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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