-17, whereas 342 batches were evaluated in the year 2015-2016, showing a 4.6% increase in 2016-17. The details of trend in volume of work viral marker wise given below in Figure 3.

7. Tulip Diagnostics Pvt. Ltd., Goa

8. Reckon Diagnostic Pvt. Ltd., Gujarat

7.2 Trend in volume of work as comparedto the previous year for Inter-laboratorySampleTesting:

A total of 584 batches of Blood Products, Recombinant Products, Viral Vaccines, Enzymes and Hormones were tested for

infectivity of HIV-Ab, HCV-Ab & HBsAg in the year 2016-17, as compared to 671 batches, in the year 2015-2016 showing a decrease of 6.94% in biologicals tested for infectivity.



605

9 1740

671

544

3 13 24

584

BLOOD

PRODUCTS

LAB

RECOMBINANT

PRODUCTS

LAB

ENZYME &

HORMONE LAB

VIRAL VACCINE

LAB

TOTAL

Nu

mb

er o

f B

atc

hes

2015-2016 2016-2017

Figure 4: Trend in volume of Inter-Laboratory Samples tested during April 2016 to March 2017 as compared to previous year (2015-2016).

8. Proposed targets for testingofnewbiologicalbeingundertaken:

• To become World Health Organization (WHO) collaborating Centre for in-vitro Diagnostics.

• Syphilis performance panel to be prepared and supplied to indigenous manufacturers for strengthening of their quality during production stage.

9. Details ofparticipation in cGMPInspections:NIL10.Participations in training/Workshop/Conference (Name of the Scientist(s), Name of

the programme, Duration and place of training, etc.):

Nameof theScientistParticipated

Nameof theTraining/Workshop/Conference

Duration PlaceofTraining

Dr. R.K. Sharma (Scientist Gr-III) & Lab Head

Participated in training programme on

“Implementing Quality Management Systems in ICTC’s under the National AIDS Control Programme (NACP) organized by the Laboratory Service Division, NACO.

18th -19th April, 2016

Lucknow,

U.P.


SCIENTIFIC PROGRESS

Attended first committee meeting to examine the unit cost of IgM test kits produced and supplied by National Institute of Virology (NIV), Pune.

21st June, 2016

NCDC, New Delhi

Attended International Briefing Workshop on WHO prequalification for Indian manufacturers of in-vitro diagnostics.

14th-16th June, 2016

Hotel The Claridges,

New Delhi

Participated in Sixth meeting of MDH 19 (Immunobiological Diagnostic Kits Sectional Committee).

20th June, 2016 BIS, New Delhi

Attended Subcommittee meeting of Bureau of Indian Standards (BIS) on Malaria diagnostics.

20th July, 2016 NIMR, New Delhi

Attended 2nd meeting of the committee to examine the unit cost of IgM test kits produced and supplied by National Institute of Virology (NIV), Pune.

09th Aug, 2016

NCDC, New Delhi

Attended meeting with regard to Diagnostic Antigen/Recombinant material /Antisera for consideration as Biological & special product under the jurisdiction of CLAA.

23rd Sep, 2016 FDA Bhawan,

New Delhi

Attended & delivered guest lecture during one day regulatory workshop on “Current Regulation on Medical Device and in-vitro Diagnostics (IVD) Kits” organized by Biotechnology Industry Research Assistance Council (BIRAC) in collaboration with Clinical Development Service Agency (CDSA) of DBT, Govt. of India.

29th Sep, 2016 CDSA, Pune



Presented a poster in National Summit on Good and Replicable Practices and Innovations in Public Healthcare Systems.

29th -31st Sep, 2016

Tirupati, Andhra Pradesh

Attended 5th Annual Conference of Indian Society of Transfusion Medicine (ISTM) and presented poster on “Strengthening of Blood Services in India - EQAS for TTI testing & Blood Grouping Serology”.

18th- 19th Nov, 2016

Bhopal

Invited for Apex Lab meeting – apresentation on the NRL-NIB

Activities were made.

23rd March,2017 NARI, Pune

Attended a meeting to discuss the revision of Pediatrics ARV drugs as per the availability of the formulation in market under the chairmanship of Spl. DGHS, Ministry of Health &

Family Welfare, New Delhi.

29th March,2017 Nirman

Bhawan,

New Delhi

Mr. Pankaj K. Sharma

(Scientist Gr.-III)

Participated in a training programme on Testing of Dengue Immunodiagnostic kits.

21st-22nd Apr, 2016 NIV, Pune

Attended expert committee meeting to examine the unit cost of IgM test kits produced and supplied by National Institute of Virology (NIV), Pune.

21st June, 2016 NCDC, New Delhi

Attended International Briefing Workshop on WHO prequalification for Indian manufacturers of in-vitro diagnostics.

14th- 16th June, 2016

Hotel The Claridges,

New Delhi

Participated in subcommittee meeting of Bureau of Indian Standards (BIS) on malaria diagnostics.

20th July, 2016

NIMR, New Delhi


SCIENTIFIC PROGRESS

Attended Second expert committe meeting of the committee to examine the unit cost of IgM test Kits produced and supplied by National Institute of Virology (NIV), Pune.

09th Aug, 2016 NCDC, New Delhi

Attended a meeting to discuss technical issues related to specification of HIV test kits under the chairmanship of Dr. K S Sachdeva, Dy. Director General (BSD) at National AIDS Control Organization (NACO).

09th Jan, 2017 NACO, Delhi

Mr.Sanjeev K. Sharma

(Jr. Scientist)

Participated in a training programme on Testing of Dengue Immunodiagnostic kits.

21st-22nd April, 2016

NIV, Pune

Participated in training on MS office, Excel & Powerpoint.

14th Jan, 2017 NIB, NOIDA

Mr. Rajeev Kumar

(Jr. Scientist)

Attended workshop on revision of ISO/IEC 17025 CD2 by Association of Indian Laboratories (AOIL).

14th Apr, 2016 Hotel Holiday Inn, New Delhi



Mr. Brijbhushan

(Lab Technician)



11. Participation inProficiencyTesting/EQAS:

a. INTERNATIONAL

• International External QualityAssessmentScheme(EQAS):

IDKL has participated in External Quality Assessment Scheme (EQAS) 2016 for HIV, HBV, HCV and Syphilis Serology with National Serology Reference Laboratory, (NSRL) Australia, a NATA-accredited

proficiency testing provider, complying with ILAC-G13:08/2007 and also a World Health Organization (WHO) Collaborating Centre for Diagnostics and Laboratory Support for HIV and AIDS and Other Blood-borne Infections and scored 100% results.

b. NATIONAL

• underNACP-IVprogramofNACO,NIb-NRL undertakes followingactivities:



• ParticipationinNational-LevelEQASfor HIV serology: Laboratory has participated in HIV EQAS in August, 2016 and February, 2017 conducted by Apex Lab, NARI Pune. NIB-NRL scored 100% matching results.

• Provider of HIV Proficiency TestingPanel for HIV serology: NIB as a National Reference Laboratory of NACO conducted two rounds of HIV EQAS in November, 2016 and February, 2017 & distributed eight HIV characterized & coded plasma panel to the nine State Reference Laboratories (SRLs) of Uttar Pradesh and one SRL of Uttarakhand. The bulk panel was also provided to 574 and 576 linked peripheral testing centers i.e. ICTCs, PPTCTs for round one and two respectively. All the 10 SRLs scored 100% matching result in both the rounds of HIV EQAS and the details as per Table 7.

Table7:HIVEQASresultsof10SRLSfromuttarPradesh&uttarakhand

S.No. NameofSRL1 IMS, BHU, Varanasi2 Himalayan Institute of Medical Science,

Dehradun3 JLN Medical College, AMU, Aligarh4 MLB Medical College, Jhansi5 KG Medical College, Lucknow6 GSVM Medical College, Kanpur7 SN Medical College, Agra8 BRD Medical College, Gorakhpur.9 LLRM Medical College, Meerut.10 Motilal Nehru Medical College,

Allahabad

12.Achievements of the laboratory: Quality Control Testing of Dengue IgM

ELISAkitandChikungunyaIgMELISAkit atNIb: Laboratory is now equipped to undertake Quality Control Testing and batch release testing of Dengue IgM ELISA kit and Chikungunya IgM ELISA kits. In this regard request letter for sending these kits to NIB has already been sent to Drugs Controller General (India) on 22nd Sep, 2016.


SCIENTIFIC PROGRESS

1. Lab/Division MolecularDiagnosticLaboratory

2. NameofHead Dr. Reba Chhabra, Scientist Grade-I &

DDQC i/c (Diagnostics)

3. Manpower inLab/Division I. NameofScientificStaff

Dr. Manoj Kumar, Scientist Grade-III

Dr. Manjula Kiran, Junior Scientist (since 17th May 2016)

Dr. Anoop Kumar, Junior Scientist (since 9th May 2016)

II. NameofTechnicalStaff:NIL

III. No.(s)ofContractualStaff:Four

4. ScientificActivitiesundertaken Molecular Diagnostic Laboratory (MDL)

is carrying out quality evaluation of: (i) Qualitative Molecular Diagnostic kits for HBV, (ii) Qualitative Molecular Diagnostic kits for HCV, (iii) Qualitative Molecular Diagnostic kits for HIV-1 and (iv) Qualitative Blood donor screening multiplex kits for HBV, HCV & HIV. During this year, two Subject Expert Committee meetings were held on 22nd August 2016 and 10th January 2017 under the chairmanship of Prof. Raies A Qadri, to deliberate on specification criteria for evaluation of molecular diagnostic kits.

MOLECuLARDIAGNOSTICLAbORATORy

Members of Subject Expert Committee of Molecular Diagnostic Laboratory

a) Collaboration with other organizations: The laboratory has networking with various blood banks for collection of non-reactive

as well as HBV, HCV and HIV reactive blood bags. During the year 2016-17 a total number of 245 plasma donor units were



collected from the blood banks/hospitals listed below:

i. G. B. Pant Hospital, Delhi

ii. Indian Red Cross Society, New Delhi

iii. Metro Hospital and Heart Institute, NOIDA

iv. G. T. B. Hospital, Delhi b)CDLNotification:No

c)NotificationofGovernmentof analyst:No

d)DevelopmentofMonographs:NIL

e)Publication(s):NIL

5.Testingofbiologicals During this period the laboratory had

evaluated 10 batches of Molecular Diagnostic Kits, which were forwarded by office(s) of CDSCO. The details are as shown in Table 1 and Figure 1.

HIV-1 , 3,

30%

HCV, 5,

50%

Multiplex

, 2, 20%

Figure 1: Molecular Diagnostic Kits (Qualitative) evaluated during the year 2016-17

Table1:DetailsofbatchesofMolecularDiagnosticKitsevaluated(2016-17)Nameofbiologicals

testedTypeof

biologicalsNo. of

batches evaluated

No. ofbatches

found to be of standard quality

No. ofbatches found to be not of standard quality

No. ofInter-lab

sampletested R

emar

ks

Qualitative Molecular Diagnostic kit for HIV-1 Molecular

Diagnostic03 03 Nil Nil Nil

Qualitative Molecular Diagnostic kit for HCV Molecular

Diagnostic05 05 Nil Nil Nil

Qualitative Blood donor screening multiplex test for HBV, HCV & HIV

Molecular Diagnostic 02

02 Nil Nil NilTotal 10 10 Nil Nil Nil

6.PreparationandsupplyofNationalStandards,SeraPanels etc.:

The laboratory has expanded the plasma panel members from 10 non-reactive to 40 non-reactive samples as per the recommendations of Subject Expert Committee meeting held on 10th January 2017. All three Nucleic acid test (NAT) positive plasma panels (HBV, HCV & HIV-1) consist of 20 NAT positive members and 40 NAT negative members


SCIENTIFIC PROGRESS

(Table 2). Each NAT positive plasma panel consists of low, medium and high range of viral load i.e. viral load in each panel varies from few copies to billion copies.

Table2:PanelsizeforevaluationofQualitativeMolecularDiagnosticKits

Marker No. ofPositivemembers No. ofNegativemembers TotalHBV 20 40 60HCV 20 40 60HIV-1 20 40 60Multiplex(HBV, HCV & HIV)

60 40 100

8. Trend involumeofworkas compared to thepreviousyear There have been a 3.3 fold increases in the number of batches evaluated (10 in FY 2016-17 as

compared to 3 in FY 2015-16) as shown in Figure 2.

3

10

0

2

4

6

8

10

12

2015-16 2016-17

To

tal n

um

be

r o

f b

atc

he

s

eva

lua

ted

Year

Trend in number of batches evaluated

Figure 2: Trend in the volume of batches evaluated in FY 2016-17 compared to FY 2015-16

8. Proposed target for testing of newbiologicalbeingundertaken:

The laboratory is in the process of standardization and validation of testing procedures for quality evaluation of viral load monitoring molecular diagnostic kits for HBV, HCV and HIV. After completion

of this activity such kits would be taken up for evaluation.

9. Details of participation in cGMPinspections:NIL

10. ParticipationinTraining/Workshop/Conferenceattended



NameofScientist (s) Nameofprogram Duration Venue

Dr.AnoopKumar12th International conference of Asian Clinical Oncology Society (ACOS)

8th-10th Apr, 2016The Ashok hotel, New Delhi.

Dr.ManojKumar

Dr.ManjulaKiran

Workshop on WHO prequalification for Indian manufacturers of in-vitro diagnostics

14th-16th Jun, 2016The Claridges Hotel, New Delhi.

Dr.ManjulaKiran Research Methodology29th Aug-02nd Sep, 2016

ICGEB, New Delhi.

Dr.ManojKumar

Dr.ManjulaKiranOperator Training for Procleix Panther system

13th-15th Feb,2017National Institute of Biologicals.

Dr.ManojKumar

Dr.ManjulaKiranOperator Training for Procleix eSAS system

16th-21st Feb, 2017National Institute of Biologicals.

Dr.AnoopKumarWorkshop on molecular virological techniques for Dengue and Chikungunya

13th Feb- 10th March, 2017

National Institute of Virology, Pune.

Dr.AnoopKumarOperator Training for Procleix Panther system

15th-17th Mar, 2017National Institute of Biologicals, NOIDA.

Dr.AnoopKumarOperator Training for Procleix eSAS system

20th-22nd Mar, 2017National Institute of Biologicals, NOIDA.

11.Achievements of theLaboratory: a)Participation in Proficiency testing

(PT)/EQAS:The laboratory participated in HCV-NAT proficiency testing (EDQM-HCV-NAT-PT-2017) with European Directorate for the Quality of Medicines and HealthCare (EDQM). The test report has been submitted to EDQM and results are awaited.

b) NIB organized a three days’ workshop in collaboration with Clinical Development Services Agency (CDSA) on “Laboratory Quality Management System (LQMS) in the area of diagnostics for the Stakeholders and Academia to strengthen their compliance towards global standards of Quality Systems and product specifications for evaluation of Molecular Diagnostics.


SCIENTIFIC PROGRESS

1. Lab/Division bloodReagentLaboratory

2. NameofHead Ms.KanchanAhuja,ScientistGradeIII

3. Manpower in theLaboratory I. NameofScientificStaff

Mr. N Nanda Gopal, Scientist Grade III Mrs. Vandana Tandasi, Junior Scientist

(since 7th Oct. 2016)

II. NameofTechnicalStaff

Mr. Subhash Kumar, Laboratory Technician

Ms. Priya Bhatt, Laboratory Assistant

III. No.(s)ofContractualStaff:Three

4. ScientificActivitiesundertaken:a) Collaborationwithotherorganization(s):NIL

b) CDLNotification:

The Blood Reagent Laboratory is notified by Government of India since 2002 for Quality Evaluation of Blood Grouping Reagents. The laboratory has the infrastructure and expertise for testing 45 different types of Blood Grouping Reagents and Gel cards.


Mrs. Kanchan Ahuja has been notified as Government Analyst for Blood Grouping Reagents as per Gazette Notification no. S.O 2393(E) published on 2nd Sept, 2015.

d) DevelopmentofMonographs:

Monograph for Anti-A1 (Lectin) and Anti-H (Lectin) prepared and sent for publication to

bLOODGROuPINGREAGENTLAbORATORy

the Indian Pharmacopoeia.

e) Publication(s):

Kanchan Ahuja, Ranjan Kumar Satapathy, Garima Gulati, Surinder Singh. A comparative study showing the potency of anti-C3d and anti-immunoglobulin G in polyspecific anti-human globulin using fresh and cryopreserved red blood cells. Asian Journal of Transfusion Science, Volume 11 Issue 1 January-June 2017; page 33-37.

f) ExpertGroupCommitteeMeetings:

1st Expert Group Committee meeting was held on 8th September, 2016 under the Chairmanship of Dr. Debasish Gupta, Professor, Dept. of Transfusion Medicine, Sri Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram to finalize the Monograph for Quality Control testing of Anti-A1 (Lectin) and Anti-H (Lectin) to be published in Indian Pharmacopoeia.

2nd Expert Group Committee meeting was held on 21st January, 2017 to deliberate about Preparation of Reference of National Reference Standard for Anti-A (Monoclonal) and Anti-B (Monoclonal) and R&D project on comparative study for viability of cryopreserved red blood cells when thawed and re-suspended in Alsever’s solution for a period of four weeks.



From left to right: 1st Expert Group Committee meeting held on 8th Sept, 2016; Mr. N. Nanda Gopal receiving a certificate of appreciation for being a trainer in National Workshop on “Laboratory Quality Management systems in Diagnostics”; Mrs. Kanchan Ahuja receiving a certificate of appreciation for being a trainer in Six days residential training on Blood Group Serology and QC testing of Blood Grouping Reagents for the

state of Odisha on “Strengthening of Blood Services”

5.Testingofbiologicals:a) A total of 94 batches of Blood Grouping Reagents and Gel Cards were received for Quality

Control evaluation, out of which 88 batches were Blood Grouping Reagents, 06 were Gel Cards and Blood Grouping Cards. Details are given below in Table 1.

Table1:Detailsofbatchesreceivedin2016-17

Manufacturer Nameof thebiologicaltested

No.ofbatches received

&evaluated

No. ofbatches

found to be of Standard Quality

No.batchesfound to be not of Standard Quality

No. of interlaboratorysampletested(blood

Products)

Rem

arks

Diagast

Anti-A 02

13 02 180 NIL

Anti-B 02Anti- D (IgM) 02Anti- D (Blend) 01Anti-A concentrated (Bulk)

03

Anti-B concentrated (Bulk)

03

Anti-D (IgM) Concentrate Bulk

02

Dominion biologicals

Anti-B 03 16 NIL NIL

Anti-A 03


SCIENTIFIC PROGRESS

Anti AB 02Anti- D (Blend) 06AHG 02

MedsourceOzone

Anti - A 03 15 NIL NIL

Anti- B 03Anti- D (Blend) 03Anti-D (IgM) 03Anti -AB 03

MerilDiagnosticPvt.Ltd.

Anti-A1 Lectin 03 09 NIL NIL

Anti-H Lectin 03Anti D Blend 03

Immucor Anti-A 03 31 NIL NILAnti-B 03Anti -AB 03Anti -M 01Anti- D (Blend) 03Anti Fya 02Anti Fyb 02Anti-Lea 03Anti Leb 02Anti N 01Anti-Jka 01Anti-K 01Anti-H Lectin 02Anti-k 01Anti-Jkb 02Anti-S 01

OrthoClinicalDiagnostics

Anti-D (Blend) 01 08 NIL NIL

Anti A/B/D card 03Anti A/B/D/Control/reverse diluent card

03

Anti Cw 01

Total 94 94 180



Total 94 batches were received for evaluation, 70 batches were from foreign manufacturers and 24 batches were from indigenous manufacturers. Details are given in Fig 1.

94

24

70

0

10

20

30

40

50

60

70

80

90

100

Total Manufacturer Indigenous

Manufacturer

Imported

Manufacturer

Nu

mb

er o

f B

atc

hes

Figure 1: Batches received from Indigenous & Imported Manufacturers (2016 -2017)

b) CollectionofSamples

The laboratory collected a total number of three hundred twenty nine (329) RBC samples from camps organized by Indian Red Cross Society, New Delhi. These

samples were grouped, sub grouped and Rh phenotyped to be used for Quality Control Evaluation of Blood Grouping Reagents and for cryopreservation. The details of the samples collected and Rh phenotyped are given in (Fig. 2 & 3).

329

102

68

95

32

5 5 10 3 4 3 2

0

50

100

150

200

250

300

350

Nu

mb

er o

f B

loo

d S

am

ple

s

Different Groups of Blood Samples

Figure 2: Blood Samples Collected in Year 2016-17


SCIENTIFIC PROGRESS

280

110

90

46

113

153 1 1

0

50

100

150

200

250

300

Total R1R1 R1r R1R2 R2r R0r rr R2R2 r'r R1RZ

Nu

mb

er o

f B

loo

d S

am

ple

s

Different Phenotypes of Blood Samples

Figure 3: Rh phenotyping of Blood Samples (2016-17)

c)InterlaboratorytestingofbloodProducts

The laboratory extended its support for Quality Evaluation of samples from of Blood Products Laboratory for Anti-A and Anti-B haemagglutination test parameter as per NIB/BRL/SOP/29/R1. A total number of 180 batches of Blood Products were tested.

6. Preparation of National ReferenceStandards,SeraPanel etc.:

a)Preparationofin-housestandards

Calibration of Anti-A, Anti-B, Anti-AB, Anti-D (IgM), Anti-D (Blend), Anti Human Globulin, Anti-A1 (Lectin) and Anti-H (Lectin) and preparation of working standards were done using Secondary Standards (in-house controls) which were calibrated against National Institute of Biological Standards and Control (NIBSC, UK). Details of reference standards are given in Table 2.

Table2:DetailsofReferenceStandard

S.No. NameofReagent Reference Standard Source

1. Anti-A 03/188, version 2; 11/11/05 NIBSC, UK

2. Anti-B 03/164, version 2; 11/11/05 NIBSC, UK

3. Anti-AB03/188, version 2; 11/11/05

03/164, version 2; 11/11/05NIBSC, UK

4. Anti-D (IgM) 99/836, version 2; 20/5/05 NIBSC, UK

5. Anti-D (IgG+IgM) 99/836, version 2; 20/5/05 NIBSC, UK

6. Anti Human Globulin 96/666, version 2; 19/04/04 NIBSC, UK



b) Preparationofcryopreservedredcellpanel:

The laboratory has cryopreserved a total number of 94 panel members and stored at -70oC. The details of the routine panel members and rare panel members are given in Fig. 4 & Fig. 5 respectively.

876

764

15 21 10 21 303 12

0

100

200

300

400

500

600

700

800

900

1000

Total A1 neg A2+ve A2B

+ve

O+ve

(R0r)

O+ve

(R1r)

O+ve

(R2r)

O neg

(rr)

B+ve

(R2r)

Nu

mb

er o

f B

loo

d S

am

ple

s

Different Group/Sub group/Phenotype (GSP) of Blood Samples

Figure 4: Status of routine cryopreserved (RBC) Cells (Store at -70°C) 2016-17

134

5 3

24

6

24

315 9 6 3 3

9 93

12

0

20

40

60

80

100

120

140

160

Nu

mb

er o

f v

ials

Cryopreserved rare red blood cells

Figure 5: Status of rare cryopreserved red blood cells (2016-17)


SCIENTIFIC PROGRESS

30843298

3975

6397

7933 8079

9305

0

1000

2000

3000

4000

5000

6000

7000

8000

9000

10000

Cryo

preserv

ed

Red

Blo

od

Sam

ple

s

Figure 6: Trend for cryopreservation of red blood cells

b) InterlaboratorytestingofbloodProducts:

The laboratory has tested 180 samples of Blood Products for Anti-A and Anti-B haemagglutination test parameter as compared to 220 batches tested in the year 2015-2016 (Fig 7).

58

143

170

220

180

0

50

100

150

200

250

2012-2013 2013-2014 2014-2015 2015-2016 2016-2017

Nu

mb

er b

loo

d p

ro

du

cts

te

ste

d

Figure 7: Trend in number of blood products tested for Anti-A and Anti-B haemagglutination test

7. Trend in volume of work ascompared to thepreviousyear:

a) Cryopreservation of red blood cells: The laboratory strengthened the repository for cryopreserved panel cells for routine and

rare red blood cells from a total number of aliquots from 8079 to 9305 (Fig 6). The laboratory prepared repository for newer rare red cells. A total number of 37 new rare panel members were cryopreserved.



8.Proposed target for testingofnewbiologicals likely tobeundertaken: The laboratory is in the process of collection and preparation of cryopreserved RBC panel for

weak D (Du) antigen to initiate the testing of reagents used for detection of weak D antigen.

9. Participation inTraining/Workshop/Conference:

S.No.Nameof theScientist(s)

Nameof theProgramme Duration Placeof the training

1.

Ms. Kanchan Ahuja

Mr. N Nanda Gopal

Training on “Role of Notification of Government Analyst under D& C Act and Good Laboratory Practice (Schedule L-1)

19th Aug,

2016National Institute of Biologicals, NOIDA

2. Mr. N Nanda Gopal Best Practices Workshop29th-31st Aug, 2016

Tirupati, Andhra Pradesh

10.Achievements of the laboratory:a. Poster presentation on “Strengthening

of Blood Services in India on EQAS for TTI testing and Blood grouping reagents” at TransMedcon 2016, Bhopal, Madhya Pradesh from 18th-20th November, 2016.

b. Participation in Proficiency testing: The staff participated in external proficiency program for Anti-A, Anti-B, Anti-D (Blend), Anti A1 (Lectin), Anti-H (Lectin) blood grouping reagents conducted by Indian Red Cross Society, Delhi on 16th Nov, 2016. The performance of the staff was found to be 100% satisfactory.


SCIENTIFIC PROGRESS

1. Lab/Division biochemicalKitLaboratory

2. NameofHead Ms.AjantaSircar,ScientistGradeIII

3. Manpower in theLab/Division: I. NameofScientificStaff

Mr. Tara Chand, Scientist Grade III & i/c

Mr. Ashwini Kumar Dubey, Scientist Grade III


Ms. Girija LV, Lab Technician

III.No.(s)ofContractualStaff:Four

4. ScientificActivitiesundertaken:a) Collaborationwithotherorganizations:

S. No.

NameofStudy

Collab- oration

Periodof

Study

Status

1.

Validation Protocol of Glucose sensing devices developed with ICMR support (Performance Validation of indigenously made devices)

ICMR, HQ New Delhi

09 Months

Collabo-ration in process

bIOCHEMICALKITLAbORATORy

b) CDLNotification:

The laboratory has been notified as Central Drug Laboratory (CDL) for Glucose Test Strips and Fully automated analyzer based Glucose Reagents vide Gazette Notification G.S.R. 908 (E) dated 22nd December, 2014.


Laboratory Head (Ms. Ajanta Sircar) has been notified as Government Analyst for the class of drugs (i.e. Glucose test strips and fully automated analyzer based glucose reagents) vide Gazette Notification S.O. 2393 (E) dated 02nd September, 2015.

d) DevelopmentofMonographs:NIL

e) Publication(s):

Biochemical Kit Laboratory has prepared document entitled “National Workshop on Laboratory Quality Management System (LQMS) in Diagnostics” from February 08-10, 2017 at National Institute of Biologicals (NIB), NOIDA India-Handbook for the National Institute of Biologicals and CDSA (Department of Biotechnology) collaborative program for conducting LQMS workshop.

Abstract titled “Overview of Self-Monitoring of Blood Glucose system evaluated at the National Institute of Biologicals, NOIDA” has been accepted for the 2nd J&K Science Congress 2017 conference.



5. TestingofGlucoseTestStrips:

NameofbiologicalsTestedNo. of

batches evaluated

No. ofbatches found

to be of Standard

Quality

No. ofbatches found to be not of Standard

Quality

No. ofInter-Lab

sampletested

Remarks

Standard

Quality(SQ)/

Notof

Standard

Quality

(NSQ)

GlucoChekbloodGlucoseTestStrips 1 1 Nil Nil SQ

AccuSureGoldRightestbloodGlucoseTestStrips

3 3 Nil Nil SQ

AccuChekGobloodGlucoseTestStrips 1 1 Nil Nil SQ

ThebestChekSafe-AccuSannuobloodGlucoseTestStrips

1 1 Nil Nil SQ

TruworthForaG30PrimabloodGlucoseTest Strips

1 1 Nil Nil SQ

TruworthForaDiamondPM10PrimabloodGlucoseTestStrips

1 1 Nil Nil SQ

ElementbloodGlucoseTestStrips 3 3 Nil Nil SQ

SugarScanbloodGlucoseTestStrips 1 1 Nil Nil SQ

MajorCareAPbloodGlucoseTestStrips 3 3 Nil Nil SQ

GluNeoLitebloodGlucoseTestStrips 1 1 Nil Nil SQ

GlucoLabAuto-codingbloodGlucoseTestStrips

3 3 Nil Nil SQ

ContourTSbloodGlucoseTestStrips 2 2 Nil Nil SQ

AccuSurebloodGlucoseTestStrips 4 4 Nil Nil SQ

OmronbloodGlucoseTestStrips 5 5 Nil Nil SQ

CareSensN,bloodGlucoseTestStrips 2 2 Nil Nil SQ

SDCodefreePlus,bloodGlucoseTestStrips 1 1 Nil Nil SQ

SDCodefree,bloodGlucoseTestStrips 2 2 Nil Nil SQ

OnCallPlusbloodGlucoseTestStrips 1 1 Nil Nil SQ

SDCheckGold,bloodGlucoseTestStrips 5 5 Nil Nil SQ

uRightTD-4286bloodGlucoseTest strips 3 3 Nil Nil SQ

VivaChekEcobloodGlucoseTest strips 3 3 Nil Nil SQ

VivaChek InobloodGlucoseTest strips 3 3 Nil Nil SQ


SCIENTIFIC PROGRESS

VivaChekFadbloodGlucoseTest strips 3 3 Nil Nil SQ

TrustChekGlucobloodGlucoseTestStrips 1 1 Nil Nil SQ

Akkiscan Zee+ Test strips 3 3 Nil Nil SQ

CareSens,bloodGlucoseTestStrips 1 1 Nil Nil SQ

CleverChekTD-4230,Test strips 1 1 Nil Nil SQ

GlucocardƩTest strips 3 3 Nil Nil SQ

betachekG5bloodGlucoseTestStrips 3 3 Nil Nil SQ

RightestbloodGlucoseTest strips 1 1 Nil Nil SQ

ProdigyNoCodingbloodGlucoseTest strips 1 1 Nil Nil SQ

G-biobloodGlucoseTest strips 3 3 Nil Nil SQ

TysonbioAC100AC200bloodGlucoseTeststrips

3 3 Nil Nil SQ

EZSmart -606 bloodGlucoseTest strips 3 3 Nil Nil SQ

Safe-AccubloodGlucoseTest strips 3 3 Nil Nil SQ

ebsensorbloodGlucoseTest strips 1 1 Nil Nil SQ

AP+PlusbloodGlucoseTestStrips 4 4 Nil Nil SQ

GlucoDrTest strips 3 3 Nil Nil SQ

TysonbioEvolve bloodGlucoseTest strips 2 2 Nil Nil SQ

GlucoDrSuperSensTest strips 3 3 Nil Nil SQ

GlucoDrAutoTest strips 3 3 Nil Nil SQ

AccuSureEasyTouchbloodGlucoseTeststrips

2 2 Nil Nil SQ

GlucoSureAutocodebloodGlucoseTest strips 3 3 Nil Nil SQ

GlucocardVitalbloodGlucoseTest strips 1 1 Nil Nil SQ

SugarChekAdvancebloodGlucoseTest strips 3 3 Nil Nil SQ

AlereG1bloodGlucoseTest strips 1 1 Nil Nil SQ

EasyTouchbloodGlucoseTest strips 2 2 Nil Nil SQ

SugarChekbloodGlucoseTest strips 3 3 Nil Nil SQ

ACCu-CHEKActiveTestStrips 3 3 Nil Nil SQ

ACCu-CHEKAvivaTestStrips 3 3 Nil Nil SQ

ACCu-CHEKPerformaTestStrips 3 3 Nil Nil SQ

MedicrossCameo bloodGlucoseTest strips 1 1 Nil Nil SQ

RheameDbloodGlucoseMonitoring strips 7 Nil 7 Nil NSQ



Dr.DiazTD-4223bloodGlucoseTest strips 1 1 Nil Nil SQ

RomoCheckPlusbloodGlucoseTest strips 1 1 Nil Nil SQ

GluTouchbloodGlucoseTest strips 1 1 Nil Nil SQ

AccuSureSoul bloodGlucoseTest strips 1 1 Nil Nil SQ

AccuSureSmartestPersona instibloodGlucoseTest strips

1 1 Nil Nil SQ

GlucoDotbloodGlucoseTest strips 1 1 Nil Nil SQ

GlucoonebG-03bloodGlucoseTest strips 1 1 Nil Nil SQ

AccuSureGoldbloodGlucoseTest strips 1 1 Nil Nil SQ

bG-02GlucoonebloodGlucoseTest strips 3 3 Nil Nil SQ

SDCodefreeGoldElectrode,bloodGlucoseTest Strips

3 3 Nil Nil SQ

SDGlucoNaviiMentor,bloodGlucoseTestStrips

3 3 Nil Nil SQ

SDCodefreePlus (SimplyAccurate),bloodGlucoseTestStrips

3 3 Nil Nil SQ

OzoCheckEasyTouchSimplebloodGlucoseTest strips

1 1 Nil Nil SQ

ElegancebloodGlucoseTest strips 3 3 Nil Nil SQ

KRIOSERightestGS700bloodGlucoseTestStrip

3 3 Nil Nil SQ

RightestbloodGlucoseTestStrips 1 1 Nil Nil SQ

urightTD-4285bloodGlucoseTestStrips 1 1 Nil Nil SQ

SDGlucoNaviiGDH,bloodGlucoseTestStrips

3 3 Nil Nil SQ

Glucolife,bloodGlucoseTestStrips 1 1 Nil Nil SQ

urightTD-4265bloodGlucoseTestStrips 3 Nil 3 Nil NSQ

equinoxEQ-TD-4286,bloodGlucoseTestStrips

1 1 Nil Nil SQ

SmartCare,bloodGlucoseTestStrips 1 1 Nil Nil SQ

dCareSmart,bloodGlucoseTestStrips 1 1 Nil Nil SQ

GlucoCareSense,bloodGlucoseTestStrips 1 1 Nil Nil SQ

GlucoCareultima,bloodGlucoseTestStrips

1 1 Nil Nil SQ

FreestyleOptiumH,bloodGlucoseTestStrips 1 1 Nil Nil SQ


SCIENTIFIC PROGRESS

6. Fully automated analyser based glucose reagents (closed system chemistry)Test:

NameofbiologicalsTestedNo. of

batches evaluated

No. ofbatches found

to be of Standard

Quality

No. ofbatches found

not to be not of

Standard

Quality

No. ofInter-

Laboratorysampletested

Remarks

Standard

Quality

(SQ)/

Notof

Standard

Quality

(NSQ)

FujifilmFuji

Dri-chemSlideGlu-pIII3 3 Nil Nil SQ

VITROSChemistryGLuSlides 3 3 Nil Nil SQbeckmanCoulter

GlucoseReagent(GLuCm)4 4 Nil Nil SQ

Ident IGlucose reagent 3 3 Nil Nil SQLabsystemsDiagnosticsGlucose (GOD/POD),

3 3 Nil Nil SQ

SyNCHRONSystemsGlucoseReagent(GLuH2)

3 3 Nil Nil SQ

ILTestGlucose (Oxidase) 3 3 Nil Nil SQGlucoseReagent (INSTRuMENTbASED) 3 3 Nil Nil SQGLuGlucoseKit

(GOD-PODMethod)3 3 Nil Nil SQ

GLuGlucoseKit

(HKMethod)3 3 Nil Nil SQ

GlucoseReagent 3 3 Nil Nil SQGlucose (GOD/POD) 3 3 Nil Nil SQSamsungLabgeoPT

biochemistryTest 91 1 Nil Nil SQ

SamsungLabgeoPT Lipid Test 5 1 1 Nil Nil SQ

7. PreparationandsupplyofNationalStandards,SeraPanel etc.:NA


169 batches of Blood Glucose Test Strips and 39 batches of Glucose Reagent were received and evaluated during this financial year. Workload has increased by 14.3% as compared to the previous year.



