Table 1: Chronology of Indian Regulation Related to Clinical Trials

  • 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