Staff Reporter / New Delhi
In a major move to promote research, innovation, and ease of doing business in the pharmaceutical sector, the Union Ministry of Health and Family Welfare has proposed amendments to the Drugs Rules, 1945. The draft notification aims to simplify the procedure for obtaining permission to import drugs for examination, testing, or analysis — commonly referred to as Form 11.
The proposed amendment introduces an acknowledgement-based system for importing small quantities of drugs meant for analytical and non-clinical testing. Under this system, applicants will only need to submit a prior intimation form, and imports can proceed based on the acknowledgement generated, eliminating the need for cumbersome licensing.
However, the simplified procedure will not apply to certain categories such as sex hormones, cytotoxic drugs, beta lactam drugs, biologics containing live microorganisms, and narcotic or psychotropic substances, which will continue to require prior licensing.
This initiative builds on the Ministry’s earlier amendment to the New Drugs and Clinical Trials Rules, 2019 in January 2026, which introduced a similar notification system for domestic test licences. The latest proposal extends this framework to imports as well.
Officials expect the amendment to significantly reduce the compliance burden on applicants, enabling start-ups and industries to initiate testing and analysis more quickly. The online intimation system is designed to provide a seamless and instant gateway for stakeholders, thereby deregulating the R&D ecosystem in pharmaceuticals.
The move is anticipated to give a strong push to research and innovation in India, while streamlining regulatory processes and aligning with the government’s broader agenda of improving the regulatory ecosystem and fostering innovation in the pharmaceutical sector.
The draft notification has been placed in the public domain for consultation. Stakeholders can submit objections or suggestions to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Kartavya Bhawan-1, New Delhi – 110001, or via email at drugsdiv-mohfw[at]gov[dot]in.
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