Indians pay dear for drug reputation

Posted in News, World

By Ranjita Biswas

KOLKATA – More than 2,500 Indians have died in the course of clinical trials in recent years, government figures reveal.

According to an affidavit filed by the health ministry in the Supreme Court in response to a petition by health NGOs, there were 80 deaths due to clinical trials between January 2005 and June 2012. Between July 2012 and August 2013, nine more such reported deaths occurred, making this total 89, according to the petitioner Swasthya Adhikar Manch (SAM), a health rights forum. Compensation was paid in 82 cases.

The ministry also admitted that 2,644 people died during clinical trials of 475 new drugs from 2005 to 2012. These people diedduring the period of the clinical trials.

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New drugs to hit market faster as govt tweaks trial policy

Posted in News, World

Jayati Ghose | New Delhi | Updated: Nov 08 2013, 08:35 IST

At a time when clinical trials (testing of new drugs on humans) have ground to a virtual halt in India due to a regulatory imbroglio and the resultant crackdown by the Supreme Court, the government is making an effort to make the relevant policy more pragmatic and conducive for the development of new medicines germane to Indian population.

According to government sources, the health ministry has decided that introductory Phase I and exploratory Phase II clinical trials of new chemical entities (NCEs) being developed and to be marketed in India can be conducted abroad. This means the Indian drug regulator will approve data generated from trials conducted on foreign soil as far as these two phases are concerned. Based on such approvals, subsequent phases of trials — Phase III and IV — can be done in India. As per rules, all four phases of any new drug being developed to be marketed in India has to be conducted within the country.

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