India deepens effort to regulate clinical trials

India's government is taking seriously the call to better regulate clinical trials, and now the country is planning to launch two independent committees tasked with overseeing the process.

The Ministry of Health and Family Welfare wants to form one committee comprised of science and regulatory experts that would formulate policy on drug approvals, clinical trials and drug bans, and a second group that would do the same for fixed-dose combinations.

The groups would propose rules on clinical trial design, size, monitoring and post-marketing requirements, according to a statement from the ministry. They would also be tasked with advising India's Central Drugs Standard Control Organization on regulatory matters.

The committees, made up of professors and legal experts from around the country, are India's latest effort to rein in the lax regulations of clinical trials that a Supreme Court justice said "are causing havoc to human life." After cases of unethical trials and unpaid compensations reached the court early this year, justices demanded CDSCO come up with a plan to make the country's clinical outsourcing industry safer.

The organization responded, proposing reforms that would require CROs and sponsors  to pay out an amount determined by the Drug Controller General of India within 30 days of injury or death in a clinical trial--and if they don't, CDSCO can cancel a trial and ban a company from conducting studies in the country. The organization also wants to mandate GMP compliance, ethics committee adherence and adverse event reporting. 

The government is seeking feedback on the proposed new committees from industry, academia and NGOs by April 7.

- read the ministry's notifications here and here (PDFs)