-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...

-The Business Standard Confusion over clinical trial compensation norms Even as the health ministry is evaluating a formula to compensate victims of clinical trials, an expert committee, headed by Ranjit Roy Chaudhury, has recommended some stringent measures that appear contrary to the formula under consideration. The committee, set up by the ministry to formulate policy and guidelines for clinical trials, has suggested that no compensation be given for therapeutic inefficiency during clinical trials...

-The Times of India As many as 2,644 people, called subjects, died during the clinical trials of 475 new drugs on human beings in last seven years and only 17 of the medicines were approved for marketing in India, the Centre has informed the Supreme Court. Responding to allegations by NGO, Swasthya Adhikar Manch, in its PIL that Indians were used as guinea pigs by foreign pharmaceutical majors for human trial of...

-Live Mint Developments a part of reforms initiated after apex court’s intervention to amend Drugs and Cosmetics Act The health ministry has tightened the norms for clinical trials by making it mandatory for companies to compensate patients who may suffer injury or death while participating in the trials even if they have not been caused by the drugs being tested.   So far, the compensation has been restricted only to cases where the...

-Live Mint Court says legal, ethical issues involved; directs govt to monitor and regulate clinical trials of all experimental drugs  The Supreme Court directed the health ministry to monitor and regulate all clinical trials of experimental drugs in the country until further notice and observed that unregulated trials have caused “havoc”. The apex court order on Thursday revoked the power of the Central Drugs Standard Control Organization under the Drugs Controller General of...