Drugs and Cosmetics Drugs and Cosmetics Act and Act and

Schedule ‘Y’Schedule ‘Y’

Mr. NAGENDRAPPA. M. HAssistant Professor

ICRI, Bangalore

OBJECTIVES OF D & C ACT OBJECTIVES OF D & C ACT 19401940

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

The main objective of the Act is to ensure that the drugs available to the people are safe and efficacious and the cosmetics marketed are safe for use.

Brief historyBrief history

The Drugs Act was enacted in 1940 The Drugs Rules were promulgated in

December 1945 and the enforcement started in 1947.

The Act as enacted in 1940 has since been amended several times.

It is now titled as Drugs and Cosmetics

Deals with…..Deals with…..

Drugs & Cosmetics Act covers a wide variety of therapeutic substances, diagnostics and medical devices.

The Central Drug Standard The Central Drug Standard

Control Organisation (CDSCO)Control Organisation (CDSCO) The Central Drugs Standard Control Organisation

(CDSCO), headed by the Drugs Controller General (India) (DCGI) discharges the functions allocated to Central Government.

The CDSCO is attached to the office of the Director General of Health Services in the Ministry of Health and Family Welfare. Schedules to the Act 1940

DCGIDCGIThe DCGI is a statutory authority

under the Act and has port offices, zonal offices with drug inspectors and drug testing laboratories functioning under him.

The main functions of the The 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 and

Rules. Laying down standards for drugs, cosmetics, diagnostics and

devices and updating IP.  Approval of Licenses as Central License Approving Authority for

manufacture of large volume parenterals and vaccines and operation of blood banks and also of such other drugs as may be notified by Govt. from time to time. 

Coordinating the activities of the States and advising them on matters relating to uniform administration of the Act and Rules in the country.

Schedules to the Rules 1945Schedules to the Rules 1945

Schedule ASchedule A

Specimens of the prescribed forms for making application for licences, issue & renewal of licences, for sending memorandum etc.

Schedule BSchedule B

Fees for test or analysis by the CDL or State drug laboratories.

Eg. Pyrogen Test – INR 500/-Bioassay of Antibiotic – INR

400/- etc.

Schedule C & CISchedule C & CI

List of biological products & other special products whose import, manufacture, sale & distribution are governed by special provision.

Eg. Sera, vaccines, toxins, antigens, antitoxins, pitutary extract, etc

Schedule DSchedule D

List of drugs that are exempted from certain provisions that are applicable to the import of drugs.

Schedule E(1)Schedule E(1)

Schedule E – omitted Schedule E1-

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

Drugs of plant originDrugs of animal originDrugs of mineral origin

Schedule F & FISchedule F & FI

Special provisions applicable to the production, testing, storage, packing & labeling of

Schedule F & FI –biological & other special products.

Schedule FII – surgical dressing. Schedule FIII – umbilical tapes.

Schedule FFSchedule FF

Details of the standards - ophthalmic preparations

Schedule G –Schedule G –

List of substances that are required to be used under medical supervision & which are labelled to be accordingly.

Eg. – Aminopterin.Ethosuximide,Pheniramine etc.

Schedule HSchedule H

List of substances that should be sold by retail only on the prescription of a registered medical practitioner.

Eg.- Diclofenac,ciprofloxacin,Inj.Ranitidine, etc

Schedule ISchedule I

Omitted

Schedule JSchedule J

Diseases or ailments which a drug may not purport or cure or make claims to prevent or cure.

Eg.- AIDS,Angina pectoris,

Schedule KSchedule K

List of drugs that are exempted from certain provisions relating to the manufacture of the drugs.

Schedule LSchedule L

Omitted.

Schedule M MI MII & MIIISchedule M MI MII & MIII

GMP & requirements of Factory premises, plants & equipments.

Schedule MI – For manufacture of Homoeopathic drugs.

Schedule MII – For manufacture of Cosmetics.

Schedule MIII - For manufacture of medical devices.

Schedule NSchedule N

List of minimum equipments which a pharmacy should possess.

Schedule OSchedule O

Standards for disinfectant fluids.

Schedule P PISchedule P PI

Schedule P – Life periods of drugs.

Schedule PI – pack sizes of drugs.

Schedule QSchedule Q

List of dyes, coloring agents & pigments permitted to be used to be used in cosmetics & soaps.

Schedule R & RISchedule R & RI

Schedule R – Standards for mechanical contraceptives.

Schedule RI – Standards for medical devices.

Schedule SSchedule S

Standards for Cosmetics.

Schedule TSchedule T

GMP For Ayurvedic, Siddha & Unani medicines.

Schedule U & UISchedule U & UI

Schedule U – Particulars to be shown in manufacturing, raw materials & analytical records of drugs.

Schedule UI – Particulars to be shown in manufacturing, raw materials & analytical records of drugs.

Schedule VSchedule V

Standards for patent & proprietary medicines.

Schedule WSchedule W

Omitted.

Schedule XSchedule X

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

Schedule Y –Schedule Y –

Requirements AND GUIDELINES for permission to IMPORT AND / OR MANUFACTURE of New Drugs FOR SALE OR to UNDERTAKE CLINICAL TRIALS

Schedule YSchedule YAmended on 20th Jan 2005Has 11 appendicesStarts with

– 1. Application for permission– 2. Clinical trial– 3. Studies in special populations:

Appendices Appendices

APPENDIX IAPPENDIX II. DATA TO BE SUBMITTED ALONG WITH THE APPLICATION TO

CONDUCT CLINICAL TRIALS / IMPORT / MANUFACTURE OF NEW DRUGS FOR MARKETING IN THE COUNTRY.

