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Apex court seeks details of clinical trials

Drug companies,investigators employed by drug companies,and ethics committees have,however,claimed that only 37 died due to drug trials,” the NGO said.

Written by Express News Service | New Delhi |
October 9, 2012 12:02:21 am

The Supreme Court on Monday asked the Centre to provide details of clinical trials conducted throughout the country since June 2005,their side effects,and deaths,if any,as well as the quantum of compensation paid to victims.

“We are concerned with the lives of human beings who become subjects of clinical trials unknowingly and helplessly,” said a Bench led by Justice R M Lodha,as it sought details of clinical trials since June 1,2005 till June 30 this year.

The SC issued notices to all state governments,except Madhya Pradesh,and Union territories,seeking to know whether they were being kept in the loop regarding clinical trials in their states. The court wanted to know if the states have any special laws or regulations pertaining to clinical trials.

The court was hearing a PIL by Indore-based NGO Swasthya Adhikar Manch,which said that clinical trials were being conducted in Madhya Pradesh without the patients being aware that they were subjects of such trials. “There is no record maintained by MP with regard to deaths which have taken place from January 2005 to December 2006. As per available information from 2007 to June 2012,2,374 deaths have taken place during these clinical trials,some died in their 30s. Drug companies,investigators employed by drug companies,and ethics committees have,however,claimed that only 37 died due to drug trials,” the NGO said. The court has already issued a notice to MP as the petition pointed out such illegal experimentation of new chemical entities which could not even be termed as drugs.

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The court declined to accept the MP government’s contention that it was in the dark about clinical trials being conducted in the state since the permissions for trials were granted by the Centre without consulting them. The court noted that clinical trials were being conducted in government hospitals by their doctors and hence,it was difficult to accept that they were completely unaware of it. “We can even issue a one-line direction that all these clinical trials which affect many people must stop forthwith. It must suffice,we are very serious about it,” observed the Bench during the proceeding,but refrained from passing any formal order,awaiting responses from states.

The court asked the Union Health and Family Welfare Ministry and others,including Central Drugs Standard Control Organisation,to file their response in the matter.

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