Govt amends rules to debar pharma firms submitting fake or fabricated data
India, Aug. 6 -- Union health and family welfare ministry has notified amendments to the Drugs Rules, 1945, empowering the licensing authority to debar further applications by pharmaceutical manufacturers that submit fake or fabricated data for the evaluation of the quality, safety, and efficacy of drugs.
An applicant submitting fabricated data earlier faced actions such as rejection of applications or cancellation of licenses. With the amendments, they would be debarred from filing further applications with the concerned regulatory authority, either in states or at the Centre as applicable, for a specified period.
In a statement issued on Thursday, the ministry called the amendments a significant step towards strengthening the integrit...
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