Health Ministry Proposes Simpler Drug Import Rules for Research and Testing

June 26, 2026 : The Ministry of Health and Family Welfare has released a draft amendment to the Drugs Rules, 1945, proposing a simplified process for importing small quantities of drugs for research, testing and analytical purposes. The initiative is aimed at promoting research and innovation in the pharmaceutical sector while improving the ease of doing business.

Under the proposed amendment, applicants importing small quantities of drugs for analytical and non-clinical testing will no longer be required to obtain a prior import licence. Instead, they will be able to import such drugs by submitting a prior intimation form and using the acknowledgement generated through the new acknowledgement-based system.

The simplified procedure, however, will not apply to certain categories of drugs. Imports of sex hormones, cytotoxic drugs, beta-lactam drugs, biologics containing live microorganisms, and narcotic and psychotropic substances will continue to require prior licensing.

The proposal follows a similar reform introduced in January 2026, when the Ministry amended the New Drugs and Clinical Trials Rules, 2019, to implement a notification-based system for domestic test licences. The current draft extends the same approach to imports for research and testing purposes.

According to the Ministry, the amendment is expected to significantly reduce the regulatory and compliance burden on applicants by eliminating licensing requirements for low-volume imports used in research and development. It is also expected to benefit startups, research institutions and pharmaceutical companies by enabling faster access to materials required for testing and analysis through an online intimation system.

The draft notification has been placed in the public domain for stakeholder consultation. Interested stakeholders may submit their comments or objections before the amendment is finalized.