9. Proposed target for testing of newbiologicalsbeingundertaken:

9.1 Newtypeofproducts:

a. New types of Self-Monitoring of Blood Glucose systems (SMBGS) that are comprehensive connected diabetes care platforms are being introduced to the Indian market. It simplifies the way patients, caregivers, and medical professionals manage diabetes. With no wires or complex communication protocols, reliable ongoing health information is immediately available to patients and caregivers via the Mobile App and to medical professionals in cloud-based Digital Diabetes Clinic. It combines diabetes monitoring hardware, mobile software and big data cloud computing infrastructure. Product monitors are compatible with both iOS and Android platforms and with any smartphone model, enabling maximum device flexibility for users. Such kinds of novel SMBGS are already being tested and the laboratory has the preparedness to test such innovative new products as and when they come to NIB for testing.

b. New types of glucose reagent samples: Glucose Reagent (Test Cartridges/Slides/ Cassettes/Dry-chemistry Cards’; analyzing the human plasma glucose values in mg/

dL units) manufactured for use with novel ‘Closed Chemistry System’ are being introduced to the Indian market. Each of these products are unique with respect to the product design, choice of sample, operating principle etc. Basically they are all portable and promise to provide results for several chemical chemistry parameters within 5-7 minutes at bedside for convenient management of critically ill patients in ICU. The portable clinical chemistry analyzer meet the needs of mobile clinics and ICUs providing a smart solution and improve efficiency in managing the treatment strategy for critically ill patients. Several such types of products as Samsung LabgeoPT, Fujifilm Dri-Chem and Cobas b221 analyzers have already been evaluated successfully by the Laboratory. The laboratory has technical preparedness for using similar platform based products as and when they arrive.

c. As recommended by the Biochemical Kit Laboratory Technical Expert Committee, an Ion Exchange HPLC based HbA1c testing platform will be procured for use as Laboratory Reference Method. Following Reference Method validation, batches of rapid test kits for HbA1c will be taken up for evaluation.

10.Details ofparticipation in cGMP inspections:None

11. Participation inTraining/Workshop/Conference:S. No.

Nameof theTrainee(s)

Nameof theTrainingPeriodofTraining

Venue Organizer

1Mr. Tara ChandMs. Sunita Koholi

Hands on equipment operation training for “ILab-650 Clinical Chemistry System”

01st -08th July 2016

BKL, NIB, NOIDA

M/s Instrumen-tation Laboratory India Pvt. Ltd. Werfen


SCIENTIFIC PROGRESS

2Ms. Ajanta SircarMr. Tara ChandSh. Ashwini Kr. Dubey

“Role of Notification of Government Analyst Under D&C Act and Good Laboratory Practice (Schedule L-1)”

19th Aug 2016

NIB, NOIDA

Dr. D. Roy, Former DDC(I), CDSCO, MoH&FW, Govt. of India

3

Mr. Tara ChandSh. Ashwini Kr. DubeyMs. Sunita KoholiMs. Aalapti Singh

Hands-on equipment operation training for “BS-480 Clinical Chemistry System”

12th -20th Sep 2016

BKL, NIB, NOIDA

M/s Mindray Medical India Pvt. Ltd., India

4Mr. Tara ChandMs. Sunita KoholiMs. Aalapti Singh

Hands-on equipment operation training for “Abbott Architect C4000 Clinical Chemistry System”

07th -17th Oct 2016

BKL, NIB, NOIDA

M/s Abbott Healthcare Pvt. Ltd. India

5

Mr. Tara ChandSh. Ashwini Kr. DubeyMs. Sunita KoholiMs. Aalapti Singh

Hands-on equipment operation training for “Samsung LABGEO PT10”

23rd-25th Jan 2017

BKL, NIB, NOIDA

M/s Samsung Electronics Co. Ltd., Korea

6 Mr. Tara Chand

BIRAC-CDSA Workshop Series 2017 Current Regulations for Medical Devices & in- vitro Diagnostic Kits in India

30th March 2017

C-CAMP, Bengaluru

BIRAC-CDSA

Title:1stMeetingofTechnicalExpertCommitteeofbiochemicalKitLaboratory



12.Achievements of theLaboratory:a. CollaborationwithICMR

The Biochemical Kit Laboratory is entering into a very prestigious collaboration with the Division of Innovation and Translational Research-Indian Council of Medical Research (ICMR), Delhi; through which it will be guiding the indigenous manufacturers who have developed low cost indigenous glucometer devices with ICMR aid. Three novel prototypes based on NIR Spectroscopy, Photo acoustic, Non-enzyme electrochemical and altered enzyme-microfluidic principles are now readying for manufacturing level. The Biochemical Kit Laboratory, through this collaboration will plan/guide and coordinate the independent validation of these products following standard norms and regulations over four more collaborating laboratories at Pondicherry, Mysore, Chennai and New Delhi. The collaborative endeavour, to be executed over two phases, will help indigenous manufacturers improve

their product design. BKL will engage with these manufacturers, discussing their product specific problems and help in finding solutions to their performance-related problems. Before these endogenously developed product manufacturers approach towards licensing on a commercial scale, the Biochemical Kit Laboratory will sensitize them regarding the Quality parameters and develop their preparedness for going to the next level.

b. Biochemical Kit Laboratory participated in a collaborative programme by National Institute of Biologicals (NIB) and Clinical Development Services Agency (CDSA), under Department of Biotechnology (DBT)- National Workshop on Laboratory Quality Management System in Diagnostics from February 08-10, 2017 at NIB, NOIDA.

c. Technical Expertise: Central Drugs testing laboratory for ‘Blood glucose Test Strip samples’ and ‘Analyzer based Glucose Reagents.’

S.No. Nameof theScientist Nameof theCommittee/ExpertPanel

1. Ms Ajanta Sircar 1. Member of Expert Committee to examine the “Specifications” and “Criteria for Acceptance” for tests performed on ‘Blood Glucose Test Strips’ and ‘Analyzer based Glucose Reagent’

2. Member Secretary of Internal Technical Expert Committee of Biochemical Kit Laboratory


SCIENTIFIC PROGRESS

1. Lab/Division bacterialVaccineLaboratory

(bacillusCalmetteGuerin&Polysaccharide)

2. NameofHead Dr. Surinder Singh, Director

(since 27th Oct 2016)

Dr. Charu M. Kamal, Scientist-II (17th May to 6th Oct 2016)

Mr. Neeraj Malik, Scientist-II (till 17th May 2016)


Dr. Akanksha Bisht, Scientist III & I/c (since 17th May 2016)

Mrs. Rashmi Srivasatava, Scientist-III (till 17th May 2016)

Mrs. Vandana Tandasi, Junior Scientist (till 6th Oct. 2016)

Mr. Harit Kasana, Junior Scientist

Mr. Ajay Kumar Ade, Junior Scientist (since 6th Dec. 2016)

II. NameofTechnicalStaff:Nil

III. No.(s)ofContractualStaff:Six

bACTERIALVACCINELAbORATORy

4. ScientificActivitiesundertaken:a. Collaborationwithotherorganizations:

Meeting of officials from WHO, National Centre for Immunobiologicals Research and Evaluation (CRIVIB), Rome and NIB on “Hands-on Training course on Determination of PRP content of Hib capsular polysaccharide in liquid vaccine presentation by High Performance Anion Exchange Chromatography coupled with Pulsed Amperometric Detection (HPAEC-PAD)” was held at NIB from 21st to 23rd February 2017.

b) CDL Notification: Gazette Notification No: G.S.R. 250 (E) - Part-II - Section 3 - Sub-Section (i) dated 15th March, 2017 for Bacillus Calmette Guerin (BCG) Vaccine.

c) NotificationofGovernmentAnalyst: No

d) DevelopmentofMonographs: NIL

f) Publication(s): Malik N, Kasana H, Choudhary V, Chaudhary H, Srivastava D, Tandasi V, Prakash A, Soni GR and Singh S. “Improved spectrophotometric pharmacopoeial method for accurate quantitation of thiomersal content in Haemophilus influenza type B (Hib)-TT Conjugate Vaccine”, International Journal of Biomedical and Advance Research 2016; 7(12): 578-581.

5. Testingofbiologicals: Table1:Detailsofthesampletesting

Nameof thebiologicalsTested

Typeofbiologicals

No. of batches evaluated

No. ofbatchesfound to be of

standard

No.ofbatchesfound to be not of standard quality

No.of InterLaboratorysampletested

Remarks

Bacillus calmette Guerin (BCG) vaccine

Bacterial vaccine 05 batches

All parameters have been standardized and verification studies performed

NAService samples received through CDSCO



Haemophilus influenza typeb (Hib)TTconjugatevaccine

Bacterial vaccine

05 batches (in process)

These service samples are being tested for standardization of QC parameters of final product.

02

Service samples received through CDSCO

Hib Pentavalentvaccine batches (Determination ofPRPcontentbyHPAEC-PAD)

Bacterial vaccine

14 batches

The lab has capacity of performing tests for Aluminium content, Free Formaldehyde, Thiomersal and Bacterial Endotoxin Tests for polysaccharide as well as other vaccines.

6. Preparationand supplyofNationalStandards,SeraPanel etc.: The lab will take up the feasibility study for the reference standard preparation in collaboration

with manufacturers and IPC.

7. Trend in volume of work as compared to the previous year is depicted inFigure1&2:

Figure 1: Number of batches received in the FY 2015-16 and 2016-17


SCIENTIFIC PROGRESS

Figure 2: 14 Hib pentavalent vaccine batches for PRP testing by HPAEC-PAD batches and 5 Hib TT

conjugate vaccines batches were received in the FY 2016-17 against none and 4 respectively in the previous year.

8. Proposedtargetfortestingofnewbiologicalsbeingundertaken:MeningococcalVaccine

9. Details ofparticipation in cGMP inspections:NIL

10. ParticipationinTraining/workshop/conference(NameoftheScientist(s),Nameof theprogramme,durationandplaceof training, etc.) is shown inTable2:

Table2:

Nameof theScientist(s) Nameof theProgramme

Duration PlaceofTraining

Mr. Harit Kasana Research Methodology 29th Aug- 02nd Sep 2016 ICGEB, New Delhi

1. Dr.Akanksha Bisht

2. Mr. Harit Kasana

3. Mr.Ajay Kumar Ade

Determination of Total and Free PRP content of Hib capsular polysaccharide in Liquid Pentavalent Vaccine presentation by HPAEC-PAD

29th December 2016-04th January 2017

Serum Institute of India Pvt.Ltd, Pune

11. Achievements of the laboratory: During the visit & meeting of officials

from WHO & National Centre for Immunobiologicals Research and Evaluation

(CRIVIB), Rome to NIB from 21st to 23rd February 2017 it has been decided that:-

1. NIB in collaboration with WHO-CRIVIB will conduct one week Hands on Training on



Determination of PRP content of Hib capsular polysaccharide in liquid vaccine presentation by HPAEC-PAD from 23rd -27th October, 2017 at Bacterial Vaccine Lab of NIB for six scientists of three Indian manufactures viz. M/s Zydus Cadila, M/s Shanta Biotech and M/s Bharat Biotech.

2. First General Meeting of the WHO Global Network of 24 National Vaccine Control and WHO contract laboratories to be held at the

National Institute of Biologicals in NOIDA, India, from 31st October- 2nd November, 2017 is being organized by the World Health Organization and hosted by the National Institute of Biologicals (NIB), India. About 55-60 participants from different National Control Laboratories of USA, Canada, Switzerland, Germany, France, United Kingdom, Belgium, Republic of Korea, China etc. are expected to participate in this meeting.


SCIENTIFIC PROGRESS

1. Lab/Division ViralVaccineLaboratory

2. NameofHead Dr. Surinder Singh, Director

(since 27th May 2016)

Dr. Charu M. Kamal, Scientist-II (17th May to 6th Oct 2016)

Mr. Neeraj Malik, Scientist-II (till 17th May 2016)

3. Manpower in the lab/division: I. NameofScientificStaff

Mr. Jaipal Meena, Scientist-III & I/c

Dr. Manjula Kiran, Junior Scientist (till May 2016)

Mr. Ajay Kumar Ade, Junior Scientist (till Nov 2016)

Ms. Archana Sayal, Junior Scientist (since Aug 2016)

VIRALVACCINELAbORATORy


III. No.(s)ofContractualStaff:Ten

4. ScientificActivitiesundertaken:a. Collaboration with other organization:

None

b. CDLNotification:Viral Vaccine Laboratory got notified as CDL under Gazette Notification No.: G.S.R. 250 (E) - Part-II - Section 3 - Sub-Section (i) dated 15th March, 2017 for the following products;

i) Measles

ii) Rubella

iii) Cell Culture Rabies Vaccine (CCRV)

c. NotificationofGovernmentAnalyst: No

d. DevelopmentofMonograph: Nil

e. Publication(s): Nil

Deligates from Royal Government of Bhutan



5. Testingofbiologicals:Table1: Details of sample testing.

Nameofbiologicals

Tested

Typeofbiologicals

No. ofbatchesEvaluated

No. ofbatchesfound

to be of standard quality

No. ofbatchesfound to be not of standard quality

No. ofInter-

laboratorysampletested

Remarks

Rabies immunoglobulin

Immunoglobulin 11 11 Nil

215 batches tested for moisture content estimation

Standardized

Hepatitis Immunoglobulin

13 13 Nil Standardized

Measles Vaccine Viral Vaccines 04 04 Nil StandardizedRubella Vaccine 03 03 Nil StandardizedMMR vaccine 05 05 Nil StandardizedCCRV 10 - - Under testingMR Vaccine 05 05 Nil StandardizedJE Vaccine 01 - - Under

StandardizationRotavirus Vaccine 05 - - Under TestingInactivated Polio Vaccine

05 - - Under Testing

Human Papilloma Vaccine

05 - - Under Testing

Hepatitis A Vaccine

10 - - Under Standardization

Hepatitis B Vaccine

05 - - Under Standardization

Varicella Vaccine 05 - - Under Standardization

6. Preparationand supplyofNationalStandards,Serapanel etc.:NIL

7. Trend involumeofworkas compared topreviousyear:Table2:Trendinvolumeofwork

s.no. Nameof theproduct No. ofbatches evaluated for theperiod

2015-16 2016-17

1. Human Rabies Immunoglobulin 22 batches 15 batches2. Human Hepatitis B Immunoglobulin,

I/M & IV17 batches 13 batches

3. Live attenuated MMR vaccine 16 batches 5 batches


SCIENTIFIC PROGRESS

4. Live attenuated Measles vaccine 01 batch 4 batches

5. Live attenuated Rubella vaccine 01 batch 3 batches

6. Cell Cultured Rabies Vaccine 30 batches 10 batches received and are under testing

7. Live attenuated Measles and Rubella Vaccine

Nil 05 batches

8. Japanese Encephalitis Vaccine 05 batches 1 batch received and are under standardization

9. Human Papilloma Virus vaccine 04 batches 05 batches received and are under testing

10. Inactivated Polio Vaccine 17 batches 05 batches received and are under standardization

11. Rotavirus Vaccine 06 batches 5 batches received and are under testing

12 Hepatitis A Vaccine Nil 05 batches received and are under standardization

13 Hepatitis B Vaccine Nil 10 batches received and are under standardization

14 Varicella Vaccine Nil 05 received and are under standardization

0

2

4

6

8

10

12

14

RabiesIg

HepatitisB Ig

Measles Rubella MMR MR

11

13

43

5 5

Number of Batches Evaluated

Figure 1: Number of Vaccines and sera samples evaluated in the FY 2016-17 for Rabies Ig, Hepatitis B Ig, Measles, Rubella, MMR and MR.

1716 4

10

168

Viral Vaccine Bacterial Vaccine

Monoclonal Antibody Enzyme & Hormone

Blood Products

Figure 2: Number of Batches Evaluated for Moisture Content in 2016-17.



8. Proposed targets for testing of newbiologicalsbeingundertaken:

S.No. Product/test Timeline1 Japanese Encephalitis

Vaccine (JEV)Dec 2017

2 Human Papilloma Vaccine (HPV)

Sept 2017

3 Hepatitis A Vaccine Dec 20174 Hepatitis B Vaccine Oct 20175 Varicella Vaccine Dec 2017

9. Details of participation in cGMPinspections:NIL

10.Participationsintraining/workshop/conference (Name of the scientist,name of programme, duration andplaceof training etc.):

a. NameofScientist(s): Mr. Jaipal Meena and Mrs. Archana Sayal

• Name of programme: Training on Estimation of D antigen content in IPV vaccine and Hepatitis B potency (in-vitro).

• Duration and place of training:17th-19th Jan, 2017, Quality Control Department, Serum Institute of India, Pune.

b. NameofScientist(s): Mr. Jaipal Meena

• Name of programme: 5th Meeting of Expert Committee on Vaccine Standards of IP 2016

• Duration and place of training:26.05.16 (one day), Central Drug Laboratory, Kasauli.

11.Achievements of theLaboratory:a. Standardization of HPV (Human Papilloma

Virus Vaccine), IPV (Inactivated Polio Vaccine), Rotavirus Vaccine and MR (Measles and Rubella) Vaccine.

b. CDL Notification for three vaccines- Measles, Rubella and Cell Culture Rabies Vaccine CCRV.


SCIENTIFIC PROGRESS

1. Lab/Division bloodProductsLaboratory

2. NameofHead Dr.J.P.Prasad,Scientist-I

3. ManPower in theLab/Division: I. NameofScientificStaff

Mrs. Sudha. V. Gopinath, Scientist-III & i/c (Since July 2016)

Mrs Madhu Y, Scientist-III


Dr. Varun Singh, Junior Scientist

Mr. Daud Ali, Junior Scientist

Mr. Ajay Ade, Junior Scientist (Till 23rd Aug. 2016)

Mr. Anirban Mukherjee, Junior Scientist (Till 9th May 2016)

Mr. Pradeep Kumar, Lab Assistant (Till 2nd August 2016)

III. No.(s)ofContractualStaff:Eleven

4. Scientificactivitiesundertakena) Collaborationwithotherorganizations:

As per the request received from Indian Pharmacopoeia Commission, the laboratory initiated method verification studies for development of monograph on indigenously manufactured Anti-D Immunoglobulin (Monoclonal) in collaboration with the product manufacturer and Indian Pharmacopoeia Commission. This product is the only monoclonal version of Anti-D IgG available in the world indicated to be used in Rh Negative mothers with no Anti

bLOODPRODuCTSLAbORATORy

-D antibodies in their serum who have just delivered rhesus positive infants. As claimed by the manufacturer, its effect in decreasing the incidence of haemolytic disease of the new-born due to Rh incompatibility has been dramatic. The finalized monograph will be communicated to Indian Pharmacopoeia Commission for inclusion in the upcoming edition of Indian Pharmacopoeia.

b) CDLNotification:

The laboratory has been declared as Central Drug Laboratory vide Gazette of India Extraordinary Part II Section 3-Subsection (i) No.684 published in December 2014 for the following products :

i. Human Albumin

ii. Human Normal Immunoglobulin (Intravenous & Intramuscular)

iii. Human Coagulation Factor VIII

iv. Human Coagulation Factor IX

v. Plasma Protein Fraction

vi. Fibrin Sealant Kit

vii. Anti- Inhibitor Coagulant Complex


1. Dr. J. P. Prasad, Scientist Grade-I & Head, Blood Products Laboratory has been notified as Government Analyst vide Gazette No. S.O 2393(E) for testing of plasma derived products published on September 2015.

2. Dr. J. P. Prasad, Scientist Grade-I & Head, Blood Products Laboratory has been notified as Government Analyst vide Gazette Notification Extraordinary Part-II, Section (3), subsection ii, published on September 2011 for blood grouping reagents.



i. Monograph for total protein estimationinHumanAlbumin,ImmunoglobulinandPlasmaProteinFractions:

Monograph on total protein estimation in human albumin, immunoglobulins and plasma protein fraction by modified Kjeldahl method developed by the laboratory has been accepted by the Indian Pharmacopoeia Expert Committee for Blood Products for publication as Method G in the general Chapter of Total protein estimation in Indian Pharmacopoeia 2018.

ii. Acceptance criteria for clottable proteininFibrinSealantkit

Modification of the current Acceptance criteria for clottable protein of Fibrin Sealant kit as given in the Indian Pharmacopoeia monograph to addresses the two types of

label claims for this parameter has been accepted by the Indian Pharmacopoeia Expert Committee for Blood Products for publication in the forthcoming edition of IP.

e) Publications:

• J. P. Prasad, Y. Madhu, Surinder Singh, G.R. Soni, N. Agnihotri, Varsha Sigh, Pradeep Kumar, Nidhi Jain, Anu Prakash, Varun Singh. “Study of twenty preparations of human albumin which failed in quality control testing due to elevated sodium content, a poor internal quality control at manufacturing unit”. Biologicals Volume 44, Issue 6, November 2016, Pages 591-599.

5. Testing of biologicals: bloodProducts

d) Developmentofmonographs


SCIENTIFIC PROGRESS

TypeofbiologicalsTestedNo. of

batches evaluated

No. ofbatches found

to be of standard quality

No. ofbatches found to beNot-ofstandard quality

No. of inter-laboratory

sample tested Rem

arks

Human Albumin 225 222 03 -

Human Normal Immunoglobulin IV 88 88 0 -

Human Normal Immunoglobulin IM 08 08 0 -

Specific Immunoglobulin IV(Hepatitis B Immunoglobulin, Anti-D Immunoglobulin)

02 02 0 -

Specific Immunoglobulin IM(Tetanus Immunoglobulin, Anti-D Immunoglobulin IM, Hepatitis B immunoglobulin, Rabies Immunoglobulin)

63 63 0

24 (Tests for Protein

Composition, Molecular Size

Distribution, Total Protein)

Human Coagulation Factor VIII (Plasma derived) 81 81 0 -

Human Coagulation Factor VIII rDNA 40 40 0 -

Human Coagulation Factor IX 18 18 0 -

Human Prothrombin Complex 1 1 0 -

Fibrin Sealant Kit 28 28 0 -

FEIBA (Anti-inhibitor coagulant complex) 7 7 0 -

Fresh Frozen Plasma

(test for human origin)12 6* 6 -

*cross reactivity with other

animal antisera which is a known aspect as

per various publication

Total 573 564 09

Osmolality test for 2 batches of Dulaglutide

& 03 batches of PEG-Interferon

6. Preparationand supplyofNationalStandards,SeraPanel etc.



The laboratory has initiated necessary preparations for developing two National Reference Standards as given below:

a) FirstNationalReferenceStandardfortotalproteinestimationofHumanAlbumin

Reference Standard for total protein estimation of plasma derived Human Albumin is not available worldwide and hence the values given by the manufacturer requires normalization to a defined standardized and harmonized value for assessing its compliance to the specified requirement. This standard will be assigned a value through collaborative study with national and international laboratories and further declared as National Reference Standard for total protein estimation in Human Albumin Solution.

b) First National Reference Standard forPotency assay of Human CoagulationFactorVIII

The indigenous biopharmaceutical companies are dependent upon the Primary Reference Standards which are, many a times in limited supply, and as a standard procedure the companies have to develop in-house standards calibrated against the primary standard. Two proposals have been approved by the scientific expert committee for Blood Products in the meeting held at NIB on 2nd February 2017 and further preparation in this regard is being taken up. The targeted time for establishment of these National Reference Standard is by March 2019.

7. Trend in volume of workas compared to previous years

Figure 1: Work volume in terms of number of

batches tested.

8. Proposed target for testing of newbiologicalsbeingundertaken

To assure the quality of imported therapeutic proteins, the laboratory has undertaken the testing of new products in the market like Recombinant Factor IX and Third Generation Recombinant Factor VIII. Since the products are non-pharmacopoeial, the compliance is assessed as per the drug product specification submitted by the manufacturer. The method qualification for testing of these products is targeted to be completed by August 2017.

9. Details of participation in cGMPinspections:1. SubjectExpert for Joint Inspection:

Dr. J.P. Prasad, Scientist-I & Head, nominated as subject expert for joint inspection of M/s. Intas Pharmaceuticals, Ahmedabad for grant of product permission of Human Coagulation Factor IX-IP, 600 IU, 26th September 2016.

2. SubjectExpert for Joint Inspection:Dr. J.P. Prasad, Scientist-I & Head nominated as subject expert for joint inspection of M/s. Intas Pharmaceuticals, Ahmedabad for grant of NOC for test license for Recombinant Factor IX, 27th September 2016.


SCIENTIFIC PROGRESS

3. Expert for External Audit of Pharmacovigilance Program of India: Mrs. Sudha V Gopinath, Scientist Grade-III, was nominated as expert member for the first External Audit of Pharmacovigilance Program of India held at Indian Pharmacopoeia Commission on 16th September 2016. She was also invited to review the Quality Manual on Pharmacovigilance Program of India for its completeness before official release.

10. Participation in training/workshop/conference

S. No.

Nameof thescientist Nameof theWorkshop/conference Durationandplace

1Dr. J.P. PrasadScientist-I & Head

5th Annual Conference of Indian Society of Transfusion Medicine (ISTM); Delivered a lecture on Experience inPlasmaDerivedProducts- Indian Perspective

18th-19thNov, 2016 Bhopal


6th Raj Bhasha Sammelan9th-11thJan, 2017JIPMER, Pondicherry


33rd Meeting of the Scientific Body of Indian Pharmacopoeia Commission, Ghaziabad

13th Dec, 2016 Malviya Smriti Bhawan- New Delhi

4

Mrs. Y MadhuScientist-III 5th National Conclave for Laboratories

2016; Increasing significance of testing and calibration in Global Supply Chain

27th-28th Oct, 2016India Habitat Center, New DelhiMd. Daud Ali,

Junior Scientist

5

Mrs. Y MadhuScientist-III Seminar on Legal Liabilities and possible

improvements in accreditation system of laboratories

5th Nov 2016Holiday Inn,New Delhi

Dr. J.P. PrasadScientist-I & Head

11. Achievements of the laboratory:

• The laboratory has tested and reported 573 batches of plasma derived products forwarded by the office(s) of the Drugs Control General of India, out of which 03 have been found to be Not-of-Standard Quality. The role of laboratory in assuring the quality of such lifesaving drugs is reiterated thereby safeguarding public health.

• The laboratory has got special appreciation from the participants during the feedback session of the “National

Workshop on Laboratory Quality Management System in Biotherapeutics’’ held at NIB from May 17-19, 2016.

• The laboratory has organized two meetings of the Scientific Expert Committee for Blood Products on 29th August 2016 and 2nd February 2017 to finalize strategies to strengthen the scientific activities of the laboratory wherein the initiatives taken by the laboratory were appreciated by the experts.



1. Lab/Division RecombinantProductLaboratory

2. NameofHead Dr. Renu Jain (Till 6th Oct. 2016)

Dr. Charu M. Kamal, Scientist Grade II (w.e.f 6th Oct. 2016)

3. Manpower in theLaboratory: I. NameofScientificStaff

Ms. Gurminder Bindra, Scientist Grade III

Dr. Meena Kumari, Scientist Grade III

Dr. Gaurav Pratap Singh, Junior Scientist (Till 1st Sep. 2016)

II. NameofTechnicalStaff: Nil

III. No.(s)ofContractualStaff:Five

4. ScientificActivitiesundertaken :a) Collaborationwithotherorganisations:

i. Collaborative studies with NationalInstitute for biological Standards andControl(NIbSC)

• WHO International Collaborative Study for the Establishment of the 2nd International Standard (IS) for Parathyroid Hormone 1-34, recombinant human (15/304). The objective of the study was to calibrate the candidate standard, 15/304, in terms of the primary calibrant by HPLC for content assay and purity evaluation.

• Establishment of the 1st WHO International Standard for Insulin, Human Biosynthetic. In this Phase I, objective of the repeat study was

RECOMbINANTPRODuCTLAbORATORy

assignment of Insulin content to the candidate standard received from NIBSC.

ii.CollaborativestudieswithCDTL,Mumbai

Laboratory has participated in Inter Laboratory Collaborative Study for Bacterial Endotoxin (BET) Assay conducted by CDTL, Mumbai. The sample Antibiotic Ceftriaxone injection USP 1.0 gm was received in the month of February 2017. Laboratory has submitted the results of BET Assay to Quality Management Unit (QMU) in April 2017 for onward transmission to CDTL, Mumbai.

b) CDLNotification:

The laboratory has been notified as Central Drugs Laboratory (CDL) vide The Gazette of India, Extraordinary, notification no. GSR 908 (E)-Part II-Sec 3 (i) on Dec 22, 2014 for class of products mentioned in Table 1.

Table1: CDL Notified recombinant productsS.No NameofProduct TypeofProduct1. Insulin Anti-Diabetic2. Insulin Analogues3. Erythropoietin Growth factors4. Filgrastim


Dr. Renu Jain has been notified as Government Analyst, approved by Ministry of Health & Family Welfare vide Gazette notification No. 1859, S.O. 2393(E) dated Sept. 2, 2015.

d) DevelopmentofMonographs:

• Contribution by laboratory towards development of IP monographs is given in Fig 1.


SCIENTIFIC PROGRESS

Contribution to

Pharmacopoeial

Monographs

Monographs

for IP 2018

Performance

Verification at NIB

for IP 2018

Revised

Monographs for

IP 2018Teriparatide

Teriparatide Injection Peg

Filgrastim

Teriparatide

Teriparatide Injection

Figure 1: Contribution of NIB in Development of IP Monographs

e) Publication(s):NIL

5. Testingofbiologicals(Table2):Product Typeof

biologicalsNo. ofbatchesEvaluated

No. ofbatchesFound

to be of StandardQuality

(SQ)

No.ofbatchesFound tobe not of Standard Quality(NSQ)

No. ofInter

laboratorysampletested

Remarks

i. Insulin Regular

ii. Insulin Biphasic

iii. Insulin NPH

iv. Insulin Bulk

Anti Diabetic - Insulin

42

127

21

1

191 Nil Nil 08: Medical Supplies

Corporation

03: Legal

i. Degludec/Aspart

ii. Glargine

iii. Aspart

iv. Lispro

v. Glulisine

vi. Determir

vii. Degludec

viii. Liraglutide

ix. Degludec/Liraglutide

x. HI Bulk

Anti Diabetic – Insulin Analogues

24

52

100

66

21

8

16

1

1

1


Corporation

• First scientific meeting for revision of Monograph on Peg Filgrastim was held at NIB on 2nd February 2017 with the respective industry stakeholders & Indian Pharmacopoeia Commission.

The verification for Peg Filgrastim monograph will be carried out by the laboratory before revised Peg Filgrastim monograph is published in IP 2018.



i. Filgrastim

ii. Peg Filgrastim

iii. Erythropoietin

iv. Interferon Alpha 2b

v. Interferon beta 1a

vi. Peg Interferon Alpha 2b

vii. Peg Interferon beta 1a

Growth Factors

0

0

18

0

1

0

2


Corporation

01: Legal

i. Teriparatide

ii. GLP - Dulaglutide

Small Peptides

1

2

3 Nil Nil --

TOTAL 505 505

6. Preparationand supplyofNationalStandards,SeraPanel etc.a) ReferenceStandardProgram

• The effective implementation of IP monographs on rDNA Biotherapeutics products which are published in IP 2014 requires suitable use of Reference Standards. For this, steps have been taken to develop National Reference Standards for Filgrastim, Peg Filgrastim, Insulin Lispro and Insulin Glargine. The road map of Reference Standard Program which has been initiated is given in Table 3 and present status is given in Table 4

Table3:RoadmapforNationalReferenceStandarddevelopmentforrDNAproducts initiatedbyNIb(N=04)

ReferenceStd-IPRS PotencyStandard Physico-chemicalStandard 2016-2018 2017-2019FILGRASTIM LISPRO PEG FILGRASTIM GLARGINE

Workbench at Recombinant Product Laboratories


SCIENTIFIC PROGRESS

Table4.DevelopmentofReferenceStandardsfrom2016-2019

S.No. Nameof theStudy Collaboration StudyPeriod Status

1 National Reference Standard preparation of Insulin Lispro

6 Laboratories

(NIB, Insulin Stakeholders, Pharmacopoeia Labs)

2016-2018 Meeting to be organized for final Unitage assignment

2 National Reference Standard preparation of Insulin Glargine

13 Laboratories

(NIB, Insulin Stakeholders, Pharmacopoeia Labs)

2017-2019 Communication initiated for the collaborative study

3 National Reference Standard preparation of Filgrastim

6 Laboratories

(NIB, Filgrastim Stakeholders, & Pharmacopoeia Labs)

2016-2018 Candidate selection has been done & communicated to respective stakeholders for material donation

4 National Reference Standard preparation of Peg Filgrastim

10 Laboratories

(NIB, Peg Filgrastim Stakeholders, & Pharmacopoeia Labs)

2016-2018 Monograph published in IP Addendum 2015 has been revised by NIB.

• A meeting for scientific discussion on development of Filgrastim Reference Standard (RS) and analysing data for candidate selection was held on April 06, 2017 at Indian Pharmacopeia Commission (IPC), Ghaziabad.

b) Supply of Indian PharmacopoeiaReference Standard (IPRS) for HumanInsulin-

The details for supply of IP Reference Standard (IPRS) for Human Insulin - available to be used in testing are available on NIB website at: http://nib.gov.in/orderinginfoIPRSHI-2.htm. During 2016-17, there have been two requests for supply of IPRS from M/s Anthem Biosciences Pvt Ltd., Bangalore and M/s Unichem Laboratories Ltd., Goa, which however, could not be processed for proforma invoice as there was no confirmation from them.

7. Trend in volume of work ascompared topreviousyear

i) Trend in different types of Recombinantbio-therapeuticProducts(Figure2)

0

50

100

150

200

250

300

20

09

-10

20

10

-11

20

11

-12

20

12

-13

20

13

-14

20

14

-15

20

15

-16

20

16

-17

20

09

-10

20

10

-11

20

11

-12

20

12

-13

20

13

-14

20

14

-15

20

15

-16

20

16

-17

20

10

-11

20

11

-12

20

12

-13

20

13

-14

20

14

-15

20

15

-16

20

16

-17

49

152

242

279

237259

271

191

37

102114

148172

209194

292

38 47 58 5632 28 22

No

. o

f B

atc

hes

rh Insulin Analogs & GLP-1 Growth Factors & Peptides

Figure 2: Trend of different types of Recombinant Biotherapeutic Products from 2009-2017

ii) Source of Recombinant bio-therapeuticproducts:ImportedvsIndigenous



0

50

100

150

200

250

300

191164

27

292

277

15 221111

No

. o

f B

atc

he

s

rh Insulin Analogs & GLP-1 Growth Factors & Peptides

Figure 3: Source of Recombinant Biotherapeutic Products in 2016-17

8. Proposed target for testing of newbiologicals andbiotherapeutics:

Laboratory is in the process of establishing testing for three new products namely Peg Interferon beta 1b, Insulin Glargine (300 IU) and Darbepoetin.

