annex i - uninfo.org · web viewthe products had similar batch number (604003) but different...

Doc. No. TFDA/DMC/MCIE/B/001

TANZANIA FOOD AND DRUGS AUTHORITY

ACTION PLAN FOR COMBATING SUBSTANDARD AND COUNTERFEIT MEDICINES 2016/17 – 2018/19

DRAFT

P. O. Box 77150, Off Mandela Road, Mabibo – External, Dar es Salaam, Tanzania Tel: +255-22-2450512/2450751/ 2452108; Fax: +255-22-2450793

Email: [email protected]; Website: www.tfda.or.tz

http://www.tfda.or.tz/

mailto:[email protected]

Contents

Glossary of terms- Definition of counterfeit medicine...........................ii

Acknowledgement......................................................................................................................... iii

Foreword.................................................................................................................................................. iv

1. BACKGROUND........................................................................................................................ 1

1.1 Rationale for developing action plan.........................................................2

2. FACTORS CONTRIBUTING TO SUBSTANDARD AND COUNTERFEIT MEDICINES IN TANZANIA.................................................................3

ANNEX I........................................................................................................................................................... 8

ANNEX II....................................................................................................................................................... 21

i

Glossary of terms- Definition of counterfeit medicine

Substandard medicines

Are those whose composition and ingredients do not meet the correct scientific specifications and which are consequently in-effective. They may occur as result of negligence, human error and insufficient human and financial resources during production.

Counterfeit medicine

Is an imitation of, or substitute for another medicine, resembles another medicine likely to deceive or bears upon its label or container the name of another medicine unless it is plainly and conspicuously marked as to reveal its true character and its lack of identity with such other medicine. It also means a label or container bears the name of an individual or company purporting to be a manufacturer of the medicine; which individual or company is fictitious or does not or it has been wholly or in part by another medicinal substance; or it purports to be it is a product of manufacturer of whom it is not truly product.

ii

Acknowledgement

I would like to take this opportunity on behalf of TFDA to thank those who in one way or another assisted in the preparation of this document. Special thanks are extended to the following TFDA staffs who worked tirelessly in the development of this action plan: Mr. Adonis Bitegeko, Mr. Erasto Mosha, Ms. Grace Shimwela, Mr. Seth Kisenge,Ms. Anitha Mshighati, Ms. Donesta Simon and Ms. Consolata Mushumbushi who compiled and edited this first edition.

Special thanks are also extended to WHO and other partners in the fight against counterfeit medicines for their valuable inputs in improving the action plan.

________________________________Mitangu A. Fimbo

Director of Medicines and Complementary ProductsTanzania Food and Drug Authority

iii

Foreword

The problem of substandard and counterfeit medicines is a growing threat worldwide. Unfortunately the information on the scale of the problem is inadequate and there are very few regional and global studies conducted.

There is no simple standard solution that is applicable to all countries to eliminate the problem of counterfeit and substandard medicines. Each country has to develop a strategy based on its own situation taking into account the available infrastructure and human and other resources.

Having this in mind, TFDA has developed this first action plan as an effort of coming-up with an effective program to combat counterfeit medicines in Tanzania. This is in line with the resolution made during the 63rd

session of the World Health Assembly that directed a time-limited and results-oriented measures to be taken by nations in ensuring the availability of quality, safe, efficacious and affordable medical products as well as the prevention and control of medical products of compromised quality, safety and efficacy such as substandard and counterfeit medicines.

Furthermore during the meeting on SSFFC (substandard/spurious/falsely-labelled /falsified/counterfeit) Working Group organized by WHO Regional Office and held in 2014 in Brazzaville - Republic of Congo, one of the tasks was to develop a Regional Plan of Action on SSFFC medical products in the WHO African region. In line with this, each nation is supposed to have its own national plan of action to combat substandard and counterfeit medicines.

It is the expectation of TFDA that this action plan will serve as a roadmap in establishment of an effective system for combating substandard and counterfeit medicines.

