New Delhi: The Union Health Ministry has published a draft notification proposing amendments to the drug rules that would require imported medicines to have a minimum residual shelf life of 12 months at the time of import into the country.
The proposed change is aimed at ensuring that patients receive medicines with adequate usable shelf life while improving the management and utilisation of pharmaceutical inventories across the supply chain.
Draft amendment issued for public consultation
The draft amendment, published through a gazette notification on June 22, proposes replacing the existing requirement that imported drugs should have a residual shelf life of more than 60 per cent at the time of import.
Under the new proposal, imported medicines would need to have at least 12 months of remaining shelf life when they enter the country.
The Health Ministry has invited objections and suggestions from stakeholders before finalising the amendment.
Exceptions for specialised products
The ministry clarified that the existing requirement of a residual shelf life of more than 60 per cent will continue to apply to biological products and radiopharmaceuticals.
Officials said these categories of medicines have specialised characteristics and public health considerations that warrant the continuation of the existing norms.
The proposed amendment, therefore, will primarily apply to other categories of imported drugs and medicines.
Better availability of medicines
According to the ministry, ensuring a minimum remaining shelf life of 12 months upon import would provide sufficient time for the distribution and consumption of medicines before they expire.
Officials said the move would help ensure that patients continue to receive medicines with adequate usable shelf life and reduce the possibility of medicines nearing expiry reaching consumers.
The ministry also believes that the proposal will improve the efficiency of the pharmaceutical supply chain by reducing avoidable wastage arising from restrictive residual shelf-life requirements.
Reduced wastage and improved supply management
Health officials said the amendment is expected to optimise inventory management and strengthen the availability of essential medicines across the country.
By allowing greater flexibility in the import of medicines, the government expects to reduce costs associated with wastage and improve the overall management of pharmaceutical supplies.
The ministry noted that the proposed changes relate solely to the residual shelf-life requirement applicable at the time of import and do not affect any other regulatory provisions.
No change in quality or safety standards
The Health Ministry clarified that the proposal does not alter any requirements concerning the quality, safety or efficacy of medicines prescribed under the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945.
Officials stressed that all existing standards relating to the manufacture, import and sale of medicines would continue to remain in force.
The draft notification is now open for public consultation, and stakeholders, including pharmaceutical companies, industry associations and healthcare professionals, have been invited to submit their suggestions and objections before the proposed amendment is finalised.
The proposed changes are expected to facilitate greater efficiency in the pharmaceutical supply chain while ensuring the continued availability of quality medicines for patients across the country.
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