The Supreme Court on Monday took cognisance of a petition highlighting the “illegal and unethical” clinical trials of new drugs by multinational pharmaceutical companies on Indian patients as such tests are either banned in the developed countries or are done under strict guidelines at a very high cost.
A bench of Justices R.M. Lodha and H.L. Gohale sought the responses of the Union government and drug controller-general of India and the health institutions’ regulator MCI on a PIL by an NGO, Swasthya Adhikar Manch from Indore in Madhya Pradesh, while issuing notice to the Centre.
“The petition is filed to apprise the Supreme Court about illegal and unethical clinical trials conducted on adults, children and even mentally ill persons in the country. These trials are being conducted in India either because they are not allowed outside India or the trials are cost prohibitive in the country of the origin of pharmaceutical companies,” the PIL stated.
In support of its case, the placed on record the statement of Union health minister Gulam Nabi Azad in Rajya Sabha admitting about such trials as well as probe report of the MP government’s economic offences wing against at least seven senior doctors in Indore’s M.Y. Hospital and Nehru Children Hospital.
Quoting form the economic offences wing report, the NGO stated that these doctors had received at least `5.10 crores from pharmaceutical companies between 2006 and 2010 for permitting such illegal trials while stating that similar practice was rampant in other states also.
The PIL also cited the report of US pharama industry estimating 300 per cent increase in the cost of clinical trials in America during past 15 years. It also stated that trials worth `1,350 crores had been conducted in Indian hospitals since 2008 alone as per the report of Clinical Trial Registry of India.