Post Strict Regulations, Govt Plans To Ease Clinical Trials Norms

It was just last year when the Union Health Ministry made extensive changes to the Drugs and Cosmetics Act, 1940, following an order by a Supreme Court.  As per the act, it is compulsory for the principal investigator of the concern Pharma company to disclose the contract between the subject and the company to the Drugs Controller-General of India (DCGI). The companies also obliged to video record the consent given by volunteers. Not just this, the act also laid down tough rules to make companies liable for any serious adverse events (SAE) like the death of, or injury to, any drug trial subject.

Kiram Mazumdar Shaw, Chairman and Managing Director of Biocon, however, pointed out that India’s reserve for trials were compelling Pharma companies to opt for abroad.  “The less than conducive environment for clinical trials in India is forcing researchers to take their studies to other global regions outside India, resulting in a setback to Indian patients,“ added Shaw.

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