The Indian government has proposed a draft amendment to Rule 31 of the Drugs Rules, 1945, aiming to ease the shelf-life requirement for imported drugs.
The current rule mandates a residual shelf life of more than 60%, but the proposed amendment would replace it with a minimum remaining shelf life of 12 months at the time of import.
The move is aimed at rationalising the residual shelf-life requirement for imported drugs and promoting ease of doing business in the country's pharmaceutical sector.
However, the existing requirement of a minimum residual shelf life of more than 60% shall continue to apply to biological products and radiopharmaceuticals due to their specialised nature and public health considerations.
The proposed amendment seeks to facilitate greater efficiency in the pharmaceutical supply chain while maintaining the availability of quality medicines for patients.
It is expected to improve the utilisation of pharmaceutical inventories across the supply chain by reducing avoidable wastage of medicines arising from restrictive residual shelf-life requirements.
The ministry has invited objections and suggestions from all stakeholders, and the final draft will be notified in the Gazette after the expiry of a period of thirty days.
