- Why in news
- On 26 June 2026 the Health Ministry invited public comments on a draft amendment to Rule 31 of the Drugs Rules, 1945, published as G.S.R. 505 (E) dated 22 June 2026. It would change the residual shelf-life rule for imported drugs.
- What it is
- The Drugs Rules, 1945 are rules made under the Drugs and Cosmetics Act, 1940. They govern the import, manufacture, sale and distribution of drugs in India. Rule 31 deals with the conditions for imported drugs, including how much shelf life must remain at the time of import.
- Parent law
- The draft amends the Drugs Rules, 1945. These rules flow from the Drugs and Cosmetics Act, 1940, and the draft leaves quality, safety and efficacy requirements under them unchanged.
- Proposed change
- The present requirement is a residual shelf life of more than 60 per cent. The draft replaces it with a minimum of 12 months at the time of import.
- Exemption
- Biological products and radiopharmaceuticals will stay under the more than 60 per cent rule, because of their specialised nature and public health considerations.
- Stage of process
- This is a draft open to public comment. Objections and suggestions go to the Under Secretary (Drugs) in the Health Ministry. It is not yet in force.
- Stated aim
- The aim is ease of doing business, less wastage of medicines and better use of inventories in the supply chain.
Don’t confuse with Drugs and Cosmetics Act, 1940 vs Drugs Rules, 1945: The Act is the parent law passed by Parliament. The Rules are subordinate legislation framed under it by the executive, and they can be amended by a notification such as this one.
Laws, judgments and statutory bodies: 30 Prelims questions since 2013 (what the law says, who chairs, legal basis). In Mains, 44 news-triggered questions, most in GS2, asking for provisions and challenges.
Why it matters
- Lower shelf-life threshold may ease imports and cut costs and wastage, supporting ease of doing business.
- A fixed 12-month floor is simpler than a percentage that varies with each product's total shelf life.
Problems
- A shorter residual shelf life may leave less time for distribution and use, so patients may get less usable shelf life.
- Enforcing the threshold needs checks at ports and across the supply chain.
Way forward
- Consider stakeholder comments before finalising the rule, and keep the stricter norm for sensitive products such as biologicals.
- Strengthen post-import quality monitoring so that the relaxation does not weaken drug safety.
Put in your answer
Draft rule, G.S.R. 505 (E): Example of a regulatory reform that eases business while keeping the stricter norm for biological products and radiopharmaceuticals.
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UPSC’s own questions that come close to this issue, from our Prelims and Mains banks.
No practice question for this one; the card may still help an answer. Why: Draft rule change with numbers (60 per cent to 12 months) but only a consultation draft; laws and rules are 23 of 327 Prelims news questions, and this is minor.
Worth revising until Prelims 2028: most news questions come within two years of the event.