Six cases of irregularities in clinical trials in India
New Delhi, March 5 : India has reported six cases of alleged irregularities in conduct of clinical trials during the last two years, parliament was informed Tuesday.
Listing steps to contain the irregularities, Health Minister Ghulam Nabi Azad told the Rajya Sabha that 12 new drug advisory committees consisting of leading experts from government medical colleges and institutes from across the country have been constituted to advise the Central Drugs Standard Control Organisation (CDSCO) in matters related to approval of clinical trials and new drugs.
Applications of investigational new drugs (IND), or new drug substances which have never been used on human beings, are evaluated by a committee, chaired by the director general of the Indian Council of Medical Research (ICMR), Azad said in reply to a question.
Registration of clinical trial in ICMR's registry at www.ctri.in has been made mandatory, he said adding that guidelines for conducting inspection of clinical trial sites and sponsor or clinical research organizations have also been prepared.
To further strengthen the regulatory provisions and the monitoring mechanism of clinical trials in the country, the Drugs and Cosmetics Rules, 1945 have been amended, he said.