India's Drug Trials Industry Threatened Due To Slow Approvals


Bangalore: Drug trials continue to be a matter of concern for India. The ethical violations in clinical trials in the nation exposed the grey areas in the regulatory system, which has struggled to oversee the booming industry. Further, slower government approval for testing new medicines in India is a threat to its ambition to be a low-cost, fast-growing hub for clinical trials. It has driven a few drug firms to move operations to other places, which adds to their costs, as reported by Reuters.

However, it is noted that India’s drug regulator and the health ministry’s medical research body disagree with any slowdown.

Drug firms protest that slow bureaucracy in New Delhi and a lack of legal clarity in regard to the conduct of clinical trials has created regulatory uncertainty in the market. Further it was alleged by health activists that companies use poor people as human guinea pigs to trial unsafe drugs without their knowledge or consent. The regulator and health activists have asked the court to shelve all trials for new chemical entities (NCEs).

Siddhant Khandekar, a healthcare analyst at ICICI Direct brokerage in Mumbai was quoted by Reuters, saying “The situation was never quite easy in India.” He further said with the Supreme Court case “the scenario has worsened and getting new approvals has become more time consuming.”