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LATEST NEWS UPDATES | SC forces Centre to stop clinical trials of 162 drugs

SC forces Centre to stop clinical trials of 162 drugs

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published Published on Oct 1, 2013   modified Modified on Oct 1, 2013
-The Times of India


NEW DELHI: The Supreme Court on Monday forced the Centre to stop clinical trials of 162 new drugs or chemical entities which had been cleared by the expert committee for testing on human beings in India.

A bench of Justices R M Lodha and Shiva Kirti Singh was about to pass an order restraining the Centre from going ahead with these clinical trials when additional solicitor general Sidharth Luthra pre-empted the order by giving an undertaking that no clinical trial would take place.

Luthra sought two weeks time from the bench and said he would be able to satisfy the court that adequate safety and damage prevention mechanisms had been put in place by the Union government to commence clinical trials of the new drugs to test whether they were fit to be permitted for release in the market.

The law officer also informed the court that after receiving suggestions on clinical trials from various stakeholders, including National Human Rights Commission and NGOs, the health ministry had constituted an expert committee under the chairmanship of Prof Ranjit Roy Chaudhury to prepare guidelines for approval of clinical trials in the country.

He said the Chaudhury committee had submitted its report and it was being considered by the government. Moreover, the Drugs and Cosmetics (Amendment) Bill, 2013, which has a separate chapter containing penal provisions for violation and non-compliance of provisions relating to conduct of clinical trials, was introduced in Parliament on August 29.

The government said it had inspected 577 clinical trials and had issued notices to investigators, sponsors and ethics committees seeking clarifications in 235 cases. Of the 1,122 applications for approval of clinical trials, 331 related to approval of global clinical trials. New Drug Advisory Committees (NDACs) have recommended approval of 285 applications, which include testing of drugs relating to AIDS, oncology, cardiology, neurology, psychiatry, metabolism and endocrinology.

The bench said there was a sudden spurt in applications for clinical trials after advocate Sanjay Parikh, appearing for NGO Swasthya Adhikar Manch, drew the court's attention to the 72nd report submitted by a parliamentary standing committee on 'alleged irregularities in the conduct of studies using human papilloma virum (HPV) vaccine PATH in India".

He said the report related to the death of girls in Andhra Pradesh who were administered HPV vaccine by Programme for Appropriate Technology and Health (PATH). The court sought response of the government on the application moved by Parikh.

Advocate Karuna Nundy too moved an application on behalf of Bhopal gas victims alleging that deaths during clinical trials were reported from Bhopal Memorial Hospital and Research Centre. The court asked Luthra to seek the health ministry's response to this.


The Times of India, 1 October, 2013, http://timesofindia.indiatimes.com/india/SC-forces-Centre-to-stop-clinical-trials-of-162-drugs/articleshow/23321842.cms


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