________________________________Hiiti B. Sillo

Director GeneralTanzania Food and Drug Authority

iv

1. BACKGROUND

A healthy population is necessary for development in any country, as people are the greatest resource of any nation. In countries where majority of the population suffers a high disease burden, economic development has been stagnant or at best very low. As a result of scientific and technological developments in the last century, medicines for prevention and treatment of most diseases affecting people in the developing countries are available. However, there is still a challenge of ensuring quality, safety and efficacy of medicines circulating on the market. This is due to increasing number of reported cases of substandard and counterfeit medicines globally. Tanzania is among the countries affected by this menace.

Substandard and counterfeit medicines pose potentially serious public health and safety concerns. Their use can result in treatment failure and contribute to medicines resistance (e.g. in the case of antimalarials that contain insufficient active ingredient), prolonged illness or even death. Treatment with counterfeited medicines such as antibiotics or vaccines may have a deleterious effect on a wide section of the population. Unlike substandard medicines where there are problems with the manufacturing process by a known manufacturer, counterfeit medicines are made by people with the intent to mislead.

These types of medicines are also associated with financial loss such as waste of scarce resources and increased health expenditures. They may also diminish public confidence in the health care system.

The Government of Tanzania developed the National Health Policy in 1990 and reviewed it in 2007. One of the objectives of the Policy is to improve and sustain the provision of pharmaceutical services by ensuring the access and rational use of safe, quality, efficacious and affordable medicines to all Tanzanians. The intension of this objective is to address the challenge of substandard and counterfeit medicines in the country. As one of the strategies to achieve the policy’s objectives, the Government enacted the Tanzania Food, Drugs and Cosmetics Act, Cap 219 which mandated Tanzania Food and Drugs Authority (TFDA) to regulate medicines to ensure their quality, safety and efficacy with overall intention of protect and promote the public health.

Some of the function of TFDA involves marketing authorization, premises registration and licensing of business, import and export control, inspection and enforcement, post marketing surveillance, control of clinical trials as well as control of promotion advertisements.

1

List of counterfeit medicines incidents reported in the country is provided as Annex I.

1.1 Rationale for developing action plan

Since the formal establishment of medicine regulatory system, several cases of counterfeit and substandard medicines have been encountered in the market.Since the year 2000 to 2014, a total of 31 counterfeit and a significant number of substandard medicines were identified during inspection, post market surveillance and several joint operations targeted such medicines. Consecutively, though capacity of TFDA in terms of enforcement has been gradually strengthened in the past years but there has been no significant decline on the number of products which do not meet quality specifications. This calls for a systematic approach in terms of prevention, detection and response towards combating substandard and counterfeit medicines.

This is the first Action plan to combat counterfeit and substandard medicines published to address the issue of counterfeit and substandard medicines in Tanzania. The action plan sets out a three year plan through a sustained program with a well elaborated objective.

TFDA has developed the action plan designed to minimize the risk of counterfeit medicines reaching patients through both the regulated and unregulated supply chains.

1.2 Objective

The main objective of this document is to provide means for preventing and combating substandard and counterfeit medicines circulating in Tanzanian market by the year 2019.

This will be achieved through the following approach:1. Prevention:

Implementing measures to prevent circulation and use of counterfeit and substandard medicines in Tanzania

2. Detection: Correctly detect counterfeit and substandard medicines in Tanzania

3. Respond: Timely and professionally respond to reported incidents of counterfeit and substandard medicines.

2

Another general objective of this document is to establish the extent of the problem of substandard and counterfeit medicines in Tanzania.