9. Details of Participation in cGMPInspections:

Joint Inspections of Biotherapeutic Manufacturing Units in India were carried out with CDSCO and state FDA along with experts from NIB. Inspections of the manufacturing units carried out for recombinant Bio-therapeutics are as under (Table 5):

Table5.NIB Experts in Joint cGMP Inspections of Biotech Facilities in India

S. No.

Date of CDSCO

Audit

Place PurposeofAudit NIbScientist

rDNAProduct

1. 25th - 26th May, 2016

M/s Intas Bio- Pharmaceuticals Ltd.,

Ahmadabad

Grant of WHO GMP Certification for rDNA products

Dr. Meena & Ms. Sudha V. Gopinath

Filgrastim, Peg filgrastim, Interferon Alfa 2b, Erythropoietin, Teriparatide

2. 30th March, 2017

M/s Virchow Biotech Pvt. Ltd., Hyderabad

Verification of Chemistry, Manufacturing and

Controls (CMC) data

Dr. Meena Teriparatide


SCIENTIFIC PROGRESS

10. Participations in Training/Workshop/Conference (Name of the Scientist(s),Nameof theprogramme,durationandplaceof training, etc.):Table6

S. No.

Nameof theScientist(s) NameofProgramme Duration Place

1. Dr. Renu Jain

Dr. Charu M Kamal

Dr. Meena Kumari

Ms. Gurminder Bindra

Role of Notification of Government Analyst under Drug & Cosmetic Act and Good Laboratory Practices (Schedule L-1)

19th Aug, 2016 NIB, NOIDA

2. Dr. Renu Jain

Dr. Meena Kumari

Ms. Gurminder Bindra

Dr. Gaurav Pratap Singh

1st Expert Committee Meeting of the Post Approval Change Applications

23rd Aug, 2016 NIB, NOIDA

3. Dr. Renu Jain India Africa Health Sciences Meet (IAHSM)

1st -3rd Sep, 2016 Vigyan Bhawan, New Delhi

4. Ms. Gurminder Bindra Short course on Upstream Processing, Analytical Characterization, Quality by Design & Process Analytical Technology

12th-14thDec, 2016

IIT, Delhi

5. Dr. Meena Kumari USP Workshop on “Biotherapeutics and Peptides”

20th-21st Feb, 2017

USP , Hyderabad

6. Dr. Charu M Kamal BIRAC 5th Foundation Day 22ndMar, 2017 DBT, New Delhi

11.Achievements of the laboratory:a. Poster Presentation on “Quality Evaluation of

rh-Insulin, Analogs & Peptides: Role of NIB in success of NCD program for Diabetes” during the 4th National NCD Summit held on 6th October 2016 at India Habitat Centre, New Delhi.

Authors: Renu Jain, Gaurav Pratap Singh Jadaun, Gurminder Bindra, Meena Kumari, Shalini Tewari, Shruti Dixit, Vandana Saklani, Gul Raj Soni, Surinder Singh.

b. Second Scientific Expert Committee Meeting for Recombinant products (rDNA) & Therapeutics Monoclonal Antibodies (TMabs)

The second meeting of the Scientific Expert Committee for rDNA and TMabs was held under the Chairmanship of Dr. S.R Rao, Advisor-DBT, Government of India, on 27th Jan, 2017 at Biosafety Unit, DBT. As part of an initiative towards Research and Development which are quantifiable and



deliverable, the following R&D projects were approved by the committee:

i. Development of National Reference Standards for rDNA products (Growth Factors);

ii. Development of National Reference Standards for rDNA products (Insulin Analogues);

iii. An Alternative method to animal testing for Quality Control testing of Erythropoietin.


SCIENTIFIC PROGRESS

1. Lab/Division EnzymeandHormoneLaboratory

2. NameofHead Dr. Richa Baranwal, Scientist Grade-III


Dr. Charu Mehra Kamal, Scientist Grade-II (1st Oct 2015 to 17th May 2016)

3. Manpower in theLaboratory: I. NameofScientificStaff:NIL


Sh. Brij Bahadur, Lab Technician

Sh. Rajeev Shrivastava, Lab Assistant

III. No.(s)ofContractualStaff:Four

ENZyMEANDHORMONELAbORATORy

4. ScientificActivitiesundertaken: Enzyme and Hormone Laboratory has

been established for quality evaluation of various therapeutic human Enzymes and Hormones viz; Streptokinase, Urokinase, Heparin, Human Chorionic Gonadotropin, Menotropin, Follicle stimulating Hormone, Somatropin etc. During the year April 2016 to March 2017 it has expanded its scientific activities utilising the infrastructure and scientific expertise of the laboratory, complying with the standards of ISO and NABL in assuring the quality of test results and measurement of traceability.

Members of First expert committee meeting

a. Collaborationwithotherorganizations:

The laboratory has initiated for the

participation in “Inter-laboratory Collaborative Study” for development of



Indian Pharmacopoeia Reference Standard (IPRS) for Heparin and Enoxaparin in collaboration with IPC. Anti Factor IIa and Xa assays of Enoxaparin sodium were already harmonized in four pharmacopoeia which are chromogenic assay (IP, Ph. Eur., BP and USP). The amendment will be incorporated in next edition of IP 2018.

b. CDLNotification: Enzyme and Hormone Laboratory got

notified as CDL under Gazette Notification No.: G.S.R. 250 (E) - Part-II - Section 3 - Sub-Section (i) dated 15th March, 2017 for the following products;

i. Streptokinase (Natural and Recombinant)

ii. Human Chorionic Gonadotropin (hCG)

iii. Human Menopausal Gonadotropin (hMG)

c. NotificationofGovernmentAnalyst:No

d. DevelopmentofMonograph:

The laboratory has prepared two monographs of Menotropin (Bulk & Injection) and also reviewed and sent comments to IPC on three monographs of Somatropin for incorporation in Indian Pharmacopoeia. All five monographs have also been published in IP 2014, addendum 2016. The laboratory has also reviewed and sent comments for three monographs of recombinant Follicle Stimulating Hormone (Bulk & Injection). The monographs are on IPC web domain for public comments and will be published in IP 2018 (Table 1).

Table1: Contribution of Enzyme and Hormone Laboratory in Monograph Development

S.No. NameofMonographPrepared/Reviewedand comments

sent to IPCStatus

1. Menotropin (Bulk) Prepared

Published in IP 2014, Addendum 2016

2. Menotropin for injection Prepared

3. Somatropin Reviewed and comments sent to IPC

4. Somatropin Conc. Solution Reviewed and comments sent to IPC

5. Somatropin for injection Reviewed and comments sent to IPC

6. Follicle Stimulating Hormone Reviewed and comments sent to IPC

On IPC web domain and will be published in IP 2018

7.Follicle Stimulating Hormone Concentrated Solution

Reviewed and comments sent to IPC

8.Recombinant Follicle Stimulating Hormone injection

Reviewed and comments sent to IPC

e.Publication(s): Nil


SCIENTIFIC PROGRESS

5. Testingofbiologicals: Table 2: Testing of Biologicals

NameofbiologicalsTested Typeofbiologicals

No. ofbatchesevaluated

No. ofbatchesfound to be of Standard Quality

No. ofbatches found to be not of Standard Quality

No. ofInter–Lab. Sampletested

Streptokinase Inj. Enzyme 3 3 -r-Streptokinase Inj. 1 1 -Heparin Inj./ for Inj. 15 15 -urokinase Inj./bulk 1 1 -HumanChorionicGonadotropin Inj.

Hormone 2 2 -

Menotropin (HumanMenopausalGonadotropin)Inj.

Hormone 8 8 -

FollicleStimulatingHormone Inj.

1 1 -

r-FollicleStimulatingHormone,Vial/PFS/Inj.

6 6 -

Somatropin Inj. 5 5 -

CoagulationFactorVIII,Powder for Inj.

Blood Product - - - 22

Anti-haemophilicFactorVIII,Powder for Inj.

- - - 21

Rituximab,Solution forInfusion

Therapeutic Monoclonal Antibody Product

- - - 2

bavituximab,Solution forInfusion

- - - 7

Adalimumab,Solution forInfusion

- - - 6

Trastuzumab,Solution forInfusion

- - - 4

Presentation of protocols in IAEC meetingfor Animal based Testing of Enzymes andHormones Dr. Richa Baranwal, Scientist Grade III, attended the IAEC meeting held on 13.01.17

at NIB, NOIDA and presented 11 protocols for ethical approval of animals for animal based QC tests of Enzymes and Hormones.



4

11

1

11

5 5

01

7

2

8

1

65

3

1 1

15

0

2

4

6

8

10

12

14

16

HCG HMG FSH r-FSH HGH STK r-STK URK HEP

No

of

Sa

mp

les

2015-2016 2016-2017

Figure 1: Trend Analysis of Samples Received during 2015-2016 and 2016-17

4542

10

20

30

40

50

2015-2016 2016-2017

Sam

ple

Vo

lum

e

Total samples- 2015-2016: 45 & 2016-2017: 42

Figure 2: Total Samples Recieved In Enzyme & Hormone Lab during 2015-16 and 2016-17

6. PreparationandsupplyofNationalStandard,SeraPanel etc.:

The laboratory has initiated the preparation of National Reference Standards. Four National Reference Standards of Enzymes and Hormones Products are needed, viz. (i) Somatropin, (ii) Streptokinase, (iii) Menotropins (Human Menopausal Gonadotropin, HMG) and (iv) Human Chorionic Gonadotropin (HCG). Mr. Mohit, Biologist, presented the projects on Preparation of National Reference Standard of Enzymes and Hormone Products and Dr. Richa Baranwal, gave a presentation

on Research & Development Project “Comparative study of conventional in-vivo potency assay of Recombinant Follicle Stimulating Hormone (r-hFSH) and alternative methods”.


a) Quality Control Evaluation: The trends of samples received for QC evaluation in laboratory and for testing of BET samples received from other NIB laboratories as compared to previous year are shown in Figure 1, 2 and 3.


SCIENTIFIC PROGRESS

29

0

5

0 0 0

2221

2

76

4

0

5

10

15

20

25

30

35

Antiheamophilic

Factor

Coagulation

Factor

Rituximab Bavituximab Adalimumab Trastuzumab

Sa

pm

le V

olu

me

Total sample - 2015-2016 : 34 & 2016-2017: 62

2015-2016 2016-2017

Figure 3: Samples Received for BET Testing in Enzyme & Hormone Laboratory From Other Laboratories During 2015-2016 and 2016-17

b) Establishment of QC testing of newerbiologicals:During 2016-17, the laboratory made efforts to standardize the QC tests of three newer Biologicals; (i) Reteplase, (ii) Haemocoagulase & (iii) Enoxaparin.

i) Reteplase (Recombinant TissuePlasminogen Activator): The service

samples of Reteplase injections and in-house reference standards were received from M/s Reliance Life Sciences for test standardization through CDSCO and QC tests standardized as per Manufacturer’s specifications as mentioned in Table 3.

Table3:QualitycontrolparametersandtestspecificationsofReteplaseS.No biological TestParameters Reference

Pharmacopoeia/anufacturer Specification

1.

Reteplase(Recombinant Tissue PlasminogenActivator)

1.Clarity–Visual Inspection

Manufacturer’s Specification

2.ParticulateMatter-Visual Inspection3. pH Potentiometric4. Identification-SDS-PAGE & Western Blot5.PurityTest-SEC-HPLC (Protein Content)4. Assay (A) Protein Concentration SEC-HPLC

(b)Activity (Potency)-Chromozym Enzymatic Assay



5. MoistureContentKarl Fisher Coulometric Method 6. Contaminants –A.Endotoxins-Need to be standardizedb.Sterility -Direct Inoculation

ii) Haemocoagulase: Haemocoagulase, an enzyme complex, having coagulative and anti-haemorrhagic properties and isolated from the poison of Bothrops jararaca or Bothrops atrox. Haemocoagulase has thrombin and thromboplastin like action on blood coagulation. During this year the laboratory made efforts to standardize the tests of Haemocoagulase shown in Table 4.

Table4:QualitycontrolparametersandtestspecificationsofHaemocoagulase

S. no.

biological TestParameters ReferencePharmacopoeia/ManufacturerSpecification

1. Haemocoagulase inj. 1.Clarity-Visual IP 2014

2.Particulate Matter-Visual IP 20143.pH-Potentiometric Manufacturer Specification4.bET -Gel Clot method

Manufacturer Specification/

Method IP 20145.AbnormalToxicity-General Test

Manufacturer Specification

6.Sterility-Membrane Filtration

Manufacturer Specification/ Method IP 2014

(iii) Enoxaparin:The laboratory made efforts to standardize the tests of Enoxaparin Identification test as shown in Table 5.

Table5:QualitycontrolparametersandtestspecificationsofEnoxaparin

S.No. biological TestParameters ReferencePharmacopoeia/ManufacturerSpecification

1. EnoxaparinSodium (LowmolecularMassHeparin)

Identification-

Absorption Maxima

IP 2014


This year the laboratory will be focusing on developing QC tests of HCG pregnancy kits and preparation of National Reference Standards.

9. Details of participation in cGMPInspections:

The Laboratory Head, Dr. Richa Baranwal inspected M/s Cadila Healthcare Limited, Ahmedabad facility. The details of inspection are shown in Table 6.


SCIENTIFIC PROGRESS

Table6: DetailsofInspectionofmanufacturingunit:S.No InspectionsDetails Date TechnicalExpert

1. Joint inspection of M/s Cadila Healthcare Limited, Ahmedabad for NOC for Multi products formulation facilities under Form 28D and 28 to manufacture Enoxaparin for export purpose in Unit 09 at CHL’s Changodar site.

29.09.16 Dr. Richa Baranwal, Scientist Grade III & Lab Head

10. Participations in Training/Workshop/Conference (Name of the Scientist(s),nameofProgramme,durationandplaceof training etc.)

Table7:Trainingattendedbylaboratorystaff:

S.No. Nameof theProgramme NameofStaff Place Duration of Training

1 Training in Recombinant Product Lab to handle HPLC based test on Insulin & Analogues

Brij Bahadur, LT Recombinant Product Lab,NIB

19/12/2016 -30/12/2016

2 Internal Training on New Biomedical Waste management rules 2016 and Biosafety Practices

Mohit Kumar, Biologist

Conference Room, Ground Floor, Administrative Block. NIB, NOIDA

10.01.2017

Jay Bajarang Singh, Biologist

11.01.2017

3. Post Training Exercise on MS Word & Excel

Brij Bahadur, Rajiv Srivastava, Jay Bajarang Singh, Sonia Sharma

Bioinformatics Lab, Ground Floor, Admin. Block,NIB

06.02.2017, 07.02.2017 14.02.2017

11.Achievementof theLaboratory: Enzyme and Hormone Laboratory got notified as CDL under Gazette Notification No.: G.S.R. 250

(E) - Part-II - Section 3 - Sub-Section (i) dated 15th March, 2017 for the following products;

i. Streptokinase (Natural and Recombinant)

ii. Human Chorionic Gonadotropin (hCG)

iii. Human Menopausal Gonadotropin (hMG)



THERAPEuTICMONOCLONALANTIbODyLAbORATORy

1. Lab/Division Therapeutic Monoclonal Antibodies

Laboratory

2. NameofHead Mrs. Sudha V. Gopinath, Scientist-III

(Till 12th July 2016)

Mr. Subhash Chand, Scientist-III (w.e.f. 13th July 2016)


Mr. Subhash Chand, Scientist III & I/c (since 17th May 2016)

Dr. Birendra Kumar, Junior Scientist

Sh. P.S. Chandranand, Junior Scientist

Dr. Richi V Mahajan, Junior Scientist (w.e.f. 2nd May, 2016)

II. NameofTechnicalStaff:NIL

III. No.(s)ofContractualStaff:Five

4. ScientificActivitiesundertaken :a. Collaborationwithotherorganizations

i. Collaboration with NIbSC, uK: The laboratory participated in NIBSC, UK collaborative study for the preparation of “1st

WHO reference reagent for the biological activity of Rituximab-like antibodies”. Experimentation for the collaborative work has been successfully completed and results have been submitted to NIBSC, UK.

ii. CollaborationwithC-CAMP,bengaluru:With aim to widen the scope for detailed physiochemical-characterization of monoclonal antibodies (mAbs) and to enhance capacity building of laboratory through networking, the draft MoUs were prepared and forwarded to the two proposed collaborators C-CAMP, Bengaluru for consensus. The MoU in principle has been agreed by both the collaborators with deliberations going on regarding the financial implications of the collaboration.

b. CDLNotification: No

c. NotificationofGovernmentAnalyst: No

d. DevelopmentofMonographs:

The laboratory has carried out the verification of Rituximab drug substance and drug product monographs and communicated to IPC in Dec. 2016 for publication in next IP edition. The decision for placing the draft monograph on IPC website is under consideration with IPC Scientific Expert committee.

e. Publication(s): NIL

5. Testingofbiologicals: The testing of Biologicals (therapeutic

monoclonal antibodies) carried out by TMA Laboratory are summarised in Table 1.


SCIENTIFIC PROGRESS

Table1.TypesandquantityofbiologicalstestinginTMALabinFy2016-17S.no Nameof

biologicalTested

Typeofbiologicals

No. ofbatchesevaluated

No. ofbatchesfound

to be of Standard quality

No. ofbatchesfound to be not of Standard quality

No. ofInter-

laboratorySampletested

Remarks

1. Rituximab Therapeutic Monoclonal Antibodies (mAbs)

11 11 NIL NIL All the samples were tested as per manufacturer’s drug product release specification registered in CTD module III.

2. Trastuzumab 4 4 NIL NIL

3. Adalimumab 6 6 NIL NIL

4. Bevacizumab 3 Under Validation Studies

6. PreparationandSupplyofNationalStandards,SeraPanel etc:

A roadmap of 2017-2020 for preparation of reference standards for Therapeutic Monoclonal Antibodies (TMABs) was presented in 2nd meeting of the NIB-Scientific Expert Committee for Recombinant Products (rDNA) & TMABs, held on 27th January, 2017. The strategic modalities for the preparation of reference standard for therapeutic monoclonal antibodies viz. planning, designing, execution of study etc. were discussed in the meeting.

7. TrendinVolumeofWorkin(2016-17) as Compared to the Previousyear:

a. QualityControl ofTherapeuticmAbs: In the current year, the laboratory has released test and analysis report of 11 batches of Rituximab, 4 Batches of Trastuzumab and 6 Batches of Adalimumab as per the manufacturer’s protocol and drug product release specifications (Fig.1). The method

verification studies for Bevacizumab have been initiated.

b. Monograph Verification: The Rituximab drug substance and drug product Indian Pharmacopoeia monograph verification have been done and the final comments have been communicated to Indian Pharmacopoeia Commission (IPC). The studies for verification of methods for development of Indian Pharmacopoeia monograph for Trastuzumab have also been also initiated and ongoing.

c. Examination of Technical DossiersApplications on Post Approval Changes(PAC): NIB Scientific Team reviews and contributes its expert opinion to these PAC applications forwarded from CDSCO to NIB on the data to support a change which would be considered sufficient to allow a determination of the impact of the change on the quality of the approved products as it relates to safety, efficacy and/or effective use of the product. Total five (N=5) PAC



applications have been examined, most of them have been on the shelf life extension.

Figure 1. Quality testing of therapeutic monoclonal antibodies in FY2016-17

d. Preparation of Guidance Document forPAC applications: The laboratory has also prepared “Guidance Document for Industry: Submission of stability data and related documents for review and expert

opinion for granting Post Approval Changes in shelf life of recombinant Biotherapeutic products and Therapeutic Monoclonal Antibodies. (CDSCO guidance Document No. - PAC/1108 Version – 1.1).

Bioanalytical Laboratory-1 of TMA Bioanalytical Laboratory-2 of TMA

8.0Proposed target for testing of newbiologicalsbeingundertaken:

Imported or indigenous mAb products seeking Marketing Authorization in India are forwarded to NIB for tests and

analysis. Strengthening activities with respect to enhancing the testing capabilities have been proposed for new products namely, i) Infliximab, ii) Pertuzumab, iii) Golimumab and iv) Etanercept.


SCIENTIFIC PROGRESS

9.0 DetailsofparticipationincGMPInspections:Table2

Table2.NIbExpertsinJointcGMP/CMCdataInspectionsofbiopharmaFacilitiesinIndia.S.No Date of

Audit Facility Inspected Typeof inspection/PurposeofAudit

(mention theproducts whereapplicable )NIb Scientists

1 26th May, 2016

M/S Intas Bio-pharmaceuticals Ltd., Ahmedabad

Joint Inspection with CDSCO for grant of WHO GMP Certification for r-DNA products.

Ms. Sudha V. Gopinath

Scientist-III2 12th

August 2016

M/s. IPCA Laboratories Ltd., Mumbai

Grant of NOC to obtain manufacturing license in Form-29 for the manufacture of test batches of Rituximab, Trastuzumab, Infliximab.

Mr. Subhash Chand

Scientist-III

3 01st & 2nd Sept. 2016

M/s Kemwell Biopharma Private Limited, Bangalore

Joint inspection for verification of CMC data including physicochemical, Biological characterization of Biosimilar “Trastuzumab Injection” manufactured at the site of M/s Kemwell Biopharma Pvt. Ltd., Bangalore on behalf of M/s Glenmark pharmaceuticals.

Mr. Subhash Chand

Scientist-III

4 20th Jan., 2017

M/s Kemwell Biopharma Private Limited, Bangalore

Follow-up visit to the inspection held on 01st & 2nd Sept. 2016

Mr. Subhash Chand

Scientist-III

10. Participations in training/workshop/conference: Participation of lab personnel in trainings/workshops/conference is summarized in Table 3.

Table3.Training,WorkshopandConferenceAttended

S.No Nameof theScientist Nameof theprogramme Duration Placeof training1. Mr. Subhash Chand

Dr. Birendra Kumar

Training on Potency Testing of Rituximab

06th Jun -11th Jun, 2016

M/s Hetero Drugs, Hyderabad

2. Mr. Subhash Chand

Dr. Richi V. Mahajan

Training on Potency Testing of Adalimumab

27th Jun.-02nd July, 2016

M/s Reliance Life Sciences, Mumbai

3. Dr. Birendra Kumar Workshop on laboratory safety by Thermo Fisher Scientific

30th June, 2016.

NIB, NOIDA

4. Mr. Subhash Chand

Mr. P.S.Chandranand

Dr.Birendra Kumar

Dr. Richi V. Mahajan

Training on Schedule L1 of Drugs & Cosmetics Act.

19th Aug, 2016 NIB, NOIDA



5. Dr. Birendra Kumar Training programme on Research Methodology organized by CDSA- DBT, Govt. of India

29th Aug - 02nd Sep 2016.

ICGEB, New Delhi

6. Mr. P.S.Chandranand 5th National Conclave of NABL

27th & 28th of October 2016

India Habitat center, New Delhi

7. Mr. Subhash Chand Downstream processing, Analytical characterization, Quality by Design, Process analytical technology

12th Dec.- 14th Dec. 2016

IIT Delhi

8. Dr. Richi V Mahajan Training on establishment of R & D facility

22nd Jan - 24th Jan 2017

Zydus Research Centre, Ahmedabad

9. Mr. Subhash Chand USP Workshop on Biotherapeutics & Peptides.

20th Feb -21 Feb., 2017

Hyderabad, India

10. Mr. P. S. Chandranand Workshop on Federation of Blood Donor Organisations of India (FBDOI)

4th & 5th March 2017

NIB, NOIDA

11.Achievementsofthelaboratory:a. The laboratory has acquired the capacity

building for quality control testing of different therapeutic monoclonal antibodies (mAbs). Since the inception of laboratory, this is the first instance of release of test and analysis reports of three different mAbs viz. Rituximab (11 batches), Trastuzumab (4 batches) and Adalimumab (6 batches) as per the manufacturer’s protocol and drug product release specifications as approved in the CTD module –III.

b. The laboratory collaborated with NIBSC, UK for the preparation of “1st WHO reference reagent for the biological activity of Rituximab-like antibodies”. Experimentation for the collaborative work has been successfully completed and results have been submitted to NIBSC, UK. Out of 16 Participants Worldwide, only 06 participants were having valid results for all

09 performances for CDC assay. NIB is one among the 06 participants who have all 09 valid assays with % CV< 10%.

c. The Rituximab drug substance and drug product monograph contributed by NIB would be the first to be published in next edition of Indian Pharmacopoeia as so far this has not been published in any of the pharmacopoeia.

d. A roadmap of 2017-2020 for development of National reference standards for Therapeutic Monoclonal Antibodies (N=6) was prepared and approved in 2nd meeting of the NIB-Scientific Expert Committee for Recombinant Products (rDNA) & Therapeutic Monoclonal Antibodies (TMABs), held on 27th January, 2017. In addition to the National Reference Standards Programme, R&D project entitled “Development of antibody liposomal


SCIENTIFIC PROGRESS

conjugates for delivery of nucleic acid based drugs” submitted by Dr. Richi V Mahajan and Mr. Subhash Chand, has been in principle appreciated and approved in 2nd meeting of the NIB-Scientific Expert Committee for

Recombinant Products (rDNA) & Therapeutic Monoclonal Antibodies (TMABs) chaired by Dr. S. R. Rao, Advisor-DBT, held on 27th January, 2017.



ALLERGENTESTINGLAbORATORy

1. Lab/Division AllergenTestingLaboratory

2. NameofHead Dr.AchlaPrasad,ScientistGrade-I

3. Manpower in theLaboratory : i. NameofScientificStaff

Ms. Shalini Tewari, Scientist Grade-III

Dr. Sanjay Mendiratta, Junior Scientist

ii. No.(s)ofContractualStaff: Three

4. Scientific Activitiesundertaken: a) Collaboration with other organisations:

The Allergen Testing Lab has two committees of subject experts constituted to undertake work on modalities of Quality Control of allergens for the first time in India. i) National Expert Committee approved by Honourable Health Minister and ii) Core committee of NIB.

The work on project entitled “Development of Techniques and Reagents for Quality Control of Clinically Important Indigenous Allergen Extracts (Cockroach and Moth)” in collaboration with Metro Hospital, NOIDA, is being continued.

b) CDLNotification: No

c) NotificationofGovernmentAnalyst: Nil

d) Development of Monographs: The Allergen Testing Laboratory developed first general monograph on “Allergen Products” for Indian Pharmacopoeia which is under publication in upcoming edition of Indian Pharmacopoeia 2018 and presently available on the website of Indian Pharmacopoeia

Commission at following link http://ipc.nic.in/super/users/categoryprep.asp?lang=1.

e) Publication(s): First general Monograph on “Allergen Products” for Indian Pharmacopoeia 2018 edition.

5. Testingofbiologicals: The Allergen Testing Laboratory is geared

up to undertake the testing of indigenous Allergen extracts manufactured by four indigenous manufacturers. The modalities for undertaking testing have been developed in consultation with the expert committee(s) constituted at NIB and are under process of implementation through CDSCO.

It will be mandatory for manufacturers to submit data on the recommended test parameters to National Institute of Biologicals for test and analysis of relevant indigenous allergens. A maximum period of 1 year has been granted to indigenous Allergen manufacturers to set up the requisite facilities at their manufacturing unit from the date of relevant notification by CDSCO.

5.1Development of laboratory techniquesfor Quality Control of Moth AllergenExtracts:

A total of 4 allergen extracts were prepared from Moth Whole Body Powder (WBP) (EM4-EM7), each using one gram of lyophilised WBP obtained from commercial source. All extraction steps were performed at 4°C which include defatting with diethyl ether, extraction in NH4HCO3, dialysis using centrifugal filtration (Amicon Ultra–Ultracel-3K) with a cut off of 3kDa followed by lyophilisation. These extracts were subjected


SCIENTIFIC PROGRESS

to immuno-biochemical tests like protein and carbohydrate estimation, ELISA, SDS-PAGE and Western Blot.

5.2EstimationofProteincontentintheMothAllergenExtracts:

Protein estimation in crude extract was done by Modified Lowry’s method using Bovine Serum Albumin (BSA) as standard at 10, 20, 30, 40, and 60µg/ml concentrations. The total concentration of protein in the sample is deduced from determining concentration of Trp and Tyr residues that reduce the Folin–Ciocalteu reagent, and measuring absorbance at 750 nm. Average protein

content of moth extracts was found to be 604.8µg/mg crude extract.

5.3SDS PAGE analysis of Moth allergenextract:

All the four allergen extracts of moth were subjected to Sodium Dodecyl Sulfate Poly Acrylamide Gel Electrophoresis (SDS-PAGE), to study their protein profile using 12% resolving and 5% stacking polyacrylamide gel (Laemmli’s method). The extracts were loaded at 50µg protein / well. A reproducible band pattern was seen for all of four extracts (Figure 1).

(a) (b)

Figure 1: (a) Protein contents of Moth extracts (b) SDS-PAGE profile of four Moth extracts

5.4ELISA for determination of specific IgEinserasamples:

Indirect ELISA tests were performed to detect specific IgE for Moth allergens using sera from patients showing Skin Prick Test (SPT) positive response to these allergens and normal healthy volunteers and. The patient sera showing specific IgE were then used in immunoblotting experiments for major allergen identification. Further work is in progress.

6. PreparationandsupplyofNationalStandard,SeraPanel etc.:

Each manufacturer will be required to prepare their own in-house reference standard for each manufactured allergen. Allergen Testing Laboratory, NIB will be the first nodal laboratory to facilitate in establishing their in-house reference preparation and to ensure batch to batch reproducibility.



7. Trend involumeofworkas compared to thepreviousyear: Conducted five National Expert Committee (NEC) Meetings during 04 May 2016- 31 Jan 2017.

Outcome of these meetings is summarised below in Table 1:

Table1:Summaryofoutcomeof5NECmeetingsheldatNIb

S.No Details ofMeatings1 4th Meeting of National Expert Committee (04.05.2016)

Recommendations of Sub-Committee on 13 IVD & Allergens dossiers accepted by NEC. Sub-Committee dissolved after dossier evaluation.

Check list to verify information to be provided by applicants to CDSCO for in-vitro and in-vivo allergen products approved

NEC to prioritize batch testing at NIB

CDSCO to issue notification to all manufacturers/importers for submitting data of four mandatory parameters to NIB

NIB to send letter/consolidated recommendations to CDSCO to issue letter for compliance by manufacturers

2 5th National Expert Committee meeting (12.7.2016):SOPs for necessary QC tests approved

Tests for Batch release confirmed (i-iv)

Monograph, Guidance Document discussed and finalised

Consolidated recommendations approved for implementation by CDSCO3 6th meeting of National Expert Committee (29.9.2016):

Monograph & Guidance Document approved

Director emphasized on QC programme of Allergens & preparation of a Road Map 4 7th meeting (the brainstorming session) (21.11.2016):

Development of Sera Bank at NIB for QC of Allergens

NIB to develop checklist for onsite inspection of manufacturing units

Core group constituted5 8th National Expert Committee meeting (31.01.2017)

Approval of R&D Proposal “Development of Quality Control measures of Moth Allergen Extract”

7.1. Prepared a checklist for CDSCO to verify information to be provided by applicants for in-vitro and in-vivo allergen products for import/manufacturing/marketing in India is placed on CDSCO website and is also in use. (http://www.cdsco.nic.in/writereaddata/ALLERGEN%20Checklist.pdf)

7.2. Consolidated recommendations of NEC and indigenous committee on allergens for DCG (I)/CDSCO for necessary communication to and compliance by manufacturers/importers are given in Table 2.


SCIENTIFIC PROGRESS

Table2:Approved recommendations for implementationbyCDSCO

S.

No

Issue Proposedaction tobe takenbyCDSCOasperrecommendationofNEC

NECMeeting

details

1.Inclusion of Allergens under Biologicals

In D&C Act Rules

Allergens should be considered as antigens and accordingly may be considered under as Biologicals instead of Drugs, under “Antigens” at Schedule C Point 5 of Drugs and Cosmetics Act 1940 and Rules1945.

4th Meeting 04.05.2016

2.Batch Release modalities

It will be mandatory for manufacturers to submit data on the mandatory test parameters to National Institute of Biologicals for Test Analysis of the allergen product.

However, for indigenous manufacturers, who are manufacturing allergens relevant to India both for diagnostic and therapeutic purposes, a maximum time period of 1 year have been granted for setting up the test facilities at their manufacturing unit from the date of relevant notification by CDSCO

3rd Meeting 10.02.16

2nd Meeting 01.10.15

1st Meeting

15.7.15

NIB will examine reproducibility of data for recommended test parameters from different manufacturers for batches submitted to NIB/ CDSCO for evaluation. For those clinical parameters which cannot be conducted at NIB, data provided by the Manufacturer will be accepted by NIB for test and analysis purpose. Safety of these allergen extracts has already been established as these have been used in patients for more than five decades in India. Hence safety parameters are required for only new antigens other than the approved list.


For test and analysis of Allergen products manufacturer has to provide the material and its stage as suggested by NIB/NEC.

3rd Meeting 10.02.16

The committee also recommended that in case of any controversy or legal challenges by the aggrieved party on evaluation of the product tested by NIB, the product can be re-tested by NIB laboratory only after taking approval from the competent authority/licensing authority under the provision of Drugs and Cosmetics rules and act.


3.Import

Mixed allergen kits are not recommended for India. 1st Meeting of NIB Committee 18.12.14

Any new allergen will be assessed by the NEC for its relevance in the country before its import.



S.

No

Issue Proposedaction tobe takenbyCDSCOasperrecommendationofNEC

NECMeeting

details

4.For import/ manufacturing/ marketing

Checklist prepared by National Institute of Biologicals and submitted to CDSCO for its onward circulation to manufacturers for necessary implementation


Office of DCG (I) will evaluate grant of import/ manufacture permission on the basis of information provided as per approved checklist at their end.

5.Recombinant Allergens

(import & use)

The recombinant allergens can only be permitted for R & D use.

For diagnostic and therapeutic purposes, approval by DCG (I) can only be granted after recommendation by NEC.

1st Meeting 01.10.15

6.Diagnosis / Immunotherapy

The allergen extracts for diagnosis and immunotherapy of Indian patients must be procured from the same manufacturer; i.e. the manufacturer/ importer of IVD must provide antigenic material used in kit/ SPT to be used for immunotherapy

1st Meeting of NIB Committee 18.12.14

7.3. Activities for World Allergy week addressed by World Allergy Organization (WAO):

i. Organized a series of lectures during World Allergy Week (Apr 4-10), 2016 on the theme “Pollen Allergies: Adapting to a changing climate” to create allergy awareness among people.

h t t p : / / w w w. w o r l d a l l e r g y . o r g /U s e r F i l e s / f i l e / I N D I A - N I B -WAO2016ACTIVITIES.pdf || http://www.worldallergy.org/UserFiles/file/WorldAllergyWeek2016Portfolio.pdf

ii. Conducted a questionnaire based survey during world allergy week 2016 to know about the status of knowledge of Allergy: Its causes and treatment among common public.

Conclusions drawn from the survey are summarized below:

• In general people know the term “Allergy” but actual meaning of Allergy is not understood.

• Suffer from allergy: can identify symptoms & causative agent from the list.

• Present sample size 341; 37 % suffer from Allergy

• Age group 1-30 years (98/125; 78 %) ~ current trend : Global changes climate Causative allergen: Dust as main cause: 56; 49% others cases Cosmetics /perfume (irritants)

• Primary consultation taken from General/Chest Physician; Skin Specialist, ENT

• Allergist: very few • Paraclinical: some • Expenditure: fair amount spent on

treatment (Pharmacotherapy)


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• Management: Diagnosis/Medicines to eat (TEMPORARY RELIEF) • Quality of life affected • Add to economic burden • Allergology needs to be developed: for better patient care

iii. Based on the results of survey, a pamphlet on Allergy awareness was released and circulated to spread information on Allergy, causes, treatment and how it impacts quality of life etc. among mass public.

