The Union Health Ministry has published two draft notifications proposing significant amendments to drug import regulations through Gazette Notification G.S.R. 505(E) dated June 22, 2026. The first draft amendment published for public consultation 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. This change aims to ensure that patients receive medicines with adequate usable shelf life while improving utilisation of pharmaceutical inventories across the supply chain. According to the ministry's statement, the proposed amendment seeks to rationalise the residual shelf-life requirement for imported drugs and further promote Ease of Doing Business in the pharmaceutical sector. The Ministry of Health and Family Welfare (MoHFW) has issued draft notifications proposing amendments to Rule 31 of the Drugs Rules, 1945, and invited comments and suggestions from stakeholders within 30 days before finalising the amendments.
In a separate draft amendment, the ministry has proposed replacing the licensing requirement for importing small quantities of drugs meant for analytical and non-clinical testing with an acknowledgement-based system. Currently, applicants are able to import drugs for clinical testing only if they have an official test licence, or Form 11. Under the proposed framework, applicants would be required to submit prior intimation online and would be allowed to import the drugs once an acknowledgement is generated. The simplified procedure would apply to imports for examination, testing and analysis, except for sex hormones, cytotoxic drugs, beta-lactam drugs, biologics containing live microorganisms, and narcotic and psychotropic substances, which will continue to require prior licences. The ministry said this proposal builds on a similar notification-based mechanism introduced under the New Drugs and Clinical Trials Rules, 2019, earlier this year for domestic test licences, and is expected to reduce compliance requirements for companies, contract research organisations, biotechnology firms and research laboratories importing small quantities of drugs for R&D purposes.
As reported by Business Standard, the proposed amendment includes important exemptions for specialized medical products. The existing requirement of a minimum residual shelf life of more than 60 per cent shall continue to apply to biological products and radiopharmaceuticals due to their specialized nature and public health considerations. This exemption ensures that the stricter requirements remain in place for products that require more stringent storage and handling protocols.
According to the ministry's statement, the proposed amendments are expected to provide sufficient time for distribution and consumption before expiry, thereby ensuring that patients continue to receive medicines with adequate usable shelf life. The amendments are anticipated to improve utilisation of pharmaceutical inventories across the supply chain by reducing avoidable wastage of medicines arising from restrictive residual shelf-life requirements. The ministry clarified that the changes are expected to improve pharmaceutical supply-chain efficiency, reduce wastage arising from restrictive shelf-life requirements and optimise inventory management while ensuring that imported medicines continue to have adequate usable shelf life before expiry. The ministry has clarified that both proposals only change the residual shelf-life requirement at the time of import and do not affect regulatory standards relating to the quality, safety or efficacy of medicines under the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945, ensuring that existing standards remain intact while improving operational efficiency.