3

2. FACTORS CONTRIBUTING TO SUBSTANDARD AND COUNTERFEIT MEDICINES IN TANZANIA

There are number of factors which contribute to substandard and counterfeit medicines in Tanzania. The main ones are mentioned below:-

i. Porous borders:Apart from the official recognized borders, there are some unofficial borders which are illegally used by some traders as routes for substandard and counterfeit medicines in Tanzania.

ii. Corruption:Corruption is regarded as one of the chief reasons of opening the floodgate to the supply and ultimately market of counterfeit drugs in Tanzania. Those who have the capital and means to import or manufacture counterfeit drugs are not poor to that effect they use their wealth to ensure that these fake drugs get into the market to the detriment of the consumers. The low incomes of law enforcement officers, the low risk of being arrested and charged for corruption and the market appetite for counterfeit drugs make it a lucrative business. Unless a concerted and dedicated effort is made to stamp out corruption in different authorities, production, supply and sale of counterfeit drugs will be a like a repeated song without any effective measures to tackle it.

iii. Demand exceeding supply:When there is high demand of certain medicine in the market manufacturers or distributors may be tempted to supply substandard/counterfeit medicines so as to maximize their profit.

iv. Weak suctions:Weak sanctions entail lack of effective enforcement mechanism by the laws and agencies in place. At the moment, the main law that could be used to successfully fight and control counterfeiting include the Merchandise Marks Act, the Penal Code, the Fair Competition Act, the Tanzania Food Drugs and Cosmetics Act, the Standards (TBS) Act, and the Intellectual Property Laws. There is the urgent need of reviewing these laws and prepare an effective legal framework that will clearly address the problem on counterfeit and substandard goods. Counterfeit products often find their way into the normal channels of commerce due to lack of strong anti-counterfeit enforcement agencies and effective sanctions intended to arrest the situation.

v. High prices:

4

When drug prices are high some unfaithful medicines suppliers / manufacturer engage themselves in supplying cheaper counterfeit and substandard medicines. Patients as well tend to seek medicines that are sold more cheaply mostly from non-regulated outlets. But such outlets are more likely to sell counterfeit medicines.

vi. Inefficient cooperation between stakeholders:The most effective means of fighting counterfeit is through collaboration between different stakeholders. Counterfeit and substandard medicines is a global supply chain problem and therefore no one entity can effectively monitor, inspect and enforce anti-counterfeit measures across national boundaries and through the supply chain within the country. This threat requires a multi-stakeholder and multi-displinary collaboration. In Tanzania, inter-sectoral cooperation between the medicine regulatory authority, police and customs services and the judiciary in combating the counterfeit and substandard medicines is ineffective, and hence counterfeiters escape detection, arrest and penal sanction.

vii. Sophisticated in clandestine drug manufacture:

The introduction of sophisticated equipment for the manufacture and packaging of medicines has increased the difficulty of detecting substandard and counterfeit medicines because counterfeiters can now imitate genuine medicines almost perfectly.

viii. Inadequate adaptation and implementation of legislations

Counterfeited medicines are more frequently in the unregulated supply chain that is through un-licensed wholesalers, parallel importers and distributors. Lack of proper enforcement of laws which controls regulation of medicines may result to in-pouring to the market of products whose safety, quality or efficacy is not guaranteed.

ix. Inadequate regional cooperation

Lack of effective regional collaboration through common strategies and exchange of information most of the time weakens the fight of counterfeit and substandard medicines since manufacture and supply of these products is a global activity.

x. Inadequate resources e.g. human resources, financial resources.

Fighting counterfeit and substandard products requires sufficient skilled manpower allocated appropriately as well as sufficient funds to conduct investigation and follow-up activities. Unfortunately the budget allocated for such activities is very limited hence this becomes a major hindrance for the fight.

5

2.1 SWOC Analysis

A SWOC analysis has been used to assess strengths, weaknesses, opportunities and constraints in order to come up with an effective and workable plan of action in preventing and combating substandard and counterfeit medicines.

