The Union ministry of health and family welfare has proposed easing the shelf-life requirement for imported drugs by replacing the current rule mandating a residual shelf life of more than 60% with a minimum remaining shelf life of 12 months at the time of import.
The draft amendment to Rule 31 of the Drugs Rules, 1945, aimed at rationalising the residual shelf-life requirement for imported drugs and further promoting ease of doing business in the country’s pharmaceutical sector, was published on June 22 for public consultation.
Currently, under the Drugs and Cosmetics Rules, 1945, a drug cannot be imported or distributed in India unless it has more than 60% of its usable shelf life remaining.
According to the health ministry statement, the draft amendment proposes revising the existing requirement of a minimum residual shelf life of more than 60% 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% shall continue to apply to biological products and radiopharmaceuticals, the notification said.
The changes were proposed after detailed consultations with the Drugs Technical Advisory Board.
The proposed amendment, according to the health ministry, 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 12 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 the 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, according to the health ministry statement.
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 placed the draft notification in the public domain to invite objections and suggestions from all stakeholders, after which the final draft will be notified in the Gazette.
“…is hereby published for information of all persons likely to be affected thereby, and notice is hereby given that the said draft rules shall be taken into consideration on or after the expiry of a period of thirty days from the date on which the copies of the Gazette of India containing these draft rules are made available to the public…,” read the notification.
Those interested should submit comments to the Under Secretary (Drugs) through email at drugsdiv-mohfw[at]gov[dot]in.
