# India Tightens Drug Approvals, Moves Import Rules Online

2026-08-06T22:56:41+00:00 | Governance | Indian Opinion Desk

Corroboration: 1 independent outlet

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.

## Coverage

- greaterkashmir.com <https://www.greaterkashmir.com/national/union-health-ministry-notifies-stricter-drugs-rules-to-debar-applicants-submitting-fake-fabricated-data-12236653>
- livemint.com <https://www.livemint.com/news/india/cdsco-drug-import-rules-online-approvals-sugam-guidance-11786009605680.html>

Tags: drug regulation, drug safety, health ministry, pharmaceuticals
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