NEW DELHI: The government is planning to dilute norms for drug testing and regulation, a move that is likely to benefit pharmaceutical companies, despite a hue and cry over unethical practices followed during clinical trials. “In the last three years, drug testing and registration has suffered due to strict norms,” Soumya Swaminathan, secretary, Department of Health Research, told The Sunday Standard.
Government data shows that more than 2,600 patients participating in clinical trials in India died between 2005 and 2012, and nearly 12,000 suffered serious adverse effects. Of these, 80 deaths and more than 500 adverse effects were attributed to trials.
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.
What spurred the Supreme Court and human rights groups into action was a 2009 USD 3.6 million study funded by the Bill and Melinda Gates Foundation to test the human papillomavirus (HPV) vaccine, which causes cervical cancer. The trial, which involved 24,777 adolescent girls, was halted by ICMR in April 2010 following reports of the deaths of seven participants 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”.
The Supreme Court put on hold trials of all new drugs in 2013. However, the health ministry convinced the court that the move was not in the interest of patients who needed new drugs. The apex court agreed, but imposed a three-tier screening process for all trials. After this, the ministry laid down fresh rules and amended existing legislation to tighten the regulatory control of clinical trials.
The ministry wants to dilute these rules, which has led pharma firms and contract research or groups to move their clinical trial programmes elsewhere.
Data shows that applications to conduct clinical trials in India fell from 480 (with 253 approved) in 2012 to 207 (with 73 approved) in 2013, after the earlier guidelines were issued. Since the Supreme Court’s decision, 162 trials approved by the DCGI have been put on hold.
Case history
● Over 2,600 patients in clinical trials in India died between 2005-12, and nearly 12,000 suffered serious adverse effects
● The SC stopped trials of all new drugs in 2013, but the ministry of health convinced the court that it was not in the interest of patients