Strengths Existence of the National Health Policy and National Medicine Policy

which advocate on importance of quality assurance system; Existence of the Tanzania Food, Drugs and Cosmetics Act, Cap 219 Existences of legislation, regulatory and administrative systems

guidelines and SOPs; Semi-autonomous status with powers to collect and utilize funds; Existence of organization structure; Existence of qualified and competent staff; Good reputation within and outside the country; Existence of TFDA zone offices; Availability of infrastructure and facilities such as office buildings and

WHO pre-qualified and accredited laboratory; Existence of programs e.g. Training program, PMS, FBD and Cohort

Event Monitoring; Existence of GPHF Minilab kit and centres; Existence of good working relationship with PMORALG; Existence and implementation of quality management system (QMS)

based on ISO standards. Centre of excellence for medicine registration Regulatory collaboration;

Weaknesses Inadequate monitoring of implementation of client service charter; Inadequate collaboration and co-operation with other institutions in the

enforcement of TFDCA; Inadequate staff mentoring and counselling system; Inadequate inspection, investigation and prosecution system; Inadequate public education of TFDA functions; Inadequate system for regulation of complementary products; Inadequate control of product promotion and advertisement; Inadequate competence in regulation of medical devices and

diagnostics; Inadequate regulations to cover pertinent matters within food and

medicines area; Non existence of TFDA zone office administrative structure;

7

Inefficient of Mini Laboratory operation; Inadequate staff.

Opportunities Access to new technologies and information in the market; Increased consumers’ demand for safe and quality products; Existence of civil society organizations that link TFDA with other

stakeholders; Availability of qualified/skilled labour form the market; Availability of qualified personnel at local government authorities; Existence of institutional frameworks for regional economic

communities e.g. EAC and SADC; Good political will and supportive Government policies; Existence of technical and financial support from development

partners such as WHO, The Global Fund, MSH, FAO, DANIDA, UNIDO, DFID, GIZ, UNICEF, IAEA, VRIL SIDA, CHAI, UNAIDS and the World Bank;

Globalization, regional economic intergration and trade liberalization that results into increased trade in regulated products and hence increasing demand for TFDA services;

Challenges Existence of porous borders; Inadequate capacity to cope with fast changes of technology; Inadequate implementation of TFDA delegation functions and power to

LGAs; Lack of approved sites to dispose hazardous waste products; Outdated medicines policy and absence of food safety policy; Resistance to behaviour change of the community; Un-harmonized regulatory system in the Regional Economic

Communities such as EAC and SADC; Limited local suppliers of reagents, chemicals, equipment and

technical services; Lack of capacities by small scale food processors to meet legal

requirements; Lack of voluntary compliance from domestic pharmaceuticals and food

manufacturers and other dealers of regulated products to meet legal; requirements;

2.2 Expected outcomes of this Action Plan

This action plan will provide a systematic approach in terms of prevention, detection and response towards combating substandard and counterfeit medicines.

8

Moreover it will assist in creating an effective communication of the threat to the public, improve collaboration with regional and international counterparts and law enforcer agencies and proportionately combating the issue of counterfeit and substandard medicines in Tanzania.

Successful implementation of the action plan will consequently have an impact on the following:

i. Ensured availability of quality and safe medicines in the marketii. Increased public confidence on the health system iii. Reduced loss in government revenue

The action plan matrix is provided as Annex II.

9

ANNEX ILIST OF ENCOUNTERED COUNTERFEIT MEDICINES IN THE MARKET

S/n

Date

Trade Name

Generic Name Dosage Form

Claimed Manufacturer Description Source of Information

Action Taken

1 1999

Metakelfin Sulfamethoxypyrazine 500mg, Pyrimethamine 25mg

Tablets Pharmacia and Upjohn Laboratory analysis confirmed that counterfeit Metakelfin contained paracetamol

Consumer The public was alerted through press release

2 2000

Ampilin Ampicillin trihydrate 250mg

Capsules

Elys Chemical Industries Ltd

Laboratory analysis confirmed the capsules contained only potato starch

TFDA inspection

The public was alerted through press release, Prosecution

3 2001

Quinine Quinine hydrochloride

Injection

Medochemie Ltd Printed labels of Quinine were pasted over the ampoule containing expired chloroquine injection manufactured by Gufic Chem Pvt India

