India Proposes Changes to Drug Import Regulations for Better Efficiency
The Union Ministry of Health and Family Welfare has taken a significant step in enhancing the pharmaceutical sector with a draft notification proposing changes to Rule 31 of the Drugs Rules, 1945. This initiative aims to rationalise the residual shelf-life requirement for imported drugs, making it easier for businesses to operate while ensuring quality healthcare access for patients.
Published on 22nd June 2026, the draft amendment suggests reducing the current requirement of having more than 60 percent residual shelf life for imported drugs to a minimum of 12 months at the time of import. However, the Ministry will maintain the existing rule for biological products and radiopharmaceuticals due to their specialized nature and public health implications.
Enhancing Drug Availability and Reducing Waste
The proposed changes are designed to streamline the pharmaceutical supply chain. By mandating that imported drugs have at least 12 months of usable shelf life upon arrival in India, the initiative ensures a sufficient timeframe for distribution and consumption, meaning patients can receive medicines before they expire.
This amendment is expected to significantly reduce unnecessary waste in medicine supplies, which often occur due to strict residual shelf-life rules. In doing so, it aims to improve the management of pharmaceutical inventories, decrease costs, and enhance the availability of essential medications in the country, ultimately benefiting Indian patients.
Invitation for Public Feedback
The Ministry has opened the floor for objections and suggestions regarding the draft notification. Stakeholders, including pharmaceutical companies and medical professionals, are encouraged to provide their feedback. Comments can be sent via mail to the Under Secretary (Drugs), Ministry of Health and Family Welfare, or through email at [email protected] within the designated period.
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