New drugs to hit market faster as govt tweaks trial policy
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.
