India proposes easier import of drugs for research and development, relaxes rules on shelf life

New Delhi: The government has proposed relaxation of rules on import of drugs and easing of shelf life norms of imported drugs to boost pharmaceutical research and development and ease of doing business.

The proposed changes to the 1945 drug rules, issued by the Department of Health, aim to reduce compliance requirements for drug companies and researchers and improve inventory management.

The first amendment simplifies the procedure for obtaining a permit to import drugs for examination, testing or analysis.

“The amendment introduces a confirmation system for the import of all drugs in small quantities for analytical and non-clinical testing purposes,” said a draft notification updated on the ministry’s website on Friday.

According to the proposal, applicants will have to submit a prior notification through an online portal and after generating the confirmation, they can import the drug.

The ministry said the change would remove licensing requirements for small-volume research imports, allowing startups, research institutions and pharmaceutical companies to begin testing without regulatory delays. “The amendment is expected to significantly reduce the burden on compliance applicants … and enable start-ups and industrial enterprises to quickly begin testing or analysis,” it said.

The proposal builds on changes to the 2019 New Medicines and Clinical Trials Rules in January 2026, which introduced a similar notification-based system for domestic trial licences.

Certain high-risk products will continue to require prior licenses, including sex hormones, cytotoxic drugs, beta-lactam drugs, biological products containing live microorganisms, and narcotic and psychotropic substances. The Mint announced the proposed exemption last year.

In a separate amendment, the Ministry proposed to replace the existing requirement that imported medicines must have more than 60% of their shelf life left upon import with a uniform minimum remaining shelf life of 12 months.

“By ensuring that imported drugs have a minimum remaining shelf life of twelve months after entering the country, the proposal provides sufficient time for distribution and consumption before expiry,” the Ministry of Health said.

“The amendment is also expected to improve the utilization of pharmaceutical stocks… optimize supply management, reduce costs and enhance the availability of essential medicines,” he said.

Draft notices are open for public feedback for 30 days.

Separately, health ministry officials said the Center has canceled the manufacturing licenses of Jackson Laboratories units in Punjab and Himachal Pradesh. The action follows an ongoing investigation into reports linking the company’s oxytocin injections to maternal deaths in Rajasthan.