Government to dilute norms for drug testing and regulation

As reported exactly by the Express, Swaminathan, who is also Director-General of the Indian Council for Medical Research (ICMR), said strict norms being followed for clinical trials during drug testing was resulting in less research in medicine, and no new drugs were being registered. She said under the new rules, fresh clinical trials related to drug policies, strategies to administer drugs for particular diseases and combination of drug therapies will be cleared by local ethics committees and wouldn’t need to go through the Drug Controller General of India (DCGI), which is responsible for approving new drugs, clinical trials and medical devices, as well as monitoring the quality of pharmaceutical products.

The stricter norms were implemented in action in 2009 after a study funded by the Bill and Melinda Gates Foundation to test the human papillomavirus (HPV) vaccine, which causes cervical cancer came into highlight. This trial allegedly resulted in the death of seven participants involving 24,777 adolescent girls. It was halted by ICMR in April 2010, and a memorandum from 68 human rights and women’s groups to the Union Minister of Health and Family Welfare opposing the trial as “unethical”.

As a result of this unprecedented development, the Supreme Court later put on hold trials of all new drugs in 2013. After much conviction by the health ministry, the apex court allowed clinical trials in India, but imposed a three-tier screening process for all trials. After which new rules and amended existing legislation were implemented by the health ministry.  to tighten the regulatory control of clinical trials.