The Union Health Ministry has published a draft notification proposing amendments to the drugs rules under which imported drugs should have a minimum residual shelf life of 12 months at the time of import.
The step would ensure that patients receive medicines with adequate usable shelf life and improve utilisation of pharmaceutical inventories across the supply chain.
The draft amendment published for public consultation vide gazette notification on June 22 proposes to revise 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 shall 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 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, officials said.
The amendment is also expected to improve 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 ministry has invited objections and suggestions from all stakeholders on the draft notification.
