MoHFW Proposes to Reduce Residual Shelf-Life for Imported Drugs to 12 Months — Draft Rule 31 Amendment

Overview The Ministry of Health and Family Welfare (MoHFW) has released a draft notification to amend Rule 31 of the Drugs Rules, 1945 . The amendment seeks to change the required residual shelf-life for imported medicines from a percentage‑based rule (>60 %) to a fixed period of 12 months at the time of import. Key Developments Draft notification issued through Gazette Notification G.S.R. 505 (E) dated 22 June 2026 . New requirement: imported drugs must have a minimum of 12 months remaining shelf‑life upon entry into India. Exception: biological products and radiopharmaceuticals will continue to follow the >60 % residual shelf‑life rule. Goal: promote Ease of Doing Business in the pharmaceutical sector while safeguarding medicine quality. Public consultation opened; stakeholders may submit comments to the Under Secretary (Drugs), MoHFW, New Delhi, or via email [email protected] within the prescribed period. Important Facts The amendment does not alter any other provisions of the Drugs and Cosmetics Act, 1940 or the broader Drugs Rules, 1945 . It solely revises the residual shelf‑life criterion applicable at the point of import. By ensuring a minimum of twelve months of usable life, the proposal aims to: Provide sufficient time for distribution and consumption before expiry. Reduce wastage caused by overly restrictive shelf‑life requirements. Improve inventory utilisation across the supply chain, lowering costs for manufacturers and distributors. Strengthen the availability of essential medicines for patients nationwide. UPSC Relevance Understanding this amendment is important for several UPSC topics: Health Policy & Governance (GS2 & GS3): Shows how the central government uses regulatory tweaks to balance public health safety with commercial efficiency. Pharmaceutical Regulation (GS3): Highlights the role of the Drugs and Cosmetics Act and its rules in ensuring drug quality. Supply Chain Management (GS3): Demonstrates measures to reduce inventory losses and improve logistics in the medicine supply chain. Ease of Doing Business (GS3): Illustrates policy steps aimed at simplifying import procedures for the pharma sector, a key driver of economic growth. Way Forward Stakeholders are encouraged to review the draft and submit observations before the deadline. If adopted, the amendment will require importers to adjust their procurement planning to meet the twelve‑month shelf‑life benchmark. Monitoring mechanisms will likely be set up to ensure compliance without compromising drug safety. Aspirants should track the final notification and any subsequent guidelines, as they will shape future regulatory practice in India’s pharmaceutical industry.