Health ministry notifies stricter drug rules
New Delhi, Aug. 7 -- The Union health ministry has amended the Drugs Rules, 1945, to empower licensing authorities to debar pharmaceutical companies that submit fake or fabricated data while seeking regulatory approvals for drugs, in a move aimed at strengthening the integrity and transparency of India's drug regulatory system.
The ministry said the amendments, notified through GS R 756(E), introduce a new enforcement mechanism in addition to the existing provisions under the Drugs and Cosmetics Act, 1940.
Until now, companies found submitting fabricated data could face rejection of applications or cancellation of licences. Under the amended rules, such entities can also be barred from filing fresh applications with the concerned state or c...
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