The Union Ministry of Health and Family Welfare has issued a draft amendment to Rule 31 of the Drugs Rules, 1945, aimed at simplifying the shelf-life requirements for imported medicines. The change is intended to promote ease of doing business while ensuring patients still have access to high-quality treatments.
Currently, imported drugs must have more than 60 percent of their original shelf life remaining at the time they enter India. The new proposal changes this rigid requirement to a flat minimum residual shelf life of 12 months upon import. This update gives distributors plenty of time to distribute and consume the medications safely while drastically reducing the unnecessary wastage of perfectly usable medicines due to the old percentages.
Due to public health considerations and their specialized nature, high-risk items like biological products and radiopharmaceuticals are excluded and will still require the original 60 percent standard. The Ministry clarified that all other safety, efficacy, and quality standards remain completely unchanged.
Written by: Pragna Biswas
Graphics by: Pramit Hazra
