Says trials of all new drugs must be supervised by health secretary
Slamming the Ministry of Health and Family Welfare, the Supreme Court on Thursday said that uncontrolled clinical trials are causing havoc in the country. The court was hearing a public interest petition filed in January last year by Indore-based non-profit Jan Swasthya Abhiyan on unchecked clinical trials in India.
In its interim order, the apex court has stated that clinical trials of all new drugs should be done under the supervision of the health secretary. The Central Drugs Standards Control Organisation (CDSCO), the agency for regulating clinical trials in the country, has been ineffective in its functioning, the court said. In May last year, the parliamentary standing committee on health had released a report highlighting the inadequacies and lax attitude of CDSCO in controlling clinical trials. “In the past eight months, nothing much has changed in CDSCO,” said Amulya Nidhi of Jan Swasthya Abhiyan.
The court also held a discussion on why trials on new chemical entities should not be stayed. New chemical entities are the new experimental drugs that attach maximum risks for participants. “We had asked for a tighter regulation on new chemical entities because most deaths are caused because of them,” said Nidhi. As many as 2,031 people died because of clinical trials between 2008 and 2011.
Advocate Sanjay Parikh, appearing for the petitioner, drew attention of the court to the data which was provided in the affidavit filed by the deputy drug controller regarding ongoing clinical trials of new chemical entities which are not approved as drugs for human use anywhere in the world.
He pointed out that as per the affidavit from January 2005 to June 30, 2012, 475 new chemical entities were tested in the clinical trials out of which only 17 were approved for marketing. In these clinical trials, a total number of 57,303 subjects were enrolled, and of them a total no of 39,022 have completed the clinical trials. In the affidavit, it was mentioned that around 11,972 subjects suffered serious adverse effects and 2,644 deaths occurred. Out of these 506 serious adverse effect cases and 80 deaths alone are stated to be related to clinical trials. Further, the details of clinical trials which caused deaths and serious adverse effects has not been given. It is not clear on what basis it has been decided that death or serious injury has been caused as a result of clinical trial while excluding other cases, said Parikh.
The court has asked the Centre to file a reply within four weeks.
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