The amendment would improve utilisation of pharmaceutical inventories by reducing avoidable wastage of medicines arising from restrictive residual shelf-life requirements
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The Centre has sought comments on two changes involving the import of drugs to facilitate research and conduct business, respectively.The first amendment proposal involves importing drugs for analysis and non-clinical testing purposes, while the other proposal involves the residual shelf-life of imported medicines.The Union Health Ministry said it proposed 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, it added that the 60 per cent-plus shelf-life requirement would continue for specialised categories including biological products and radiopharmaceuticals.The proposal sought to bring in ‘greater efficiency’ in the pharmaceutical supply chain, the Ministry said.“By ensuring that imported drugs have a minimum remaining shelf life of twelve 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 an adequate usable shelf life.”The amendment would improve utilisation of pharmaceutical inventories by reducing avoidable wastage of medicines arising from restrictive residual shelf-life requirements, the note added.The Ministry clarified that the proposal was relevant only to the residual shelf-life requirement at the time of import of the drugs, and did not alter any other regulatory requirements on quality, safety or efficacy of medicines under the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945.Acknowledgement-based systemIn a separate proposal aimed at promoting research and innovation in the pharmaceutical sector, the Health Ministry said it was simplifying the procedure for obtaining permission to import drugs for examination, test or analysis -commonly known as Form 11.“The amendment introduces an acknowledgement-based system for import of all drugs in small quantities for analytical and non-clinical testing purposes,” the Ministry said. Applicants wanting to import such drugs would need to submit a prior intimation form” and import the drug, once an acknowledgement was received, the Ministry said.The simplified procedure would be applicable for importing drugs for analytical and non-clinical testing, except for certain drugs belonging to the categories of sex hormones, cytotoxic drugs, beta lactam drugs, biologics containing live microorganisms, and narcotic and psychotropic substances - which shall continue to require prior licensing, it added.In January 2026, the Ministry had amended the New Drugs and Clinical Trials Rules, 2019 - introducing a similar notification system for domestic test licences. The present proposal also expands this system to include imports, the note said.The amendment will reduce the compliance burden on applicants by eliminating licensing requirements for importing small quantities of drugs for testing or R&D purposes, it said, benefiting start-ups and companies that can now initiate testing or analysis quickly. Published on June 26, 2026
