SC stays clinical trial of untested drugs in absence of mechanism

The Supreme Court has stayed approval of clinical trials granted by Centre for 162 drugs. “No clinical trials should be allowed for new drugs till an efficient mechanism is introduced in place to monitorthem and to protect the lives of people on which drugs are tested”, the apex court has said.

The Bench headed by Justice R M Lodha said, “a system must be introduced in place to protect the lives of people and asked the Centre not to allow clinical trials for untested medicines”. The Centre assured the apex court thatit will not allow clinical trials for 162 drugs, which was earlier permitted by Central Government. The court also sought the Centre to consider suggestions of various stakeholders in putting in place a mechanism to avoid any serious and adverse impact.

The court had earlier said that clinical trials of untested drugs on humans require certain mandatory standards to be followed and had also directed the government to put in place a mechanism to monitor them.It had 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 by multi- national pharma companies.

In an affidavit, the Centre had admitted that 2,644 people died during clinical trials of 475 new drugs between 2005 and 2012."Around 11,972 serious adverse events (excluding death) were reported during the period from January 1, 2005 to June 30, 2012, out of which 506 events were found to be related to clinical trials," the Centre had said.

The apex court was hearing a PIL, filed by NGO Swasthya Adhikar Manch, alleging large scale clinical drug trials across the country by various pharmaceutical firms using Indian citizens as guinea pigs in those tests.

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