Indian Supreme Court: Unregulated trials causing 'havoc'

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The clamor for reform of India's clinical trial regulations has reached a fever pitch over the past year, and now the country's Supreme Court is ordering the Health Ministry to keep a close eye on applications for new studies.

The court heard a case claiming that many patients around the country were unwittingly enrolled in clinical trials without consent, The Times of India reports, and Justice R.M. Lodha said India has long failed to protect its citizens from the dangers of unregulated studies.

"Uncontrolled clinical trials are causing havoc to human life," Lodha said. "There are so many legal and ethical issues involved with clinical trials and the government has not done anything so far."

The court ordered the health secretary to monitor trial applications, but, in light of India's lax and loophole-laden regulations, that may not do much to prevent unethical tests. Under Indian law, there are no minimum clinical standards for trials, so any physician can conduct a legal trial at any private clinic, and, as the Times notes, doctors convicted of pursuing secret trials on children are often fined less than $100.

The court joins a chorus of critics demanding reforms of India's trial regulations, echoing officials and humanitarians who warn that some CROs and pharmas exploit loopholes in the law and endanger some of the country's poorest residents. Furthermore, some in the industry warn that the increasing bad press on Indian drug trials might scare potential partners away to up-and-coming markets like Taiwan and South Korea.

But others in India's drug industry say tightening regulations will only increase the cost of doing business in the country, possibly pricing out local CROs and drugmakers and making the country's clinical research market affordable only for multinational pharmas.

- read the Times story

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