Slow approvals put India's drug trials industry at risk
Published on Feb 13, 2013 5:50 AM
MUMBAI/NEW DELHI (REUTERS) - Slower government approval for testing new medicines is threatening India's aspirations to be a fast-growing, low-cost hub for clinical trials, and has prompted some drugs firms to shift operations elsewhere, adding to their costs.
While India's drug regulator and the health ministry's medical research body deny any slowdown, interviews by Reuters with pharmaceutical companies, lobby groups, industry watchers and healthcare activists tell a different story.
Drugs firms complain that sluggish bureaucracy in New Delhi and a lack of legal clarity on how to conduct clinical trials have created a climate of regulatory uncertainty in the market.
That has been exacerbated by a high profile case in the Supreme Court between the regulator and health activists, who allege that companies used poor people as human "guinea pigs" to trial unsafe drugs without their knowledge or consent, and without proper state scrutiny. They have asked the court to suspend all trials for new chemical entities (NCEs) - substances that may be turned into a new drug after tests.
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