Norms for clinical trials in India eased: setback to safety?

vacc_1900675fWith the aim to speed up innovation and research in India, the Health Ministry has amended the Drug and Cosmetics Act, exempting clinical trials conducted at academic institutions from taking the hitherto mandatory permission from the Drug Controller General of India (DCGI).

Public health experts say the move is a setback for those working towards a safer, more transparent clinical trials regime. The once booming clinical trials in India came under the Supreme Court scrutiny in 2013, after at least 370 deaths were attributed to Serious Adverse Events (SEAs) during such trials. In September 2013, the apex court ruled that no new clinical trials be permitted until the regulatory mechanism was reformed.

Read the article in The Hindu

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