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.

 Themain 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
 TheDCGI 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 E1-

List 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
 Amended on 20th Jan 2005
 Has 11 appendices
 Starts with
– 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
 APPENDIX 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 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…
 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
TOXICITY STUDIES)
 GeneralPrinciples
 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
 Appendix V
INFORMED 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: _____/_____/______

 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
– Patient’s 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
– 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 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