- 1952:
New Drug Definition
- 1970:
Guidelines on introduction of new drug & Clinical Trials
- 1988:
Schedule Y, Rule 122A, 122B, 122C
- 2001:
Amendment of Rule 122 (introduction of fee structure, PMS etc.)
- 2001:
Indian GCP Guidelines
- 2005:
Revised Schedule Y
- 2006:
Indian Council of Medical Research-Ethical Guidelines for Biomedical Research
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