Drugs and Cosmetics Act and Schedule Y

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

OBJECTIVES OF D & C ACT 1940



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 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..
 Drugs

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

The Central Drug Standard 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

DCGI
 The

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 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 1945

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

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

Schedule E(1)
Schedule E omitted  Schedule E1List of poisonous substances under Ayurvedic, Siddha & Unani System. Drugs of plant origin Drugs of animal origin Drugs of mineral origin


Schedule 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 FF

Details of the standards ophthalmic preparations

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 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 I

Omitted

Schedule J
Diseases or ailments which a drug may not purport or cure or make claims to prevent or cure. Eg.- AIDS, Angina pectoris,


Schedule K


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

Schedule L

Omitted.

Schedule 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 N

List of minimum equipments which a pharmacy should possess.

Schedule O

Standards for disinfectant fluids.

Schedule P PI

 

Schedule P Life periods of drugs. Schedule PI pack sizes of drugs.

Schedule Q

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

Schedule R & RI

Schedule R Standards for mechanical contraceptives. Schedule RI Standards for medical devices.

Schedule S

Standards for Cosmetics.

Schedule T

GMP For Ayurvedic, Siddha & Unani medicines.

Schedule 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 V

Standards for patent & proprietary medicines.

Schedule W

Omitted.

Schedule X

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

Schedule Y

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

Schedule Y
on 20th Jan 2005  Has 11 appendices  Starts with
 Amended
1. Application for permission
2. Clinical trial 3. Studies in special populations:

Appendices

APPENDIX I
I.

DATA TO BE SUBMITTED ALONG WITH THE APPLICATION TO CONDUCT CLINICAL TRIALS / IMPORT / MANUFACTURE OF NEW DRUGS FOR MARKETING IN THE COUNTRY.
Introduction Chemical and pharmaceutical information Animal Pharmacology (for details refer Appendix IV) Animal Toxicology (for details refer Appendix III) Human / Clinical pharmacology (Phase I) Therapeutic exploratory trials (Phase II) Therapeutic confirmatory trials (Phase III) Special studies Regulatory status in other countries Prescribing information Samples and Testing Protocol/s

1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11.

APPENDIX I-A IDATA 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 II
STRUCTURE, CONTENTS AND FORMAT FOR 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
3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15.

Statement of compliance List of Abbreviations and Definitions Table of contents Ethics Committee: Study Team: Study Objective: Investigational Plan: Trial Subjects Efficacy evaluation Safety Evaluation Discussion and overall Conclusion List of References Appendices

Appendix III
ANIMAL TOXICOLOGY (NON-CLINICAL (NONTOXICITY STUDIES)
 General

Principles  Systemic Toxicity Studies



Appendix IV ANIMAL 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)

Appendix V INFORMED CONSENT



Checklist for study Subjects 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: Subjects Initials: _______________ 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 Sponsors 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. [ ]

              
                    

Subjects Name:_______________

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

Date: _____/_____/______ Signatorys Name: ______________________________________________________

Appendix VI
FIXED DOSE COMBINATIONS (FDCs)
 Refer

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

Contd

4 categories
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

Appendix VII
UNDERTAKING 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 Patients confidentiality Well-being of patients Safety reporting deadlines

Appendix VIII ETHICS 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 IX
STABILITY 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..
 Study

conditions for drug substances and formulations intended to be stored under general conditions

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

12 months

 Accelerated
40C 2C/75% RH 5% RH

6 months

     

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

Long term
5C 3C

12 months 6 months

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

 Study

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

   Long term -

20C 5C

12 months

Appendix X


CONTENTS OF THE PROPOSED PROTOCOL FOR CONDUCTING CLINICAL TRIALS

Appendix XI
Data Elements for reporting serious adverse events occuring in a clinical trial

thank you

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