Govt invites public comments on draft amendment to rationalise residual shelf-life requirement for imported drugs
New Delhi, June 26
The Union Ministry of Health and Family Welfare has published a draft notification proposing amendments to Rule 31 of the Drugs Rules, 1945, with the objective of rationalising the residual shelf-life requirement for imported drugs and further promoting Ease of Doing Business in the pharmaceutical sector.
According to the press release by the Ministry of Health and Family Welfare, the draft amendment, published for public consultation vide Gazette Notification G S R 505 (E) dated 22nd June 2026, proposes to revise the existing requirement of a minimum residual shelf life of more than 60 per cent for imported drugs to a minimum residual shelf life of 12 months at the time of import.
However, in view of their specialised nature and public health considerations, the existing requirement of a minimum residual shelf life of more than 60 per cent shall continue to apply to biological products and radiopharmaceuticals.
The proposed amendment seeks to facilitate greater efficiency in the pharmaceutical supply chain while maintaining the availability of quality medicines for patients. By ensuring that imported drugs have a minimum remaining shelf life of twelve months upon entry into the country, the proposal provides sufficient time for distribution and consumption before expiry, thereby ensuring that patients continue to receive medicines with adequate usable shelf life.
The amendment is also expected to improve utilisation of pharmaceutical inventories across the supply chain by reducing avoidable wastage of medicines arising from restrictive residual shelf-life requirements. This, in turn, is expected to optimise supply management, reduce costs, and strengthen the availability of essential medicines in the country, the release stated.
The Ministry has clarified that the proposed amendment pertains solely to the residual shelf-life requirement applicable at the time of import of drugs. The proposal does not alter any other regulatory requirements relating to the quality, safety or efficacy of medicines under the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945.
The Ministry has invited objections and suggestions from all stakeholders on the draft notification.
— ANI
Reader Comments
Good step for Ease of Doing Business, but I hope they're keeping the 60% rule for vaccines and biologics. Those are life-saving, and we can't afford to compromise there. Also, what about regular monitoring of drug quality after import? We need more than just shelf life checks.
Makes sense from a supply chain perspective. Similar rules exist in the US and EU. The key will be enforcement - if customs and CDSCO work together effectively, this could streamline imports. Just need to ensure small Indian pharma companies aren't disadvantaged by cheaper imports with shorter shelf lives flooding in. 🇮🇳
Finally, a sensible reform! I run a small pharmacy chain, and so many imported medicines expire before we even sell them because of the old 60% rule. This change means less waste and more availability of essential drugs. But please, Ministry, ensure the 12-month rule is strictly enforced - no shortcuts! 👍
This seems like a win-win: less waste, better supply, and patients still get medicines with adequate shelf life. I just hope they don't relax quality checks in the name of business ease. The 60% rule for biologics is a good safety net. More transparency in the import process would also help. 📋✅
A thoughtful change. The old 60% rule was causing unnecessary shortages and price hikes for imported drugs in India. This aligns with global standards. However, I'd like to see a data-driven analysis of how this will impact medicine prices for patients. Also, what about drugs with shorter shelf lives
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