In the absence of a regulatory mechanism to monitor clinical trials of untested drugs on patients in the face of increasing casualties, the Supreme Court on Friday directed the Centre to hold consultation with States and evolve regulations within six weeks.
The Bench of Justices RM lodha and Madan B lokur took notice of the fact that when new drugs were introduced by pharma companies into the market there was no mechanism to prevent deaths and side-effects caused as a result of these trials.
Taking a grim view of the situation, the bench observed, “All these companies are treating India as a haven for clinical trials but its turning to be hell for India.” ASG Sidharth luthra informed the
Court that all deaths reported were prior to January 2013 as since then efforts have been made to frame regulations and amend laws.
The PIl petitioner Swasthya Adhikar Manch referred to a Parliamentary Committee report to suggest that the system of clinical trials operated without any checks and balances. The bench directed the Centre to convene a meeting of Chief Secretaries or Health Secretaries of all the states to frame a law for regulation of clinical trials of drugs and granted four weeks for such deliberations to take place.
The Court asked NHRC and other NGOs to contribute their suggestions and directed the Centre to prepare response to the same by September 24, the next date of hearing.