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Government tightens guidelines for clinical trials-Vidya Krishnan and Jacob P Koshy

-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...

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Drug testing on trial

-The Hindu In a typical case of putting the cart before the horse, the Health Ministry is now in the process of amending the Drugs and Cosmetics Rules, 1945 to regulate human clinical trials taking place in the country. More than the death of over 2,000 people during 2008-2011 in clinical trials, it was the recent rap by the Supreme Court that has shaken the government from its “deep slumber” and...

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No need to amend law on rape, effective implementation is all that is needed: SC -Utkarsh Anand

-The Indian Express The Supreme Court on Wednesday noted that there was no need to amend existing laws relating to rape since legal provisions already provided for completion of the trial within two months. “It is all about the implementation. The only thing you have to do is to implement the existing laws. We have also clarified in several cases. No further amendment is required in the law as it sets the...

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Drug Trials in India causing havoc to human life: SC-Vidya Krishnan

-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...

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Drug Trials 'causing havoc in the country': SC

-Deccan Herald The Supreme Court said Thursday that unregulated clinical trials of new drugs were causing "havoc" in the country as it ordered the health ministry to monitor any new applications for tests. The comments were made during a hearing on a petition detailing deaths and health problems caused by clinical trials carried out on Indians, often without their knowledge or consent. "Uncontrolled clinical trials are causing havoc to human life," Justice RM...

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