Clinical Trials

  • Clinical trials in India are regulated by Schedule Y of the Drugs and Cosmetics Rules.
  • Till January 2005, clinical trials of new drugs being developed outside India were permitted  only with a “phase lag”: a phase 2 trial could be conducted in India only after phase 3 trials were completed elsewhere.
  • Phase 1 trials of foreign drugs were not permitted, except for drugs of special relevance to India. This clause enabled, for example, phase 1 trials of HIV vaccines in India
  • As of January 2005, an amendment of Schedule Y of the Drugs and Cosmetics Rules did away with the phase lag in international clinical trials conducted by foreign sponsors.
  • There are no longer any restrictions on “concurrent phase” clinical trials in India. Phase 2 and phase 3 trials of drugs discovered abroad may now be conducted in India in the same phase and at the same time as they are conducted in other parts of the world
  • The trial sponsor must obtain approval from the DCGI before starting a trial.
  • A PIL was filed claiming abuse of the system in India. There have been about 2000 clinical trial related deaths. The Supreme Court sent notice to the center in response to the PIL.
  • Health Ministry is now in the process of amending the Drugs and Cosmetics Rules, 1945 to regulate human clinical trials taking place in the country.
  • (terminology) Phase I clinical trials implies the initial administration of the candidate drug to humans to find the maximum tolerated dose. Phase II is exploratory and Phase III are pre-marketing/confirmatory trials

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