Fig 1: Director, NIB releasing Allergy pamphlet at NIB during World Allergy Week

7.4. Prepared a Guidance Document for Regulation and Control of in-vivo Allergen products intended to provide guidance on the type of data which should be included in applications for marketing authorisation for allergens. It is available on NIB website (http://www.nib.gov.in/Updated%20Guidance_document_Allergen%20Lab_NIB07112016.pdf)

7.5. Performed review of 13 Technical dossiers forwarded by CDSCO for expert opinion on issue of license to applicants considering relevance of products to Indian patients :

Listof13technicaldossiersforwardedbyCDSCOforreviewandexpertopinion

DossierReview of in-vitro Allergy diagnostic kits/Allergen Extracts

i. M/s Alcit India (Indigenous)

ii. M/s. Phadia

iii. M/s Creative Diagnostics (Indigenous)

iv. M/s Siemens limited.

v. M/s Omega Dx (Asia) Pvt. Ltd.

vi. M/s Allergopahrma GmBh & Co.KG (M/s Merck Specialities Pvt. Ltd.)

vii. M/s Astra Biotech (M/s Nucleus Inc)

viii. M/s Zentech S.A (M/s Nucleus Inc)

ix. M/s Fugen Biomed, Gujarat.

x. M/s BioMerieux India Pvt. Ltd



10. Participation in training/workshop/conference :S. No.

Nameofscientist(s)

Nameof theprogramme DurationPlaceof

programme

1

Dr. Achla Prasad

Ms. Shalini Tewari

Dr. Sanjay Mendiratta

Presented a scientific paper

“Immunobiochemical Analysis of Moth Allergens for Quality Control” at 50th Golden Jubilee National Conference of Indian College of Allergy Asthma & Applied Immunology, ICAAICON 2016

Dec 22-25, 2016

VPCI, New Delhi

2Dr. Achla Prasad

GLP Re-Certificate Inspection of Torrent Pharmaceuticals Ltd.

June 1-3, 2016

Gandhinagar

3Dr. Achla Prasad

GLP Surveillance cum extension in scope inspection of Laila Nutraceuticals Research Development Centre

June 24-25, 2016

Vijaywada

4Dr. Achla Prasad

GLP Surveillance inspection of Jubilant Biosys Ltd.

Sep.8-9, 2016 Bangalore

5Dr. Achla Prasad GLP Pre- Inspection of Dabur Research

Foundation Oct. 6-8, 2016

Ghaziabad

xi. All Cure Pharama

xii. M/s Thermo Fisher India Pvt. Ltd.: Phadia.

xiii. Astra Biotech

Review of dossiers and expert opinionresulted in streamliningandweaningoutimport of 28.3%Allergen Products fromIndianmarketwhicharenotrelevantforIndianpopulation

8. Proposed targets for testingofnewbiologicals:i. Four new Allergens are proposed to be

taken up for Quality Control and Test and Analysis purpose:

a. Cynodon dactylon (bermudaGrass)

b. Dermatophagoides farinae (HouseDustMite)

c. Cassia siamea (KassodTree)

d. Alternaria alternata (Fungi)

ii. Develop network for sera collection.

iii. To establish procedures to perform test and analysis of above four proposed diagnostic and therapeutic indigenous allergens.

iv. To undertake proposed Research & Development activities on Quality Control of Moth Allergens.

9. Details of participation in cGMPinspections:None


SCIENTIFIC PROGRESS

6Dr. Achla Prasad GLP Final Inspection of Dabur Research

Foundation Feb. 6-8, 2017

Ghaziabad

7Dr. Achla Prasad GLP Surveillance cum extension in scope

inspection of Natural Remedies Pvt. Ltd. March 10-11, 2017

Bangalore

8Dr. Sanjay Mendiratta

Panel Member of Selection Committee for selection of Laboratory Technician for Project “Study of HLA-DR3 and or DQII restricted CD4+helper T-cells in type I Diabetes in North India”.

Jan 04, 2017 NIP, Delhi

9Dr. Achla Prasad GLP inspectors Conclave Dec 23, 2016

India Habitat Centre, Delhi

11. Achievements of the laboratary:1) Allergen Testing Laboratory is the first

lab in the country to undertake Quality Control testing and analysis of allergen products and contributing significantly towards improving modalities for the same. Ensuring availability of quality allergens for patient care will help in reducing disabilitating impact of allergies and improving quality of life of allergy patients.

2) Consolidated recommendations of two Committees on Allergens have been communicated to DCG(I)/CDSCO for further notifications by their office to manufacturer/importers for compliance.

3) Publication of the first general Monograph on Allergen Products is

underway in Indian Pharmacopoeia 2018 edition.

4) Prepared a Guidance Document for Regulation and Control of in-vivo Allergen products intended to provide guidance on the type of data which should be included in applications for marketing authorization for allergens.

5) Prepared a checklist for verification of information to be provided by application at CDSCO to obtain manufacturing/import license for manufacturing/importing Allergen products.

6) National Expert Committee identified and approved following group of scientists/ institutions for undertaking R&D work on Allergens in collaboration.



S.No.Nameof CollaboratingFaculty/Expert

Institute/Centre

1.Dr. S.N. Gaur and

Dr. Raj Kumar Vallabhbhai Patel Chest Institute, Delhi

2. Dr. M.K Agarwal Metro Hospital and Heart Institute, NOIDA, UP3. Dr. Nagendra Prasad. K. V Allergy Physician, Bengaluru Allergy Center, Bangalore

4. Dr. V.K. JainDepartment of Respiratory Medicine, Mahatma Gandhi Medical College & Hospital, Jaipur (Rajasthan)

5. Dr. Surya Kant King George’s Medical University, Lucknow, UP

6. Dr. W.A. ShaikhGrant Medical College and Sir J.J. Group of Hospitals, Mumbai, Maharashtra

7. Dr. Naveen Arora Institute of Genomics and Integrative Biology, Delhi

8. Dr. A. K. JainAllergy & Immunotherapy Clinic,

National Institute of T.B, R.D, MOH & FW, Delhi


SCIENTIFIC PROGRESS

ANIMALFACILITy

1. Lab/Division AnimalFacility

2 NameofHead Dr.Shikhayadav(ScientistGrade-II)

3. Manpower in the/Division: I. NameofScientificStaff

Dr. Suresh Kumar (Scientist Grade- III)


Mr. Prdeep (Lab. Assistant),

Mr. Parminder Kumar (Jr. Animal Care taker)

Mrs. Shobha (Peon)

III. No.(s)ofContractualStaff:

Fifteen (Animal Care Staff)

Animal Facility is a central support unit for all laboratories of NIB which performs in-vivo tests for quality control evaluation of biologicals received in the institute. The facility also ensures timely availability of laboratory animals for various in-vivo tests by a planned breeding program and the staff of the facility ensures high quality animal husbandry and care that meets the requirements of animal welfare regulations and guidelines provided by CPCSEA.

4. ScientificActivitiesundertaken:a) Collaborationwithotherorganizations:

Collaboration with IIT, Delhi: Dr. Archana Chugh, Associate Professor, IIT, Delhi has collaborated with Dr. Shikha Yadav for the project titled “Corneal delivery of antifungal-peptide conjugate encapsulated nanoparticle

formulation in an experimental animal model of Fusarium solani”.

Collaboration with CSIR-IGIB, Delhi: Dr Shikha Yadav has collaborated with Dr. Vijay Pal Singh, IGIB, Delhi for project titled “Evaluation of A1 and A2 variants of β-casein in cow milk as factors causing allergic airway disease in murine model” .

b) CDLNotification:NO

c) NotificationofGovernment.Analyst:NIL

d) DevelopmentofMonographs:NIL

e) Publication(s):

• Ramendra Patil, Pandey and Suresh Kumar. 2017 “Nano Medicine and immune response”. Indian Journal of Hospital Infection, Vol 1, No 1. PP 27.29

• Suresh Kumar, Ramendra Patil Pandey, Vijay K. Bharti, Nitika Sharma, Jai Bajarang Singh, Abhishek Chanchal and Saheem Ahmad. 2017 “Evaluation of nanoparticles pyrogenicity”. European Journal of Biomedical and Pharmaceutical Sciences, Volume 4(3), 168-183.

5. Testingofbiologicals: In-vivo QC evaluation tests i.e. Abnormal

Toxicity Test, Pyrogen Test, Potency & Identity Assays & other miscellaneous tests have been performed on a total of 996 samples of different biologicals forwarded by the laboratories of NIB. A total of 405 samples were tested for Abnormal Toxicity, 523 samples for Pyrogen, 62 samples for Identity and Potency Assay and 6 samples for safety test of BCG vaccine. A total of



Table1:DetailsofAnimalsused&suppliedin2016-17S. No.

Species Strain AnimalProvided in theyear2016-17QCTesting Research Sold tooutside

institutes1. Mice Swiss Albino 5426 - 70

Balb/c 250 262 1642. Rats SD Rats 944 - 780

Wistar Rats 80 - 1303. Guinea Pigs Duncan Hartley 836 - 104. Rabbits New Zealand White 58 - -

Total 7594 262 1154GrandTotal 9010

7594

262

1154

0

1000

2000

3000

4000

5000

6000

7000

8000

9000

QC Testing Research Sold to outside

Institutes

Rabbits G. Pigs Rats Mice

Figure 1: Details of Number of Animals Used & Supplied in 2016-17

7594 animals were used to conduct these in-vivo QC tests, 262 were used for research

and 1154 were sold to other institutes, details of which are provided in Table 1 & Figure 1.

5.1Approval of protocols by IAEC: All the experiments involving animals have to be approved by the IAEC, constituted by CPCSEA. In the year 2016-17, three IAEC meetings were organized in which 54 ongoing protocols and 5 new protocols were reviewed & approved by the committee. The facility maintained all relevant records to ensure compliance to the approvals granted

by the committee and progress under each approved protocol was put up for review by IAEC regularly in each meeting.

5.2. Abnormal Toxicity Test is conducted to determine the presence of any toxic substance in biological products intended for parenteral administration. The details of number of samples of various products and number of animals used are provided in Table 2.


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Table2:DetailsofdifferentproductstestedforAbnormalToxicity(2016-17)

Laboratory NameofProduct No. ofSamples2016-17

No. ofAnimalsused

Mice G.Pigs

bloodProducts

Human Albumin* 212 1085 434Dried Human Antihemophilic Fraction. (Factor VIII) 82 410 164Human Specific Immunoglobulin (I/M) (SPIG-IM) 41 205 82Human Normal Immunoglobulin (I/M) (IGIM) 8 40 16

Enzymes&Hormones

Human Chorionic Gonadotropin (hCG) 2 10 -Streptokinase (STK) 3 15 -Urokinase (URK) 2 10 -HEM 3 15 -

Vaccines

Human Rabies Immunoglobulin (RIg) 18 90 36Human Hepatitis B Immunoglobulin (HBIg) 16 80 32Rubella Vaccine (R-VAC) 3 15 6Live Attenuated MMR Vaccine (MMR) 5 25 10Japanese Encephalitis Vaccine (JEV) 1 5 2M-VAC 4 20 8MR-VAC 5 25 10

Total 405 2050 800

*Including five repeat tests

5.3PyrogenTest is conducted to detect the presence of any pyrogenic substance in the drugs & vaccines intended for parenteral administration and are prescribed in the Indian and other Pharmacopoeia. The details of number of samples of various products are provided in Table 3.

Table3:DetailsofdifferentproductstestedforPyrogenTest(2016-17)

Laboratory NameofProductNo. of samples

2016-17

Blood Products

Human Albumin 224Dried Human Antihemophilic Fraction

(Factor VIII)

110

Normal Immunoglobulin (I/V) (IGIV) 85Normal Immunoglobulin (I/M) (IGIM) 07Human Specific Immunoglobulin (I/M) (SPIG-IM) 42Human Specific Immunoglobulin (I/V) (SPIG-IV) 02Plasma Protein Fraction (PPF) 02Factor-IX 15



Viral VaccineHuman Rabies Immunoglobulin (RIg) 19Human Hepatitis B Immunoglobulin (HBIg) 17

Total 523

5.4Identity and PotencyAssay is done to establish the identity and determine the strength and activity of the products before their use in humans. The details of different product tested for Potency assay are provided in Table 4.

Table4:DetailsofdifferentproductstestedforPotencyAssay(2016-17)

Laboratory NameofProductNo. of samples

( 2016-17)

No. ofAnimalsusedRats Mice

Enzyme&Hormone

hCG 04 128 -r-FSH 11 330 -HMG-LH 08 234 -HMG-FSH 08 252 -

ViralVaccine

CCRV* 1 136Rabies Immunoglobulin 22 - 3120Japanese Encephalitis Vaccine (JEV)*

1 -30

Inactivated Polio Vaccine* 1 80 -Papilloma vaccine* 1 90

Recombinant Product

Erythropoietin*5 - 250

Total 62** 1024 3626

*Under Standardization

**Includes batches used for preparation of in- house reference standards

5.5 MiscellaneoustestsperformedinAnimalFacility(Table5)

Table5:

Nameof testNo. ofSamples No. ofAnimalsused

Mice G.Pigs

Virulent Mycobacterium of BCG Vaccine 6 - 36

Total 6 - 36

6. PreparationandSupplyofNationalStandards,SeraPanel etc.:NIL


The details of the trend in the volume of

work in terms of samples received for in-vivo quality control tests since 2009-2017 has been provided in Figure 2 and trend in


SCIENTIFIC PROGRESS

terms of number of animals provided from Animal Facility is provided in Figure 3.

27

166191

223

622

518

475

405

0

127

172 190

522543 550

523

017 31 29

147

91112

62

0 0 9 1137

119

17 6

0

100

200

300

400

500

600

700

2009-10 2010-11 2011-12 2012-13 2013-14 2014-15 2015-16 2016-17

Abnomal Toxicity Test Pyrogen Test

Identity & Potency Assay Miscellaneous Test

27310

403453

13281271 1154 996

Figure 2: Number of Samples Received for in-vivo Quality Control Tests (2009-2017)

188

18602222

2802

9417

102069826

9010

0

2000

4000

6000

8000

10000

12000

2009-10 2010-11 2011-12 2012-13 2013-14 2014-15 2015-16 2016-17

Figure 3: Number of Animals Provided from Animal Facility (2009- 2017)


As a central facility, Animal Facility will take up mandatory in-vivo testing required

for new products taken up by any laboratory of NIB.

9. Participation in cGMP inspections:NIL



10. Participations in Training/Workshop/Conference

Dr Shikha yadav, Scientist Grade II &Head,AnimalFacility

• Invited as Guest Faculty to give a talk on “Perioperative Care, Surgical Technique, Anaesthesia & Analgesia in Laboratory Animals” and provide hands-on training in a workshop on “Handling and Care of Lab Animals” organized at School of Life Sciences, Jawaharlal Nehru University, Delhi on 12-13th August 2016.

• Attended symposium on “Using high quality rodent disease models in pharma R&D” organized by Vivo Bio Tech Ltd in Delhi on 26th August 2016.

• Invited as Guest Faculty to give a talk on “Techniques in aseptic rodent surgery” in a workshop on “Animal Welfare and Ethics in Experimental Animal Research” organized by Defence Institute of Physiology and Allied Sciences (DIPAS), Ministry of Defence, DRDO, Delhi on 7-9th September 2016.

• Invited as Course Co-ordinator and Guest Faculty for the only FELASA (Federation of European Laboratory Animal Science Association) Accredited Certificate Course in Laboratory Animal Science (CCLAS) in India, conducted by Tamilnadu Veterinary and Animal Sciences University (TANUVAS) and delivered lecture on “Ethical Evaluation: An International Perspective, Humane end points & Severity Evaluation” on 23rd September 2016.

• Attended International Conference

on “Advances in Laboratory Animal Science for Modeling Human Diseases” in Bangalore on 14-15th October, 2016 organized by Biocon Bristol-Myers Squibb R&D Centre (BBRC) and Laboratory Animal Scientists Association (LASA), India.

• Invited as Course Co-ordinator and Guest Faculty in the 3rd “Certificate Course on Laboratory Animal Science (ICLAS)” at CSIR- Institute of Genomics & Integrative Biology (IGIB), Delhi from 5th-16th December 2016 which is based on FELASA (Federation of European Laboratory Animal Science Association) guidelines.

• Invited as guest faculty in the course on “Management and Ethical Use of Laboratory Animals in Research” organized by JNU-NIAW from 15th-25th March 2017 at Ballabhgarh, Faridabad, and delivered lectures on several critical topics in Laboratory Animal Science.

Dr.SureshKumar,ScientistGrade-III

• Delivered talks on “Pros and Cons of Animal Experimentation” and CPCSEA guidelines for Laboratory Animal Facility, SOPs required & Health Indicators of Animals for Internship students from DUVASU, Mathura organized by National Institute of Animal Welfare, Ministry of Environment, Forest & Climate Change, Ballabgarh, on 11th June 2016 & 25th June 2016.

• Delivered talk on “Role and guideline of CPCSEA” for B. Pharmacy students from Jaipur conducted by National Institute of Animal Welfare, Ministry of


SCIENTIFIC PROGRESS

Environment, Forest & Climate Change, Ballabgarh, on 30th July 2016.

• Invited as external expert in CSIR- Assessment Committee constituted in the area of Biosciences & Biotechnology at CSIR-National Botanical Research Institute Lucknow, on 17th October 2016 for the assessment of scientists.

• Delivered talk on “Pain Management in Laboratory Animals” in one day seminar-cum-workshop on “Animal Ethics and Experimentation” conducted by Centre for Medical Biotechnology, MDU University Rohtak, on 22nd October 2016.

• Delivered talk on “Biomedical Waste Management Guidelines 2016 & Biosafety Practices to:

• BIBCOL personnel in the training provided by NIB on 2nd September 2016.

• FDA personnel in the training provided by NIB from 19-23rd September 2016.

• Participants of Certificate Course on Laboratory Animal Science (CCLAS) at CSIR Institute of Genomics & Integrative Biology on 9th December 2016.

• Bench Biologists & Laboratory Attendants of NIB from 10th-12th Jan 2017.

• Participants of National Workshop on Laboratory Quality Management System in Diagnostics organized by NIB and CDSA from February 08-10, 2017.

Mr.Prdeep (LabAssistant)&Ms.NitikaSharma(benchbiologist)

• Undergone lab orientation & in-house trainings on all SOPs related to Animal Husbandry & care, operation and maintenance of equipment and performance of QC tests.

11. Achievements of the laboratory: a) AnnualInspectionofAnimalFacility:The

annual inspection of the Animal Facility was done by IAEC on 25.10.2016 as per the CPCSEA requirement. The CPCSEA nominees submitted the inspection report to CPCSEA strongly recommending the Animal Facility for further approval as it was an excellent facility meeting all CPCSEA requirements.

b) Dr. Shikha Yadav was nominated by CPCSEA, Ministry of Environment, Forest & Climate Change as Member of Institutional Animal Ethics Committee (IAEC) of:

• Jawaharlal Nehru University, Delhi

• R V Northland Institute, Dadri, Greater NOIDA, U.P.

• Curadev Pharma Pvt. Ltd., Sector 83, NOIDA, U.P.

• Indira Gandhi National Open University (IGNOU), Delhi

c) Dr. Suresh Kumar was nominated by CPCSEA, Ministry of Environment, Forest & Climate Change as Member of Institutional Animal Ethics Committee (IAEC) of

• Daiichi Sankyo India Pharma Private Ltd, Gurgaon, Haryana

• Center for Medical Biotechnology, M.D. University, Rohtak, Haryana



e) Total RevenueGeneratedbyAnimalFacilityduringApril2016-March2017

S.No. Source Revenuegenerated (Rs.)

1.Revenue from in-vivo QC tests performed at Animal Facility

2,57,19,211/-

2.Revenue obtained by selling of Lab Animals to other institutes

2,00,136/-

Total revenuegeneratedatAnimalFacility 2,59,19,347/-

d) SaleofAnimalstootherinstitutesin2016-17

• In 2016, NIB had got permission from CPCSEA to provide laboratory animals to other CPCSEA registered institutes in the country and the registration number had been modified to 824/GO/Rbibt/S/04/CPCSEA (Research and

breedingin-houseuseandfortradingpurpose).AnimalFacilityhad startedproviding good quality laboratoryanimals to other research andeducation institutes of the countryinMay2016 andprovided a total of1154 animals to several institutes inDelhiandneighboringstates.

f) Commitment of NIb for implementationof 3R’s

As commitment towards the 3R’s, the scientists of Animal Facility and laboratories worked in close coordination to reduce the number of animals used in the quality

control testing by testing of more than one batch of same product at the same time with a common reference or control group. This enabled us to save a large number of laboratory animals in the year 2016-17, the details of which are provided below;

S.No. Details ofQCTest NumberofAnimalsSaved

1.Potency Assay for Rabies Immunoglobulin (RIg)

840 mice

2 Potency assay for various hormones 150 rats

Total 990 animals

SuPPORTSERVICES


SCIENTIFIC PROGRESS

QuALITyMANAGEMENTuNIT

1. Lab/Division Quality Management Unit

2. NameofHead Dr. J. P. Prasad-Quality Manager

(Since 6th Oct. 2016)

Dr. Renu Jain- Quality Manager (From 1st Apr. to 6th Oct. 2016)

3. Manpower in theunit: I. NameofScientificStaff

Ms. Y. Madhu- Deputy Quality Manager (1st Apr. 2016 to 3rd Feb. 2017)

Mr. Subhash Chand- Deputy Quality Manager (Since 3rd Feb. 2017)

Mr. N. Nanda Gopal- Deputy Quality Manager

Mr. P.S. Chandranand- Deputy Quality Manager

Mr. Sanjeev K. Sharma- Deputy Quality Manager (Since 3rd Feb. 2017)


III. No.(s)ofContractualStaff:Two

4. Aimsand scopeof theunit: Quality Management is a wide-ranging

concept which covers all activities that individually or collectively influence the quality of end results or products. It serves as a management tool with elements of:

a) An appropriate infrastructure, encompassing the organizational structure, procedures, processes, personnel and resources;

b) Systematic action necessary to ensure

adequate confidence that a product testing laboratory will satisfy the given requirements for quality.

The unit ensures inter-relationship between the laboratories and other technical & administrative departments for compliance of technical and management specifications. In addition, also ensures vertical relationship between pharmacopoeial body and the regulatory system. The objective of Quality Management System is continuous improvement in the following areas: i. Enhancement of Scope for ISO/IEC

17025: 2005 requirements ii. External Assessment by NABLiii. Quality System Documentationiv. Equipment Maintenance v. Annual Internal Quality Auditvi. Management Review Meetingvii. Assuring the Quality of Test Resultsviii. Implementation of Integrated QHSE

Management System

a. Enhancement of Scope for ISO/IEC17025:2005Requirements

The scope of Accreditation in discipline of Chemical & Biological tests have been accredited for 91 products in seven different categories namely:

i. Biotechnology Derived Products

ii. Immunological Products

iii. Enzymes iv. Vaccinesv. Hormones vi. Other Specified

Tests which include Biochemical Kits

vii. Biopharmaceuticals

b. ExternalAssessment(DesktopSurveillanceAudit2018)byNAbL



Table 1: Trend in Accreditation of biological & Chemical tests for ISO/IEC 17025: 2005(2011-2016)

AreasPeriod

2011-2013 2013-2015 2016-2018Laboratories 7 10 10Products 19 61 91Tests

(Biological and Chemical)

28

(16+12)

70

(34+36)

226

(86+140)

Table 2: Authorized signatories approved (N = 38) during the onsite audit in disciplines ofbiologicalandChemicalTests

Sr. Area Laboratory DisciplineofTestingAuthorizedSignatories

2016-2018

1 Diagnostics

Biochemical Kits Biological 03

Blood Grouping Reagents Chemical & Biological 05

Immunodiagnostic Kits Biological 06

2 Therapeutics

Blood Products Chemical & Biological 05

Enzymes & Hormones Chemical & Biological 04

Recombinant Products Chemical & Biological 04

3 VaccinesBacterial Vaccine Chemical & Biological 02

Viral Vaccine Chemical & Biological 05

4Facilitatingunits

Sterility Biological 02Animal Facility Biological 02

QualitySystemDocumentation

i. Presently the Quality Management System of NIB is strengthened with vast documentation procedures as summarized below (Table 3):

For an accredited laboratory to maintain its accreditation status, it is mandatory that the laboratory continues to comply with the requirements of ISO/IEC 17025: 2005 and NABL policies. Once a laboratory has been accredited for the first time, NABL conducts onsite surveillance visit within the first year of accreditation to verify the continued compliance. In the subsequent accreditation cycles of 2 years, instead

of onsite surveillance visits, NABL has evolved a monitoring system for verifying the continued compliance of the laboratory by conducting desktop surveillance.

In March 2017, NIB submitted the application for its continued compliance. The renewal is awaited for ten product testing laboratories at NIB depicted in Tables 1 & 2


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Table3:S. No.

Laboratory /unitNameNumberof

Manual /SOPsManualN=3

1. Quality Manual-Apex Quality document 012. Biosafety Manual 013. Purchase Manual 01

DocumentofQHSEN=24. QHSE Level – I document 015. QHSE Level – II document 01

StandardOperatingProcedures(SOPs)N=588A. ManagementSystemProcedures

6. Quality Management Unit 377. Sample Receipt & Report Dispatch Unit 078. Institutional Biosafety Committee 02

B. TechnicalProcedures9. Biochemical Kit 17

10. Blood Grouping Reagent 8111. Immunodiagnostic Kit 3812. Blood Product 5713. Enzyme & Hormone 5814. Recombinant Product 11215. Bacterial Vaccine 3516. Viral Vaccine 4417. Sterility 1718. Animal Facility 2419. Molecular Diagnostic Kit 3020. Therapeutic Monoclonal Antibody 29Formats21. QMU Approved Formats 869

ISO/ IEC 17025: 2005 Accredited

Labs

Labs not in scope of

Accreditation

ii. Review & Revision of Standard Operating Procedures (SOPs) and Manuals

SOPs Review Alert Calendar is issued to all areas of Diagnostic Laboratories, Therapeutic Laboratories, Vaccine Laboratories and Facilitating Units to maintain the periodic review interval from Jan- Dec 2017.

c. EquipmentMaintenance

Authorized list of equipment usage is being updated timely with the details of preventive maintenance e.g. AMC/Calibration done with due date. An Alert Calendar for Fixed and Moveable Equipment for year 2017 has been released to all users of the laboratory and the Stores & Purchase Unit



which includes activity for: a) AMC, b) Validation and c) calibration. These services are rendered by OEMs of the equipment and NABL accredited agencies under seven categories viz., Temperature Controlled, Mass/Volume, UV-Vis Absorbance, Potentiometer Measurements, Centrifuge, Tele-thermometers, Mercury Based Thermometers etc.

d. AnnualInternalQualityAudit:

The annual internal quality audit was conducted as per the operating procedure of Internal Audit prepared by the Quality Management Unit, with evidence of Witness for the On – site testing, documentation of assessment sheet and the auditors’ observations with their recommendations and the non-conformances.

There are two different ways of auditing the processes of Quality Management System: Horizontal and Vertical Auditing.

Horizontal audit is the process of auditing across many departments in the organization. Horizontal audit was conducted in various sections like Management Systems (QMU & SRRDU, Store & Purchase), Technical Areas (10 laboratories under Scope for ISO/IEC

17025 accreditation) in phased manner for the year 2017-2018.

Verticalaudit applies to different procedures followed by each division/department in the organization. Vertical audit was conducted in all technical areas applied for accreditation including Sterility and Animal Facility.

The unit had planned a calendar schedule to conduct Internal Audit of the quality system in two phases which includes auditing of Store & Purchase Activity in Phase I; and Product Testing Laboratories and Sample Receipt & Report Dispatch Unit in Phase II. In Phase I, the internal audit was carried out for Store & Purchase Activity of 10 NABL accredited Laboratories on Sep 1st & 2nd, 2016 and in Phase II, ISO/IEC 17025:2005 audit was carried out for 10 laboratories namely Biochemical Kit, Blood Grouping Reagent, Immunodiagnostic Kit, Blood Product, Enzyme & Hormone, Recombinant Product, Bacterial Vaccine (BCG & Polysaccharide), Viral Vaccine and Facilitating Units like Sterility, Animal Facility and Sample Receipt & Report Dispatch Unit by a team of NIB Internal Auditors with a defined audit schedule from December 14th – 16th, 2016.

Figure 1: Trend in Non-Conformance reported from 2013-2016 showing the sub clauses of both Management and Technical Requirements


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Figure 2: Trend in Non-Conformance reported from 2013-2016 showing the sub clauses of both Management and Technical Requirements

e. ManagementReviewMeeting

A review of the management system was conducted on March 9th, 2017 using a formal agenda whose action were to be taken in time bound manner and are based on the Input and Output Reviews. Record of the Management Review Meeting, Minutes and the Action Taken Report (ATR) are circulated.

f. AssuringtheQualityofTestResults

i. ProficiencyTesting(PT)

PT Calendar for the period 2014- 2017 has been prepared and communicated to all the concerned laboratories in the areas of chemical and biological tests to comply with the requirements of accredited scope. The calendar mainly focuses on the following test areas:

a) Potency assays by HPLC in Human Insulin and Insulin Glargine

b) Total Protein in Human Albumin

c) Moisture Content by KF Method in Various Vaccines and Biotherapeutic Products

d) Diagnostics like Glucose estimation and Serology (HIV/ Hepatitis/Syphilis)

ii. Implementation of Internal QualityControl (IQC) Checks for dataanalysis

Analysis of IQC in various test parameters of different testing laboratories under the scope of accreditation was initiated as a part of assuring the quality of test results. During this activity, QMU has prepared and circulated formats to laboratories to compile the data and for preparation of trend charts and performance evaluation of internal controls. The formats are designed as per WHO Guidelines & ISO/IEC 17025: 2005 requirements with the following components:

i. Use of Certified reference material/reference material

ii. Use of internal quality control material

iii. Replicate testing using same or different method

iv. Retesting of retained item

v. Replicate calibration using same or different method

vi. Recalibration of retained items



vii. Use of control charts using control samples

viii. Use of control charts using check standards

ix. Correlation of results for different characteristics of an item

x. Any other technique(s)

The risk based approach for any in-consistency of test results is being continuously monitored by effective mechanism of trend data by all the testing laboratories on quarterly basis.

g. Implementation of Integrated Quality,Health, Safety andEnvironment (QHSE)ManagementSystem

QHSE review meeting was organized on March 28th, 2017 by QMU with members of Cross Functional Team (CFT) to review the QHSE objectives for year 2017-18 and status of previous Internal Audit findings and Corrective Action taken and readiness for

QHSE Certification Audit to be scheduled on April 27th, 2017 (Stage-I Audit) and June 5th-7th, 2017 (Stage-II Audit).

5. ScientificServicesundertaken Trainings:

The management has formulated the goals with respect to the training. A Training Calendar has been prepared in coordination with the Training Unit, NIB, for identifying training needs and providing training of personnel. The training programme is relevant to the present and anticipated tasks of the laboratory with respect to technical and management requirements and On-Job-Specific activities.

Scientific and technical persons who are working in the areas of product testing laboratories, Engineering unit, Stores and Purchase and Quality Management Unit, have been trained, as enlisted below in Table 4.

Table4:ParticipationinTrainings/workshop/conferencesNameofScientist/Attendedby

NameofProgram DurationOrganizer&PlaceofTraining

ManagementSystems–LQMS,Quality,Health , Safety&Environment (QHSE)

Dr. Renu Jain

Mr.NeerajMalik

Mr.RajeevKumar

Workshop on ISO/IEC 17025: Revisions

14th April 2016Hotel Holiday Inn, Delhi

All therapeutics staff ofNIbalongwith externalparticipants,N=29

National Workshop on LQMS Biotherapeutics

17th – 19th May, 2016 NIB, NOIDA

Ms.GurminderbindraWorld Accreditation Day 2016

9th June, 2016India Habitat Center, New Delhi

Dr.RebaChhabra

Dr.R.K.Sharma,

Mr.N.NandaGopal

Workshop on best practices on NHM

29th-31st Aug, 2016 Tirupati, AP


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Dr.ManjulaKiran

Mr.HaritKasana

Dr.birenderKumar

Workshop on Research Methodology

29th Aug - 2nd Sep, 2016

ICGEB, Delhi

Dr. Renu JainIndia Africa Health Sciences Meet

1st-3rd Sep, 2016Vigyan Bhawan, New Delhi

Dr. Renu Jain

Ms.Gurminderbindra

Dr.MeenaKumari

4th National NCD Summit 6th Oct, 2016India Habitat Center, New Delhi

NIbStaffTrainingonColdRoomDataLogger

N=25

Operation & Maintenance of Data Logger - LISA LINE

26th Oct, 2016 NIB, NOIDA

Dr.AchlaPrasad

Dr.SanjayMendiratta

Ms.ShaliniTewari

Golden Jubilee National Conference of Indian College of Allergy, Asthma & Applied Immunology

23rd -25th Oct, 2016

Vallabhbhai Patel Chest Institute, University of Delhi, Delhi

Ms.yMadhu

Mr.PKMohapatra

Mr.PSChandranand

Mr.Md.DaudAli

Mr.KallolSaha

5th National Conclave of Laboratories

27th -28th Oct, 2016India Habitat Center, New Delhi

Dr. Renu Jain

Dr. JPPrasad

Ms.yMadhu

Dr.MeenaKumari

Mr.Pankaj Sharma

Seminar on Legal Liabilities and Possible Improvements in Accreditation System for Laboratories

5th Nov, 2016Hotel Holiday Inn, Delhi

Ms.SudhaVGopinath

External Expert: External Audit (technical) of NCC-PvPI for the year 2016 as per the requirement of QMS of PvPI.

16th Sep, 2016 IPC, Ghaziabad

NIbStaff

N=37

Internal Training on MS Word, MS Excel and MS Powerpoint

6th, 7th & 14th Feb, 2017

NIB, NOIDA

AllDiagnosticsStaff ofNIbalongwith externalparticipants,N=38

National Workshop on LQMS Diagnostics

8th -10th Feb, 2017 NIB, NOIDA



SAMPLERECEIPTANDREPORT DISPATCHuNIT

1. Lab/Division Sample Receipt and Report Dispatch Unit

2. NameofHead Dr. Reba Chhabra, Scientist-I DD (QC) i/c

3. Nameof in-charge Ms. Rashmi Shrivastava, Scientist Gr III


Dr. Manoj Kumar, Scientist Gr III (till 9th May 2016)

4. ManPower in theDivision: I. NameofScientificStaff:

Mr. Anirban Mukherjee, Junior Scientist (since 10.5.2016)

Dr. Anoop Kumar Meena, Junior Scientist (till 09.5.2016)

II. NameofTechnicalStaff:

Mr. Mohit Sharma, Lab Assistant (since 10.5.2016)

III. No.(s)ofContractualStaff:Nine

5.AimandScope: SRRDU has been functional as an independent

unit since 2008. The unit is main entry point for all the samples that are received in the institute as well as the exit point from where all the reports are dispatched. Samples of various Biotherapeutics, Diagnostics, and Vaccines are received from the National Drug Regulatory authorities as well as several government medical organizations like Indian Red Cross Society, Rajasthan Medical Services Corporation, Jammu and

Kashmir Medical Services Corporation etc. A proper turnaround time is maintained in evaluating these batches and releasing the reports.

6. Workflowof theunit The complete workflow of department

has been well documented as per ISO 17025:2005 in approved SOPs for different categories of biologicals and is an ongoing process for continuous improvement in the efficiency of the system.

All samples that are received are critically checked with respect to the essential official documents, proper temperature as per label claim, required quantities, testing fee. These checks are always as per the published and revised guidelines uploaded on Institute website.

SRRD Unit at NIB

7.Sample receipt records: In FY 2016-17, total of 2005 samples have

been received under various categories (Fig. 1). Amongst them 1832 nos. from regulatory body, 48 nos. from Government Medical Supplies, 5 survey samples, 14 legal samples and 106 as service samples were received.


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0

200

400

600

800

1000

1200

1400

1600

1800

2000

Regulatory Government Survey Legal Service

1832

485 14

106

Total samples received in NIB

Figure 1: Total no. of samples received in NIB

Total 1832 samples are received by regulatory bodies which have been divided in two parts; diagnostics and therapeutics featuring the sample category of indigenous and imported as given in Fig 2.

