Updated on 5 September 2013
The Government of India, in an attempt to make reforms in the regulatory environment, formulated new rules for conducting drug trials in the country. The amendment made to Schedule Y of the Drugs and Cosmetics Rules, 1945, now makes it mandatory for investigators and sponsors to address issues of serious adverse events such as death of subjects involved in trials and mandates grant of adequate compensation in such cases. These new rules also highlight that an independent ethics committees would be set up under medical institutes to monitor ongoing drug trials. It specifies that in case the sponsor fails to provide the proper medical treatment or financial compensation as per the orders, then the authority may cancel or suspend the license of the sponsor to carry out the clinical trials and may even debar it from carrying any clinical trial in future in India.
The NIH shocker
Meanwhile, in the wake of this amendment, the National Institute of Health (NIH) in the US, presented a shocker for the country, when it suspended almost 40 ongoing clinical trials in India. Expressing concern about the new regulations, the NIH said that it looks forward to hearing clarifications from India on the important issue. Following the footsteps of the NIH, several private sector players from the US and Canada withdrew their clinical trials from India, claiming that the amendment could lead to "unreasonable claims" by subject-patients.
Furthermore, industry experts, who participated in the US-India Bio-Pharma and Health Care Summit 2013 in Boston, US, also said that the current policy and environment in the country was not conducive to conduct clinical trials.
McKinsey's 2013 report that was prepared for the USA India Chamber of Commerce identified that India's clinical trial policies were the biggest hurdles in the country's booming pharma sector. "While both global and Indian industry leaders opine that India's intellectual property (IP) scenario needs to be addressed and clarified, they have highlighted that it is in fact the clinical trials infrastructure and policy that are the biggest obstacles for India to meet its potential of driving R&D innovation at a
large scale," the report said.