NEW DELHI: The Supreme Court on Monday ordered the government to video record clinical trials of five new drugs, making it tougher for multinationals to shirk responsibility when testing of their patented medicine reacts adversely on patients.
A bunch of petitions in the apex court had complained about lax implementation of the clinical trial regime and alleged that multinational manufacturers had exploited the loopholes to make India the testing ground of their new drugs.
Countering senior advocate Colin Gonsalves and Sanjay Parekh who argued for halting clinical trial of 162 new drugs permitted by the Drug Controller General till their usefulness for India was established, additional solicitor general Sidharth Luthra said the government had established a three-tier scrutiny system comprising New Drugs Advisory Committee, technical committee and apex committee to examine applications for clinical trials in India.
A bench of Justices R M Lodha and S K Singh said as far as the five new drugs permitted for clinical trial after the three-tier examination of its necessity were concerned, it would like patients undergoing clinical trials to be video recorded and the recordings preserved. It also asked the government to keep the identity of patients who were video recorded confidential.
Since the remaining 157 drugs were cleared before the three-tier system was put in place, the court ordered that they be subjected to scrutiny by technical committee and the apex committee keeping in mind three parameters - assessment of risk against benefits, innovation value compared to the existing options and medical need in the country.
The court said it would consider the petitioners' plea for halting the ongoing clinical trial for these 157 drugs after getting a report from the technical committee and the apex committee. Petitioners cited the parliamentary committee report on clinical trials to argue that norms were followed in breach and that most of the drugs under trial would benefit the multinationals.
Taking into account the petitioners' concern, the bench asked Luthra whether the government had information as to how many drugs under clinical trial in India were patented outside. "The clinical trials conducted in India must help us and not others. The apprehension of the petitioners must be allayed reasonably," it said.
"With regard to the suggestions received by the central government from various stakeholders — National Human Rights Commission, advocate Sanjay Parekh, SAMA Resource Group for Women and Health & Locost Standard Therapeutics and Indian Society for Clinical Research and the central government's views thereon shall be considered by this court on December 16 along with pending applications."
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