0

100

200

300

400

500

600

700

800

900

1000

IndigenousImported

IndigenousImportedDiagnostics

Therapeutics

141

571

197

923

Figure 2: Indigenous and imported samples received in NIB

In financial year 2015- 16, total no. of type of biologicals were 177 and it got increased to 185 in financial year 2016- 17. (Fig. 3)



172

174

176

178

180

182

184

186

FY 2015-16

FY 2016-17

177185

Figure 3: Number of types of biologicals

8.SamplesEvaluatedand report released:a) Total 1900 reports were released in financial year 2016-17. Figure 4 shows the turnaround time

taken by laboratories in evaluating the samples from two categories vis-à-vis Therapeutics and Diagnostics. As per the regulatory guidelines, all the biologicals that fall into the category of C and C1 class of drugs should be evaluated within 90 days and others within 45 days of turnaround time.

745

3

Diagnostics- TAT- 45 days

DIAGNOSTICS WITHIN TAT

DIAGNOSTICS ABOVE TAT

1131

21

Therapeutics-TAT- 90 days

THERAPEUTICS WITHIN TAT

THERAPEUTICS ABOVE TAT

Figure 4: Turnaround time (TAT) from sample receipt till release of report

The figure 5 shows the quality of biologicals divided in Standard Quality and Not of Standard Quality within respective categories of Therapeutics and Diagnostics.


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0

200

400

600

800

1000

1200

SQ NSQ SQ NSQ

DIAGNOSTICS THERAPEUTICS

736

12

1149

3

Figure 5: Quality of Biologicals reported to be of Standard Quality (SQ) and not of Standard Quality (NSQ)

9. SampleStorageandRecordKeeping Retained samples are stored in designated

cold rooms of the Unit or at room temperature at different location depending upon the label claims of sample. There is one walk-in cold room of 2-8°C and one -20°C. Samples are stored as per the location assigned and displayed on the main door of cold room.

All the necessary details are entered in the register. Samples from the retained lot are issued as per the lab request for different purposes like training etc. All the necessary records are maintained in the register. Complete unit is under CCTV surveillance for necessary security and maintenance of samples and records.



TRAININGuNIT

1.Lab/DivisionTrainingunit

2. NameofHead Dr.RebaChhabra,Scientist-IDD(QC)i/c

Diagnostics&Training

3. Manpower in theLab/Division: I. NameofScientificStaff Dr Richa Baranwal, Scientist Grade-III,

I/cTraining Unit Mr. Jaipal Meena, Scientist Grade-III Mr. N. Nanda Gopal, Scientist

Grade-III Dr. Manjula Kiran, Junior Scientist. Mr. Sanjeev Kumar Sharma, Junior

Scientist Dr. Anoop Kumar, Junior Scientist II. NameofTechnicalStaff: NIL III. No.(s) ofContractualStaff: One

4. Aim&Scope: The training unit of National Institute of

Biologicals (NIB) comprises of the scientific staff of the Institute- who, along with their scientific duties are given additional responsibilities to function for synchronizing and implementing the training related activities of the Institute. The training unit functions in line with NIB mandate 3.1.3 as laid down in Memorandum of Association. NIB imparts trainings to regulatory officials, manufacturers, industries, notified Government Analysts, blood bank officials and post graduate students for building up the ‘National Talent Pool of Skilled and Trained Manpower’ for indigenous manufacturing, domestic consumption and

export of biologicals which is expected to increase significantly year over year and also in Quality Control of Biologicals in Government and Private sector which will help to bridge the gap as there is an acute shortage of skilled and hands-on trained manpower in the field of Biologicals.

5. TrainingActivitiesundertaken: Details of trainings conducted by the Training

Unit are placed in the “Training Section” of the annual report.

5.1 Training to blood bank officials withNationalHealthMission(NHM)

Blood Services are a crucial component of curative healthcare amenities. Adequate and safe supply of blood and blood components is essential to enable care of critical patients in the hospitals. The mission of the “Blood Cell” under NHM is to develop a coordinated long term action plan for the development and integration of diverse activities in the area of blood banking with a careful consideration of priorities and optimal use of resources and funds to ensure effective blood services in the country.

NIb in collaboration with NHM, has conducted a series of three training programmes on “Six Days ResidentialTraining of blood bank Officials for thestate of Odisha” in three batches with total 79 participants for Govt. Blood Bank Officials at NIB, NOIDA, for technical support in Strengthening Blood Services in Odisha in the following areas:

i. EQAS for Transfusion Transmitted Diseases and Blood Group Serology


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ii. Training for Use of Cell counters and It’s Quality Assurance

iii. Haemovigilance training (Blood Bank Officials/Clinicians/Donors)

iv. Analysis of gaps in Blood Bank Management

v. Total Quality Management Systems

vi. The objective of the training is to improve the standards of Blood Banks and the Blood services in our country.

This initiative will facilitate in building up a “National Talent Pool of Skilled andTrained Manpower” to improve better quality, safety and efficacy of blood and blood products, well-equipped blood centers with adequate infrastructure, the requirements of current Good Laboratory Practices (GLP) and strengthen TotalQualityManagementSystem.

The training programs have helped blood banks of our country in improving their standards and thereby providing excellent and high quality services for safeguarding public health in our country.

5.2 “Training of Trainers for e-Rakt KoshSoftware Training & Strengthening ofbloodServices”

NIB in collaboration with NHM, Government of India, conducted six day residential training programme on “Training of Trainersfor e-Rakt Kosh Software Training &Strengthening of blood Services” for 11 Blood Bank officials of the states; Assam, Bihar, Chhattisgarh, Gujarat, Jharkhand, Madhya Pradesh, West Bengal, Uttarakhand, Uttar Pradesh, Tamil Nadu and Telangana. The programme aimed at strengthening

blood services in these states in the areas of e-Rakt Kosh software for transparent & streamlined workflow of the blood services, transfusion transmitted diseases, blood group serology, equipment maintenance & their quality assurance, haemovigilance training, analysis of gaps in blood bank management and total quality management system.

5.3 NationalworkshoponLaboratoryQualityManagementsystem(LQMS)inDiagnostics

NIB, NOIDA, in collaboration with Clinical Development Services Agency (CDSA), DBT conducted National Workshops at NIB in the area of Diagnostics with the objective to make the participants aware about the basics of LQMS, so that they can enhance their quality deliverables while working in the area of Diagnostics. The participants were selected from National level, and most of them belonged to manufacturing, quality control and quality assurance departments; academic institutions and regulatory bodies.

The participants were made aware of:

i. Understand all applicable global standards of Quality systems and product specifications for evaluation of diagnostics.

ii. Basics of Laboratory Quality Management System (LQMS) and address the following key areas:

a) The role of National Control Laboratory (NCL) in lot release.

b) Need for LQMS and key steps in its implementation, organisation and Responsibilities of key staff, Personnel & Premises, Management Requirements, Technical Requirements and Quality Risk Management



c) Comprehend analytical control strategy and expectations

d) Understand the role of National Control Laboratory (NCL) in lot release

e) Importance of Reviewing the Manufacturers & NCL test data

f) To be able to accurately interpret the Quality Control Plan

g) Be aware of all global Reference Standard Quality systems

h) To be able to assess the magnitude and direction of error, when results are OOS (out of specification), documents, records, standard operating procedures involved in establishment of processes.

5.4 Training of students from variousuniversitiesatNIbunder“NationalSkillDevelopment & Hands-on-Training onQualityControlofbiologicals”program

Keeping in mind the Honourable Prime Minister of India, Shri Narendra Modi’s, “Pradhan Mantri Kaushal Vikas Yojana

(PMKVY)” which emphasizes on Skill Development, the institute provided training on “National Skill Development and Hands-on Training in Quality Control of Biologicals” for M.Sc. Biotechnology, M.Sc. Biochemistry and M.Sc. Microbiology students of North East (N.E.), Guwahati University, Universities of Jammu, Himachal Pradesh, Uttarakhand and CRI, Kasauli and M. Pharma students of NIPER Kolkata, Mohali, Guwahati and JSS Ooty, Mysore.

The objective of this training programme was to develop and enhance analytical skills and technical knowledge of M. Sc. Biotechnology students and M. Pharma students through Hands-on Training in Quality Control of Biologicals in NABL accredited and CDL notified laboratories of Biotherapeutics, Diagnostics and Vaccines in techniques like HPLC, Electrophoresis, ELISA, Bacterial Endotoxin testing, Cell culture aseptic handling, sub culturing and maintenance, cell line based potency assays, animal handling, use of laboratory animals in QC testing of Biologicals and to create awareness about global scenario of drug testing.

Release of Blue & Green Book on Laboratory Quality Management System- Diagnostics


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5.5TrainingofPostGraduateStudents fromdifferentuniversitiesatNIb.

The institute provides 4-8 weeks training programme and 3-6 months dissertation/project work in Quality Control of Biologicals in various NIB laboratories to Post Graduate Students of various universities and institutes. The training on various analytical platforms makes them proficient, help in their future research endeavours and enable them to get good job opportunities.

5.6 Training to Manufacturers/Industryrepresentatives and notified GovernmentAnalysts

A training programme under the collaborative initiative of ‘Strengthening of Food & Drugs Regulation including Testing Laboratories in the State of Punjab’ was conducted at National Institute of Biologicals over a span of five days, for 2 Analysts from Food & 1 from the Drugs Sections on Analytical Techniques, Laboratory Quality Management System (LQMS) and working knowledge in the Online Sample Tracking Applications for Quality Control for evaluation of the products.



HAEMOVIGILANCEPROGRAMMEOFINDIA(HVPI)

Haemovigilance Programme of India (HvPI), at the national level, was launched on 10th December 2012 by National Institute of Biologicals (NIB), NOIDA, Ministry of Health & Family Welfare, Government of India, as the National Coordinating Centre (NCC) in 90 medical institutions within the country. The aim of this program is to track Adverse Reactions associated with Blood Transfusion and Blood Donation. Implementation and coordination of activities of Haemovigilance Programme of India is one of the mandates of NIB as per its bye-laws 3.4.1 as approved by the Governing Body of the Institute chaired by Secretary (Health & F.W.)/Chairman, Governing Body of NIB. Presently, 514 centres located in Blood Banks, Medical Colleges/Institutions, Govt./Private Hospitals are enrolled under this program. Data in Transfusion Reaction Reporting Form (TRRF) from various centres across the country enrolled under HvPI is being collected through software, Haemo-Vigil indigenously developed by IT Cell of HvPI. Till 30th April 2016, about 3807 Adverse Transfusion Reaction Reports have been reported by the Centres under HvPI all over the country. The analysis of transfusion reaction reports for the period from 24th January 2013 to 30th April

2016 has been reviewed, analyzed by Quality Review Panel of HvPI, the report in this regard has been prepared and will be submitted to ministry. Under ambit of HvPI a National Blood Donor Vigilance Programme (NBDVP) was launched on 14th June, 2015 on World Blood Donor Day at Science City, Kolkata “to track Adverse Reactions associated with Blood Donation in the country”.NCC-HvPI, NIB has so far organized 29 CMEs across the country & trained about 5550 participants which includes blood bank officials, clinicians, nurses & blood bank technical staff.

1. ActivitiesunderHvPIduring2016-17

1.1 Meetings/TrainingWorkshopsConductedfor CMEs: NIB under Haemovigilance Programme of India (HvPI) organized 04 CMEs across the country during this period & trained about 650 participants which included blood bank officials, clinicians, nurses & blood bank technical staff in reporting of Adverse Transfusion Reactions to National Coordinating Centre at NIB.

Haemovigilance Programme of India (HvPI) organized 04 CMEs across the country


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Quality Review Panel & Signal Review Panel meeting under HvPI

1.2.2Meeting of HaemovigilanceProgramme of India was held under the chairpersonship of Prof. Neelam Marwaha, Head, Department of Transfusion Medicine, PGIMER, Chandigarh on 20th January, 2017 at NIB, NOIDA w.r.t. review of quality of data submitted by the Reporting Centres in the revised Transfusion Reactions Reporting Forms and Donor Vigilance Forms and to prepare the report of transfusion reactions reported earlier via Haemo-Vigil by the various Reporting Centres for the period from January, 2013 to April, 2016 to be submitted to the Ministry of Health and Family Welfare.

1.2.3Meeting of Core Group-HvPI: The Meeting of Core Group-Haemovigilance Programme of India was held under the chairpersonship of Dr. Surinder Singh, Director, National Institute of Biologicals, NOIDA on 12th April, 2017 w.r.t. installation of a Toll-

Free number for HvPI by this year end, to discuss about the quality of new reports submitted by the Reporting Centres via new Haemo- Vigil & Donor-Vigil Software, the strategies to create awareness about safe blood transfusion practices amongst various stakeholders & also to establish a Regional Haemovigilance Network platform among the neighbouring countries i.e. Bhutan, India, Nepal, Bangladesh and Sri Lanka.

1.3Workshops: 1.3.1 Two Days National Workshop

on Voluntary blood Donation forPreparingRoadMap forAchieving90-100% True Voluntary bloodDonation in India was organized by NIB, NOIDA in collaboration with Federation of Blood Donor Organizations of India (FBDOI), West Bengal on 4th & 5th March, 2017 at NIB. 100 blood donor motivators & organizers from all across the country had participated in the said workshop.

1.2 Meetings:

1.2.1 Meeting of Quality Review Panel& Signal Review Panel underHvPIheld on 11th & 12th May, 2016 respectively at National Institute of Biologicals, NOIDA to analyze

quality and completeness of data in the Transfusion Reaction Reporting Form (TRRF) submitted to National Coordinating Centre (NCC), NIB & to interpret the potential signal detected from the submitted data.



Participants of National Workshop on Voluntary Blood Donation

1.3.2 InNorthEastTwoDaysWorkshoponHaemovigilance,DonorVigilance&VoluntarybloodDonationwas held on 24th & 25th March, 2017 at Agartala in collaboration with Federation of Blood Donor Organizations of India, West Bengal & Tripura State Blood Transfusion Council. About 120 participants including Blood Bank Officials, Blood Donor Motivators

& Regulators had attended the said workshop.

1.3.3 Shri. Bhanualal Saha, Hon’ble Finance Minister, Govt. of Tripura had inaugurated the workshop on 24th March, 2017 and Shri Manik Sarkar, Hon’ble Chief Minister of Tripura had graced the CME as Chief Guest on the closing day i.e. 25th March, 2017.

Workshop on Haemovigilance, Donor Vigilance & Voluntary Blood Donation


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1.4LaunchofSoftwaresunderHvPI:

• New Version of Haemo-Vigil Software launched on 1st May, 2016.

• National Blood Donor Vigilance Software i.e. Donor-Vigil Software launched on 14th June, 2016 during CME on Voluntary Blood Donation on World Blood Donor Day organized by NIB in collaboration with FBDOI at Darjeeling.

CentresEnrollment&ReportingofTransfusionReactions: 175 new centres have been enrolled under HvPI during this period & NCC, NIB have received a total 1383 Transfusion Reaction Reporting Forms by the centre via Haemo-Vigil Software and reports received with respect to reactions associated with blood donation via Donor-Vigil Software is about 1354 during this period.Collaboration with bhutan: A 13 member delegation of Blood Technical Advisory

Committee (BTAC) Members, Blood Bank and Nursing Staff of Bhutan visited NIB, India from 19th to 21st October, 2016 for 3 days workshop w.r.t. study Haemovigilance Programme of India & establishment of Haemovigilance system in Bhutan. Subsequent to this, NIB officials had undertaken visit to Bhutan from 07th to 11th November, 2016 with regard to INDO-bHuTANCME on Haemovigilance for EstablishmentofHaemovigilance System inbhutan. IT Cell of HvPI had developed a dedicated Haemo-Vigil Software for Bhutan for this visit as per Bhutanese request which was officially handed over to Bhutan on the last day of the CME i.e. on 11th Nov, 2016. Further, hands-on Training on the Haemo-Vigil Software developed for Bhutan was imparted to the Blood Bank officials of Bhutan by NIB. Subsequently a software manual for the usage of this software has also been developed by NIB & handed over to Bhutan.

NIb,HaemovigilanceTeaminThimphu,bhutanfrom07th-11thNovember,2016toestablishHaemovigilanceSysteminbhutan

Honorable Secretary, Ministry of Health & Family Welfare, Govt. of India has received a letter from Secretary, Royal Government of Bhutan, expressing his sincere gratitude for providing all necessary support in building institute and capacity of their health professional

on Haemovigilance Programme. Further, in his letter he stated that this was possible because of unwavering support that they received from the NIB. To further strengthen the Haemovigilance Programme they have proposed a formal collaboration between NIB & Royal Centre for



Disease Control, Bhutan to strengthen evaluation of Transfusion Transmissible Infections (TTI) Test Kits. Recently Ministry of Health & Family Welfare, Govt. of India has accorded approval in this regard.InternationalHaemovigilanceNetwork(IHN):India is a member of IHN since December 2014.

During the said period Officer In-Charge of HvPI was invited to join as a Board Member of IHN. Presently she is one of the Board Member of IHN.NewsletterPublications: HvPI division pub-

lished 2 newsletters during this period.

Volume: 5, Issue: 9, January-June, 2017Volume: 4, Issue: 8, July-December, 2016


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INFORMATIONTECHNOLOGyCELL

1. Division InformationTechnologyCell

2. NameofHead Dr.RebaChhabra,ScientistGrI

3. Manpower in theLaboratory: I. Name of Scientific & Technical

Staff

Ms. Rashmi Shrivastava, Scientist Grade III (Since 4th Jan 2017)

Mr P.S.Chandranand Junior Scientist (Since 4th Jan 2017)

Mr Deepak Mahajan, Computer officer

II. No.(s)ofContractualStaff:One

4. IT enabled services undertakenduring theyear2016-17:

a) Digitizationoftechnicalrecords

The Institute intends to make significant progress to achieve a paper-free office in all its Divisions/Sections/Laboratories in the next two years. In this regard, initiative was taken in the Sample Receipt and Report Dispatch (SRRD) Unit to digitize the Scientific & Technical Records from the year 2009 to 2017. A limited tender enquiry was floated by the Institute for Scanning & Digitization of Scientific & Technical Records of the Institute. The service agency has scanned & digitized 741,776 records of the SRRD Units. All the scanned & digitized records had been linked with Sample Tracking System.

b) SecurityAuditforWebbasedapplications:

A limited tender enquiry was floated by the Institute for Security Audit of the Institute Website i.e., http://nib.gov.in, Sample Tracking module, inventory module, Hemovigil and Donorvigil software. The security audit was conducted as per Govt. of India guidelines from CERT-IN empanelled auditors and submitted its compliance audit report and certificate to National Informatics Centre (NIC). The Cyber Security Division of NIC has also conducted the compliance audit and notified that the website of the Institute has gone a third-party audit for web application security vulnerabilities and has been declared safe for hosting.

c) NetbankingFacility

The IT Cell has implemented the integration of Net-banking facility with Sample Tracking System for online deposit of testing fee. Daily Dispatch of Reports. IT Cell receives the Final reports of quality control evaluation of biologicals to upload on the Institute’s website under the header “Daily Dispatch Report”. This work has been completed satisfactorily.

Further, the first phase of recruitment of manpower (Two Technical Associates-software) for in-house software development has been completed.



INTERNATIONALCOOPERATION

a) NIb’sEngagementwithWHO:

• Dr.uteRosskopf,ScientistWHOandDr.ChristinaVonHunolstein,Director,bacterial Vaccine unit CRIVIV-ISSRomeItaly visited NIB from 21st -23rd February 2017, to discuss, oversee and finalize the arrangements to be made for the forthcoming Second WHO Global Network of National Vaccine Control Laboratories (GNNVCL) meeting and training workshop to be held at NIB as here under:

• 23rd-27th October,2017: One week Hands on Training workshop on potency testing of Hib Vaccine will be held at Bacterial Vaccine Lab of NIB for six scientists of three Indian manufactures viz. M/s Zydus Cadila, M/s Shanta Biotech and M/s Bharat Biotech in collaboration with WHO and CRIVIV-ISS Rome.

• 31st October to 2nd November,2017: Second WHO Global Network of National Vaccine Control Laboratories (GNNVCL) for 24 countries and 2 WHO contract laboratories meeting will be held at NIB. The first meeting of GNNVCL was held in Netherlands from 30th August 2016 to 2nd September 2016. Further Dr. Singh, Director, NIB is one of the four members of the interim steering committee of WHO initiative of GNNVCL.

b) NIb’sEngagementwithbhutan:

• Institute is extending its services in establishment of Haemovigilance system to Bhutan. Further, Secretary (MoHFW) Govt. of India has received a proposal dt. 9th January, 2017 from Secretary Health, Royal Government of Bhutan appreciating NIB’s support in building institution and capacity of their health professional on Heamovigilance Programme. Further he has requested that NIB may extend technical support to setup a Transfusion Transmitted Infection (TTI) test kits evaluation Capacity at Royal Centre for Disease Control, Thimphu, Bhutan.

c) NIb’sEngagementwithAfricanCountries:

• Haemovigilance Programme of India: A request via mail dated 16th January, 2017 has been received from Ethiopia to extend NIB’s support for Haemovigilance System in their country. As desired NIB has forwarded the documents to them which will aid in establishing their Haemovigilance System. The Ethiopian Counterpart is in constant dialogue with officer In-charge of Haemovigilance Programme of India via email in this regard.

• Director NIB apprised the committee members that NIB vide letter No.1/Dir Off/2016-17/NIB/ 3114 dated 31.01.2017 addressed to Sh. Sudhanshu Pandey, IAS, Joint Secretary, Department of Commerce, Govt. of India has identified the following four


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areas regarding NIB’s engagement with Africa:

• Skill development in Quality Control Testing of Biologics

• Establishing ISO 17025 compliant Laboratory system

• Establishment of National Control Laboratory for testing of Biologicals

• Haemovigilance Programme

• Further, Hon’ble High Commissioner of Embassy of Zambia during “Ambassadors’ Meet” at Taj Mahal Hotel, New Delhi, expressed to Director, NIB, the willingness to visit NIB in the month of March, 2017 to identify the areas of cooperation between Health agencies in Zambia and NIB.



ELECTRICALANDMECHANICAL ENGINEERINGWORKS

The NIb campus specifically Laboratory &Animal House building is complementedby various engineering services/facilities/installation to facilitate the day to dayscientific activities. The detailed informationabout thevariousengineeringworks/services/facilities and installations undertaken duringtheFinancialyear2016-17 is asunder: 1. Up-gradation of Sterility Lab. At ground

floor of Laboratory Building.2. Renovation of Guest House in NIB Campus

NOIDA.3. Renovation of Heamovigilance Coordination

Division, at NIB, NOIDA.4. Conference Hall, Audio-visual Systems in

Laboratory Building.5. Administration of various Electrical and

Mechanical engineering services/facilities installation of day to day operation and maintenance & repairing, which are provided/installed in the various buildings/ areas of NIB Campus.

6. Repair works of Transformer 33/11kV of electrical power system.

7. Installation of Wireless Data Logging system in All Cold rooms, Incubators installed in Lab & Animal House Building to M/s. HLL, NOIDA.

8. Co-ordination with CPWD for undertaking STP/ETP plant.

9. Energy Audit work to M/s. FICCI.

Apart from the above the Institute has finalized the services contracts for annual operation & maintenance contract and AMCs/CMCs of the following Engineering Services/facilities and

fixed scientific equipment during the financial year 2016-17:1. Award of operation and maintenance contract

for the Institute’s 33/11kV electrical power system through open tender process.

2. Award of operation and maintenance contract for internal electrical services, installed in the Laboratory & Animal House Building complex through open tender process.

3. Operation and comprehensive maintenance contract for fire-fighting system, water supply system, water softening plant system, neutralization system including centralized water softening plant of the Institute.

4. Operation and maintenance contract for CCTV Surveillance system and Access Control system installed in various building/ locations/areas of the Institute.

5. Operation and maintenance contract for HVAC plant System including Window/ Split Cassette and package type AC units installed in various buildings of the Institute.

6. Operation & maintenance of 3x2.8T/Hr at 10.5kg/Sqcm Steam Generating Boiler including Economizers and allied accessories etc.

7. Operation and maintenance of 20 Nos. Walk-in-cold Rooms, Constant Humidity Chambers and Environment Rooms, installed in the Laboratory & Animal House Building.

8. Operation and maintenance contract for Sterilizers, Glass Washers, Glassware Dryers, Tunnel Washers and Case & Rack Washers installed in the Animal House facility of the Institute.


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9. Operation and maintenance contract for centralized R. O. Plant system installed in the Laboratory & Animal House.

10. Repair and maintenance of the following engineering installation/facilities/fixed scientific equipment under AMC/CMC contract with OEM or their authorized service agency in India, which are installed in various buildings/areas of the Institute namely: Elevators/Lifts, Centralized UPS system, Electrical appliances, LED Signage, Telecommunication/EPABX system/PRI lines services, Bio-Safety Cabinets & Laminar Air Flow Stations, Under Counter Freezers, Chemical Fume Hoods, Refrigerators and Bio-waste Disposal including follow up with external agencies/departments like BSNL, PVVNL, U.P. Pollution Control Board and NPC & PESO (formerly Department of Explosives, Government of India) respectively for environmental & safety consent orders.

Civilworksundertakenduring theyear:

1. Providing interior setup and furnishing for setting-up of Haemovigilance Division at 2nd Floor of the Administrative Building.

2. Providing interior setup and furnishing of Sample Receipt and Report Dispatch (SRRD) Unit in the Laboratory Building.

3. Coordination for signing of MoU between NIB and M/s HITES for execution of works for “Conversion of Ground Floor of Library Building into Class Rooms”.

4. Maintenance works (Painting, repairs etc.) in all the three floors of Animal House.

5. Installation of outdoor signages for Roads and Buildings of the Institute.

6. Provided controls, checks, systems and documentation as per ISO requirements for QHSE Audit/Certification.

7. Complete support for repairs & maintenance of all Buildings (area of Buildings more than 35,000 Sqm.), services and Institute campus.

8. Coordination and follow up with CPWD, for installation of Effluent Treatment Plant (ETP) and Sewage Treatment Plant (STP).

9. Provided complete support for various Trainings and Workshops of CDSCO, NHRM, Drugs Survey, Haemovigilance etc. held in the Institute.

10. Renovation of Two model Suites in the Guest House.



NATIONALDRuGSuRVEy

THECOREEXPERTCOMMITTEE

This report would not have been possible without the thought leadership and guidance of Members of Drug Survey—Core Expert Committee:

Dr.SurinderSinghDirector,National Institute of Biologicals,NOIDA.

Dr.G.N.SinghDrugs Controller General of India and Secretary- cum-Scientific Director, Former Dy. Drug Controller, Indian Pharmacopoeia Commission, Central Drugs Standards Control Ghaziabad.

Dr.G.SelvarajFormer Director Drug Control, Tamil Nadu.

Dr.R.A.Singh NewDelhi.Director,Regional Drugs Testing Laboratory, Chandigarh.

Dr.ShaktiKumarGuptaMedical Supdt. and Head of Department, Hospital Administration,AIIMS, New Delhi.

Dr.bikashMedhi Professor, Department of

Pharmacology,PGIMER, Chandigarh.

Shri.P.D.ShethFormer Vice President,International PharmaceuticalFederation (FIP),New Delhi.

Dr.D.RoyDrugs Controller General of India and Secretary- cum-Scientific Director, Former Dy. Drug Controller, Indian Pharmacopoeia Commission, Central Drugs Standards ControlOrganisation,New Delhi.

Sh.bejonKumarMisraFounder,Partnership for Safe Medicine-India,New Delhi.

Dr.G.ParthasarthiProf. & Dean, Faculty of Pharmacy,JSS University,Mysore.

Dr.AkankshabishtScientist-III and Officer In-charge,Drug SurveyNational Institute of Biologicals,NOIDA.


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PREFACE

The Indian Pharmaceutical Industry is presently the third largest in the world (volume wise). In terms of value, the size of the industry is approximately Rs. 200,000 Crores (USD 30 billion), out of which more than half is exported to different countries across the globe. The Indian Pharmaceutical sector has shown an exponential growth over last 10 years. The growth of the sector over a short period of time has thrown up challenges for up scaling the regulatory structure in the country. Availability of quality medical products, especially drugs is important from the perspective of health of the consumers. NSQ drugs may lead to not only sub-therapeutic dosage, but also give rise to anti-microbial resistance which is a major health concern.With such a large domestic pharmaceutical market, circulation of Spurious and Not of Standard Quality Drugs (NSQ) can lead to grave and adverse consequences for both consumers and Drug manufacturers. Spurious and NSQ Drugs is a patient safety issue as it can challenge quality of treatment, lead to emergence of drug resistance, spread of diseases and cause economic burden on the society. It is a shared responsibility of all stakeholders to tackle the challenges of Spurious and NSQ Drugs.In March 2014, a project report prepared by National Institute of Biologicals (NIB) was submitted to the Ministry of Health & Family Welfare, Government of India to carry out a National Survey for estimation of the extent of problems of Spurious and NSQ Drugs in the country. In April 2014, the Ministry of Health & Family Welfare accorded in principle approval for undertaking the Survey under the overall supervision and guidance of the Director, NIB and subsequently, on 28th July 2014, the Ministry

approved the conduct of the all India Survey in the country at an estimated cost of Rs. 8.5 Crore (USD 1.25 million).To plan and undertake this National Drugs Survey, the NIB constituted a Core Expert Committee, a Consultative Expert Committee and a Statistical Design Committee with their Terms of References. A unique, innovative and cost effective AKS-Drug Survey Software was developed in-house at NIB to facilitate collection, collation, segregation, analysis and retrieval of Drug Survey data. The software mapped sampling activities of the Sample Drawing Officers (SDOs) in the field and facilitated track and trace of drugs samples at various stages of Drug Survey.The execution of the Drugs Survey began with a Pilot Study in the National Capital Region (NCR) in January, 2015. This study was statistically designed by the Indian Statistical Institute (ISI), Hyderabad. In all, 212 samples were drawn from 37 retail outlets and subjected to test/analysis at the Indian Pharmacopoeia Commission (IPC) Laboratory at Ghaziabad. Four samples were declared NSQ and none was found to be spurious. Feedback from the Pilot Study was used to improve Drugs Survey design, Data Collection Forms and AKS-Software.Thereafter, the main countrywide Drug Survey was rolled out across the country in April, 2015 and 47,954 samples were drawn from retail outlets, Government Sources and Ports by 932 Sample Drawing Officers (SDOs) from States/UTs and 13 from CDSCO. All the 47,954 samples received at NIB were physically examined by trained Drugs Inspectors of CDSCO. Of these, 47,954 samples drawn under the Survey, 633 samples (1.32%) were found to be out of list of the selected 224 molecules. Further, 309 Drugs



samples (0.64%) were found either damaged or lost in transit. These samples were retained at NIB and the balance 47,012 Drugs Samples were subjected to test & analysis as per the prescribed Pharmacopoeia and sent to 10 Central/State Government Drugs Testing Laboratories in accordance with the decision taken by the Ministry of Health & Family Welfare, Govt. of India.Based on a review of 47 Global Drugs Quality Surveys published between 1992-2015, it was found that this Survey had several unique features. Firstly, the statistical design of the main Drug Survey included as many as 224 Drug molecules belonging to 15 different therapeutic categories of National List of Essential Medicines (NLEM) 2011. Secondly, as part of this Survey, 47,954 drug samples from 23 dosage forms in 654 districts of 36 States and Union Territories were drawn. Thirdly, IT driven AKS software exclusively developed in-house at NIB to monitor activities of the Survey. Fourthly, a nationwide training in drugs survey methodology was imparted in 28 centres to more than 1800 Sample Drawing Officers (SDOs) and representatives of Civil Society/Pharmacy Council of India (PCI). The role of the Civil Society/Pharmacy Council of India (PCI) representatives was to observe the process of drawing drugs sample by SDOs in accordance with the sampling methodology. An animated training module was specially prepared to facilitate the training. Fifthly, the Survey covered the legitimate supply chain which included drawing of 33,656 samples from 5717 Retail Outlets, 8369 samples from 1421 Government Sources and 4987 samples from 8 air/sea ports. It is pertinent to mention that 38.8% of the samples were drawn from rural areas of villages and Taluk Headquarters. Sixthly, all the

samples were subjected to test/analysis as per pharmacopoeia requirements.

ObJECTIVES

TheSurveywasconceptualisedtofindanswerstothefollowingquestions:

• What proportion of samples fail in quality testing?

• What proportion of samples at different points of regulated and informal distribution chain fail quality testing?

• What proportion of samples at geographical regions fail quality testing?

• What specific quality tests do the samples fail?

• Are any of the deficiencies critical i.e. could they substantially affect treatment efficiency and / or cause harm to the patient etc.?

basedonthequestionsposedabove,followingobjectivesweresetfortheSurvey:

• Estimate proportion of specific critical quality standards at different points of supply chain

• Estimate proportions of Spurious and not of standard quality Drugs (NSQ) in the country

• Identify possible causes of findings

• Propose possible strategies and implementation plan to address the problems identified.


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DRuGSuRVEySTAKEHOLDERS

Figure 1: Various stakeholders of Drug Survey

MOH&FWNIb CDSCO

GOI

StateDrugsPSM-India PCI

Controllers

NIMS- ISI,Kolkata/ Central/StateGovt.

ICMR/NSSO Hyderabad DrugsTestingLabs

IPC

uNIQuEFEATuRES

In many ways, this “Survey of Extent of Spurious and Not of Standard Quality Drugs in The Country” was first of its kind conceptualised to understand the quality of Drugs being sold in the domestic market. The outcome of the Survey would help in gathering evidence for regulatory purpose, better enforcement and coordination between Central and State Drug regulatory

authorities. It should also show exact picture about the quality of medicines in domestic market and thereby offer opportunities for improvement. Above all, a periodic exercise of this type at state as well as national level based on methodology employed would instil confidence in consumers about quality of medicines.



The followingare theunique featuresof thisNationalDrugSurvey:


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To fulfil the objectives, the Survey design took into considerations all imaginable situations in the country as vast and diverse as India with large manufacturing base and distribution points. These features made the Survey unique which

can serve as a model for conducting similar Surveys not only in India but countries across the globe and were taken into consideration while conceptualizing the Drugs survey.

SuMMARyOFFINDINGSSurveyAspectsThe survey was conducted to assess the quality of drugs pertaining to the formulations under 224 molecules selected from the National List of Essential Medicines-2011. As per the objectives, the survey was conducted for three sources, namely, Retail Outlets, Government sources and Ports. The results of the survey are summarized below:

a) 33,656 drug samples drawn from 5,717 Retail Outlets and 8,369 samples drawn from 1,421 Government sources were subjected to laboratory test/analysis. In the case of Ports, 4,987 samples drawn from 1708 consignments from 8 ports were subjected to laboratory test/analysis.



b) The total number of samples drawn from 3 sources together was 47,012 from 183 different molecules of which 46 molecules accounted for nearly 80% of the samples. About 33% of the samples were drawn from Municipal Towns, 26% from Villages, 23% from Corporation Areas, 13% from Taluk headquarters and 5% from Metropolitan Cities.

c) For Retail Outlets and Government sources, the samples were selected based on the 3-stage survey design. One of the main hurdles in the selection of samples was in the first stage sampling where the sources were to be selected from the list of retail outlets and government sources. The major difficulty faced here was that the lists of sources with addresses were not readily available, and some States could only provide the number of sources. This was an important area where the State Drug Authorities need to improve their databases for future needs. Despite the problem of getting complete list of sources with their addresses, the selection of sources was tackled with reasonable satisfaction due to untiring efforts of NIB in obtaining the lists to the maximum extent possible.

d) In terms of obtaining samples from the randomly selected sources, the execution has been reasonably satisfactory. In about sixty percent of the cases, the samples were actually drawn from the specified locations. However, in case of five states (Manipur, Andhra Pradesh, West Bengal, Sikkim and Telangana), it was observed that there were problems in obtaining samples from assigned sources. The reasons for this may be investigated. The inclusion of

representatives of Civil Society /Pharmacy Council of India in the sample collection teams was specifically designed to neutralize any biases that might arise due to aberrations of this kind.

e) The implementation of second stage sampling, the molecule selection at the sources, was taken care by the very design itself by providing the random lists of molecules for each Source independently. In the third stage one formulation was selected from each selected molecule using the prescribed method of random sampling.

