Clinical trial regulation soon: Govt to SC

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trials of untested drugs require certain mandatory standards to be followed trials of untested drugs require certain mandatory standards to be followed
SummaryExisting Act has no provision for a jail term over clinical trials violating the norms.

The Centre on Friday told the Supreme Court that changes in law are being made to regulate clinical trials of drugs. Pointing out that the ministry of health was trying to get the “deficiency” relating to the penal provisions addressed by replacing the Drugs and Cosmetics Act with a 2013 amendment Bill, Additional Solicitor General Siddharth Luthra said it intended to table the amendments in the monsoon session of Parliament.

The existing Act does not have even a single provision prescribing for a jail term over clinical trials conducted in violation of the norms.

A large number of deaths due to such uncontrolled trials and inadequate compensation have triggered much criticism and protests, forcing the government to put fresh trials on hold.

A bench of Justices R M Lodha and Madan B Lokur, while hearing a PIL by NGO Swasthya Adhikar Manch seeking a ban on drug trials, said it was more concerned with the human risks associated with such trials.

The NGO had alleged that clinical trials by several pharmaceutical companies were going on indiscriminately in various states.

Such trials of untested drugs on humans require certain mandatory standards to be followed, the apex court said, while directing the government to put in place a mechanism to monitor them.

“Certain standards and protocol should be followed while conducting clinical trials of drugs on humans. We are concerned about human life,” Justice Lodha said, asking the Centre to consider suggestions of the National Human Rights Commission on the issue.

“How do you monitor that clinical trial does not result in death and there are no side effects? There should also be proper compensation,” it said.

The bench granted four weeks time to the Centre to convene the meeting of chief secretaries or health secretaries of all the states to frame a law for regulation of such trials and asked the health ministry to file an affidavit in this regard by September 24.

In an affidavit submitted as per the apex court's directive, the Centre had conceded that at least 80 people have lost their lives due to such trials in the last seven years. The ministry said that Serious Adverse Events (SAEs) of deaths during the clinical trials between 2005 and 2012 have been 2,644, out of which 80 were attributable to clinical trials. Other deaths could be due to terminal illness and other life-threatening diseases.

There were around 12,000 incidents

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