Health Ministry Proposes Easier Drug Import Rules for Testing and R&D
The Union Health Ministry has proposed amendments to the Drugs Rules, 1945, aimed at simplifying the process for importing drugs meant for examination, test, or analysis. The key change introduces an acknowledgement-based system for importing small quantities of drugs for analytical and non-clinical testing purposes.
Under the proposed framework, applicants will need to submit a prior intimation form. Based on the acknowledgement generated after submission, they can proceed with the import without requiring a separate licence. This streamlined procedure will apply to most drugs, except for certain categories such as sex hormones, cytotoxic drugs, beta lactam drugs, biologics containing live microorganisms, and narcotic and psychotropic substances. These exceptions will continue to require prior licensing as before.
The move follows a similar amendment made in January 2026 to the New Drugs and Clinical Trials Rules, 2019, which introduced a notification system for domestic test licences. The current proposal extends this facility to imports, aiming to reduce the compliance burden on applicants.
According to a senior health official, this change is expected to significantly deregulate the research and development (R&D) sector in pharmaceuticals. Start-ups and industries will be able to initiate testing or analysis more quickly. The online intimation system is designed to provide a seamless and instant gateway for stakeholders.
The Ministry has placed the draft notification in the public domain for stakeholder consultation, inviting feedback before finalising the rules.
Separately, the Ministry has also published a draft notification proposing amendments to Rule 31 of the Drugs Rules, 1945. This amendment seeks to rationalise the residual shelf-life requirement for imported drugs, further promoting ease of doing business in the pharmaceutical sector.
Currently, imported drugs must have a minimum residual shelf life of more than 60% at the time of import. The proposal revises this to a minimum of 12 months remaining shelf life. However, for biological products and radiopharmaceuticals, the existing requirement of more than 60% will continue, given their specialised nature and public health considerations.
The proposed change is intended to facilitate greater efficiency in the pharmaceutical supply chain while ensuring the availability of quality medicines. By requiring a minimum of 12 months shelf life upon entry, the rule provides sufficient time for distribution and consumption before expiry. This is expected to reduce wastage from overly restrictive shelf-life requirements, optimise inventory management, lower costs, and strengthen the availability of essential medicines in the country.
The Ministry clarified that the proposed amendment only concerns the residual shelf-life requirement at import. It does not alter any other regulatory requirements under the Drugs and Cosmetics Act, 1940, or the Drugs Rules, 1945, relating to quality, safety, or efficacy.