TFDA inspection

Inspection was conducted in 4 suspected Regions i.e. Tabora, Iringa, Dar es salaam and Dodoma in collaboration with Regional authorities, Prosecution

10

4 2005

Gentrisone Gentrisone Cream Shin Poong, South Korea The active ingredientwas replaced with hand and body lotion

TFDA inspection

Public was alerted through press release, Batches were recalled from the market

5 2005

Halfan Halfan Tablets Smithkline Beecham - TFDA inspection

Inspection was conducted in Arusha region where the suspected product was found, The public was alerted through press release

11

6 2007

Ampishel Ampicillin trihydrate

Tablets Shelys Pharmaceutical Ltd, Tanzania

The active ingredient was replaced with potato starch powder

TFDA inspection

Batches were recalled, Prosecution

7 2007

Cialis Tadalafil, 20mg Tablets Eli Lily & Company Ltd, UK

The active ingredient i.e. Tadalafil was mixed another erectile dysfunction drug (Sildenafil). Packaging material colors (green & yellow) are very bright

TFDA inspection

Inspection of suspected drug outlets was done and 1 pkt was confiscated. The public was alerted through press release

8 2007

Vicks Kingo Vicks Kingo Lozenges

Glaxo SmithKline Ltd Lozenge colour was not white in colour as the genuine product and the shape was round instead of oval. It had no menthol odour

TFDA inspection

Inspection of suspected drug outlets was done the counterfeit products were confiscated. Public Press release was published

12

9 2008

Celestamine

Tablets Schering-Plough Red tape both sides to seal the box, the tape is marked “laborex Kenya”, iii. Lot No. on the blister 7ycen02003 and on the box 7ycen02001, Blister pack is goldfish while the original is silver

TFDA inspection

Inspection of suspected drug outlets in Dar es salaam and Arusha was done and the counterfeit products were confiscated. Public Press release was published.

10 2011

Elphedren Ephedrine 30mg Tablets Brown & Burk Pharmaceuticas Ltd, India

The products had similar batch number (604003) but different shelf lifes, The word "Batch" was written as "Match"

TFDA inspection

The public was alerted through press release. Letter to recall the products were issued.

13

11 2011

Elphedrin Ephedrine 30mg Tablets PharmaceuticalManufacturing Company Ltd, Kenya

TFDA inspection

The public was alerted through press release.Letter to recall the products were issued.

12 2011

Coartem 20/120

Artemether 20mg Lumefantrine 120mg

Tablets Norvatis Pharmaceutical Corporation, Suffern, New York, USA

Product was already expired and Manufacturing date was changed from 2007 to 2009 and expiry date from 2009 to 2012,

TFDA inspection


14

13 2011

Penizin-V Pheoymethylpenicillin 250mg

Tablets Zenufa Laboratories Ltd, Tanzania

Batch Number 1044. counterfeit Penizin-V resembles registered Penizen-V with similar batch number and manufacturer but different dates for manufacturing and expirym. The generic name was written "Pheoymethypenicillin" instead of "Phenoxymethylpenicillin", .Tablets had no penicillin odour, stained and crushed

TFDA inspection


14 2011

Erythromycin

Erythromycin Stearate BP 250

Tablets Astra Lifecare (India) Pvt. Ltd

This contained Ibuprofen tablets instead of erythromycin tablets. Original labels were removed and replaced with labels indicating Erythromycin tablets. The labels were pale, and the word "tablets" was written as "tables". Strength appeared as 25mg instead of 250mg

TFDA inspection


15 2011

Laifin Tablets

Sulphamethoxazole & Pyrimethamine

Tablets None Batch Number LF001, Product did not have manufacturer name, it resemble Laefin Tablets manufactured

TFDA inspection

The public was alerted through press release.

15

by Laboratories & Allied Ltd, Kenya. Contained active ingredient Sulphamethoxazole instead of Sulphametopyrazine which is found in Laefin.