LabTestResultsandQualityofDrugsThe total number of samples tested was 47,012 of which 33,656 were from Retail Outlets, 8,369 were from Government sources and 4,987 were from Ports. About 80% of the samples drawn From Retail Outlets and Government sources were Tablets. The total number of tests performed such as identification, dissolution, assay, etc., were 69. Of these, all tests were not applicable to all formulations. The main results of the analysis of lab tests are summarized below:

National Survey NSQ and SpuriousDrugsDatabase

a) Out of the 47,012 samples tested, 13 samples were found to be Spurious and 1,850 samples were found to be NSQ. Therefore, the estimated percentage of NSQ Drugs in India is 3.16% and of Spurious drugs is 0.0245%.


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RetailOutletsa) Total 1,011 samples out of the 33,656

samples tested from Retail Outlets were found to be NSQ and 8 samples were found to be Spurious

b) The estimated percentage of NSQ formulations from Retail Outlets in India is 3% and is not expected to be more than 3.19% (the upper 95% confidence limit), and the estimated percentage of Spurious drugs from retail outlets is 0.0237%.

c) State wise, NSQ percentage estimates for Retail outlets varied from 0 to 8.82% percent (with the exception of Lakshadweep); Three States/UTs i.e.

Andaman and Nicobar Islands, Dadra and Nagar Haveli, Goa had 0% NSQ. Fourteen States/UTs had NSQ percentage below the national average of 3% for Retail Outlets. Eighteen States had NSQ percentage above the national average of 3% for Retail Outlets. States/UTs like Mizoram, Nagaland, Meghalaya, Manipur, Tripura, Puducherry, Gujarat, and Punjab were on the higher side of NSQ (4.20 – 8.82%) whereas, States/UTs

like Andaman and Nicobar Islands, Dadra and Nagar Haveli, Goa, West Bengal, Delhi, Jharkhand and Kerala were on the lower side of NSQ (0 - 1.97%).

d) The total number of non-compliance out of all tests of all samples from Retail Outlets was 1,251. Out of 69 tests performed on these samples, they failed in 28 tests, of which, Dissolution and Assay accounted for 56.4% of the non-compliance (Fig.3a)

GovernmentSourcesa) Total 839 samples out of the 8,369 samples

tested from Government sources were found to be NSQ and 5 samples were found to be Spurious.

b) The estimated percentage of NSQ formulations from Government sources in India is 10.02% and the 95% confidence interval for the same is 9.38% to 10.68% and the estimated percentage of Spurious drugs from Government sources is 0.0597%. State wise, NSQ percentage estimates varied from 0 to 17.39% with the exception of Sikkim. Four UTs i.e. Chandigarh, Dadra and Nagar

Figure2:DrugsSurveyNSQandSpuriousDrugsData-Sourcewise

Spurious: 0.0237% NSQ: 3%RETAILOuTLETS

Spurious: 0.0597% NSQ: 10.02%GOVT.SOuRCES

Spurious: NIL NSQ: NILPORTS(IMPORTS)



Haveli, Daman and Diu and Lakshadweep had 0% NSQ. Eighteen States/UTs had NSQ Percentage below national average of 10.02% for Government sources. Thirteen States had NSQ percentage above national average of 10.02% for Government sources. States like Meghalaya, Mizoram, Arunachal Pradesh, Nagaland, Telangana, Uttarakhand, Uttar Pradesh and Punjab were on the higher side of NSQ (11.39 - 17.39%) whereas Chandigarh, Delhi, Orissa, Tamil Nadu and West Bengal were on the lower side of NSQ (0 - 7.93%).

c) During analysis of samples declared NSQ from Government supply chain, the following trend was observed: Civil Hospital Stores: 11.03% NSQ, State Government Medical Store Depots: 10.44% NSQ, ESI Dispensaries: 9.01% NSQ, CGHS Dispensaries: 4.11% NSQ.

d) The total number of non-compliance out of all tests of all samples from Government sources was 1,177. Out of 69 tests performed on these samples, they failed in 27 tests, of which, Assay and Dissolution accounted for 46.1% of the non-compliance (Fig.3b).

Figure 3: Contribution of tests to failures of sample

Portsa) Samples were drawn from 8 Ports from

1708 consignments. 97% of the samples came from Mumbai and Chennai Ports.

b) None of the samples were found to be NSQ or Spurious.

RECOMMENDATIONS

The consumers have a right to access Drugs that are safe and of good quality and the Government of India is committed towards it. Spurious and NSQ Drugs can adversely impact the quality of treatment and cause harm to patients, besides contributing to emergence of Drug resistance and spread of disease. Countering the problem of circulation of Spurious and NSQ Drugs requires support and cooperation of all the stakeholders i.e. policy makers, drug regulatory and law enforcement agencies, drug testing laboratories, manufacturers, distributors including retailers, healthcare professionals and members of Civil Society.


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The Ministry of Health and Family Welfare, Government of India decided to conduct a “Survey of Extent of Problems of Spurious and Not of Standard Quality (NSQ) Drugs in The Country”. The Ministry assigned the planning and conduct of this survey to Director, National Institute of Biologicals (NIB). A budgetary allocation of Rs. 8.5 Crores (USD 1.25 Millions) for this study was made by the Ministry and it also facilitated the study by providing all support to NIB. At the heart of the drug survey was its innovative methodology devised by Drugs Survey – Core Expert Committee of NIB. As per the directions of the Ministry, drug samples drawn under the survey were tested in the seven Central and three State Government Drug Testing Laboratories. All of these laboratories are accredited by NABL. These drug testing laboratories rose to the occasion and tested the allocated samples by augmenting human resource, infrastructure capability and quality systems. The laboratory test/analysis data was analysed by Indian Statistical Institute, Hyderabad which, besides presenting the main results of the estimates of extent of Spurious and NSQ Drugs also addressed various issues in connection with this survey viz. source wise and location wise distribution of samples drawn under survey, hit rates, inclusion probabilities of selected molecules, contribution of tests to failure of samples, analysis of date expired samples, NSQ percentages for molecules, dosage forms and manufacturers, etc.The “Survey of Extent of Problems of Spurious and Not of Standard Quality (NSQ) Drugs in the Country” has identified problems related to quality of Drugs in the country. It underlines the roles of stakeholders in addressing these problems.The recommendations for the role andresponsibility of the various Stakeholders inaddressingtheproblemsofSpuriousandNSQ

Drugs in the countryareashereunder:

A) GOVERNMENT The fact that the NSQ from Government

sources are 3.17 times higher than in the retail highlights that there is something amiss in the existing procurement processes especially in states where the NSQ is much higher than the National average. Further, lack of uniform levels of enforcement may be leading to difference in the extent of NSQ in retail outlets and Government supply chain in different States/UTs. The NSQ’s are much higher in case of parenterals as compared with oral dosage forms and this area therefore needs special attention.

To improve the Quality of Drugs both in retail and Government supply chain, the

Government needs to focus on the following strategies:

1. Minimise NSQ drugs in theGovernment sources.

To address these problems the governmentshould evolve following strategies withimplementationplan:a) There is a need for Government procurement

agencies to revisit their procurement guidelines with respect to criteria for qualifying the manufacturers. The agencies should develop and implement risk based pre-inspection norms for selection of manufacturers of quality Drugs and adopt quality testing of each consignment from NABL Accredited laboratories.

b) Government warehouses, medical store depots and pharmacies should have adequate storage facilities and provision for temperature and humidity control, sufficient air conditioned space, refrigerators, deep



freezers etc. along with their annual maintenance contracts. These facilities, should be inspected at least once a year by a joint team of CDSCO and State Licensing Authorities (SLA). Alternatively, third party inspections by accredited bodies could be considered, however, this will not be a substitute for regulatory inspections.

c) Agencies should conduct regular skill development training for the medical store officers, pharmacists and other staff members for handling of Drugs, inventory control, Good Storage and Warehousing Practices and proper documentation in digital format.

d) Government Hospitals should set up modern hospital pharmacies manned by an officer with appropriate pharmacy qualifications.

e) Entire data of Government Drugs Supply Chain should be digitised for efficient inventory control, monitoring and surveillance.

2. Reduce dependence on imports of Active Pharmaceutical Ingredients(APIs)

In this Drug Survey over a period of three months, 4987 samples were drawn at the air ports/sea ports. It was observed that 98.51% of these samples were that of APIs of which 91.87% were from China. One company from China alone accounted for 26.82% of APIs imported into our country. In light of these facts, it is imperative that Government may take measures to upscale existing indigenous production capacity of APIs and set up new manufacturing units to enhance production to meet the country’s need.

3. Create aNationalDigitalDatabaseRegistry

In order to draw Drug samples from Retail Outlets and Government sources the list of all registered sources was needed to begin with. The States/UTs provided the lists of registered sources for 4,24,525 Retail Outlets in 572 districts out of 676 districts in the country. For the remaining 104 districts, the States/UTs were able to provide information for only the number of registered outlets i.e. 32,978, without any information in respect of Addresses of outlets, Licensing details etc. Even for those outlets where the information was made available, the quality of the data on registered outlets was inadequate. With regard to Government sources, the total number was 10,555 but the complete information was available only for 3,060 sources. This highlights the inadequacy of existing systems put in place by the State Licensing Authorities.

The Government should create a National Digital Database of all distributors, retailers/ pharmacies, Government sources, name and contact information of licensed pharmacists which should be regularly updated. Preferably, the data should get updated automatically.

4. Laboratory Infrastructure The 10 Government drug testing laboratories

engaged in this survey faced a number of challenges in carrying out testing of drug survey samples in terms of instrumentation, columns, consumables, and adequate manpower. However, the resources were augmented and keeping the requirement in view, testing was undertaken in two/three shifts.

Learning from this experience, Ministry should augment the existing Central and State drug testing capacity besides setting


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up additional new drug testing laboratories to cope with the testing of large number of surveillance and regulatory Drugs samples. These laboratories need to be equipped with sufficient number of trained analysts, latest instrumentation and with adequate provision for consumables. All drug testing laboratories should be made ISO 17025 compliant. Government must provide adequate budgetary support to laboratories in this regard.

5. NationalDrugsRegulatoryTrainingAcademy

The Government should consider setting up of a National Training Academy in Drugs Regulatory Sciences to create a National Talent pool of skilled regulatory manpower which will contribute in realizing the objective of India becoming the Pharmacy of the World.

Continued training is critical to ensure that drugs regulators remain proficient in their operational functions and in their understanding of current Good Manufacturing Practices, Good Laboratory Practices and Good Distribution Practices. Training in Quality System should address the operational activities, behavioural issues and work culture e.g., team building, communication and attitudinal change.

The National Training Academy should institutionalize training of drug regulators, both new recruits and in-service officials, to enhance their depth and width of regulatory know-how, skill and competence in various areas of drug regulation, enforcement and data integrity. The training should be conducted by experienced faculty on a regular basis and participants should be subjected to

pre- and post-training assessments including behavioural aspects and skill development. Modern digital technology tools should be leveraged to achieve these objectives and to integrate all stakeholders in the system so as to create a National Regulatory Knowledge Sharing Platform to bring transparency, accountability and traceability in the drug supply chain management throughout the country.

Eventually the Government may consider upgrading the National Training Academy to a University of Drug Regulatory Sciences.

b) DRuGREGuLATORS For this study, a total of 47,012 samples

wereanalysedofwhich8samples(0.023%)fromRetailOutletsand5samples(0.059%)fromGovernment sourceswere found tobeSpurious.Thesesamplesfailedtomeetidentification test of the labelled drug orhad zero active ingredient. Further, 1011samples (3%) from Retail Outlets and839 samples (10.02%) fromGovernmentsources were declared NSQ for variousreasons.

Toaddress theseproblems theregulatorsshould evolve following strategies andimplementationplan:

1. Use digital technology to establish seamless functional integration of Centre -State/ State –State drugs regulatory activities to share information especially in respect of Spurious and NSQ drugs for rapid regulatory intervention and batch recall.

2. Enforcement of regulatory guidelines for drug manufacturing, storage, sale, distribution and recall.



3. Adopt modern drug detection technology to implement rapid scanning, visual and analytical identification of potential Spurious and NSQ products in the rural and urban markets of country. Mobile Drugs laboratory technology be used to facilitate rapid detection of NSQ drugs and enforcement at remote rural locations besides cities and towns.

4. Facilitate regulation for transparent and secure drug distribution system which results in product traceability and reconciliation throughout the supply chain in case of quality issue or nationwide recall. Further, enforce procedures that ensure that the quality and integrity of the products are not compromised during transportation i.e. the identity of the product is not lost, the product is not contaminated, adequate precautions are taken against misappropriation and pilferage and appropriate environmental conditions are maintained, e.g. using cold chain for thermo-labile products and storage at appropriate temperature.

5. The Central and State/UT Drug Controllers, while granting the marketing approval for a drug, should ensure that in-process quality testing plans, including validated methods and specifications along with the stability study data is included in the application. The inspection should also be carried out to confirm that the in-process tests were done, as described in the plan, and ascertain that the results were within specifications. To avoid delays in testing the sample, these validated methods and specifications provided with the applications should also be shared with drug testing laboratories.

6. During routine surveillance the number of samples drawn by the Centre and the States should always be statistically significant to

ensure quality, safety and efficacy of drugs. Besides, surveillance samples, risk based criteria be used to draw samples. More samples of parenterals and other drugs that did not meet the quality standards be drawn.

7. Robust GMP inspections be carried out by a joint team comprising of an officer of CDSCO and State representatives. Laboratory personnel of both State and Center should also be involved in the inspection process. Overseas manufacturing units from where imports are taking place should also be inspected.

8. A central licensing portal should be developed to ensure that the entire data about licensed premises and the product is available centrally. It would be necessary to develop a system of surveillance to identify nonlicensed manufacturers operating in different States

9. A suitable track and trace mechanism for monitoring of the movement of drugs in the domestic and international commerce should be evolved over a period of time.

10. The CDSCO should also organise training programs for manufacturing units in association with Department of Pharmaceuticals, WHO and other regulators. The manufacturing units that do not conform to GMP/GLP be asked to stop production.

11. Focused attention should be given to ensuring quality of parenterals since more NSQs amongst parenterals have been observed in this survey. This is more so, as parenterals are administered when patients are in much more critical state.

12. Robust recall mechanism must be put in place to withdraw a batch of the drug which is declared Not of Standard Quality or Spurious from the entire supply chain.


SCIENTIFIC PROGRESS

13. The strength of regulators should be increased appropriately to ensure more robust inspection, collection, testing and analysis of samples. Their capabilities, skills and regulatory knowledge should be assessed on a regular basis.

C) GOVERNMENTDRuGTESTINGLAbORATORIES

NSQsamplesfromRetailOutletsdidnotcomplywith1,251laboratorytests,outofwhich 420 non-compliance (33.6%) werein dissolution and 283 non-compliance(22.6%) were inAssay. Similarly, out of1,177 tests failed by NSQ samples fromGovernment sources 282 non-compliance(23.96%)wereinassayand261(22.18%)were indissolution.

For testing of 47,012 samples thelaboratories took about 371 days onan average from the dispatch of firstconsignment of samples for testing andthe last Test &Analysis report receivedbyNIb.

To address these problems the DrugsTesting Laboratories should evolvefollowing strategies with implementationplan:

1. Enhancement of the existing testing capacity. Further they should equip themselves with sufficient trained manpower, latest instrumentation which is validated and calibrated in a regular manner and get themselves accredited.

2. Equip themselves to have regular access to reference substances, validated methods and consumables like HPLC and GC columns to perform pharmacopoeial tests. They should also make provisions for replacement, annual maintenance of all instrumentations

and utilities to ensure optimum performance and desired outcomes.

3. Analytical and documentation skills of Government Analysts need to be upgraded by regular training programmes within the country and abroad. Their testing capabilities, skills and technical knowledge should be assessed on a regular basis.

D) DRuGMANuFACTuRERS 47,012DrugsSamplesdrawnandsubjected

totest/analysisundertheSurveywerefrom1719manufacturingunits.Thedataof1,850NSQsamplesshowedthatthesewerefrom569manufacturingunits.Ofthese,10%ofmanufacturing units were responsible forabout 50%ofNSQ samples.Further, onethird of totalNSQ sampleswere from 22manufacturingunits.

The reasons for non-compliance wasmainlyduetofailureinassay,dissolutionand related substances. These defectsgenerally happen when the GMP andGLPrequirementsarenotfullycomplianti.e. Quality of input raw materials areunsatisfactory, products arenotproperlyformulated, manufactured and/or arenot able to withstand adverse conditionsduringdistributionand storage.

Toaddresstheseproblemsthemanufacturersandtheirassociationsbothprofessionalandtrade, should evolve following strategieswith implementationplan:

1. Create work culture of quality bottom-up and top- down so as to own quality of their products through-out the production and supply chain including distribution and retailing. Further, there should be continual training of all employees to ensure that they remain proficient in their operational



functions, understanding of current GMPs and GLPs and their implementation.

2. Systems should be put in place for promptly implementing corrective actions and preventive steps on non-compliance reports, complaints from consumers, non-conformances from regulatory inspections and product quality monitoring including product recall.

3. Ensure data integrity in manufacturing operations and laboratory test/analysis data.

4. Manufacturers should allocate sufficient resources for developing robust quality systems for laboratory analysis of the finished drug products, in process quality control, stability studies and control samples.

5. This also calls for a need to set up the third party conformance bodies who would need not be involved in regulatory work but will help industry to ensure compliance with GMP/GLP.

E) DRuG DISTRIbuTORS ANDRETAILERS

Amongthe33,656samplescollectedfromretail outlets, 1011 (3%) samples werefound tobeNSQ.

To address these problems of NSQ inRetail, the distributors and retailers andtheir trade associations should evolvefollowing strategies with implementationplan:

1. Retailers are the first port of call for the consumers for getting their supply of safe and quality Drugs. They must ensure that Drugs are procured from authorized channels and maintain proper records of procurement to track and trace the movement of the Drugs from the manufacturer to the user.

2. Retailers and distributors should modernize and digitize the mechanism of procurement and inventory control of all their operations and ensure presence of qualified pharmacists to dispense Drugs as required by law.

3. Retailers should ensure that storage conditions for Drugs and materials are in compliance with the labelling provisions of the law. Drugs should be stored in conditions which assure that their quality is maintained throughout their shelf life.

4. Retail organisations should train all personnel involved in distribution and dispensing activities on the requirements of Good Distribution Practices including documentation. They should undergo regular training to acquire the appropriate competency and experience to perform their tasks.

5. Retailers should quarantine and promptly notify regulators about a drug that has been identified as suspect, meaning that it may be Spurious, NSQ or potentially harmful. In instances of product recall, they must cooperate with the regulatory agencies.

6. System of third party inspections of retail outlets including in hospitals, dispensaries, wellness centres should be put in place to ensure adherence to the requirement of Good Distribution Practice (GDP)/Good Storage Practice (GSP).

F) CIVILSOCIETy Inall, samples from15therapeuticareas

were selected for survey. Among these523 samples belonging to anti-infectiveDrugs and 516 samples belonging togastrointestinal medicines were foundto be NSQ. From consumer perspective,Drugs survey samples belonging to anti-


SCIENTIFIC PROGRESS

infective Drugs and gastrointestinalmedicines accounted formore than 50%of allNSQsamples.

To address these problems the consumerassociations should evolve followingstrategieswith implementationplan:

1. Identify and promote consumer friendly retail outlets which display retail licence from competent authority, have a presence of Pharmacist, proper reporting and redressal mechanism is in place i.e. consumer complaint number, toll free number or website address of the competent authority.

2. Create technology enabled awareness campaigns for consumers to empower them to differentiate between Genuine and Spurious Drugs by examining batch number, expiry date, packaging, track and trace technologies. Create awareness amongst consumers to always insist on a proper receipt while purchasing medicines with all information as mandated in the law.

3. Consumer Organisations should participate with regulators in countrywide and state-wide surveillance of quality of Drugs. This can be in form of institutionalised engagement with States/Centre Government on Drug quality monitoring and surveys.

G) HEALTHPROFESSIONALS This study examined 183drugmolecules

belonging to branded and genericformulations from different therapeuticcategories. The results showed that 114samples (12.30%) of pantoprazole, 111samples(11.19%)oforalrehydrationsaltsand 62 samples (28.31%) of gentamicinfailed inquality testing.

Such information needs to be communicatedtothehealthprofessionals

who regularly prescribe, dispense andadminister medicines to patients. To address the problems of Spurious andNSQDrugs, thehealthprofessionals andtheirAssociationsmaybe engaged in thefollowing roles:-

1. Inform regulators about consumer complaints related to quality of drugs.

2. Medical, Dental, Nursing and Pharmacy Councils should train students about hazards of Spurious and NSQ Drugs.

3. Healthcare professionals must engage with Government and Civil Society in creating awareness among patients and general public, about the perils of Spurious and NSQ Drugs.

4. Pharmacy Council of India may consider including Drug Survey methodology in pharmacy education curriculum.

NIbRESOuRCEPERSONS

Following resource persons from NIb madeactive contribution in the National DrugSurvey:

CONSuLTANT -DRuGSuRVEyDr.MohammadAhmedKhan

CONSuLTANT - ITMr.SunishSinghal

SuPPORTSTAFFMr.SatyajeetSingh (TechnicalAssociate)Mr.VarunChopra (TechnicalAssociate)Mr.ShaikAbdulRahaman (TechnicalAssociate)


SCIENTIFIC PROGRESS

TRAININGS,WORKSHOPS&MEETINGS


SCIENTIFIC PROGRESS

A training program results in strengthening of skills that need to be improved and presents a prime opportunity to expand the knowledge base and skills of students and professionals. Therefore, providing the necessary training creates an overall knowledgeable work force which can work in teams and independently without constant help and supervision. However, such development opportunities are expensive. To address the issue in the field of Biologicals a training unit has been established at National Institute of Biologicals (NIB) comprising Dr. Reba Chhabra, DD(QC) i/c Diagnostics & Training, Dr Richa Baranwal, Scientist Grade-III, I/c Training Unit, Mr. Jaipal Meena, Scientist Grade-III, Mr. N. Nanda Gopal, Scientist Grade-III, Dr. Manjula Kiran, Junior Scientist and Mr. Sanjeev Kumar Sharma, Junior Scientist. These scientific staffs of the Institute, along with their scientific duties are given additional responsibilities to function for synchronizing

and implementing the training related activities. The training unit functions in line with NIB mandate 3.1.3 as laid down in Memorandum of Association. NIB imparts trainings to regulatory officials, manufacturers, industries, government analysts, blood bank officials and post graduate students for building up the ‘National Talent Pool of Skilled and Trained Manpower’ for indigenous manufacturing, domestic consumption and export of biologicals which is expected to increase significantly year over year and also in Quality Control of Biologicals in Government and Private sector which will help to bridge the gap as there is an acute shortage of skilled and hands-on trained manpower in the field of Biologicals. Laboratories of NIB have been involved in organizing several different trainings, workshops, talks and meetings as depicted in Figure. 1.

TRAININGS,WORKSHOPS&MEETINGS ORGANIZEDATNIb

Figure1: Number of Talks, meetings, workshops and trainings organized by NIB labs. BPL: Blood Products Laboratory, EHL: Enzyme and Hormone Laboratory, IDKL: Immunodiagnostic Kit Laboratory, RPL:

Recombinant Product Laboratory, AFL: Animal Facility Laboratory, BKL: Biochemical Kit Laboratory. VVL: Viral Vaccine Laboratory, BVLP: Bacterial Vaccine Laboratory (Polysaccharide), TMA: Therapeutic Monoclonal Antibodies Laboratory, MDL: Molecular Diagnostic Laboratory, QMU: Quality Management

Unit, SRRDU: Sample Receipt and Report Dispatch Unit, BVLB: Bacterial Vaccine Laboratory (BCG)



S. no. Training /Conferenceorganized Duration1. Six day residential training of blood bank officials for the state of

Odisha on strengthening of blood services 25th -30th April, 2016 (batch-1)7th-12th May ,2016 (batch-2)4th - 9th July, 2016 (batch-3)

2. National Skill Development & Hands-on Training on Quality Control of Biologicals to Pharmacy students of JSS,Ooty

2nd May, 2016

3. National Skill Development & Hands-on Training on Quality Control of Biologicals to Pharmacy students of NIPER,Kolkata

25th Jul-5th Aug, 2016

15 March, 20174. National Skill Development & Hands-on Training on Quality Control

of Biologicals to Pharmacy students of NIPER,Guwahati8th -26th Aug, 2016

5. National Skill Development & Hands-on Training on Quality Control of Biologicals to Pharmacy students of NIPER,Mohali

22nd Aug- 2nd Sep, 2016

6. Training of trainers for e-raktkosh software training & Strengthening of Blood Services” for forty one Govt. Blood Bank Officials of Elevendifferent States of Assam, Bihar, Chhattisgarh, Gujrat, Jharkhand, Madhya Pradesh, West Bengal, Uttarakhand, Uttar Pradesh, Tamil Nadu, Telangana.

7th - 12th Nov, 2016

NIB in collaboration with ClinicalDevelopmentService Agency (CDSA) under Translational Health Science and Technology Institute (THSTI), Faridabad, an autonomous institution of DBT, conducted 2 National Workshops on Laboratory Quality Management Systems in Bio-therapeutics and Diagnostics for various stakeholders i,e. academia, Industry, quality control labs and regulatory bodies across the country. NIB provides a platform for manufacturers of various Biologicals for establishing quality control methods for their products as per the regulatory

requirements. Further, NIB in collaboration with National Institute ofAnimalWelfare (NIAW) Ballabhgarh, Ministry of Environment, Forest and Climate Change, Govt. of India, carried out training programs on CPCSEA guidelines for laboratory animal facility. In the year 2016-17 a total of 271participantswere trainedwhichincluded CPCSEA nominees, M. Pharma, B. Pharma students, NGO members, Veterinarians etc. Details of training imparted by different Labs of NIB is mentioned below.

Lab/DivisionImmunodiagnostic Kit Laboratory

NameofHead Dr. R.K Sharma, Scientist Gr.-III

1. TheLaboratoryconductedthefollowingTraining/ConferenceProgramme:


SCIENTIFIC PROGRESS

7. National Skill development & Hands-on Training Programme on Quality Control of Biologicals for M.Sc. Microbiology & Biochemistry students of universityof Jammu&CRIKasauli

16th- 28th Jan, 2017

8. National Skill development & Hands-on Training Programme on Quality Control of Biologicals for students of universityof Jammu,HimanchalPradesh,Guwahati&uttarakhand

14th Feb-04th Mar, 2017

2.TheLaboratoryconductedthefollowingMeetings/Workshops:S.no. Workshoporganized Duration

1. 3rd TechnicalExpertCommitteeMeeting IDKL for strengthening activities of Immunodiagnostic Kit Laboratory

26th April, 2016

2. Workshop for distribution of HIV Proficiency Test Panel for HIV Serology (Round1, 2016) to State Reference Laboratory of UP & Uttarakhand by NACO-NRL, NIB

16th November, 2016

3. 4th TechnicalExpertCommitteeMeeting IDKL for strengthening activities of Immunodiagnostic Kit Laboratory

26th April, 2016

4. National Workshop on Laboratory Quality Management Systems (LQMS) in Diagnostics in collaboration of Clinical Services Development Agency (CDSA), Department of Biotechnology, Ministry of Science and Technology

08th February, 2017-

10th February, 2017

5. Workshop for distribution of HIV Proficiency Test Panel for HIV Serology (Round2, 2016) to State Reference Laboratory of UP & Uttarakhand by NACO-NRL, NIB

15th February, 2017

Training imparted tomedical diagnosticsstakeholdersandpostgraduatestudents:

1. Imparted two days hands-on-training on Quality Control Evaluation to two Application Specialist of M/s Abbott Healthcare Private Limited, Mumbai and one Application specialist of M/s Siemens Healthcare Private Limited, Gurgaon at Immunodiagnostic Kit

Laboratory, NIB on 10th-11th May, 2016 and 02nd-03rd June, 2016, respectively.

2. Imparted summer training & conducted a dissertation report “Quality Control of Immunodiagnostic Kits” for a M.Sc. Biotechnology student from AMITY University, NOIDA from 25th May 2016-30th Jun 2016.



Lab/Division Molecular Diagnostic Laboratory

NameofHead Dr. Reba Chhabra, Scientist Grade-I & DDQC i/c (Diagnostics)

Following training have been provided in the field of Molecular Diagnostics:S. No.

Title of the training Area of training

Date NumberofParticipants

1. Training on Quality Control testing of Biologicals to B. Pharma students from JSS University, Ooty

Molecular Diagnostics

23rd-24th May, 2016

07

2. National Skill Development Training Program for Pharmacy Post Graduate students of NIPER, Kolkata


4th Aug, 2016

16

3. National Skill Development Training Program for Pharmacy Post Graduate students of NIPER, Guwahati


17th-19th Aug,2016

22

4. National Skill Development Training Program for Pharmacy Post Graduate students of NIPER, Mohali


23rd, 24th and 30th Aug,2016

31

5. “National Skill Development and Hands-on Training Program on Quality control of Biologicals” for M.Sc. Biotechnology students of University of Jammu, Himachal Pradesh, North East Universities of Dibrugarh and Guwahati


23rd-27th Jan, 2017

24

6 National Workshop on “Laboratory Quality Management System in Diagnostics” organized by NIB in collaboration with Clinical Development Services Agency (CDSA)


8th-10th Feb, 2017

10

National Skill Development Training Program for Pharmacy Post Graduate students of NIPER,

Mohali

Training to participants of Workshop on Laboratory Quality Management System in

Diagnostics


SCIENTIFIC PROGRESS

1. Lab/Division Blood Reagent Laboratory

2. NameofHead Ms. Kanchan Ahuja, Scientist Grade III

Followingtraininghavebeenprovided:S. No.

Title of the training Area of the Training

Venue Date Numberofparticipants

1. Training on Quality Control testing of Biologicals to B.Pharma students from JSS University, Ooty

Blood Group Serology

Blood Reagent Laboratory, NIB

15th-16th June,2016

07

2. Six days residential training on Blood Group serology and QC testing of Blood Grouping Reagents for Blood bank officials for the state of Odisha on “Strengthening of Blood Services” organized by NIB and National Health Mission for three batches

Blood Group Serology and QC testing of Blood Grouping Reagents


25th-30th April, 2016

2nd-7th May, 2016

4th-6th July, 2016

79

3. National Skill Development Training Program for Pharmacy Post Graduate students of NIPER, Kolkata



01st Aug, 2016 16

4. National Skill Development Training Program for Pharmacy Post Graduate students of NIPER, Guwahati

Blood group Serology


16th-18th Aug,2016 22

5. National Skill Development Training Program for Pharmacy Post Graduate students of NIPER, Mohali

Blood group Serology


26th , 28th Aug & 1st Sept, 2016

31

6. Training of trainers for e-Rakt Kosh software training & Strengthening of Blood Services organized by National Health Mission and National Institute of Biologicals from 10 different states

Blood Group Serology and QC testing of Blood grouping reagents


7th-12th Nov, 2016

41



7. National Workshop on “Laboratory Quality Management Systems in Diagnostics” organized by NIB in collaboration with CDSA (Clinical Development Services Agency)

Blood Group Serology and QC testing of Blood grouping reagents


8th-10th Feb, 2017

10

8. “National Skill Development and Hands on Training on Quality Control of Biologicals” for M.Sc. Biotechnology students of Universities of Jammu, Himachal Pradesh, Dibrugarh and Guwahati



20th-22nd Feb, 2017

24

Hands-on training for participants at BRL on “Training of trainers for e-Rakt Kosh software training & Strengthening of Blood Services”.

Hands-on training of Post Graduate students of NIPER, Mohali under National Skill Development Training Program for Pharmacy at BRL

BRL orientation for the participants in the National Workshop on “Laboratory Quality Management systems in Diagnostics”

Hands-on training for M.Sc. Biotechnology students of Universities of Jammu, Himachal Pradesh, Dibrugarh and Guwahati “Quality control of Biologicals” at BRL


SCIENTIFIC PROGRESS

Lab/DivisionBiochemical Kit Laboratory

NameofHead Ms. Ajanta Sircar, Scientist Grade III

Trainingorganized:S.No. Title ofTraining Area of

TrainingDate Participants

organization1. Training on Quality Control

Testing of Biological ProductsBiochemical kits 08th -10th

June 2016M. Pharm Students of J.S.S. College of Pharmacy, Ooty, Tamil Nadu, India)

2. National Workshop on Laboratory Quality Management System in Diagnostics at

National Institute of Biologicals (NIB), NOIDA.

A collaborative program with Department of Biotechnology (DBT) and National Institute of

Biologicals (NIB)

Biochemical kits 08th -10th Feb, 2017

Manufacturers/

Stakeholders

3. National Skill Development and Hands- On Training Program on Quality Control of Biologicals

Biochemical kits 23rd, 30th-31st March, 2017

M. Pharmacology students of NIPER Kolkata

LQMS Training given by Lab to LQMS trainees



Lab/DivisionBlood Products Laboratory

NameofHead Dr. J. P. Prasad, Scientist-I

Trainings/workshops/conference orga-nized1. The Laboratory has actively participated in

“National Workshop on Laboratory Quality Management System in Biotherapeutics’’ from May 17th-19th, 2016 at National Institute of Biologicals, NOIDA. The objective of the workshop was to provide a learning platform through a highly intensive, hands-on-training in NIB’s state-of-the-art laboratory accredited as per ISO/IEC 17025:2005 requirements.

2. The laboratory has imparted training to 21 postgraduate students from NIPER, Guwahati on various techniques used in quality control testing of Plasma Derived Products from August 2016.

3. Imparted training to 32 students from J & K University and CRI Kasauli, on protein composition by Cellulose Electrophoresis and determination of sodium content by Atomic Absorption Spectrometry in Human Albumin from 17th-20th January, 2017.

4. Imparted training to 41 Pharmacy Post Graduate students of NIPER Kolkata on “Determination of molecular aggregates by SEC-HPLC and determination of sodium content in Human Albumin Solution by Atomic Absorption Spectrometry” from 15th-31st March, 2017.

5. Imparted training to 32 M.Sc. Biotechnology students of Universities of Jammu, Himachal Pradesh, Dibrugarh and Guwahati from 14.02.17 to 04.03.17 on Determination of protein composition by cellulose acetate electrophoresis and determination of sodium content in Human Albumin solution by Atomic Absorption Spectrometry

National Workshop on Laboratory Quality Management System in Biotherapeutics


SCIENTIFIC PROGRESS

Lab/Division Bacterial Vaccine Laboratory (Polysaccharide & BCG)

NameofHead Dr. Surinder Singh, Director (since 27.10.2016)

Dr. Charu M. Kamal, Scientist-II (17.05.2016- 06.10.2016)

Mr. Neeraj Malik, Scientist-II (till 17.05.2016)

Trainingorganized:S.No Title ofTraining Area of

TrainingDate Participants

1 Quality Control Testing parameters of Bacterial Vaccines

Bacterial Vaccine

28.07.16, 29.07.16

Pharmacy Post Graduate Students of NIPER, Kolkata


Bacterial Vaccine

12.08.16,

16.08.16 & 19.08.16

Pharmacy Post Graduate Students of NIPER, Guwahati


Bacterial Vaccine

23.08.16, 24.08.16 & 29.08.16

Pharmacy Post Graduate Students of NIPER, Mohali

4 Four days Workshop on the lot Release system of NIB and learn the Lot Release Procedures of various vaccines and biologicals

Bacterial Vaccine

29.11.16 -02.12.16

9 Drug officials of Drug Regulatory Authority, Royal Government of Bhutan.

Lab/Division Viral Vaccine Laboratory

Name of Head Dr. Surinder Singh, Director (since 27.10.2016)

Dr. Charu M. Kamal, Scientist-II (17.05.2016- 06.10.2016)

Mr. Neeraj Malik, Scientist-II (till 17.05.2016)

TrainingsOrganized:

(A) National Skill Development Training Program for Pharmacy Post Graduate Students of NIPER, Kolkata (41 students from 15th-31st March,2017).

