NEW DELHI: In a major crackdown on regulatory fraud in the pharmaceutical sector, the Centre has amended the Drugs Rules, 1945 to empower drug regulators to temporarily debar companies that submit fake or fabricated data while seeking approvals for drugs and related licences.Under the amended rules notified by the Union health ministry on Thursday, applicants found submitting fabricated data will not only face rejection of their applications or cancellation of existing licences, but can also be barred from filing fresh applications before the concerned licensing authority, whether at the Centre or in the states, for a specified period. The action will be taken only after issuing a show-cause notice, and affected applicants will have the right to appeal.The new provision will apply to all applications filed under the Drugs Rules, 1945, and is aimed at deterring companies from submitting false scientific data to secure regulatory approvals.The ministry said regulatory decisions on the quality, safety and efficacy of medicines are based on scientific data submitted by applicants. Fabricated data undermines the integrity of the approval process, raises questions about the quality of medicines and can pose serious risks to public health.
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The amendment is intended to strengthen accountability and ensure that drug approvals are backed by reliable scientific evidence.Officials said the amendment is part of the government’s broader effort to align India’s drug regulatory framework with global best practices by promoting ethical compliance while taking stricter action against companies that indulge in malpractice.
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