Union Health Ministry has proposed amendments to the Drugs Rules, 1945 to simplify the procedure for obtaining permission for import of drugs for examination, test or analysis. The amendment introduces an acknowledgement-based system for import of all drugs in small quantities for analytical and non-clinical testing purposes.
Under the revised provisions, applicants intending to import such drugs will be required to submit a prior intimation form and may import the drug based on the acknowledgement generated upon submission of such intimation.
The simplified procedure shall be applicable for import of 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, said a release issued by the Health Ministry.
The Ministry has already carried out amendments to the New Drugs and Clinical Trials Rules, 2019 in January 2026 introducing a similar notification system for domestic test licences. The present proposed amendment expands it to imports also.
The amendment is expected to significantly reduce the compliance burden on applicants by eliminating licensing requirements for importing small quantities of drugs for testing or R&D purposes.
“This will play a substantial role in deregulating the R&D sector in pharmaceuticals and enable start-ups and industries to quickly initiate testing or analysis. The online intimation system will offer a seamless and instant gateway for the stakeholders,’’ explained a senior health official. The draft notification has been placed in the public domain for stakeholder consultation.
Meanwhile, the Ministry has also published a draft notification proposing amendments to Rule 31 of the Drugs Rules, 1945, with the objective of rationalising the residual shelf-life requirement for imported drugs and further promoting ease of doing business in the pharmaceutical sector.
The draft amendment, proposes to revise the existing requirement of a minimum residual shelf life of more than 60% 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% 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. 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.
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, in turn, is expected to optimise supply management, reduce costs, and strengthen the availability of essential medicines in the country.
The Ministry has clarified that 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.
Published – June 26, 2026 08:18 pm IST