(B) National Skill Development and Hands-

On Training Program on Quality Control of Biologicals for M.Sc. Biotechnology students of Jammu, Himachal Pradesh, Dibrugarh and Guwahati (26 students from 14thFeb-04thMarch,2017).



(C) National Skill Development and Hands- On Training Program on Quality Control of Biologicals for M.Sc. Biotechnology students of Jammu and Himachal Pradesh (24 students from 16th-28thJan,2017).

(D) Training on Analytical Techniques, Laboratory Quality Management System and Online Sample Tracking Software Applications (3 participants from 19th-23rd Sep,2016).

(E) National Skill Development & Hands on Training on Quality Control of Biologicals for Pharmacy Post Graduate Students of

NIPER, Mohali (31 students from 22nd Aug-09thSep,2016).

(F) National Skill Development & Hands on Training on Quality Control of Biologicals for Pharmacy Post Graduate Students of NIPER, Kolkata (16 students from 25th July-05thAug,2016).

(G) National Skill Development and Hands-on-training on Quality Control of Biologicals Pharmacy Post Graduate Students of NIPER- Guwahati (21students08th-26thAug,2016).

(H) Training to be imparted by NIB on Quality Control Testing of Biological Products (7studentsfrom02ndMay-18thJune,2016).

Training on Quality Control Testing of Biological Products

Workshopheld:Delegates from The Royal Government ofbhutan participated in the four days’ Workshopon theLotRelease system ofNIb and learnttheLotReleaseProceduresofvariousVaccinesandbiologicals which was scheduled at NIB from 29thNov-02ndDec,2016. All the delegates were

given hands-on training on various biological and chemical testing parameters of vaccines in Viral Vaccine and Bacterial Vaccine Laboratory, NIB. The documentation procedure and sample tracking system was thoroughly demonstrated to them.


SCIENTIFIC PROGRESS

Lab/Division Recombinant Product Laboratory

NameofHead Dr. Renu Jain (Till October 6th 2016)

Dr. Charu M. Kamal, Scientist Grade II (w.e.f 6th October 2016)

1.Hands-on-TrainingsonQualitycontrolandQualityManagementSystem:

S.No TrainingProgramme PeriodofTraining TraineesOrganization

1. Hands-on training : 02 M. Tech students on

a. Assessment of Endotoxin by Gel Endotoxin Test

b. Evaluation of sensitivity of silver staining kits from various commercial available sources using sample of protein (GCSF)

16th June - 16th July 2016

Jaypee Institute of Biotechnology

2. Hands-on training: Quality Control of Recombinant Products

M. Pharm students

b. M.Sc. Microbiology & Biochemistry students

c. M.Sc. Biotechnology students

d. M. Pharm students

a. 6th-8th Sep. 2016

b. 17th-20thJan2017

c. 15th-17thFeb.2017

d.16th, 20th-22ndMar 2017

a. NIPER, Mohali

b. CRI, Kasauli

c. Univ. of Jammu, Himachal Pradesh & Guwahatid. NIPER, Kolkata

3. Training on Laboratory Quality Management System

20th Sep 2016 FDA Punjab

4. Training to manufacturer for product development requiring QC Testing of Critical Quality Attributes:

a. Potency assay (cell line based) on Pegfilgrastim

b. Quality control of Insulin & Insulin Analogs

a. 5th- 15th Dec 2016

b. 9th -14th Jan 2017

a. Serum Institute of India, Puneb. Unichem Labs, Goa



Training on Potency assay of Pegfilgrastim to scientists of Serum Institute of India, Pune

2. National Workshop on LaboratoryQualityManagement System (LQMS) inbiotherapeutics:

National Workshop of Laboratory Quality Management System in Biotherapeutics from 17th to 19th May 2016 was held at NIB in collaboration with Clinical Development Services Agency (CDSA, DBT). In this workshop, personnel from various organizations dealing with QC & QA, regulatory activities etc. in the area of Human Biotherapeutics have participated.

The objective of the workshop was to provide a learning platform through a highly intensive, hands-on-training in NIB’s state-of-the-art laboratory as per ISO/IEC 17025:2005 requirement.

TheLearningTools developed by NIB and CDSA for LQMS were as follows:

• Green book: Pre course Distance Learning Material in LQMS Bio therapeutics.

• blue book: Hand book on implementation of LQMS aspects.

The workshop was attended by 29 participants from all over the nation and there were eminent speakers from NABL, CDSCO, Biotherapeutic Industry, Indian Institute of Management, Bureau of Indian Standards and faculty from National Institute of Biologicals. Participants will be assessed after six months for implementation.

Lab/Division Enzyme and Hormone Laboratory

NameofHead Dr. Richa Baranwal, Scientist Grade-III (since 17.05.2016)

Dr. Charu Mehra Kamal, Scientist Grade-II (01.10.15 -17.05.2016)


SCIENTIFIC PROGRESS

Hands-on Training of Biological Products

2. Training provided under National Skill Development & Hands-on-Training on QualityControlofbiologicalsS.no. Nameof theProgramme No. of Participants/Group Duration of

Training1. Summer Training/Dissertation

of B. Tech +

M. Tech Biotech Students

01 23.05.16 to 31.06.2016

01 20.06.16 to 31.07.2016

2. Hands on Training on Quality control of Biologicals

07 Students (M. Pharm 1st Year) of J.S.S. College of Pharmacy, Ooty, Tamil Nadu, India)

01.06.16 to 03.06.16

3. National Skill Development and Hands- on Training on Quality control of Biologicals

132 students (M.Sc. Biotechnology, Microbiology & Biochemistry Students, M. Pharm students of NIPER Kolkata, Mohali, Guwahati

July 2016-March 2017

1. Training Provided to Post GraduateStudents and M. Pharmacology studentsofNIPERs

Keeping in view Honourable Prime Minister, Shri Narendra Modi Ji, Pradhan MantriKaushal Vikas yojana which emphasizes on Skill Development “National SkillDevelopment & Hands-on-Training onQuality Control of biologicals” training

programmes were coordinated for Post Graduate Students of Biotechnology, Microbiology, Biochemistry and Pharmacy. Hands-on Training in the areas of human therapeutics Enzyme and Hormone was provided in Laboratory to develop and enhance analytical skills and technical knowledge of participants.



Lab/Division Therapeutic Monoclonal Antibodies Laboratory

NameofHead Mrs. Sudha V. Gopinath, Scientist-III (Till 12 July, 2016)

Mr. Subhash Chand, Scientist-III (w.e.f. 13 July, 2016)

1. TrainingsOrganized:The Trainings organized for Post-graduate/Undergraduate students in quality evaluation of therapeutic mAbs during 2016-17.

S.no. Nameof training No. ofTrainee

PeriodofTraining

TraineeOrganisations

1 Application of HPLC (IEC) in QC testing of Therapeutic monoclonal antibodies (mAbs)

01 May 2016 to July 2016

Amity Institute of Biotechnology, NOIDA

2 Introduction to Capillary Electrophoresis system & application of CZE in characterization of mAbs

07 11th May 2016 to 12th May 2016

JSS College of Pharmacy, Ooty, Mysore

3. NationalworkshoponLaboratoryQualityManagementsysteminbiotherapeutics

NIB, NOIDA in collaboration with CDSA, DBT conducted National Workshops at NIB in the areas of Biotherapeutics from 17.05.16-19.05.16 with the objectives to make the participants aware about the basics of Laboratory Quality Management System (LQMS) so that they can enhance their quality deliverables while working in the area of biotherapeutics. Enzyme and Hormone Laboratory was one of the laboratory involved in training of participants during workshop. The participants were made aware of:

I. Understand all applicable global standards of Quality systems and product specifications for evaluation of biotherapeutics and diagnostics.

II. Basics of Laboratory Quality

Management System (LQMS) and address the following key areas:

a) The role of National Control Laboratory (NCL) in lot release,

b) Need for LQMS and key steps in its implementation and organization

c) Responsibilities of key staff, Personnel & Premises, Management Requirements, Technical Requirements and Quality Risk Management

The training programme created awareness by making the participant to understand the basic requirements to develop and implement LQMS in a laboratory set up, to strengthen their compliance towards QMS standard, to apply for accreditation purpose and to deliver consistent, high-quality, cost-effective laboratory services through implementation of LQMS.


SCIENTIFIC PROGRESS

3 Animal Cell culture technology & Environmental Monitoring

02 14th June to 14th July, 2016

Gautam Buddha University, Gr. NOIDA

4 National Skill Development and hands- On Training Program on Quality Control of Biologicals; Application of CZE in characterization of mAbs

33 14th Feb. to 04th March, 2017

M.Sc Biotechnology students of Jammu, Himachal Pradesh, Dibrugarh and Guwahati.

5 Determination of charge variants by Cation exchange chromatography in mAb sample

01 07th Feb to 25th March, 2017

Dr. APJ Abdul Kalam Technical University, Lucknow, U.P.

6 Charge Variants analysis of mAbs and their effect on the bioassay.

01 Jan. 2017 to June 2017.

Shri Guru Ram Rai Institute of Technology & Science, Patel Nagar, Dehradun, Uttarakhand.

7 Total (N) 45

2. ScientificExpertMeetingsOrganized: The following Scientific Expert meetings

were organized in the FY 2016-17 for deliberation and discussions on the various lab activities;

i) 2nd meeting of the NIB-Scientific Expert Committee for Recombinant Products (rDNA) & Therapeutic Monoclonal Antibodies (TMABs) organised under Chairmanship of Dr. S. R. Rao, Advisor-DBT, held on 27th January, 2017 at National Productivity Council-Biosafety Unit –DBT (RCGM).

ii) 1st Scientific Sub-committee meeting for finalization of Pending Post Approval

Change (PAC) Applications on r-DNA Products and Therapeutic Monoclonal Antibodies Products was organized under the Chairmanship of Dr. Anurag Rathore, Professor, Department of Chemical Engineering, IIT Delhi, on Aug 23 2016 at NIB.

iii) Monograph Meeting with Indian Pharmacopoeia Commission (IPC) Team organized on 24.10.2016 at NIB to discuss the updates on the Draft Monograph of Rituximab DS & DP.



Lab/Division Animal Facility

NameofHead Dr. Shikha Yadav (Scientist Grade- II)

TrainingsorganizedS.No. Details ofTrainingsProvided Numberof

Participants

1. Training of CPCSEA nominees on IAEC’s of various institutes of the country on request received from National Institute of Animal Welfare, Ministry of Environment, Forest and Climate Change, Ballabhgarh, Faridabad-Delivered lecture on “CPCSEA guidelines for laboratory Animal Facility, SOPs required & Health Indicators of Animals” followed by visit to Animal Facility. ( 8 batches)

228

2. Summer training was given to a student from Amity University, NOIDA on the topic “Assuring Safety of human albumin and anti-hemophilic fraction by in-vivo regulatory tests” from 25th May-28th June 2016.

1

3. Training of Scientists from National Institute of Animal Health, Baghpat, UP on 29-30th November 2016 to get acquainted with general animal husbandry practices, handling and health assessment of these animals, minor procedures on lab animals during ongoing experiments and performing in-vivo QC tests and documentation as per ISO and process for obtaining ISO 17025 accreditation at CCSNIAH.

4

4. One week hands on training on “Ethical use of laboratory animals in Regulatory Testing” for M. Pharmacology Students of NOIDA Institute of Engineering and Technology (NIET), Greater NOIDA from 27th Feb- 3rd March 2017.

6

5. Post graduate students of various universities like Jammu, Himachal Pradesh and Guwahati and institutes like NIPER Kolkata, Mohali and Guwahati, J.S.S college of Pharmacy, Ooty and CRI Kasauli were also trained in Animal Facility, during Skill Development & Hands-on Training on “Quality Control Testing of Biological Products” organized by NIB.

174

6. NIB has contributed in the JNU –NIAW coursework on “Management and Ethical Use of Laboratory Animals in Research” from 15-25th March 2017 at NIAW (MoEF), Ballabgarh by providing visit to Animal Facility of NIB and guest lectures on several topics.

43

Total Number of Trainees in 2016-17 456


SCIENTIFIC PROGRESS

Lab/Division Quality Management UnitNameofHead Dr. Renu Jain- Quality Manager (From 01.04.2016-06.10.2016)

Dr. J. P. Prasad-Quality Manager (From 06.10.2016-till date)

Talks delivered by NIb Scientists todiverse audience at various places tobroadentheknowledgeandimportanceofQualityControl:Dr. Renu Jain, Quality Manager

• Talk on “Role of National Control Laboratory (NCL) and Implementation of Laboratory Quality Management System (LQMS) at NIB” on:

1. 25th Jul, 2016 to M. Pharm Students NIPER, Kolkata

2. 8th Aug, 2016 to M. Pharm Students NIPER, Guwahati

Ms.yMadhu,DeputyQualityManager

• Talk on “Hands-on Documentation Structure & Records’’ at NIB on: 1. 25th Jul, 2016 to M. Pharm Students

NIPER, Kolkata2. 8th Aug, 2016 to M. Pharm Students

NIPER, Guwahati

• Talk on “LQMS requirements documents & records and Hands-on Documentation Structure & Records’’ at NIB on:1. 16th Jan, 2017 to M.Sc. Microbiology

and Biochemistry students of Jammu and CRI Kasauli.

Mr.SubhashChand,DeputyQualityManager

• Talk on “LQMS requirements documents & records and Hands-on Documentation Structure & Records’’ at NIB on:

1. 20th Feb, 2017 to M.Sc. Biotechnology Student of Jammu, Himachal Pradesh, Guwahati and Uttrakhand.

2. 20th Mar, 2017 to M. Pharmacology students of NIPER, Kolkata

Mr.N.NandaGopal,DeputyQualityManager

• Talk on “Occurrence Management-CAPA and Hands-on Documentation Structure & Records’’ at NIB on: 1. 25th Jul, 2016 to M. Pharm Students

NIPER, Kolkata2. 8th Aug, 2016 to M. Pharm Students

NIPER, Guwahati3. 22th Aug, 2016 to M. Pharm Students

NIPER, Guwahati

• Talk on “Hands-on Measurement Traceability’’ with respect to Sample management, equipment, reference material and quality control evaluation and reporting of results at NIB on:1. 16th Jan, 2017 to M.Sc. Microbiology

and Biochemistry students of Jammu and CRI Kasauli.

2. 23rd Feb, 2017 to M.Sc. Biotechnology Student of Jammu, Himachal Pradesh, Guwahati and Uttrakhand.

• Talk on “Continual Improvement’’ at NIB on

1. 23rd Mar, 2017 to M. Pharmacology students of NIPER, Kolkata.



Mr. P. S. Chandranand, Deputy QualityManager

• Talk on “Assuring the quality of test results’’ and “Hands-on Measurement Traceability’’ with respect to sample management, equipment, reference material and quality control evaluation and reporting at NIB on :

1. 25th Jul, 2016 to M. Pharm Students NIPER, Kolkata



• Talk on “Assuring the quality of test results’’ at NIB on 16th Jan, 2017 to M.Sc. Microbiology and Biochemistry students of Jammu and CRI Kasauli.

1. 21st Feb, 2017 to M.Sc. Biotechnology Student of Jammu, Himachal Pradesh, Guwahati and Uttrakhand.

2. 21st Mar, 2017 to M. Pharmacology students of NIPER, Kolkata

Mr. SanjeevKumar Sharma,DeputyQualityManager

• Talk on “Equipment: Purchase, Management & Maintenance’’ at NIB on:

1. 22nd Feb, 2017 to M.Sc. Biotechnology Student of Jammu, Himachal Pradesh, Guwahati and Uttrakhand.

2. 22nd Mar, 2017 to M. Pharmacology students of NIPER, Kolkata

Lab/Division Sample Receipt and Report Dispatch Unit

NameofHead Dr. Reba Chhabra, Scientist-I DD (QC) i/c

TrainingRecord:

Imparted to

• Officials from FDA Punjab (Sep 2016)

• Bhutan delegates (Nov 2016)

Attended by staff

• Role of Govt analyst under D&C act and good lab practices (Schedule L1, Aug 2016)

Internal training attended by staff

• Sample tracking (Dec 2016)

• Physical record management (Dec 2016)


SCIENTIFIC PROGRESS

Headof theAdministration: Dr. Reba Chhabra

I/c. Deputy Director (Admn)During theyear2016-17, the followingappointmentshavebeenmadeby the Institute:-

Name Designation

Shri Ashwini Kumar Dubey Scientist Grade-III

Sushil Kumar Dixit Jr. Hindi Translator

Duringtheyear2016-17,thefollowingofficialhavebeengrantedFinancialupgradationundertheMACPS inNIb:-

Name Designation

Shri. P. C. P. Mahapatra Administrative Officer

Meetingsof theGeneral/GoverningbodyThe10thMeetingof theGeneralbodywasheldon19.12.2016.

Compositionof theGeneralbody:

SecretaryHealth&FamilyWelfare ChairmanMinistry of Health & Family Welfare,Nirman Bhawan, New Delhi.

Secretary MemberDepartmentofbiotechnology,New Delhi

Secretary,DHR&DG, ICMR MemberAnsari Nagar, New Delhi – 110029

AdditionalSecretary (Health) MemberMinistry of Health & Family Welfare,Nirman Bhavan, New Delhi – 110011.

REPORTOFTHEADMINISTRATIVEWORK



AdditionalSecretary&F.A. MemberMinistry of Health & Family Welfare,Nirman Bhawan, New Delhi – 110011.

DirectorGeneral ofHealthServices, MemberMinistry of Health & Family Welfare,Nirman Bhawan, New Delhi – 110011. DrugsControllerGeneral (India), MemberDirectorate General of Health Services,F.D.A. Bhawan, Kotla RoadNew Delhi - 110002.

JointSecretary MemberMinistry of Health & Family Welfare,Nirman Bhawan, New Delhi – 110011.

Secretary MemberHealth & Family Welfare, H. Block Secretariat,Govt. of Andhra Pradesh,Hyderabad, Andhra Pradesh

Secretary MemberHealth & Family Welfare Department,Government of West Bengal,Writers Building, Kolkata.

Chairman MemberSerum Institue of India Ltd.,212/2 Hadapsar,Pune - 411 028

Director MemberPasteur Institute of India,Coonoor – 643 103(The Neelgiris)


SCIENTIFIC PROGRESS

TheChairman-cum-ManagingDirector MemberNational Dairy Development Board,Anand, Gujrat.

ManagingDirector MemberHaffkinebio-PharmaceuticalCorpn.Ltd.,Acharya Donde Marg,Parel, Mumbai.

Director, MemberSecretaryNIB, NOIDA

The 26thMeetingof theGoverningbodywasheldon19.12.2016

Compositionof theGoverningbody:

Secretary(Health&FamilyWelfare) ChairpersonMinistry of Health & Family WelfareNirman Bhavan, New Delhi-110011

Secretary(DbT),Govt.ofIndia MemberBlock No.2, C.G.O. Complex Lodhi Road, New Delhi – 110003.

Secretary,DHR&DG,ICMR MemberAnsari Nagar, New Delhi – 110029

DirectorGeneralofHealthServices MemberDirectorate General of Health Services, Nirman Bhavan, New Delhi- 110011.

AdditionalSecretary(Health) MemberMinistry of Health & Family WelfareNirman Bhavan, New Delhi – 110011.



AdditionalSecretary&F.A. MemberMinistry of Health & Family WelfareNirman Bhawan, New Delhi – 110011 DrugsControllerGeneralofIndia MemberDirectorate General of Health Services, Nirman Bhavan, New Delhi- 110011. JointSecretary MemberMinistry of Health & Family Welfare, Nirman Bhavan, New Delhi - 110011.


The 25rdMeetingof theStandingFinanceCommitteewasheldon15.11.2016

Compositionof theStandingFinanceCommittee:

AdditionalSecretary ChairmanMinistry of Health & Family Welfare,Nirman Bhawan, New Delhi

Addl.DG,ICMRorhisnominee MemberIndian Council of Medical Research,Ansari Nagar,New Delhi - 110029.

JointSecretary MemberMinistry of Health & Family Welfare,Nirman Bhawan,New Delhi - 110011


SCIENTIFIC PROGRESS

DrugsControllerGeneral(I)orhisnominee Member(NotbelowtherankofAsstt.DrugsController(I))FDA Bhawan,New Delhi - 110002

Director(IFD) MemberMinstry of Health & Family Welfare,Nirman Bhawan,New Delhi - 110011.




Aims and Scope The aim of the Rajbhash unit is to educate, train the employees of Institute to use Hindi language in day-to-day official works as per the rules of Rajbhasha. This unit also provides a platform to employees of the Institute to involve themseleves and participate in various activities during celebration of the ‘Hindi Pakhwara’ and other activities organized by Nagar Rajbhasha Bhasha Karyanvyan Samiti, NOIDA.

The constitution of the Rajbhasha Committee of the Institute is as under :-

Dr.SurinderSingh ChairpersonDr.RebaChhabra ViceChairpersonShriP.C.P.Mahapatra MemberShriS.K.Sharma MemberShri.R.PJoshi MemberShri.SushilKumarDixit MemberShri J.P.Pant Member-Secretary

The Committee has organized various programmes to promote the use of Hindi language in day-to-day official work.

MiscellaneousAcademicactivitiesShri Sushil Kumar Dixit Jr. Hindi Translator and Shri Rajeev Kumar Jr. Scientist participated in “Chitra Adharit Kaavya Lekhan Pratiyogita” held on 24/08/2016 in Indian Oil Corporation ltd. Noida in Overall Guidance of Narakas Nagar Rajbhasha Bhasha Karyanvyan Samiti, NOIDA.

Participation inMeetings/Workshops1. Shri Sushil Kumar Dixit Jr. Hindi Translator

and Shri R.C.Dalai Jr. Accountant attended

a three-days “Ahil Bharteeya Rajbhasha sammelan aur Chintan Shivir” organized by Rajbhasha Seva Sansthan, New Delhi, from 28 September, 2016 to 30 September, 2016 at Puri. In this Occasion Hon’ble, Member of Parliament (Loksabha), Dr. Prashanna Kumar Pathshani,and Hon’ble, Member of Parliament (Rajyasbha) Smt.Sarojni Hembram Awarded participation Certificate.

2. Shri Pawan Kr. Sharma Data Entry Operator and Shri Sanjeev Kumar Store Assistant attended a three-days “Hindi Sangosthi and Karyashala” organized by Rajbhasha Sansthan,Vasant Vihar New Delhi, from 25 to 27 October, 2016 at Nainital Uttarakhand.

3. Dr. J.P. Prsasad Scientist Grade I, and Shri Sushil Kumar Dixit Jr. Hindi Translator and attended a three-days “6th Rashtriya Rajbhasha sammelan” organized by Jawaharlal Nehru Chikitsa Shiksha Evam Anusandhan Sansthan-JIPMER, Puducherry, from 09 January, 2017 to 11 January, 2017 at Puducherry Over all Guidance of MinsitryofHealthandFamilyWelfare.

Rajbhasha Inspection Hindi cell, National Institute of Biological Inspected by Smt Pratibha Mallik, Dy Director (Implementation) Regional Implementation Office (North Region-2) Rajbhasha Vibhag Ministry of Home Affairs, Govt of India on 22-12-2016. She gives some points to Implementation of Oficial Language Policy more effective in her Inspection Report.

WorkshopOrganisedHindi cell, National Institute of Biological

RAJbHASHA(HINDI)


SCIENTIFIC PROGRESS

organised Hindi Pakhwara from 01/09/2016 to 15/09/2016 by the guidelines issued by Rajbhasha Vibhag Ministry of Home Affairs, Govt of India in this program talks deliverd by various officials of the Institute. Various type of competition also organised in this pakhwara programme for the officials of the Institute. Shri Ajay Kumar Sadasya Sachiv Narakas Nagar Rajbhasha Bhasha Karyanvyan Samiti, NOIDA. was the Chief Guest in the valedictory program of Hindi Pakhwara.

buDGET&FINANCEDuring the year 2016-17, the approved Budget Estimate (BE) allocation was Rs. 34.00 Crore and the Revised Estimate (RE) was also Rs. 34.00 Crore. The Institute generated a

revenue of Rs. 15.99 Crore (Including Service Tax) from various sources, i.e., Fee for testing of various biological products, and Fee for Training Programmes, Rents received from Hostel & Guest Houses and interest on the Saving Bank Account etc.

Particulars Amount (Rs. inCrore)

Budget Estimate (BE) 34.00

Revised Estimate (RE)/Final Estimate

34.60

Expenditure incurred during the year

33.65

Details of the expenditure incurred on various Heads may be viewed from the Audited Annual Accounts of the Institute given in the Report.



PERSONNEL

A. (Scientific&Technical)S.No Name Designation

1. Dr. Suridner Singh Director

2. Dr. G.R. Soni Scientist Grade-I Dy. Director (Admn.) q/c

3. Dr. Reba Chhabra Scientist Grade-I, Dy. Director (Admn.) i/c

4. Dr. Achla Prasad Scientist Grade-I

5. Dr. Renu Jain Scientist Grade-I

6. Dr. J. P. Prasad Scientist Grade-I

7. Dr. Shikha Yadav Scientist Grade-II (Sr. Vet.[Path.])

8. Sh. Neeraj Malik Scientist Grade-II

9. Dr. Charu Mehra Kamal Scientist Grade-II

10. Mrs.Ajanta Sircar Scientist Grade-III

11. Mrs Sudha V Gopinath Scientist Grade-III

12. Mrs Kanchan Ahuja Scientist Grade-III

13. Dr. R. K.Sharma Scientist Grade-III

14. Ms. Gurminder Bindra Scientist Grade-III

15. Ms. Shalini Tewari Scientist Grade-III

16. Ms. Rashmi Srivastava Scientist Grade-III

17. Ms. Richa Baranwal Scientist Grade-III

18. Dr. Suresh Kumar Scientist Grade-III (Jr. Vet.)

19. Mrs. Madhu Y. Scientist Grade-III

20. Dr. Meena Kumari Scientist Grade-III

21. Dr. Akanksha Bisht Scientist Grade-III

22. Sh. Tara Chand Scientist Grade-III

23. Dr. Manoj Kumar Scientist Grade-III

24. Sh. Pankaj Kumar Sharma Scientist Grade-III

25. Sh. N. Nanda Gopal Scientist Grade-III

26. Sh. Subhash Chand Scientist Grade-III

27. Sh. Jaipal Meena Scientist Grade-III

28. Sh Ashwini Kumar Dubey Scientist Grade-III

29. Dr. Sanjay Mendiratta Jr. Scientist

30. Sh. Harit Kasana Jr. Scientist

31. Dr. Gaurav Pratap Singh Jadaun Jr. Scientist


SCIENTIFIC PROGRESS

32. Ms. Vandana Tandasi Jr. Scientist

33. Dr. Manjula Kiran Jr. Scientist

34. Dr. Birendra Kumar Jr. Scientist

35. Dr. Varun Singh Jr. Scientist

36. Sh. Sanjeev Kumar Sharma Jr. Scientist

37. Sh. Rajeev Kumar Jr. Scientist

38. Sh.P.S.Chandranand Jr. Scientist

39. Md. Daud Ali Jr. Scientist

40. Dr. Richi V. Mahajan Jr. Scientist

41. Dr. Anoop Kumar Jr. Scientist

42. Dr. Anirban Mukherjee Jr. Scientist

43. Ms. Archana Sayal Jr. Scientist

44. Sh. Ajay Kumar Ade Jr. Scientist

45. Sh. Kallol Saha Lab Technician

46. Ms. Girija L.V. Lab Technician

47. Sh. Subhash Kumar Lab Technician (PWD)

48. Sh. Brij Bhushan Lab Technician

49. Sh. Brij Bahadur Lab Technician

50. Sh. Mohit Sharma Lab Assistant

51. Sh Rajiv Kumar Shrivastava Lab Assistant

52. Sh. Prdeep Kumar Lab Assistant

53. Ms. Priya Bhatt Lab Assistant

54. Sh. Narender Kumar Lab. Assitant

55. Sh.Parminder Kumar Junior Animal Care Taker

b. (Administration,Procurement&Accounts) 86. Name Designation

56. Sh. P.C.P. Mahapatra Administrative Officer & Procurement Officer i/c

57. Sh. S. K. Sharma Budget & Finance Officer

58. Sh. J.P. Pant Section Officer

59. Sh. P.K. Mohapatra Section Officer (Admin.)

60. Sh. Sushil Kumar Dixit Jr. Hindi Translator

61. Sh. Vikash Kumar Senior Accountant

62. Sh. R. C. Dalai Jr. Accountant



63. Sh. Deepak Mahajan Computer Officer

64. Sh. Pawan Kumar Sharma Data Entry Operator

65. Sh. Manmeet Singh Private Secretary

66. Sh. R.K. Arora Steno Grade-III

67. Sh. Pardeep Kumar UDC

68. Sh. Upender Nath Sharma Cashier

69. Sh. Dhirender Singh UDC

70. Sh. Sanjeev Stores Assistant

71. Sh. Partho Pratim Mondal Stores Clerk

72. Sh. Prem Chand Gupta Stores Clerk

73. Sh. Pardeep Kumar UDC

74. Ms. Savita Rai Receptionist

75. Sh. Gobind Singh Rawat Staff Car Driver Grade-II

76. Sh. Ravi Dutt Staff Car Driver Grade-II

77. Sh. Harinder Singh Chauhan Staff Car Driver Grade-II

78. Sh. Leela Kishan Staff Car Driver Grade-II

79. Sh. Bijender Singh Group ‘C’

80. Sh. Suraj Pal Group ‘C’

81. Sh. Subhas Chand Group ‘C’

82. Sh. Rakesh Group ‘C’

83. Sh. P.C.Diwan Group ‘C’

84. Ms. Shobha Group ‘C’

85. Ms. Rajinderi Devi Group ‘C’

C.EngineeringS.No NAME DESIGNATION

86. Sh. Mukesh Kumar Assistant Engineer (Electrical)

87. Sh. R.P.Joshi Assistant Engineer (Civil)

88. Sh. Subhash Chand Junior Engineer (Electrical)

89. Sh.Chandra Pal Junior Engineer (Mechanical)

90. Sh.Amarjeet Singh Junior Engineer (Mechanical)

91. Sh. Krishna Kumar Junior Engineer (Civil)

92. Sh. H.P.Vashisht Electrician


SCIENTIFIC PROGRESS

EMPOWERINGCONSuMERS:RIGHTTOINFORMATIONACT,2005

In terms of Section 4 (1) (b) and 4 (2) of the Right to information Act, 2005, the Institute has nominated the following officers as CPIO and Appellate Authority under the RTI Act, 2005:

1. Dr. Reba Chhabra, Scientist Gr.-I - Appellate Authority

2. Sh. S.K. Sharma, BFO - Central Public Information Officer (CPIO)

During the year (2016-17), the Institute received the following applications to obtain various types of information under the RTI Act:-

Openingbalance

No. ofApplicationsReceived as

transfer fromotherPAu/s

6 (3)

Revived(including

cases transferred

to otherPAs)

Noof casestransferred

to otherPAs

u/s 6 (3)

Decisionwhere

request/appeal

Rejected

Decisionwhere

request/appeal

Accepted

RegistrationFee

Collected(in Rs.) u/s

7 (1)

Request 7 5 22 1 - 29 190

First

Appeals- 1 - - - 1 1


financial statEmEnts

AUDITOR’S REPORT



InDEPEnDEnT AUDITOR’S REPORT

Report on the Financial Statements

We have audited the attached financial statements of national Institute of Biologicals (herein after called “nIB”), which comprise the Balance Sheet as at 31st March,2017, the Income & Expenditure Account and Receipt and Payment Account for the year ended, and a summary of the significant accounting policies and other explanatory information.

Management’s Responsibility for the Financial Statements

The Management is responsible for preparation of these financial statements that give a true and fair view of the financial position and financial performance of NIB in accordance with the accounting principles generally accepted in India. This responsibility includes design, implementation and maintenance of adequate internal controls relevant to the preparation and presentation of the financial statements that give a true and fair view and are free from material misstatement, whether due to fraud or error.

Auditor’s Responsibility

Our responsibility is to express an opinion on these financial statements based on our audit We Conducted our Audit in accordance with Standards of Auditing issued by ICAI. Those Standards require that we comply with ethical requirements and plan and perform the audit to obtain reasonable assurance about whether the financial statements are free from material misstatement.

An audit involves performing procedures to obtain audit evidence about the amounts and the disclosures in the financial statements. The procedures selected depend on the auditor’s judgment, including the assessment of the risks of material misstatement of the financial statements, whether due to fraud or error. In making those risk assessments, the auditor considers internal control relevant to the NIB’s preparation and fair presentation of the financial statements in order to design audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the entity’s internal control. An audit also includes evaluating the appropriateness of the accounting policies used and the reasonableness of the accounting estimates made by the Management, as well as evaluating the overall presentation of the financial statements.

We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our audit opinion on the financial statements.



Report on Other Legal and Regulatory Requirements

1. Attention is invited to :

• note no.1 regarding non consideration of bank balances by nIB

• note no.2 regarding non provision of leave encashment, gratuity and bonus

• Note no.8 regarding non confirmation of balances from third party

• note no.11 regarding internal Audit System at nIB

• note no.13 regarding long outstanding Advances to the parties

• note no.17 regarding utilization of Grants

2. we report that:

(a) We have obtained all the information and explanations which to the best of our knowledge and belief were necessary for the purposes of our Audit;

(b) In our opinion, the proper books of account have been kept by the NIB so far as it appears from our examination of those books;

(c) In our opinion, the Balance Sheet, Income & Expenditure account dealt with by this report complies with the accounting standards issued by the ICAI; and

(d) In our opinion, the Balance Sheet, Income & Expenditure account dealt with by this report are in agreement with the books of account maintained by NIB.

OpinionSubject to our observations/ comments in Para 1 of “Report on Other Legal and Regulatory Requirements” above, in our opinion and to the best of our information and according to the explanations given to us, the aforesaid financial statements give a true and fair view:

1) In the case of Balance Sheet of the state of affairs of the NIB as at 31st March, 2017; and



2) In the case of Income and Expenditure account, of the Income & expenditure for the year ended on that date.

