New Delhi: According to a draft notification released by the Indian Union Health Ministry, imported medicines must have a minimum residual shelf life of 12 months at the time of import.
The move is expected to improve the utilisation of pharmaceutical inventory throughout the supply chain and ensure that patients receive medicines with a sufficient usable shelf life.
The draft amendment, published for public consultation through a gazette notification on June 22, proposes revising the existing requirement of a minimum residual shelf life of more than 60 per cent 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 per cent will continue to apply to biological products and radiopharmaceuticals.
The proposed amendment seeks to facilitate greater efficiency in the pharmaceutical supply chain while maintaining the availability of quality medicines for patients, the ministry said.
By ensuring that imported drugs have a minimum remaining shelf life of 12 months upon entry into India, the proposal provides sufficient time for distribution and consumption before expiry, thereby ensuring that patients continue to receive medicines with an adequate usable shelf life, officials said.
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 is expected to optimise supply management, reduce costs and strengthen the availability of essential medicines in the country, they said.
The ministry said 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 Indian Union Health Ministry has invited objections and suggestions from all stakeholders on the draft notification.
