News Post Strict Regulations, Govt Plans To Ease Clinical Trials Norms   Email this page
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Bangalore: Clinical trials in India have seen a drastic fall after stringent norms were introduced following Supreme Court directives. Not only have the number of trial approvals in the country reduced, there has also been a significant reduction in the number of sponsoring Pharma firms applying for such approvals. Recently, during an event, Union health Minister Ghulam Nabi Azad hinted that the government is on the talk for relaxing norms for clinical trials in India, reports Nirmalya Dutta of Health.India.
The Union Minister, at an event held in biopharma company Biocon’s facility, said “There has been more than 50 percent drop in clinical trials after stringent regulations were put in place last year. We did it to improve transparency, but that should not happen at the cost of innovation. Industry feels that regulations we have made are too difficult. I think we need to strike a balance, considering the rise in some deadly diseases,” reports Health.India. 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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