Saturday, 3 August 2013

Amendment in Rules, a Hindrance to Clinical Trials in India?

Bangalore: India, which was once the hub and most preferred destination for clinical trials by the foreign and western companies may not conduct clinical trials anymore. The main reason behind this is an amendment to the regulations by the Directorate General of Drugs Control in India where it is compulsory for the companies and educational institutions to bear all medical expenses of those people who volunteer for conducting clinical trials on them, reports Seethalakshmi S for Times of India.

So, many U.S. and Canadian companies have stopped clinical trials in the country as they feel that it will likely lead to "unreasonable claims" by patients who is taken as the subject for clinical trials. Reputed Scientific agencies such as the National Institute of Health in the U.S. have discontinued trials in India.

According to the researchers, the First Amendment to the Drugs and Cosmetics Rules, 2013 for clinical trials includes some problematic clauses, wherein one of the clause states that for an injury/illness occurring to a clinical trial subject, he or she shall be given free medical management as long as required. An injury or illness mentioned in the clause does not clearly specify on the type or cause of injury.