Letter to recall the products were issued. Manufacturer said to emborse the tablet to differentiate it and avoid such problem to occur again

16 2012

Eloquine Quinine Sulphate USP 300mg

Tablets Elys Chemical Industries Ltd, Kenya

Laboratory analysis confirmed that counterfeit Eloquine contained Metronidazole

TFDA inspection

The public was alerted through press release. Inspection of all pharmaceutical premises in DSM, Mwanza, Arusha, Mbeya, Dodoma and Kilimanjaro.The suspects were arrested and the case is still under investigation.

17 2012

Praziquantel 600mg & Amodiaquine Hydrochloride 200mg

Praziquantel 600mg & Amodiaquine Hydrochloride 200mg

Tablets Tanzania Pharmaceutical Industries (TPI)

Product was labelled to contain Praziquantel 600mg and Amodiaquine Hydrochloride 299mg. Batch number was

TFDA inspection

The public was alerted through press release. The suspects

16

erased and was labelled with a word MSD.

were arrested and the case is still under investigation.

18 2012

Sulxine & Primine

Sulphadoxine & Pyrimethamine

Tablets Micro Labs Limited, India The product was labelled with registration number TAN 07 512 JO1E MIC which is registration number of another registered product

TFDA inspection

The public was alerted through press release. The suspects were arrested and the case is still under investigation.

19 2012

Diosulph Sulphadoxine & Pyrimethamine

Tablets Keko Pharmaceutical Industries (1997) Limited

The product (BN 051110) was labelled with a word MSD

TFDA inspection

The public was alerted through press release. The suspects were arrested and the case is still under investigation.

17

20 2012

TTVIR-30 Nevirapine 200 Lamivudine 150 Stavudine 30mg

Tablets Tanzania Pharmaceutical Industries Ltd

The product (BN OC.01.85) was re labelled as if was manufactured by TPI while in actual fact it was manufactured by another facility

Health Facility in Tarime, Mara region

The public was alerted through press release.

21 2013

Asmox Amoxicillin 250mg Capsules

Astra Lifecare (India) Pvt. Ltd

The product (BN 592, Mafg date 06/2011, Exp date 05/2014) was not in the list of batches manufactured by Astra Lifecare (India) Pvt. Ltd. The shelf life is 3 years while registered one (Asmox 250mg Capsule) has shelf life of 2 years

TFDA inspection

The public was alerted and the product was removed from the market

18

22 2013

Penizin-v Pheoymethylpenicillin B.P 250mg


The product (BN TT0 036, Mafg date 08/12, Exp date 09/15) was written as PENIZIN-V while the real one is PENIZEN-V, and the shelf life is 3 years while is 1 year for the real one. also the API was written as Pheoymethylpenicillin Tablets B.P 250mg instead of Phenoxymethylpenicillin Tablet B.P 250mg and name of manufacturer as Zenufa Laoratories Ltd.

TFDA inspection


23 2013

Eloquine Quinine Sulphate USP 300mg

Tablets Elys Chemical Industries Ltd, P.O.Box 4011 00100 Nairobi, Kenya

The product (BN GE410, Mafg date 10/2011, Exp date 12/2015) was

TFDA inspection


19

24 2013

Asdoxin Doxycycline BP 100 mg

Capsules


The counterfeit batch was not in the list of batches manufactured by Astra Lifecare (India) Pvt. Ltd.

TFDA inspection


25 2013

Halfan Halofantrine Hydrochloride

Tablets GSK GlaxoSmithKline Limited

BN 311866, Mfg 10/11 Exp 10/14, has no active ingredient Halofantrine Hydrochloride

GlaxoSmithKline Limited

GSK initiated voluntary product withdraw

26 2013

Metakelfin Sulphamethopyrazine + pyrimethamine

Tablets Pfizer Laboratories Ltd BN F838A, Mfg 08/2012 Exp 12/2016, content of the active ingredients differ from genuine product, Tablets are off white as compared to genuine which is white in colour. Product Information leaflet

