Now Reading: Health Ministry tightens drug import rules, sets one-year shelf life
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Health Ministry tightens drug import rules, sets one-year shelf life
The Story in Brief
The Union Health Ministry has amended Rule 31 of the Drugs Rules, 1945, mandating that imported drugs must have at least one year of residual shelf life at the time of import, according to a notification issued on 29 October.
For biological drugs and radiopharmaceuticals, the existing norm of 60 per cent of labelled shelf life remains in place. The amendment replaces a previous percentage-based requirement and is intended to reduce wastage, optimise supply management, and improve availability of essential medicines, the ministry said.
Business Standard, citing an anonymous official, reported that the move aims to ease import procedures and improve ease of doing business. The ministry had sought public comments on the proposal through a draft notification in June 2026 before finalising the rules.
Indian Opinion Analysis
Both outlets report the same amendment neutrally. The Hindu Business Line frames the change primarily as a regulatory tightening aimed at preventing near-expiry drugs from entering India and reducing wastage, while Business Standard leads with the ease-of-doing-business angle, quoting an anonymous official and industry executives praising the shift to a fixed threshold. The balanced reading is that the policy is simultaneously a consumer-safety measure and a process-simplification move. The next concrete step is implementation under the amended Rule 31, effective from the 29 October notification date.
Coverage: 2 sources, 2 neutral
Sources (2): thehindubusinessline.com (neutral report), business-standard.com (neutral report)
This brief was synthesised by AI from the 2 sources linked above, so one read covers every framing they carry. Methodology and corrections.