1. Introduction

2. Chemical and pharmaceutical information

3. Animal Pharmacology (for details refer Appendix IV)

4. Animal Toxicology (for details refer Appendix III)

5. Human / Clinical pharmacology (Phase I)

6. Therapeutic exploratory trials (Phase II)

7. Therapeutic confirmatory trials (Phase III)

8. Special studies

9. Regulatory status in other countries

10. Prescribing information

11. Samples and Testing Protocol/s

APPENDIX I-AAPPENDIX I-A

DATA REQUIRED TO BE SUBMITTED BY AN APPLICANT FOR GRANT OF PERMISSION TO IMPORT AND / OR MANUFACTURE A NEW DRUG ALREADY APPROVED IN THE COUNTRY.

Introduction

Chemical and pharmaceutical information

Marketing information

Special studies conducted with approval of Licensing Authority

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

CLINICAL STUDY REPORTS CLINICAL 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, the start 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 study from the protocol development to the trial closure should be given here. This section will only summarize the important conclusions derived from the study.

II Contd…II Contd…

3. Statement of compliance

4. List of Abbreviations and Definitions

5. Table of contents

6. Ethics Committee:

7. Study Team:

8. Study Objective:

9. Investigational Plan:

10.  Trial Subjects

11. Efficacy evaluation

12. Safety Evaluation

13. Discussion and overall Conclusion

14. List of References

15.  Appendices

Appendix IIIAppendix IIIANIMAL TOXICOLOGY (NON-CLINICAL ANIMAL TOXICOLOGY (NON-CLINICAL

TOXICITY STUDIES)TOXICITY STUDIES)

General Principles Systemic Toxicity Studies

 

Appendix IVAppendix IVANIMAL PHARMACOLOGYANIMAL PHARMACOLOGY

General Principles  Systemic Toxicity Studies

– Single-dose Toxicity Studies – Repeated-dose Systemic Toxicity Studies – Dose-ranging Study

Male Fertility Study Female Reproduction and Developmental Toxicity Studies  Local toxicity  Allergenicity/ Hypersensitivity Genotoxicity Carcinogenicity (see Appendix I, item 4.8)

Conditions Under Which Safety Pharmacology Studies Are Not Necessary Application Of Good Laboratory Practices (GLP) Etc……………………

 

 

Appendix VAppendix VINFORMED CONSENTINFORMED CONSENT

Checklist for study Subject’s informed consent documents – Essential Elements:– Additional elements, which may be required

–

Format of informed consent form for Subjects participating in a clinical trial  

Informed Consent form to participate in a clinical trial Study Title: Study Number:   Subject’s Initials: _______________ Subject’s 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 giving any reason,

without my medical care or legal rights being affected.   [ ] (iii) I understand that the Sponsor of the clinical trial, others working on the Sponsor’s behalf, the Ethics Committee and the regulatory authorities will not need my permission to look at my health records both in respect of the current study and any further research that may be

conducted in relation to it, even if I withdraw from the trial. I agree to this access. 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 that 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: _____/_____/______   Signatory’s Name: ______________________________________________________   Signature of the Investigator: ____________________________ Date: _____/_____/______   Study Investigator’s Name: __________________________________________________   Signature of the Witness ______________________ Date:_____/_____/_______   Name of the Witness: _______________________________________________________

Appendix VIAppendix VIFIXED DOSE COMBINATIONS (FDCs) FIXED DOSE COMBINATIONS (FDCs)

Refer to products containing one or more active ingredients used for a particular indication(s).

Contd……Contd……

1. one or more of the active ingredients is a new drug– 2. First time combination of individually approved/marketed drugs,

where the ingredients are likely to have significant interaction of a pharmacodynamic or pharmacokinetic nature

3. Combination already marketed, but in which it is proposed either to change the ratio of active ingredients or to make a new therapeutic claim.

4. Combined only for the purpose of convenience

4 categories

Appendix VIIAppendix VIIUNDERTAKING BY THE INVESTIGATORUNDERTAKING BY THE INVESTIGATOR

   Full name, address and title of the Principal Investigator Name and address of the site Name and address of all clinical laboratory facilities

Commitment To follow – Protocol– Guidelines– Ethical guidelines– Patient’s confidentiality– Well-being of patients– Safety reporting deadlines

Appendix VIII Appendix VIII ETHICS COMMITTEEETHICS COMMITTEE

Composition– At least 7 members– Quorum 5 members– 1.basic medical scientists (preferably one pharmacologist).– 2. clinicians – 3. legal expert – 4. social scientist / representative of non-governmental

voluntary agency / philosopher / ethicist / theologian or a similar person– 5. lay person from the community.

Responsibilities

Appendix IXAppendix IXSTABILITY TESTING OF NEW DRUGSSTABILITY TESTING OF NEW DRUGS

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

To check– Susceptibility to change in

quality, safety, and/or efficacy

In 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).

Contd…..Contd…..Study conditions for drug substances and

formulations intended to be stored under general conditions

 Long term

– 30°C ± 2°C/65% RH ± 5% RH 12 months

Accelerated – 40°C ± 2°C/75% RH ± 5% RH 6 months

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

    Long term

– 5°C ± 3°C 12 months

Accelerated – 25°C ± 2°C/60% RH ± 5% RH 6 months

 

Study conditions for drug substances and formulations intended to be stored in a freezer

  Long term - 20°C ± 5°C 12 months

Appendix XAppendix X

CONTENTS OF THE PROPOSED PROTOCOL FOR

CONDUCTING CLINICAL TRIALS

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

events occuring in a clinical trialevents occuring in a clinical trial

thank youthank you

Mr. NAGENDRAPPA. M. HAssistant ProfessorICRI, Bangalore