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SC seeks firm set-up to regulate new drugs' clinical trials
Friday July 26, 2013 8:18 PM, IANS

The Supreme Court Friday asked the central government to discuss with states all facets of a legal framework to regulate and monitor clinical trials of new drugs by foreign firms across India.

A bench of Justice R.M.Lodha and Justice Madan B. Lokur also asked petitioner Swasthya Adhikar Manch, the National Human Rights Commission (NHRC), NGOs and other organisations to submit their suggestions for strengthening the legal regime to regulate clinical trials so as to minimise the harm to the patients upon whom the new drugs were being tested.

The court asked the union health secretary to call a meeting of the chief secretaries/health secretaries of the states and union territories and report to it on the outcome as it directed the next hearing Sep 24.

The court's order came on a public interest litigation by Swasthya Adhikar Manch of Indore and others who sought a halt to "unethical" clinical trials by multinational drug companies of their new products in India and treating of Indian patients as guinea pigs.

Complimenting the NGO and others for focusing on the issue, Justice Lodha said: "Your efforts have brought some changes. They (government) have become conscious of difficulties or the problems people are facing."

Noting that the central govenment has taken some measures to strengthen the mechanism to regulate the clinical trials, the court said: "What we are interested in is that what has happened in the past should not get repeated. Arrest the recurrence of death and side effects because of clinical trials."

The court's observation came after Additional Solicitor General Siddartha Luthra told the court that the government was bringing amendments to the law that will put in place a stringent regulatory mechanism and provide for punitive punishment for those violating it.

He told the court that amendments would be effected in the monsoon session of parliament.

Making clear that it was up to the government to take the call to put in place a strong legal regime to regulate the clinical trials, the court said that alternatively it will have to step in.

In the course of the hearing, the court asked Luthra why can't there be a committee to oversee the clinical trials.

"Why don't you consider constitution of an oversight committee to oversee all such clinical trials?" it asked.

"Technology must grow", Justice Lodha said, adding that "regulation has to be in such a way that no harm is caused (to the patients tht was begin tested upon) or it is minimized".

The court's observation came in response to Luthra's submission that the available medicines had to develop to treat new strains of diseases. He said that people suffering from ailments defying treatments volunteer to be tested on new medicines.

Senior counsel Colin Gonsalves, appearing for one of the petitioners, said the statutory provision for regulating clinical trials was good but was not being enforced.

On the other hand, senior counsel Sanjay Parikh told the court that there was nothing new in the government response and it was same as it had given to the Parliamentary Standing Committee on Health.

"New chemical entities that have not been tested should not be allowed to be tested in India as they were resulting in deaths," Parikh said, alleging that in fact it were the drug companies that were authoring reports on their drugs on which the drug controller was putting his signatures.


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