Pfizer Laboratories Ltd

Zone Managers were informed to conduct Investigative Inspection

27 2013

Chlorazen Chloramphenicol Capsules

Zenufa Laboratories Ltd Counterfeit product is found in jar packing

Zenufa Laboratories

Zone Managers

20

while genuine one is packed in blister pack of 10 x 10

Ltd were informed to conduct Investigative Inspection

28 2013

Strain I-2 Thermotolerant Newcastle Disease

Vaccine Tanzania Vaccine Institute (TVI)

Chanjo bandia na halisi zinasambazwa zikiwa na vifungashio tofauti kwa maana ya ukubwa wa chupa na lebo tofauti kwa maana ya rangi na uandishi wa taarifa (product information).

Consumers Investigative Inspection was conducted. Public was alerted through Press release and media and recall was instituted

29 2013

Penizin-V Pheoymethylpenicillin B.P 250mg


The product (BN TT0 036, Mafg date 08/12, Exp date 09/15) was written as PENIZIN-V while the real one is PENIZEN-V, and the shelf life is 3 years while is 1 year for the real one. also the API was written as Pheoymethylpenicillin Tablets B.P 250mg instead of Phenoxymethylpenicillin Tablet B.P 250mg and name of manufacturer as Zenufa Laoratories Ltd.

Operation Giboia


21

30 2013

Asdoxin Doxycycline BP 100mg

Capsules


The product with BN 144 was not imported by authorized importer, hospital pack label color, strength and words differs from genuine one, and it the written Anatomical Classification is different from genuine one

Operation Giboia


31 2014

Quinine Sulphate 300mg

Quinine Sulphate 300mg

Tablets

Elys Chemical Industries Ltd

The product doesn’t have Quinine Sulphate 300mg as active pharmaceutical ingredient instead it has metronidazole

Post Market Surveillance

Investigation conducted. Manufacturer informed.

22

ANNEX IIACTION PLAN FOR COMBATING COUNTERFEIT MEDICINES

Description Required inputs Annual Budget Estimate 2016/17

Annual Budget Estimates 2017/18

Annual Budget Estimates 2018/19

Segment 4 Description (GFS Code

Description)

Unit of Measur

e

No. of Days

Unit Cost of Input

No. of

Units

Estimates No. of

Units

Estimates No. of

Units

Estimates

1 2 3 4 5 6

7 8 9 10 11

SPECIFIC OBJECTIVE 1 :Prevention of the circulation and use of counterfeit and substandard medicines in Tanzania

1 Train stakeholders in charge of law enforcement such as police, Judiciary, Customs officials, LGAs on counterfeit and substandard medicine issues

Special allowance

Day 2 50,000

15

1,500,000

17

1,650,000

18

1,815,000

Conference facilities

PC 2 30,000

100

6,000,000

110

6,600,000

121

7,260,000

Perdiem domestic

Day 3 120,000

100

36,000,000

110

39,600,000

121

43,560,000

Travel ticket domestic

Trips 1 20,000

100

2,000,000

110

2,200,000

121

2,420,000

Total Activity 45,500,000

50,050,000

55,055,000

2 Conduct sensitization meeting with stakeholders (manufacturers, importers, distributors) on quality assurance systems to prevent counterfeiting and dangers of counterfeit and substandard medicines.

Perdiem domestic

Day 30 120,000

3

10,800,000

3

11,880,000

4

13,068,000


Day 1 30,000

100

3,000,000

110

3,300,000

121

3,630,000

Diesel Trip 1 2,300

1,400

3,220,000

1,540

3,542,000

1,694

3,896,200


Trips 3 500,000

23

1 1,500,000 1 1,650,000 1 1,815,000Total Activity

18,520,000 20,372,000

22,409,200

3 Conduct awareness programmes for consumers and patients on identification and dangers of counterfeit and substandard medicines

