Drug manufacturers and other applicants found submitting fake or fabricated data to obtain regulatory approvals can now be barred from filing fresh applications under stricter rules notified by the Centre, in a move aimed at tightening oversight of India's pharmaceutical sector.

The Union Health Ministry has amended the Drugs Rules, 1945, empowering licensing authorities to debar applicants who furnish fabricated information in support of applications filed under various provisions of the rules. The new provisions, notified through G.S.R. 756(E), add to the existing penalties under the Drugs and Cosmetics Act, 1940.

Until now, applicants found to have submitted fabricated data could face rejection of their applications or cancellation of existing licences. Under the amended rules, the licensing authority can also prohibit such entities from filing fresh applications with the concerned State or Central regulator for a specified period.

The ministry said the debarment provision will apply to all applications submitted under the Drugs Rules, 1945. However, before any such action is taken, the applicant must be issued a show-cause notice, and the rules also provide for an appeal mechanism.

The move comes amid the government's broader push to strengthen India's drug regulatory framework and curb malpractice in the pharmaceutical sector.

According to the ministry, regulatory decisions on the quality, safety and efficacy of medicines are based on the scientific data submitted by applicants. Submission of fake or fabricated information undermines the integrity of the approval process, raises concerns over drug quality and could pose risks to public health.

The government said the amendment is intended to deter such misconduct, improve accountability among applicants and ensure that approvals are based on reliable scientific evidence.

The ministry said the changes are aligned with efforts to bring India's regulatory framework in line with global best practices, while promoting compliance among drug manufacturers and distributors and strengthening action against entities found indulging in malpractice.

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