The Telegraph
Tuesday , April 22 , 2014
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SC ruling on clinical trials

New Delhi, April 21: The Supreme Court today asked the Centre to allow clinical trials on new pharmaceutical compounds only after ensuring to the extent possible that their potential benefits outweigh their risks and they are needed in India.

A bench of Justices R.M. Lodha and Kurien Joseph, responding to a public interest petition by a non-government organisation called Swasthya Adhikar Manch, also told the Centre to ensure that the candidate compounds are innovations over existing drugs.

The court, while issuing this directive, granted eight weeks time to the government to file an affidavit recording the steps it has taken to pay compensation for patients who had died or had suffered serious side effects linked to clinical trials.

The NGO’s petition has alleged that many patients in India have been used by pharmaceutical companies as “guinea pigs” for clinical trials of new pharmaceutical compounds with not enough emphasis on the safety of patients and whether the compounds being tested on volunteers are needed by India.

The court told the additional solicitor general Siddhartha Luthra to ensure that the three parameters — related to safety, innovation and need for India — are followed by the government when it approves clinical trials of new pharmaceutical compounds.

The court also asked why the government does not set up a “body or an office” to ensure that compensation is paid to patients who had faced serious side effects or to family members of patients who died through the clinical trials.

Justice Lodha, heading the bench, said the body or the office thus appointed by the government could initially pay the compensation and thereafter recover the money from the pharmaceutical company concerned. “A person who is in need of relief must get compensation. You as a government must act as a facilitator. We don’t know how much suffering a person must be undergoing,” the bench said.

The Supreme Court had last month expressed shock at what it said was a “disturbing” figure of 3,458 deaths and 14,320 serious side effects documented among volunteers of clinical trials that were conducted in India between 2005 and 2012.

The government, through Luthra, had told the court that only 89 deaths and 506 serious adverse events were attributable to clinical trials — the other deaths among the participants were because of the natural progression of terminal illnesses. Luthra said about 85 victims have been paid compensation.

“We want the government to only allow clinical trials of drugs that will be made available to Indian population,” said Amulya Nidhi, a member of the Swasthya Adhikar Manch. Between January 2007 and June 2005, Nidhi said, the government had approved clinical trials involving more than 400 new pharmaceutical compounds, citing data submitted by the health ministry to the court. But only 17 of these drugs have been approved in India so far.