7211994 drugs and cosmetics act and schedule y

8/4/2019 7211994 Drugs and Cosmetics Act and Schedule Y

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Drugs and Cosmetics ActDrugs and Cosmetics Act

andandSchedule YSchedule Y

Mr. NAGENDRAPPA. M. H Assistant Professor

ICRI, Bangalore


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OBJE CTIV E S OF D & C ACTOBJE CTIV E S OF D & C ACT 19401940

The Drugs and Cosmetics Act 1940provides the central legislation, whichregulates import, manufacture,distribution & sale of drugs & cosmetics inthe country.

The main objective of the Act is to ensurethat the drugs available to the people aresafe and efficacious and the cosmeticsmarketed are safe for use.


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Brief historyBrief historyThe Drugs Act was enacted in 1940

The Drugs Rules were promulgated inDecember 1945 and the enforcementstarted in 1947.The Act as enacted in 1940 has sincebeen amended several times.It is now titled as Drugs and Cosmetics


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Deals with..Deals with..Drugs & Cosmetics Act covers awide variety of therapeuticsubstances, diagnostics andmedical devices.


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The Central Drug Standard ControlThe Central Drug Standard Control

Organisation (CDSCO)Organisation (CDSCO)The Central Drugs Standard Control Organisation(CDSCO), headed by the Drugs Controller General

(India) (DCGI) discharges the functions allocated toCentral Government.

The CDSCO is attached to the office of the DirectorGeneral of Health Services in the Ministry of Health andFamily Welfare. Schedules to the Act 1940


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DCGI DCGI The DCGI is a statutory authorityunder the Act and has port offices,zonal offices with drug inspectorsand drug testing laboratoriesfunctioning under him.


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The main functions of theThe main functions of the

Central Government are:Central Government are:Approval of new drugs introduced in the country.Permission to conduct clinical trials.Registration and control on the quality of imported drugs.Laying down regulatory measures and amendment of Acts andRules.Laying down standards for drugs, cosmetics, diagnostics anddevices and updating IP.Approval of Licenses as Central License Approving Authority formanufacture of large volume parenterals and vaccines andoperation of blood banks and also of such other drugs as may benotified by Govt. from time to time.Coordinating the activities of the States and advising them onmatters relating to uniform administration of the Act and Rules inthe country.


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Schedules to the Rules 1945Schedules to the Rules 1945


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Schedule A Schedule A Specimens of the prescribed forms for makingapplication for licences, issue & renewal of licences, for sending memorandum etc.


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Schedule BSchedule BF ees for test or analysis by the CDL orState drug laboratories.

E g. Pyrogen Test INR 500/-B ioassay of Antibiotic INR 400/-

etc.


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Schedule C & CISchedule C & CIList of biological products & other special

products whose import, manufacture, sale &distribution are governed by special provision.

E g. Sera, vaccines, toxins, antigens, antitoxins,

pitutary extract, etc


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Schedule DSchedule D

List of drugs that are exempted fromcertain provisions that are applicable to theimport of drugs.


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Schedule E( 1)Schedule E( 1)Schedule E omittedSchedule E 1-

List of poisonous substances under Ayurvedic, Siddha & Unani System.

Drugs of plant origin

Drugs of animal originDrugs of mineral origin


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Schedule F & F ISchedule F & F ISpecial provisions applicable to theproduction, testing, storage, packing &

labeling of Schedule F & F I biological & otherspecial products.Schedule F II surgical dressing.Schedule F III umbilical tapes.


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Schedule FFSchedule FF

Details of the standards -ophthalmic preparations


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Schedule GSchedule G

List of substances that are requiredto be used under medical supervision &

which are labelled to be accordingly.E g. Aminopterin.

E thosuximide,

Pheniramine etc.


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Schedule HSchedule HList of substances that should be sold by

retail only on the prescription of a registered

medical practitioner.E g.- Diclofenac,

ciprofloxacin,

Inj.Ranitidine, etc


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Schedule ISchedule I

O mitted


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Schedule JSchedule JDiseases or ailments which a drug may not purport or cure or make claims to

prevent or cure.E g.- AIDS,

Angina pectoris,


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Schedule K Schedule K

List of drugs that are exempted fromcertain provisions relating to themanufacture of the drugs.


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Schedule LSchedule L

O mitted.


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Schedule M MI MII & MIIISchedule M MI MII & MIII

GMP & requirements of F actory premises, plants & equipments.

