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India Drug Regulator Drafts Law For Power To Punish Unethical Trial Acts

This article was originally published in PharmAsia News

Executive Summary

The Drug Controller General of India is said to be drafting a proposal to give the health ministry power to punish companies that violate ethical standards in clinical trials. The proposed change would become a separate provision of the Drugs and Cosmetics Act in an effort to improve the country's image in the wake of the death of an infant in a trial that had a violation of ethics guidelines. The government now lacks the power to punish offenders because the ethical guidelines they work under are voluntary. Some experts say many pathology laboratories in India do not follow good laboratory practices and fake data. (Click here for more
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