Bill shows the way

Bill shows the way

To tighten regulations around clinical trials, a bill was drafted in 2002. Framed as per the guidelines of Indian Council of Medical Research (ICMR), it was submitted to the Ministry of Health and Family Welfare in 2007 to be tabled in Parliament. But it has seen no progress ever since.

“We hope to table it in Parliament next year,” says ICMR director-general V M Katoch. But public health activists are sceptical. “It seems the government is under the industry’s pressure. The bill has not even been made public for people’s comments,” says Anand Rai, health activist and doctor.

The bill, still unnamed, controls unethical practices during clinical trials. It asks for creating an independent biomedical research authority, an apex body that would grant permissions and monitor clinical trials, say sources in the ministry. It makes registration of ethics committees and CROs mandatory. Maximum punishment prescribed for those found guilty of malpractices is 10 years with a penalty of Rs 20 lakh.

“Unlike in the West, the guilty is never punished in India,” says Nandini Kumar, former scientist ‘F’, ICMR. Also, participants are rarely compensated for trial injury (see ‘No one liable for trial mishap’). “The two important bodies which regulate and monitor clinical trials—DCGI and ethics committees—should be audited by an independent authority. At present, there is no clarity on who appoints ethics committees, who its members are and on what basis they clear trials,” says Amar Jesani, founder member, IJME.

“The government should prioritise the diseases on which trials are to be conducted,” says Anneleies Den Boer, coordinator of medicines project at Amsterdam based non-profit Wemos. Health experts suggest transparency to improve the system. Independent audits of clinical trials should be conducted and made public, says Irene Schipper, researcher with the Centre for Research on Multinational Corporations, a Dutch non-profit. Richard Cash, visiting professor from Harvard University at the Public Health Foundation of India, Delhi, thinks training ethics committee members, trial site auditors and principal investigators should be mandatory. “Just telling the subject about the trial is not enough. It should be ensured the subject understands a trial’s pros and cons well,” he says.

Understanding how ethically trials are being conducted globally will be possible once the committee set up by US President Barack Obama presents its report in August. The International Research Panel was formed in November last year after the revelation that in 1946 and 1948 prisoners in Guatemala were infected with syphilis, a sexually transmitted disease, to test the effect of penicillin. It came to light as late as October last year.

The panel will present its report on the efficacy of US rules and the international standards for the protection of human subjects in scientific studies. It has experts from Argentina, Brazil, China, Egypt, Guatemala, India, Russia, Uganda, Belgium and the US. “The panel’s findings will bring more clarity and pave way for further debate on the subject,” says Kumar.

Names of some trial subjects have been changed on request (With inputs from Aparna Pallavi in Madhya Pradesh)