Schedule MI F or manufacture of Homoeopathic drugs.Schedule MII F or manufacture of Cosmetics.Schedule MIII - F or manufacture of medical devices.


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Schedule NSchedule N

List of minimum equipments which apharmacy should possess.


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Schedule OSchedule O

Standards for disinfectant fluids.


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Schedule P PISchedule P PI

Schedule P Life periods of drugs.

Schedule PI pack sizes of drugs.


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Schedule QSchedule Q

List of dyes, coloring agents & pigmentspermitted to be used to be used incosmetics & soaps.


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Schedule R & RISchedule R & RI

Schedule R Standards for mechanicalcontraceptives.

Schedule RI Standards for medicaldevices.


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Schedule SSchedule S

Standards for Cosmetics.


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Schedule TSchedule T

GMP F or Ayurvedic, Siddha & Unanimedicines.


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Schedule U & UISchedule U & UI

Schedule U Particulars to be shownin manufacturing, raw materials &analytical records of drugs.

Schedule UI Particulars to be shownin manufacturing, raw materials &analytical records of drugs.


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Schedule V Schedule V

Standards for patent & proprietary medicines.


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Schedule W Schedule W

O mitted.


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Schedule XSchedule X

List of drugs whose import,manufacture & sale, labelling &packaging are governed by specialprovisions.


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Schedule Y

Schedule Y

Amended on 20 th Jan 2005Has 11 appendicesStarts with 1. Application for permission

2. Clinical trial

3. Studies in special populations :


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App endices App endices


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APPENDIX IAPPENDIX II . DATA TO BE SUBM I TTED ALONG W I TH THE APPL IC AT ION TO

C ONDU C T C LI N IC AL TR I ALS / IMPORT / MANUFA C TURE OF NEW DRUGS FOR MARKET I NG I N THE C OUNTRY.

1 . Introduction2. Chemical and pharmaceutical information3. Animal Pharmacology (for details refer App endix IV)4. Animal Toxicology (for details refer App endix III)5. Human / Clinical pharmacology (Phase I)6. Thera peutic ex p loratory trials (Phase II)7. Thera peutic confirmatory trials (Phase III)

8. S pecial studies9. Regulatory status in other countries10. P res c ribing information11. S amples and Testing P roto c ol/s


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APPENDIX IAPPENDIX I- -AA

DATA REQU IRED TO BE SUBM ITTED BY AN APPL IC ANT FOR GRANT OFPERM ISS ION TO IMPORT AND / OR MANUFA C TURE A NEW DRUGALREADY APPROVED I N THE C OUNTRY.

IntroductionC hemical and pharmaceutical informationMarketing informationSpecial studies conducted with approval of Licensing Authority


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Appendix IIAppendix IISTRUCTURE, CONTENTS AND FORMAT FOR STRUCTURE, CONTENTS AND FORMAT FOR

CLINICAL STUDY REPORTSCLINICAL STUDY REPORTS

Title Page:-Title of the study, the protocol code, name of the investigational product tested,

development Phase, indication studied, a brief description of the trial design, thestart and end date of patient accrual and the names of the Sponsor and the participating Institutes ( Investigators).

Study Synopsis (1 to 2 pages): A brief overview of the studyfrom the protocol development to the trial closure should be given here. Thissection will only summarize the important conclusions derived from the study.


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II ContdII Contd3. Statement of com p liance4 . List of Abbreviations and Definitions5. Table of contents6. Ethics C ommittee:7. Study Team:8. Study Objective:9. Investigational Plan:

10. Trial Subjects11. Efficacy evaluation12. Safety Evaluation13. Discussion and overall C onclusion14 . List of References

15. Appendices


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Appendix IIIAppendix IIIANIMAL TOXICOLOGY (NONANIMAL TOXICOLOGY (NON- -CLINICALCLINICAL

TOXICITY STUDIES)TOXICITY STUDIES)

General PrinciplesSystemic Toxicity Studies


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Appendix IVAppendix IV

ANIMAL PHARMA

COLOGYAN

IMAL PHARMA

COLOGYGeneral Principles

Systemic Toxicity Studies Single-dose Toxicity Studies

Re peated-dose Systemic Toxicity Studies Dose-ranging Study

M ale Fertility StudyFemale Re p roduction and Develo pmental Toxicity StudiesLocal toxicity

Allergenicity/ Hy persensitivityGenotoxicityCarcinogenicity (see App endix I, item 4.8)

