India has amended the Drugs Rules, 1945, introducing stricter penalties for pharmaceutical companies and applicants that submit fake, manipulated, or fabricated data during the drug approval process. Under the revised framework, licensing authorities can reject applications, cancel existing licenses, and temporarily debar companies from filing fresh applications.

The move is aimed at strengthening regulatory oversight, improving transparency, and ensuring the integrity of drug approval submissions. The new rules signal a tougher stance on compliance and data authenticity in India's pharmaceutical sector.

India drug approval: Health ministry notifies amended rules

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