India group wants change in clinical trial regs for children
India's clinical trial regulations (or lack thereof) have long been the subject of international debate, and now the country's National Commission for Protection of Child Rights (NCPCR) is looking to enact standardized rules for trials on children, saying many are subjected to studies without their parents being made aware.
As the Times of India reports, the NCPCR is meeting with the health ministry and the Medical Council of India to discuss policy changes that would protect the nation's children from unsafe and unagreed-to clinical trials. Commission member Vandana Prasad told the paper that they want to create a nationwide regulatory body to ensure that children aren't exploited.
NCPCR took up the issue after hearing of a trial on a newborn in Indore in which the parents were never notified and the child died, and the Times reports that the same hospital conducted unconsented trials on about 2,500 children between 2005 and 2008, resulting in at least four deaths.
While there's no shortage of governmental and humanitarian support for clinical trial reform in India, the country's regulatory bramble makes it hard to enforce new initiatives. As it stands, there are no minimum clinical standards for trials in India, so any physician can conduct a legal trial at any private clinic, leaving patients vulnerable to a wealth of abuses. Furthermore, consent forms given to trial participants are usually laden with medical jargon that confuses the often poor subjects, and many are required to sign away their right to compensation in the event of injury or death.
Regulators and commerce chiefs in Indian government say it's in the industry's best interest to tighten and standardize its regulations, as the mountains of bad press over the past few years might scare potential clients away to up-and-coming markets like Taiwan and South Korea. But some in India say clamping down will increase costs, possibly pricing out local drugmakers and making the country's clinical research market affordable only for multinational pharmas.
- here's the Times story