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Clinical Trial Bill to be Tabled (India)

This article was originally published in PharmAsia News

Executive Summary

The proposed Central Drug Authority (CDA) bill that includes imprisonment of five years and a fine of Rs 20 lakh for those found violating norms of clinical trials will be tabled during the upcoming monsoon session of the Parliament. Drugs controller general of India Dr M. Venkateswarulu says the CDA bill has been framed with an aim to check the increasing clinical trials being conducted in the country. "As of today, there's no act or law to monitor the clinical research and drug trials in the country," he states. "There cannot be any compromise in clinical research and the trials that are being done in the country," he adds. "There is need for more transparency and knowing about the associated risk factors." He further says the draft CDA bill is ready, and the Parliament will take a decision on the final quantum of punishment. Expressing concern over the growing tendency of pharma industry to outsource work, he asserts there should be a limit to outsourcing of work. "The people who undergo clinical trials of drugs should not be exploited. They should be well informed about the risks. Their safety should be ensured. There should be proper communication with people while conducting trials." Thomas Adam, president and chief executive officer of the Association of Clinical Research Professionals (ACRP), says clinical trials will begin to 'migrate' to India in large numbers. "Young talent will be the driving force in attracting this to India," he says. (Click here for more
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