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Centre Strengthens Drug Approval Rules to Curb Fake Data
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The Centre has strengthened India's drug regulatory framework by empowering licensing authorities to debar companies and applicants that submit fake or fabricated data in support of applications under the Drugs Rules, 1945, according to an official statement issued on Thursday.
The Ministry of Health and Family Welfare (MoHFW) said the new provisions have been notified through amendments to the Drugs Rules, 1945, and are aimed at improving transparency, accountability and integrity in the country's drug approval process.
Under the revised rules, applicants found submitting fabricated or misleading data may face rejection of their applications or cancellation of existing licences.
The ministry noted that scientific data submitted by applicants forms the basis for evaluating the quality, safety and efficacy of drugs.
It said the submission of fake or fabricated data compromises the integrity of the regulatory process, raises concerns over the quality of drugs and may pose serious risks to public health.