The Supreme Court on Thursday castigated the Union government for being negligent in curbing illegal clinical trials despite the deaths of at least 2,374 persons who had undergone the dubious testing for unregistered drugs between 2007 and 2012.
During the resumed hearing of a PIL filed by an NGO Swasthya Adhikar Manch, the court sought an end to illegal clinical trials of untested drugs by multinational companies. The NGO has alleged that massive clinical drug trials, estimated at Rs8,000 crore annually by various pharmaceutical firms, use Indian citizens as guinea pigs.
“The drug trials are creating havoc in the country,” the court said, adding that all clinical trials will be done under the supervision of the Union health secretary. “You have to protect the health of the citizens of the country. It is your obligation. Deaths must be arrested and illegal trials must be stopped,” the bench said and directed the Centre to “handle the menace” in an effective manner.
The judges slammed the government for slipping into “deep slumber” on the issue and for being indifferent in evolving an effective mechanism to stop ‘rackets’ of some multinational drug companies which conduct illegal clinical trials.
In 2004, doctors at the Bhopal Memorial Hospital and Research Centre, an exclusive institute for the victims of the 1984 gas leak disaster, recruited unsuspecting survivors for clinical trials, without their knowledge or consent.
It is said that 14 participants died during the course of the trials. In an Indore-based hospital, 32 people died in clinical trials between 2005 and 2010.
A parliamentary panel says that the Central Drug Standard Control Organisation (CDSCO) is in collusion with drug companies and doctors, and approving at least one drug every month, without conducting clinical trials or seeking expert medical opinion.
A report quoting CDSCO says an estimated 150,000 people are enrolled for clinical trials in India. It has been reported that the number of ‘subjects’ in clinical trials between 2009 and 2012 were 352,475. The government says serious adverse events resulting in deaths “may occur during clinical trials due to various reasons. These deaths could be due to life-threatening diseases like cancer, cardio-vascular conditions like congestive heart failure/stroke and other serious diseases”.