New Delhi: In a move aimed at boosting pharmaceutical research and improving ease of doing business, the Union Health Ministry has proposed amendments to the Drugs Rules, 1945 to simplify the import of small quantities of drugs meant for examination, testing and analysis.
Under the proposed changes, applicants importing drugs for analytical and non-clinical testing purposes will no longer be required to obtain a licence in most cases. Instead, they can import such drugs through an acknowledgement-based system by submitting a prior intimation online and receiving an automated acknowledgement.
The simplified procedure will apply to imports intended for research, testing and analysis. However, certain categories, including sex hormones, cytotoxic drugs, beta-lactam drugs, biologics containing live microorganisms, and narcotic and psychotropic substances, will continue to require prior licensing and regulatory approval.
The ministry said the proposal builds on amendments made earlier this year to the New Drugs and Clinical Trials Rules, 2019, which introduced a similar notification-based mechanism for domestic test licences.
Officials said the new framework is expected to reduce compliance burdens, accelerate research and development activities, and enable pharmaceutical companies, startups and research institutions to begin testing projects more quickly.
The draft notification has been released for public consultation, with stakeholders invited to submit suggestions and objections before the amendments are finalised.
The initiative is part of the government’s broader efforts to streamline regulations, promote innovation and strengthen India’s pharmaceutical research ecosystem.
