Medindia

X

India Reports Six Cases of Clinical Trial Irregularities

by Bidita Debnath on  March 6, 2013 at 11:46 PM Clinical Trials News   - G J E 4
The parliament was informed that India has reported six cases of alleged irregularities in conduct of clinical trials during the last two years.
 India Reports Six Cases of Clinical Trial Irregularities
India Reports Six Cases of Clinical Trial Irregularities
Advertisement

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.

Advertisement
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.

Source: IANS
Advertisement

Post your Comments

Comments should be on the topic and should not be abusive. The editorial team reserves the right to review and moderate the comments posted on the site.
User Avatar
* Your comment can be maximum of 2500 characters
Notify me when reply is posted I agree to the terms and conditions

You May Also Like

Advertisement
View All