Now Reading: India Tightens Drug Approvals, Moves Import Rules Online
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India Tightens Drug Approvals, Moves Import Rules Online
The Union Health Ministry has amended the Drugs Rules, 1945, to let licensing authorities bar applicants who submit fake or fabricated data. The action requires a show-cause notice and allows an appeal.…
The Story in Brief
The Union Health Ministry has amended the Drugs Rules, 1945, to let licensing authorities bar applicants who submit fake or fabricated data. The action requires a show-cause notice and allows an appeal. Earlier penalties included rejecting applications or cancelling licences. The ministry said reliable scientific evidence is needed to assess drug quality, safety and efficacy.
Separately, Mint reports that the Central Drugs Standard Control Organisation plans to move drug import approvals online through the SUGAM portal. Overseas manufacturers will need registration for both facilities and products, factory and quality records, stability data, QR codes and samples from three production batches. Importers must use an Indian authorised agent and pay fees including $10,000 for site registration and $25,000 for inspections.
The Indian Opinion
Claims that tougher paperwork alone will make medicines safer are too easy, while complaints that every new compliance step is harassment ignore the risks of weak data and imported products. The useful test is execution: will CDSCO process applications promptly, publish reasons for refusals and apply debarment fairly after hearings? Its handling of the first disputed case, and the time taken for online approvals, will show whether reform improves safety or merely adds delay.
Sources (2): greaterkashmir.com, livemint.com
This story was synthesised by AI from the 2 sources linked above.
Updated: this story now draws on 2 sources.
