Report: Indian drug-related trial deaths rose in 2012

Tools

In India, drug-related clinical trial deaths rose in 2012, and sponsors and CROs remain loath to pay compensation to families, Business Standard reports.

Citing a Drugs Controller General of India source, the Indian news outlet reports that at least 20 people died of drug-related adverse events last year, an increase over 2011's 16. At the same time, overall clinical trial deaths numbered 272 by August, pacing below the 438 in 2011 and 667 in 2010, according to Business Standard.

However, the problem of compensation remains, as the outlet cites a DCGI source saying monetary compensation has only been paid in one instance for 2012's hundreds of deaths. But CROs and pharmas say they're only playing by the rules: Indian law doesn't require a certain amount to paid out in the event of death in a clinical trial, and it does not specify a timeframe in which compensation should take place.

The clamor for reform in India only gets louder by the moment. Most recently, Indian Supreme Court Justice R.M. Lodha said poorly regulated trials are "causing havoc to human life," and the court ordered the country's Health Ministry to keep a close eye on applications for new studies.

However, increased scrutiny can only do so much in the face of lax laws. In India, there are no minimum clinical standards for trials, meaning any physician can conduct a legal trial at any private clinic.

The reform movement has united government, industry and humanitarian outfits, but some in India's drug industry worry that strengthening safety regulations will only jack up the cost of doing business in the country, possibly pricing out local companies and making India's clinical research market affordable only for multinational drugmakers.

- read the Business Standard story

Related Articles:
Indian Supreme Court: Unregulated trials causing 'havoc'
India group wants change in clinical trial regs for children
Indian regulators want crackdown on unethical CROs

Filed Under