AAJV AnD ASSOCIATES

Chartered Accountants

Reg. no. 07739n

Sd/- AnIL KUMAR AGGARWAL

Place of Signature: nOIDA Partner

Date: 12/09/2017 M. no. 098261


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-



NATIONAL INSTITUTE OF BIOLOGICALS (Ministry of Health and Family Welfare, GOI)

SCHEDULES FORMING PART OF BALANCE SHEET AS AT 31st MARCH 2017

SCHEDULE 1 - CORPUS/CAPITAL FUND For Current Year ended on 31.03.2017 For Previous Year ended on 31.03.2016

Balance as at the beginning of the year 2,08,35,68,787.76 2,08,12,65,653.76

Add: Grant Utilised for Security Deposits - 2,95,550.00

Add: Increase in Stock of Fuel for Boillers & D.G Set -27,78,451.00 11,97,654.00

Add: Grant utilised for Security Deposits - Electricity - - 8,09,930.00

Add: Receipts from sale of Assets - 2,08,07,90,336.76 - 2,08,35,68,787.76

Add: Capital Assets Fund

Balance at the beginning of the year 11,27,17,780.00 8,46,19,012.00

Addition during the year 8,49,48,845.00 2,80,98,767.00

Transfer from WIP - 19,76,66,625.00 - 11,27,17,779.00

Add: Grant utilised for advances of previous years 65,29,206.00 4,67,60,067.00

Add: Grant Utilised for Advances during the Current Year against goods & services 1,95,39,616.00 3,86,90,852.00

Add: Grant utilised for Prepaid Expenses Increase/Decrease during the year - Electricity -34,37,990.00 -23,071.00

BALANCE AS AT THE YEAR END 2,30,10,87,793.76 2,28,17,14,414.76

SCHEDULE 2 - CURRENT LIABILITIES AND PROVISIONS For Current Year ended on 31.03.2017 For Previous Year ended on 31.03.2016

A. CURRENT LIABILITIES

1. Sundry Creditors

a) HSCC 1,54,57,028.00 1,59,78,192.00

b) Goods 1,07,94,325.00 2,62,51,353.00 1,16,47,309.00 2,76,25,501.00

2. Advances Received

-Advance Sale of Refrence standards & for SERB Project 4,14,400.00 -

- Fund received for SERB Project 8,76,000.00

-Receipts payable to MOH & FW, GOI 4,65,37,358.00 1,44,65,822.12

-Earnest Money Deposit 26,74,400.00 5,05,02,158.00 25,12,500.00 1,69,78,322.12

3.Statutory Liabilities

-TDS (Professional) 1,68,408.00 1,34,843.00

-TDS (Contractors) 3,45,298.00 2,15,026.00

-WCT 1,18,212.00 52,356.00

-CST 17,400.00 5,800.00

-Swachh Bharat Cess Pyable -10,032.00 45,208.00

-UPTT 750.00 6,40,036.00 3,498.00 4,56,731.00

4. Other Current Liabilities

-Security Deposit/Retention Money 32,96,549.80 23,64,864.80

-Salary Payable 59,36,112.00 56,90,377.00

-Expenses Payable 16,52,879.00 1,28,868.00

-Claim Payable 78,917.00 1,11,085.00

-Employee’s Contribution to NPS - 3,754.00

-Employer Contribution to NPS (Payable) 1,72,877.00 33,797.00

-Payable to Staff 3,79,057.00 -

-TDS Payable to NIB-Drugs Survey - 318.00

-TDS Payable to NIB-GPF - 1,15,16,391.80 1,356.00 83,34,419.80

B. PROVISIONS

1. For Gratuity 54,27,154.00 45,41,806.00

2. Accumulated Leave Encashment 45,82,956.00 1,00,10,110.00 49,31,931.00 94,73,737.00

Unspent/Surplus Grant Payable to MOHFW, Govt. of India 3,57,97,999.13

TOTAL 9,89,20,048.80 9,86,66,710.05


National Institute of Biologicals N

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146,15

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2.84

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391,40

4,30

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380,08

6,79

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362,98

7,72

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23,201

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5,14

6,39

0.00

-

28,348

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11,103

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1,54

0,95

6.68

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12,644

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12,098

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15,703

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18,657

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1,77

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20,429

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7,64

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1,19

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8,83

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3.43

11,016

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11,593

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1,94

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911,73

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167,22

0.86

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200,97

0.64

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200,97

0.64

190,92

2.10

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190,92

2.10

10,048

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10,048

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6,18

7,25

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77,054

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6,26

4,31

3.00

5,60

2,14

4.30

174,68

4.80

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5,77

6,82

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585,11

4.70

487,48

3.90

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1,75

5.00

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877.50

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2,63

2.50

7,24

5.00

6,36

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119,11

2.00

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119,11

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29,805

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27,879

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54,584

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2,13

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56,390

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4.43

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9,60

1.45

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54,584

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942,76

3,96

8.71

1,27

3,82

5,85

0.98

1,30

3,51

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2,13

3,90

6,68

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5,45

2.43

835,33

7,39

6.51

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1.43

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SCHEDULE 4 - CURRENT ASSETS , LOANS & ADVANCES For Current Year ended on 31.03.2017 For Previous Year ended on 31.03.2016

A. CURRENT ASSETS

1. Cash balances in hand 18,712.88 28,418.00

2. Balance with Banks :

- Saving Accounts 9,92,98,718.47 10,39,20,365.47

3. Stamps in hand 8,425.00 9,93,25,856.35 5,042.00 10,39,53,825.47

TOTAL (A) 9,93,25,856.35 10,39,53,825.47

B. LOANS, ADVANCES AND OTHER CURRENT ASSETS

1. Loans

(a) Staff Advances

- Computer Advance 12,900.00 30,900.00

- Scooter Advance 16,000.00 3,000.00

- House Building Advance 2,74,230.00 4,18,230.00

- Tour Advance - 13,500.00

- LTC Advance 7,660.00 -

- Festival Advance 29,700.00 48,650.00

- Motor Car Advance 1,14,000.00 1,50,000.00

- Departmental Advances - 4,54,490.00 7,400.00 6,71,680.00

(b) Other Entities engaged in activities of NIB

- Advance to A-CDSCO DRUG SURVEY 10,00,000.00 4,145.00

- Advance to CPWD 10,00,000.00 5,73,90,000.00

- Advance to DAVP 3,582.00 3,582.00

- Advance to DGS&D (Computer) 2,01,392.00 16,43,021.00

- Advance to HSCC (ETP) 5,69,091.00 5,69,091.00

- Advance to HSCC (Other work) 6,48,934.91 6,48,934.91

- Advance to IOCL 26,951.00 10,32,241.00

- Advance to National Physical Laboratory 42,665.00 -

- Advance to NICSI 1,01,933.00 1,01,933.00

- Advance to NIN NCLAS 1,162.00 1,162.00

- Advance to PNB A/C-Custom 10,449.00

- Advance to Sunhare kal ki Pahle 35,95,710.91 50,000.00 6,14,54,558.91

2. Advances and other amount recoverable in cash

or in kind or for value to be received:

a) On capital Account

-Advance to HLL Life Care Ltd against Equipments 2,84,59,918.00 2,85,69,346.00

b) Deposits

-Bank Deposit for sales tax registration 25,000.00 25,000.00

-Security Deposit with Balmer Lorrie 3,00,000.00 3,00,000.00

-Security Deposit with PVVNL 79,57,678.00 79,57,678.00

-Security Deposit with Padam Petroleum 25,000.00 25,000.00

-Security Deposit with NOIDA 9,30,750.00 9,30,750.00

-Security Deposit with Telephone 10,000.00 10,000.00

-Security Deposit with PNG(IGL) 1,92,000.00 1,92,000.00

-Security Deposit with Gas (BPCL) 3,550.00 3,550.00

-CENVAT Recoverable 9,81,448.00 3,88,85,344.00 20,86,260.00 4,00,99,584.00

3. Claim Receivable 21,98,029.00 10,58,801.00

4. Sundry Debtors 1,560.00

5. Pre-paid Expenses 2,90,972.00 37,28,962.00

6. Stock-Fuel for Boillers & D.G Set 44,80,613.00 72,59,064.00

7. TDS Receivable (2014-15) - 1,25,544.00

8. TDS Receivable (2016-17) 39,453.00 22,093.00

9. Grant Receivable/Payable to MOHFW, GOI 44,62,839.87 -

TOTAL (B) 5,44,07,451.78 11,44,21,846.91

TOTAL (A+B) 15,37,33,308.13 21,83,75,672.38

SCHEDULE 5 - RECEIPTS FROM TESTING & SALES For Current Year ended on 31.03.2017 For Previous Year ended on 31.03.2016

1. Receipts from Testing

-Sample Testing Fee Receipts 12,99,56,756.00 12,99,56,756.00 3,67,84,465.00

2. Receipts from Sales

-Sale of Refrence Standards/Panel 8,80,000.00 6,80,000.00

8,80,000.00 6,80,000.00

TOTAL 13,08,36,756.00 3,74,64,465.00




SCHEDULE 6 - GRANTS/SUBSIDIES (Irrevocable Grants & Subsidies Received)

For Current Year ended on 31.03.2017 For Previous Year ended on 31.03.2016

Grant Received During the year 29,62,00,000.00 34,60,00,000.00

Grant unutilized b/f from the previous year 3,57,97,999.13 1,91,559.71

Total 33,19,97,999.13 34,61,91,559.71

Grant Adjusted towards Revenue Expenditure:

Current Year Expenditure 31,71,10,532.00 26,47,22,795.58

Less: Expenses Adjusted from current year income 14,05,37,358.00 17,65,73,174.00 4,68,35,822.12 21,78,86,973.46

(taken to income & expenditure Account) 15,54,24,825.13 12,83,04,586.25

Less: Grant utilized for purchase of fixed Assets 71,23,967.00 58,35,240.00

Less: Advances of Previous Year Utilized

Less: Grant utilized for advances against Fixed Assets/ Goods/Services/Deposits for C.Y

1,95,39,616.00 3,86,90,852.00

Less: Current Year income transferred to MOH & FW 9,40,00,000.00 3,23,70,000.00

Less: Current Year Income Payable to MOH & FW 4,65,37,358.00 1,44,65,822.12

Less: Increase in Stock of Fuel for Boillers & D.G Set -27,78,451.00 11,97,654.00

Add: Previous Year’s Advance adjusted towards Goods & Services 10,96,835.00 11,35,390.00

Less: Prepaid Expenditure during the year - Electricity -34,37,990.00 -23,071.00

Less: Security Deposits - Balmer Lawrie - 1,00,000.00

Less: Security Deposits - IGL & BPCL - 1,95,550.00

Less: Security Deposits - Electricity - 8,09,930.00

Grant Payable/(Receivable) to Govt. of India (Refer schedule-4)

-44,62,839.87 3,57,97,999.13

SCHEDULE 7 - INTEREST EARNED For Current Year ended on 31.03.2017 For Previous Year ended

on 31.03.2016

1) On Saving accounts 80,02,020.00 72,20,370.00

2) On Loans To Employees/Staff 62,975.00 74,739.00

TOTAL 80,64,995.00 72,95,109.00

SCHEDULE 8 - OTHER INCOME For Current Year ended on 31.03.2017

For Previous Year ended on 31.03.2016

a) Usage receipts for Hostel, Guest House & Conference Hall 4,60,800.00 8,74,100.00

b) Sale of Tender Forms 27,478.00 53,500.00

c) Training Fees 1,24,000.00 50,000.00

d) Misc Receipt 1,80,740.00 4,85,156.12

e) Interest Income - HSCC 5,21,164.00 5,82,619.00

f) Sale of Lab Animal 2,92,606.00 -

g) License Fees 28,819.00 30,873.00

TOTAL 16,35,607.00 20,76,248.12

SCHEDULE 9 - ESTABLISHMENT EXPENSES

For Current Year ended on 31.03.2017


a) Salary and Wages 7,52,28,800.00 5,97,14,220.00

b) Allowances and Bonus 4,75,614.00 2,15,939.00

c) Employer’s Contribution to NPS/ other Fund 21,64,229.00 14,64,259.00

d) Staff Welfare expenses 17,03,175.00 11,71,267.00

e) Expenses on Employee’s Retirement and Terminal Benefit 1,06,32,472.00 47,26,080.00

f) Others

-Medical Reimbursement 16,32,635.00 20,43,148.00

-LTC Expenses 7,62,507.00 6,66,758.00

-Reimbursement of Tution Fees 8,34,900.00 10,34,152.00

-Honorarium 38,000.00 5,000.00

-Recruitment Expenses 1,47,168.00 1,848.00

TOTAL 9,36,19,500.00 7,10,42,671.00




SCHEDULE 10 - OTHER ADMINISTRATIVE EXPENSES

For Current Year ended on 31.03.2017


a) Consultants/Cont. Emp.Payment 2,89,28,756.00 2,91,48,996.00

b) Purchase of office consumables 8,21,403.00 13,42,782.00

c) Office Maintenance 1,50,67,716.00 67,37,396.00

d) Rent, Rates and Taxes 39,258.00 1,53,940.00

e) Vehicles Running and Maintenance 1,76,214.00 6,12,765.00

f) Postage, Telephone and Communication Charges 8,28,771.00 7,59,988.00

g) Printing & Stationary 29,18,670.00 17,76,296.00

h) Travelling and Conveyance Expenses 18,76,290.00 9,96,682.00

i) Expenses on Seminar/Workshops 4,65,235.00 3,04,376.00

j) Auditor’s Remuneration 60,000.00 62,618.00

k) Professional Charges 24,43,568.00 23,33,784.00

l) Advertisement and Publicity 10,10,815.00 27,08,200.00

m) Other Expenses:

- Miscellaneous Expenses 19,850.00 13,522.00

- Security Services expenses 1,19,43,141.00 1,13,20,626.00

- Honorarium (others) 3,02,000.00 1,68,400.00

- House Keeping Charges 64,09,612.00 81,09,768.00

- Hiring of Vehicles 39,72,939.00 27,39,821.00

- Hindi Promotion 1,07,145.00 46,105.00

- Bank Charges - 16,037.58

- Internet Access Charges 8,30,053.00 3,67,487.00

- Travelling (others) 10,46,943.00 5,28,794.00

- Newspapers & Periodicals 3,12,963.00 2,29,717.00

- Other Office Expenditure 41,513.00 7,11,840.00

- Pest Control Charges 2,07,304.00 2,47,007.00

- Consultancy Charges- HLL 2,88,558.00 -

TOTAL 8,01,18,717.00 7,14,36,947.58

SCHEDULE 11 - LAB SERVICES - OPERATION & MAINTENANCE EXP For Current Year ended on 31.03.2017


a) Electricity and Water Charges 6,13,61,836.00 5,26,59,885.00

b) Repair & maintenance - Lab Equipments 91,03,200.00 88,15,590.00

c) Operation & Maintenance - Electrical 35,94,334.00 26,49,169.00

d) Operation & Maintenance - DG Sets 55,35,322.00 14,08,217.00

e) Operation & Maintenance - HVAC Plant 84,23,281.00 67,70,967.00

f) Operation & Maintenance - Boiler 16,96,779.00 15,10,870.00

g) Operation & Maintenance - Water Supply system 25,94,965.00 21,56,210.00

h) Operation & Maintenance - Air Compressor 33,165.00 37,785.00

i) Operation & Maintenance - Cold Room 22,15,731.00 26,13,198.00

j) Operation & Maintenance - BMS 10,76,063.00 19,13,779.00

k) Operation & Maintenance - Lifts 6,63,811.00 14,68,797.00

l) O & M Acces Control System 9,53,825.00 10,57,163.00

m) Purchase of Lab Consumable 1,51,72,748.00 1,18,35,969.00

n) Purchase of Lab Chemicals 21,07,276.00 31,38,932.00

o) Purchase of Kits & Reagents 1,52,71,290.00 1,51,24,380.00

p) Purchase of Lab Animal 1,92,000.00 -

q) Consumption of Fuel for Boillers & D.G Set

Opening Balance of Fuel 72,59,064.00

Add: Purchases 1,03,87,225.00

Less: Closing stock 44,80,613.00 1,31,65,676.00 88,94,109.00

r) Bio-Waste Disposal Charges 2,11,013.00 1,88,157.00

TOTAL 14,33,72,315.00 12,22,43,177.00




RECEIPTS AND PAYMENTS ACCOUNT FOR THE YEAR ENDED 31ST MARCH 2017

RECEIPTS Current Year Previous Year PAYMENTS Current Year Previous Year

1. Opening Balance 1. Expenses -Cash in Hand 28,418.00 37,786.00 -Establishment Expenses 7,52,39,640.00 7,03,67,012.00 -Bank Balance 10,39,20,365.47 5,61,47,397.13 -Administrative Expenses 52,24,575.00 7,21,84,930.58 -Stamps in Hand 5,042.00 692.00 -Lab Services- O&M Exp 9,05,70,221.00 12,34,40,831.00 2. Grants Received 2. Payments made against funds -From Government of India 29,62,00,000.00 34,60,00,000.00 -Advance to HLL Lifecare Limited (Net) 1,94,70,000.00 18,30,000.00 -Advance to IOCL 1,26,50,000.00 7,63,237.00

3. Interest Received: -Advance to CPWD

-

3,43,90,000.00 -On Bank deposits 80,02,020.00 72,20,370.00 -Advance to CDSCO - Drug Survey 10,00,000.00 - -Interest Recovered from Scooter, HBA &

Computer advance

- 74,739.00 -Advance to DGS&D (Computer) - 16,43,021.00

-Advance to Contractors & Suppliers (Net) 10,77,681.00 - 4. Other Income - Advance to A-Hartrodit Pvt. Ltd. - 4,145.00 -Receipts from Hostel/Guest houses 3,71,775.00 8,74,100.00 - Advance to PNB Custom - 10,449.00 -Sale of Tenders Forms 29,428.00 53,500.00 - Advance to Sunhare kal ki Pahle - 50,000.00 -Sample testing receipts 14,58,75,833.00 3,67,84,465.00

-Sale of Reference Standards 8,80,000.00 6,80,000.00

3. Expenditure on Fixed Assets & Capital

Work-in-Progress

-Training fees 1,24,000.00 50,000.00 -Machinery & Equipment 26,94,761.00 8,46,667.00 -Licence Fee - 30,873.00 -Computers 4,97,155.00 -Other Interest Income - 10,67,775.12 -Computers & Computer Software 4,26,844.00 11,91,187.00 -Miscellaneous Receipts 2,91,966.00 - -Furniture & fixture 3,22,320.00 54,781.00 -Sale of Lab Animals 2,92,606.00 -Office Equipments 18,87,712.00 28,06,154.00 -Vehicle - 83,906.00 5. Other Receipts -Books 70,494.00 3,24,076.00 Recovery from Staff Advances -Tools - 31,313.00 -Computer Advance - 33,900.00 -Scooter Advance - 38,000.00 4. Refund of surplus money/Loans -House Building Advance - 1,44,000.00 -To the Government of India 9,40,00,000.00 3,23,70,000.00 -Tour Advance 2,81,155.00 3,02,800.00 -Last Year Receipts Paid to Ministry 1,44,65,822.00 3,55,60,617.00 -Motor car Advance - 30,000.00 -LTC Advance 7,466.00 4,60,881.00 5.Other payments -Festival Advance - 65,100.00 Advances disbursed during the year -Departmental Advance 46,053.00 30,20,326.00 -Scooter Advance 30,000.00 - -Advances to Contractors Utilized during the year

during the year

- - -Festival Advance 45,000.00 72,000.00

-Advance Received for Reference Standards 4,14,400.00 - -Computer Advance 24,000.00 -Advance Received from NISCI - -Tour Advance 7,27,500.00 2,95,300.00 -EMD received during the year 92,31,500.00 19,23,000.00 -LTC Advance 4,98,675.00 4,36,881.00 -Security Deposit/Retention Money Received

during the year

2,64,923.00 6,64,210.80 -Departmental Advance 4,90,134.00 30,27,726.00

-Net Claims received during the year 39,27,514.00 1,35,464.00 -Motor Car Advance - 1,80,000.00 -Net Increase in payment of Statutory dues - 2,66,919.00 -Other Advance 1,92,873.00 2,68,291.00 -Creditors for Fixed Assets/Capital Goods - - -Security Deposit (Travelling) - 1,00,000.00



As per our report of even date attached

For AAJV & ASSOCIATES For National Institute of Biologicals Chartered Accountants FRN NO. 007739N

Sd/- Sd/- Sd/- CA Anil Kumar Aggarwal Partner (M.No. 098261)

S.K. Sharma Dr. Reba Chhabra (Budget & Finance Officer) (Sc. Gr.-I/Dy. Director(Admn. i/c)

Sd/- Place : Noida Dr. Surinder Singh Date : 12/09/2017 (Director)

-TDS Receivable received 1,47,637.00 27,527.00 -Security Deposit (Electricity) - 8,09,930.00 -Received from IPC - Haemovigilance 20,00,000.00 - -Security Deposit released during the year 6,03,505.00 -

-Decrease in Debtors - - -Security Deposit (Gas-BPCL) - 3,550.00

-Claim Payable - - -Security Deposit (PNG-IGL) - 1,92,000.00

-Employee’s Contribution to NPS - 19,072.00 -EMD released during the year 87,34,700.00

- Adv Rec for Hospitality Expenses-IPC 9,00,000.00 -Statutory Liabilities Paid 2,89,49,642.00

- -Adv Rec From CDSCO 2,00,000.00 - -Receivable from IPC - Haemovigilance 20,00,000.00 - - Fund Recd From Science & Engineering Board

(SERB)

8,76,000.00 - -Net Service Tax paid during the year 1,062.00 3,50,909.00

- Receipts from Spurious Drug Survey - 3,25,93,616.00 -Payment made for Expense Payable 57,172.00 5,82,619.00 -Payment to Suppliers of Goods & Services 11,35,61,912.00 6.Closing Balances -Cash in Hand 18,713.00 28,418.00 -Bank Balance 9,92,98,718.47 10,39,20,365.47 -Stamps in Hand 8,425.00 5,042.00

TOTAL 57,43,18,101.47 48,87,46,513.05 TOTAL 57,43,18,101.47 48,87,46,513.05




DETAILS OF GRANT UTILISATION FOR THE FINANCIAL YEAR 2016-17

Amount in Rs.

PARTICULARS GIA - SALARY GIA - GENERAL GIA - ASSETS TOTAL

RECEIPTS

Grant unutilized b/f from the previous year 4,57,000.00 1,94,02,999.13 1,59,38,000.00 3,57,97,999.13

Grant in Aid Received From Ministry 7,95,00,000.00 1966,00,000.00 2,01,00,000.00 29,62,00,000.00

TOTAL RECEIPTS (A) 7,99,57,000.00 2160,02,999.13 3,60,38,000.00 33,19,97,999.13

LESS:- EXPENDITURE INCURRED & PROVISION

Establishment Expenses 9,36,19,500.00 9,36,19,500.00

Administrative Expenses 8,01,18,717.00 8,01,18,717.00

Lab Services-Operation & Maintainance Exp 1433,72,315,.00 14,33,72,315.00

Increase in Stock of Fuel for Boillers & D.G Set -27,78,451.00 -27,78,451.00

Payment made for Fixed Assets during the year:

Additions in Fixed Assets 8,49,48,845.00 8,49,48,845.00

Less: Advance of Previous year utilized against Fixed Assets -778,24,878.00 -7,78,24,878.00

Advance against Fixed Assets, Goods & Services (Net) 1,95,39,616.00 1,95,39,616.00

Less: Advance of Previous year utilized against Goods & Services -10,96,835.00 -10,96,835.00

Prepaid Expenditure during the year -34,37,990.00 -34,37,990.00

TOTAL CURRENT YEAR EXPENDITURE / UTILISATION (B) 9,36,19,500.00 2161,77,756.00 2,66,63,583.00 33,64,60,839.00

GRANT RECEIVABLE/PAYABLE TO GOI (2016-17) (B-A) -1,36,62,500.00 -1,74,756.87 93,74,417.00 -44,62,839.87



nATIOnAL InSTITUTE OF BIOLOGICALS SCHEDULE-12 (Forming part of Financial Statement as on 31.03.2017)

(A) SIGnIFICAnT ACCOUnTInG POLICIES 1. Basis of Accounting

The financial statements have been prepared as prescribed by ICAI in accordance with generally accepted accounting principles. The National institute of Biologicals (here and after referred as NIB) adopts accrual system of accounting, however, the incomes i.e. receipts from Sale of Reference Standard, Sample testing charges, Training Fee received, Rent received from Hostel/Guest House and Interest on advances are recognized on cash basis.

The accounting policies adopted and applied in the preparation of financial statements by the NIB are consistent with those used in the previous years.

2. Fixed Assets and Depreciation

a) Fixed assets are stated at cost less accumulated depreciation.

b) Depreciation has been provided to the extent of 95% on S.L.M on the basis of rates as prescribed in schedule XIV of the Companies Act 1956. The depreciation rates applied on various assets is given below –

FIXED ASSETS RATES OF DEPRECIATIOn CHARGED

Machinery & Equipment - 4.75%

Office Equipment - 7.07%

Building - 1.63%

Furniture & Fixtures - 6.33%

Typewriter - 13.91%

Vehicles - 9.50%

Air Conditioner - 13.91%

Computer& Computer Software - 16.21%

Cycle Rickshaws - 9.50%

Tools - 4.75%

Books - 40.00%

c) In respect of additions to fixed assets made during the year, depreciation has been provided for the full year and in respect of sale/disposal of fixed assets, no depreciation



has been provided, but it has no financial implication due to this deviation from the prescribed provisions of the ICAI.

d) The depreciation has been charged to the grant (Corpus Fund/Capital Fund) and is recognized in the Income & Expenditure account over the useful life of the asset as a contra item as per AS-12 Prescribed by the ICAI.

e) The depreciation on Fixed Assets has been charged at old rates till the F.A.R. is completed and asset are identified.

3. Grant In Aid

a) The Grants-in-Aid received from the Ministry of Health & family Welfare (MOH &FW), Government of India is accounted for on accrual basis. Accordingly, any deficit / surplus of grant has been shown as Grant Receivable / Payable to the MOH &FW.

b) The grants utilized for the purchase of fixed assets have been shown under the head of Capital Assets Fund.

c) Further grants utilized for advances against fixed assets, goods & services have also been shown under the head of Corpus/Capital Fund.

d) A chart for receipt and utilization of Grant according to its grant head has been prepared and shown at Sr.No.17 to Notes on Accounts to the financial statement. The inter head adjustments have been made in case of excess/deficit of grants received.

4. Inventory Valuation

Stock of Diesel has been valued at cost based on First in First out (FIFO) method.

5. Employee Remuneration & Benefits

All Retirement and other Terminal Benefits such as Gratuity, Leave Encashment and Bonus etc. are not accounted on year to year basis and the same are recognized in the year of occurrence of event.

6. Revenue Recognition

a) Income and expenditure are accounted for on accrual basis, as they are earned or incurred however, the incomes i.e. rent received from hostel/guesthouse, Sample testing charges, sale of reference standard, bank interest and interest on staff advances are accounted on Cash basis.

b) From 2013-14 onwards, Consultancy charges paid for procurement of Fixed Assets is considered as revenue expenditure.



7. Provision

A provision is recognized, when an enterprise has a present obligation as a result of past event; it is probable that an outflow of resources will be required to settle the obligation, in respect of which a reliable estimate can be made. Provisions are determined based on best estimate required to settle the obligation at the balance sheet date. These are reviewed at each balance sheet date and are adjusted to reflect the current best estimates.

8. Contingent Liabilities and Contingent Assets

A disclosure for a contingent liability is made when there is a possible obligation that may, but probably will not, require an outflow of resources. Where there is a possible obligation or a present obligation but the likelihood of outflow of resources is remote, no provision or disclosure is made.

(B) nOTES On ACCOUnTS1. The balance which is lying with the Bank as on 31.03.2017 is not considered in the Books

of NIB. The income is unaccounted to the extent interest received on following accounts: (Figures in Rupees)

Sl. no.

Type of Ac-count

Opening Bal-ances as on 01.04.2016

Fund T/F from nIB

A/c

Interest Earned

Fund Uti-lized for Dis-bursement of

Pension

Balance as on

31.03.2017

1. N I B - P e n -sion A/c

3,31,739 76,00,000 34,605 73,32,131 6,34,213

Due to non-consideration of above mentioned figures, Income and Assets are understated to the extent of Rs.34,605/- and Rs.6,34,213/- respectively.

2. Provision for Leave Encashment and Gratuity has not been made during the year, as exact liability has not been ascertained by approved actuary. Similarly, the provision on account of bonus payable during the year has not been made as the exact liability has not been ascertained.

3. Sundry Creditors includes a sum of Rs 1,54,57,028/-, which is payable to M/s HSCC(I) Ltd. on account of construction of Laboratory & Animal House and consultancy fee. This amount is payable from the last many years, due to some technical defects intimated to HSCC and which was not yet rectified. The Institute is also in process of reconciliation and final settlement of this with the HSCC.

4. All liabilities are recognized to the extent information available.

5. NIB transfers all the Receipts earned during the year from its various operations to the Ministry of Health & Family Welfare and already transferred an amount of Rs.9,40,00,000/- out of total receipts of Rs.14,05,35,984/-. The balance amount of Rs.4,65,35,984/- is shown as “Receipts Payable” to MOH&FW under the head of “Current Liability”.



6. NIB has maintained Fixed Assets detail in soft format and keeping hard copy of the same for records. Further, physical verification of fixed assets & stores was in process at the balance sheet date.

7. The depreciation of Rs.545,84,367.26/- has been charged to the Income & Expenditure account. Since the Institute is fully aided by the Government of India, therefore depreciation is charged to the Grant (Corpus Fund/Capital Fund) and is recognized in the Income & Expenditure account over the useful life of the asset as a contra item.

8. Party’s balances including balance with HLL and HSCC are subject to confirmations. Further, the interest earned on funds available with HSCC has been recognized in the books of NIB on the basis of details provided by them and Interest received amounting to Rs. 5,21,164/- for Lab & Animals House works has been recognized as income and the same is reduced from amount payable to HSCC.

9. During the Financial Year 2016-17, NIB has transferred Rs. 76,00,000/- to “NIB Pension Fund Account”, shown as an expense in the books of NIB. This amount has been kept in a separate bank account and utilized for disbursement of Pension/Family Pension to the NIB ex-official and balance of that bank is not reflected/shown in the books of NIB along with the interest thereon.

10. Purchase of Diesel to the extent utilized during the year has been recognized as expenditure and the balance amount is shown as stock (as ascertained by the Institute) forming part of Current Assets.

11. Internal audit system is to be introduced which will further strengthen the Internal Control System.

12. NIB has not gathered any information from suppliers/service providers about their status under Micro, Small and Medium Enterprises (Development) Act, 2006 not pertain to NIB during the year. Therefore, the required information, regarding the dues outstanding to Micro, Small and Medium Enterprises as on 31.03.2017 and interest payable, if any, are not recognized and reported.

13. The advances to contractors & suppliers includes the following:

Sl. no. Party’s name Amount (in Rs.)

Remarks

1. M/s HSCC (I) Ltd., Noida

12,18,025.91 Amount of Rs.5,69,091/- was provided for Effluent Treatment Plant (ETP) & Rs 6,48,934.91/- for other work is subject to confirmation. This amount is outstanding for last many years.



2. M/s HLL Lifecare Limited, Noida

2,84,59,918/- The account with HLL Lifecare Ltd. has not been reconciled. Total Payments made during the year, was Rs.1,94,70,000/- and Lab Equipment to the tune of Rs.1,95,79,428/- has been procured out of the advances with them.

3 NICSI 1,01,933/- Outstanding since October 2014 and need to be adjusted against expenditure incurred.

4. CPWD 5,73,90,000/- The amount was lying as advances, out of this, Rs. 5,63,90,000/- has been transferred to CWIP as the major work has already been completed in earlier years but due to non-availability of relevant documents, the amount was kept in advances. Balance amount of Rs. 10 Lakhs is still lying as advance with CPWD on account of work yet to be completed.

14. Separate books as well as bank accounts are being maintained for various projects/schemes on behalf of other entities by the Institute. Their balances as per respective books as on 31.03.2017 are given below. Interest income thereon and balances therein belong to other entities, hence are not included in the books of accounts of NIB.

S.nO. Account TypeInterest earned during the year

Balance as on 31.03.2017

1. NIB-Haemovigilance A/c 31,459/- 1,75,207/-

2. NIB-UPSAC A/c 8,942/- 4,86,699/-

3. NIB-Drug Survey A/c 2,00,449/- 3,18,824/-

4. NIB-Training & Workshop 29,957/- 4,03,448/-

5. NIB-HITES 1,28,567/- 2,77,789/-

15. NIB-GPF Trust manages the General Provident Fund (GPF) of NIB employees and has obtained a separate Income Tax PAN. Interest of Rs. 2,58,750/- as reflected in 26As of NIB pertains to NIB-GPF trust. The IFCI Ltd has not deducted TDS on Investment of securities with them. The same has been recognized in the books of NIB-GPF.



16. Previous year’s figures have been regrouped/reclassified/rearranged, wherever necessary.

17. Utilization of Grants Received during the year:

S.nO.

(1)

nature of Grant

(2)

Opening Balance

(3)

Amount Received

(4)

Amount Utilized

(5)

Excess/ (Shortfall)

Utilized(6=3+4-5)

i. GIA-Assets 1,59,38,000 2,01,00,000 2,66,63,583 93,74,417

ii. GIA-Salary 4,57,000 7,95,00,000 9,36,19,500 (1,36,62,500)

iii. GIA-General 1,94,02,999 19,66,00,000 21,61,77,756 (1,74,757)

Total 3,57,97,999 29,62,00,000 33,64,60,839 (44,62,840)

18. Certain Cheque issued but become stale as on the date of Audit and reversed in the subsequent year.

For AAJV AnD ASSOCIATES FOR nATIOnAL InSTITUTE OF BIOLOGICALSChartered Accountants (FR no. 07739n)

Sd/-CA Anil Kumar Aggarwal Sd/- Sd/-Partner S.K. SHARMA Dr. Reba Chhabra(M. No. 098261) (Budget & Finance Officer) (Sc. Gr.-I/ Dy. Director (Admn.) I/c)

Sd/- Place: noida Dr. Surinder SinghDate: 12/09/2017 (Director)



InDEPEnDEnT AUDITOR’S REPORT

The Members,General Provident Fund,

National Institute of Biologicals,Ministry of Health & Family WelfareGovernment of India,A-32, Sector-62 (Institutional Area)Noida-201307

1. We have audited the attached Balance Sheet of the National Institute of Biologicals- General Provident Fund as at 31st March 2017 and Income & Expenditure Account along with Receipts & Payment Account for the year ended on that date annexed thereto. These Financial Statements are the Responsibility of the “NIB-GPF” Management. Our Responsibility is to express an opinion on these Financial Statements Based on our Audit.

2. Further we report that:

a) We have obtained all the information and explanations which to the best of our knowledge and belief were necessary for the purpose of our audit.

b) In our opinion proper books of accounts as required by law have been kept by the Institute so far as it appears from our examination of books.

c) The Balance Sheet and the Income & Expenditure Account dealt with by this report are in agreement with the books of accounts.



3. In our opinion and to the best of our information and according to the explanations given to us, the said accounts exhibit a true and fair view.

a) In the case of Balance Sheet of the state of affairs as at 31st March 2017; and

b) In the case of the Income & Expenditure Account Excess of Income over Expenditure for the year ended 2017.

For AAJV AnD & ASSOCIATESChartered Accountants(FRn 007739n)

Sd/-(CA AnIL KUMAR AGGARWAL) Partner(M. no 098261)

PLACE: nOIDADate: 12/09/2017


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A. SIGnIFICAnT ACCOUnTInG POLICIES 1. Method of accounting: The accounts have been prepared under the Historical cost convention on accrual basis.

2. Revenue Recognition: The Revenue has been recognized on accrual basis.

3. Fixed Assets: There are no fixed assets.

4. Investments: Investments are Non Trade Investments and are stated at cost and are held in the name of

the “National Institute of Biologicals General Provident Fund” (herein after referred to as “NIB-GPF”).

B. nOTES TO ACCOUnTS 1. Investment in the bonds have been stated at the cost therefore the effect of the change in the

value of the bond as on date of balance sheet has not been quantified and considered.

2. TDS Recoverable of F.Y. 2016-17 from NIB is shown in the current assets.

3. The previous year’s figures have been regrouped/reclassified/rearranged, wherever necessary to confirm to the current period presentation.

For AAJV & ASSOCIATES Chartered Accountants FRN NO. 007739N

Sd/-

FOR NATIONAL INSTITUTE OF BIOLOGICALS General Provident Fund

Sd/- Sd/- CA Anil Kumar Aggarwal Partner (M.No. 098261)

S.K. Sharma Dr. Reba Chhabra (Budget & Finance Officer) (Sc. Gr.-I/Dy. Director(Admn. i/c)

Sd/- Place : Noida Dr. Surinder Singh Date : 12/09/2017 (Director)

SCHEDULE - 5(Forming part of Financial Statement as on 31.03.2017)

nATIOnAL InSTITUTE BIOLOGICALSGeneral Provident Fund

annual report - national institute of biologicalsnib.gov.in/annual_report/national intitute of...

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