India proposes easier drug imports for R&D, relaxes shelf-life rules
New Delhi: The government has proposed easing drug import rules and relaxing shelf-life norms for imported medicines to promote pharmaceutical research and development and improve
New Delhi: The government has proposed easing drug import rules and relaxing shelf-life norms for imported medicines to promote pharmaceutical research and development and improve ease of doing business. The draft amendments to the Drugs Rules, 1945, released by the health ministry, aim to reduce compliance requirements for pharma companies and researchers and improve inventory management. The first amendment simplifies the procedure for obtaining permission to import drugs for examination, test, or analysis. Quick answers to key questions ā¢ 5 QUESTIONS 1 What are the proposed changes to drug import rules in India for research and development? āµ The proposed changes aim to simplify the drug import process for research and development by introducing an acknowledgement-based system and relaxing shelf-life requirements, allowing low-volume research imports without regulatory delays. 2 Why is the Indian government relaxing shelf-life norms for imported drugs? āµ The relaxation of shelf-life norms ensures imported drugs have a minimum remaining shelf life of twelve months, providing adequate time for distribution and consumption, and improving inventory management.
3 How will the new drug import regulations affect startups and research institutions in India? āµ The new regulations will enable startups and research institutions to import low-volume drugs for testing more efficiently by removing licensing requirements and reducing compliance burdens. 4 What impact will these regulatory changes have on pharmaceutical companies in India? āµ The regulatory changes are expected to optimize supply management, reduce costs, and strengthen the availability of essential medicines, facilitating easier pharmaceutical research and development. 5 Should pharmaceutical companies be concerned about high-risk products under the new drug import rules? āµ Yes, high-risk products will still require prior licenses as per existing rules, ensuring strict oversight for drugs such as sex hormones, cytotoxic drugs, and narcotic substances. āThe amendment introduces an acknowledgement-based system for import of all drugs in small quantities for analytical and non-clinical testing purposes,ā according to the draft notification updated on the ministry's website on Friday.
Also Read | Drug regulator orders hair colour makers to adhere to product standards Under the proposal, applicants will need to submit a prior intimation through an online portal and can import the drug once an acknowledgement is generated. The ministry said the change would eliminate licensing requirements for low-volume research imports, allowing startups, research institutions and pharmaceutical companies to begin testing without regulatory delays. "The amendment is expected to significantly reduce the compliance burden on applicants... and enable start-ups and industries to quickly initiate testing or analysis," it said. The proposal builds on amendments made to the New Drugs and Clinical Trials Rules, 2019, in January 2026, which introduced a similar notification-based system for domestic test licences. Some high-risk products will continue to require prior licences, including sex hormones, cytotoxic drugs, beta-lactam drugs, biologics containing live microorganisms, and narcotic and psychotropic substances. Mint had reported on the proposed exemption last year.
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