DRUGS AND COSMETICS (IIND AMENDMENT) RULES, 2005

Contents:

REQUIREMENTS AND GUIDELINES FOR PERMISSION TO IMPORT AND / OR MANUFACTURE OF NEW DRUGS FOR SALE OR TO UNDERTAKE CLINICAL TRIALS

(1) Application for permission

(2) Clinical trial 

(3) Studies in special populations

APPENDIX I

DATA TO BE SUBMITTED ALONG WITH THE APPLICATION TO CONDUCT CLINICAL TRIALS / 

IMPORT / MANUFACTURE OF NEW DRUGS FOR MARKETING IN THE COUNTRY

Appendix II

STRUCTURE, CONTENTS AND FORMAT FOR CLINICAL STUDY REPORT

Apendix III

ANIMAL TOXICOLOGY (NON-CLINICAL TOXICITY STUDIES

Appendix IV

ANIMAL PHARMACOLOGY

Appendix V

INFORMED  CONSENT

Appendix VI

FIXED DOSE COMBINATIONS (FDCs)

Appendix VII

UNDERTAKING BY THE INVESTIGATOR

Appendix VIII

ETHICS COMMITTE

Appendix IX

STABILITY TESTING OF NEW DRUG

Appendix X

CONTENTS OF THE PROPOSED PROTOCOL FOR CONDUCTING CLINICAL TRIALS

Appendix XI

 Data Elements for reporting serious adverse events occurring in a clinical trial

Download link: (DRUGS AND COSMETICS (IIND AMENDMENT) RULES, 2005)
http://dbtbiosafety.nic.in/act/Schedule_Y.pdf

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Drugs and cosmetics corrected up to 30 th April 2003

CONTENTS:
The Drugs and Cosmetics Act, 1940,
as amended by the Drugs (Amendment) Act, 1955,
the Drugs (Amendment) Act, 1960, the Drugs (Amendment) Act, 1962,
the Drugs and Cosmetics (Amendment) Act,1964,
the Drugs andCosmetics (Amendment) Act, 1972,
the Drugs and Cosmetics (Amendment) Act, 1982,
the Drugs and Cosmetics (Amendment) Act, 1986
and the Drugs and Cosmetics (Amendment) Act,1995.. . . .
The Drugs and Cosmetics Rules, 1945 as corrected upto  30.04.2003
Notification issued under the Drugs and Cosmetics Act . . .

ARRANGEMENT OF SECTIONS

CHAPTER I
INTRODUCTORY


CHAPTER II
THE DRUGS TECHNICAL ADVISORY BOARD, THE CENTRAL DRUGS
LABORTORY AND THE DRUGS CONSULTATIVE COMMITTEE


CHAPTER III
IMPORT OF DRUGS AND COSMETICS


CHAPTER IV
MANUFACTURE, SALE AND DISTRIBUTION OF DRUGS AND COSMETICS



CHAPTER IVA
PROVISIONS RELATING TO AYURVEDIC SIDDHA AND UNANI DRUGS
SECTION



CHAPTER V
MISCELLANEOUS








Download (Free download of Drugs and cosmetics corrected up to 30 th April 2003):
http://www.cdsco.nic.in/html/Copy%20of%201.%20D&CAct121.pdf

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Posted in: Pharmacy acts