Advertisement PC 1 5,000,000

3

15,000,000

3

16,500,000

4

18,150,000

Special allowance

Day 4 50,000

5

1,000,000

6

1,100,000

6

1,210,000

Refreshments Person 40,000

45

1,800,000

50

1,980,000

54

2,178,000


19,580,000

21,538,000

4 To conduct operations and inspections in collaborations with relevant Law enforcement agencies.

Perdiem domestic

Day 3 120,000

15

5,400,000

17

5,940,000

18

6,534,000

Special allowance

Day 3 50,000

100

15,000,000

110

16,500,000

121

18,150,000

Diesel Trip 1 2,300

2,000

4,600,000

2,200

5,060,000

2,420

5,566,000


Trips 100,000

7

700,000

8

770,000

8

847,000


28,270,000

31,097,000

5 Advocate for the introduction of training modules on regulatory affairs in the curricula of Pharmacy students

Perdiem domestics

Day 3 120,000

5

1,800,000

6

1,980,000

6

2,178,000

Refreshments Person 1 10,000

15

150,000

17

165,000

18

181,500


Trips 1 100,000

5

500,000

6

550,000

6

605,000

Special allowance

Days 1 50,000

15

750,000

17

825,000

18

907,500


3,520,000

3,872,000

6 Develop communication strategy through TFDA website and hotline for

Special allowance

Day 3 50,000

6

900,000

7

990,000

7

1,089,000

24

reporting counterfeit and substandard medicines.

Contract PC 1 20,000,000

1

20,000,000

1

22,000,000

1

24,200,000

Special allowance

Days 1 50,000

3

150,000

3

165,000

4

181,500


23,155,000

25,470,500

Total Objective 131,770,000

144,947,000

159,441,700

SPECIFIC OBJECTIVE 2 : Detection of counterfeit and substandard medicine in Tanzania

1 Training of inspectors on techniques to identify counterfeit and substandard medicines

Perdiem Day 2 120,000

20

4,800,000

22

5,280,000

24

5,808,000

Travel cost domestic

Trip 1 30,000

20

600,000

22

660,000

24

726,000


Days 1 30,000

20

600,000

22

660,000

24

726,000

Stationeries PC 1 5,000

20

100,000

22

110,000

24

121,000


6,710,000

7,381,000

2 Acquire detection gadgets and screening devices in each Zone office.epair of office equipment and appliances by June 2016

Device PC 1 10,000,000

5

50,000,000

6

55,000,000

6

60,500,000


55,000,000

60,500,000

3 To conduct sensitization to healthcare providers on forms for reporting quality & safety of medicines

Perdiem Day 2 120,000

20

4,800,000

22

5,280,000

24

5,808,000

Travel cost domestic

Trip 1 30,000

20

600,000

22

660,000

24

726,000


Days 1 30,000

20

600,000

22

660,000

24

726,000

Stationeries PC 1 5,000

20

100,000

22

110,000

24

121,000

Total Activity 56,00 61,60 67,76

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0,000 0,000 0,0004 Contribute to the WHO Global SSFFC

medical products Monitoring and Surveillance System.

Total Activity

5 Identify focal person responsible for counterfeit and substandard medicines issuesTotal ActivityTotal Objective

62,100,000 68,310,000

75,141,000

*SPECIFIC OBJECTIVE 3: Response to reported incidents of counterfeit and substandard medicines

1

To Conduct press conferences on operations/inspections findings

Total Activity

2

Review of Standard Operating Procedure for Handling of counterfeit and substandard medicine incidentsTotal Activity

3 To develop register or database for recording confirmed cases of counterfeit and substandard medicines

*SPECIFIC OBJECTIVE 4: To establish the extent of the problem of substandard and counterfeit medicines

1 To conduct baseline survey in order to establish the magnitude of the problem of substandard and counterfeit

TOTAL BUDGET 193,870,000

213,257,000

234,582,700

26

Note:* The activities of these specific objectives do not need funds.

27

annex i - uninfo.org · web viewthe products had similar batch number (604003) but different...

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