India aims to make new clinical trial rules permanent with draft bill

07-Jan-2015 - Last updated on 07-Jan-2015 at 08:34 GMT

India’s CDSCO (Central Drugs Standard Control Organization) has released a new draft bill that would amend the country’s landmark law governing pharmaceuticals from 1940.

If passed, the amended law would include new rules that require research companies to compensate individuals or their families if a trial causes injury or death.

“Whether the injury or death of a person in the course of a clinical trial, has been caused due to such clinical trial or not, shall be determined by such authority and in such manner as may be prescribed,” the proposed bill says.

Released in May, the compensation formula – which replaced a formula that would’ve allowed compensation due to product failures -- would rely on a subject’s age, risk factors for disease and a base amount of compensation of about $13,000.

A meeting in September clarified that for cases where a significant adverse event (SAE) causes permanent disability, compensation should be 90% of what the subject would’ve received if he died. And in cases where an SAE causes a life-threatening illness, the amount of compensation is linked to the days of hospitalization.

The compensation formula was released after an order from the country’s Supreme Court criticized CDSCO for lax trial regulations that resulted in a number of deaths in trials.

John Lewis, SVP of ACRO (Association of Clinical Research Organizations) told Outsourcing-Pharma.com that he has yet to review this latest legislation but the Ministry of Health actually did recently issue some compensation guidelines that look “like a positive step in terms of clarifying the compensation issue though we still have some questions around the distinction between a ‘Mild’ and a ‘Moderate’ Risk Factor and who would make the ultimate determination of this.”

Despite an early spike in trial approvals in 2014, the largest CROs seem to be continually pushing out of the subcontinent. As of May 2014, Quintiles, PPD and Parexel each were running one trial in India, though back in 2012 they combined to run more than 15 trials.

CROs, clinical research associates and ethics committees may also have to register as part of a raft of new trial regulations released in July that also ensure trials are properly designed and that investigators work on a maximum of three trials at one time.