Conditions Under Which Safety Pharmacology Studies Are Not Necessary


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Appendix VAppendix VI NFORMED

CONSENT

I NFORMED

CONSENTC hecklist for study Subjects informed consent

documents Essential Elements:

Additional elements, which may be required

f f d f f b l l l


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Format of informed consent form for Subjects participating in a clinical trialInformed C onsent form to participate in a clinical trialStudy Title:Study Number:

Subjects Initials: _______________ Subjects Name:_______________

Date of Birth / Age: _________________

Please initial box (Subject)(i)I confirm that I have read and understood the information sheet dated ___ for the above study and have had the

opportunity to ask questions.

[ ](ii)I understand that my participation in the study is voluntary and that I am free to withdraw at any time, without givingany reason, without my medical care or legal rights being affected.[ ](iii)I understand that the Sponsor of the clinical trial, others working on the Sponsors behalf, the Ethics C ommittee and the regulatory authorities will not need my permission to look at my health records both i n respect of the current study and

any further research that may be conducted in relat ion to it, even if I withdraw from the trial. I agree to this acc ess. However, I understand that my identity will not be revealed in any information released to third parties or published.

[ ](iv)I agree not to restrict the use of any data or results t hat arise from this study provided such a use is only for scientific purpose(s)[ ]

(v)I agree to take part in the above study.

[ ]

Signature (or Thumb impression) of the Subject/Legally Acceptable Representative:_____________

Date:_____/_____/______

n r


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Appendix VIAppendix VI

FIXED DOSE COMBINATIONS (FDCs)FIXED DOSE COMBINATIONS (FDCs)Refer to products containing one or more activeingredients used for a particular indication(s).


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ContdContd

1. one or more of the active ingredients is a new drug

2. First time combination of individually approved/marketeddrugs, where the ingredients are likely to have significantinteraction of a pharmacodynamic or pharmacokinetic nature

3.C

ombination already marketed, but in which it is proposedeither to change the ratio of active ingredients or to make a newtherapeutic claim.

4. Combined only for the pur pose of convenience

4 categories

A d IIA d II


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A ppendix V IIA ppendix V IIUNDERTAK I NG BY THE I NVEST I GATOR UNDERTAK I NG BY THE I NVEST I GATOR

Full name, address and title of the PrincipalI nvestigator Name and address of the siteName and address of all clinical laboratory facilities

C ommitmentTo follow

Protocol Guidelines Ethical guidelines Patients confidentiality Well-being of patients Safety reporting deadlines


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Appendix VIII Appendix VIII ETHICS COMMITTEE ETHICS COMMITTEE

C omposition At least 7 members

Quorum 5 members 1 .basic medical scientists ( p referably one pharmacologist). 2. clinicians 3. legal ex pert 4. social scientist / re presentative of non-governmental

voluntary agency / philosopher / ethicist / theologian or a similar person

5. lay person from the community.

Responsibilities


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Appendix IXAppendix IXSTAB I LITY TEST I NG OF NEW DRUGSSTAB I LITY TEST I NG OF NEW DRUGS

To provide the info on the effect of environmental factorson drug(s)/formulation

To check Susceptibility to change in

quality, safety, and/or efficacy

I n case of formulations the testing should cover physical, chemical, biological, and microbiological attributes, preservative content (e.g., antioxidant, antimicrobial preservative), functionality tests (e.g., for a dose delivery system).


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Contd..Contd..Study conditions for drug substances andformulations intended to be stored under generalconditions

Long term 30 C 2C /65% RH 5% RH 12 months

Accelerated 4 0C 2C /75% RH 5% RH 6 months


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Study conditions for drug substances and formulationsintended to be stored in a refrigerator

Long term 5C 3C 12 months

Accelerated 25 C 2C /60% RH 5% RH 6 months


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Study conditions for drug substances andformulations intended to be s tored in afreezer

Long term- 20 C 5C 12 months


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Appendix XAppendix X

CONTENTS OF THE PROPOSED PROTOCOL FOR

CONDUCTING CLINICAL TRIALS


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Appendix XIAppendix XIData Elements for reporting serious adverseData Elements for reporting serious adverse

events occuring in a clinical trialevents occuring in a clinical trial


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thank youthank you

Mr. NAGENDRAPPA. M. H Assistant Professor ICRI, Bangalore

7211994 drugs and cosmetics act and schedule y

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