India proposes easier drug imports for R&D, relaxes shelf-life rules

India Proposes Easier Drug Imports for R&D, Relaxing Shelf-Life Rules

Theindiapostdaily.com – New Delhi: India’s government is considering revising drug import regulations and shelf-life standards for foreign medicines to foster pharmaceutical innovation and enhance business efficiency. The proposed changes, outlined in draft amendments to the 1945 Drugs Rules, aim to streamline compliance processes for research entities and improve inventory handling.

Simplified Import Process for R&D Purposes

The initial amendment introduces a streamlined procedure for importing drugs in small quantities for testing or analysis. According to the updated draft notification on the health ministry’s website, this shift to an acknowledgment-based system eliminates the need for traditional licensing for non-clinical and analytical uses. Applicants can now submit a prior intimation through an online portal, with the drug allowed for import once an acknowledgment is issued.

“The amendment introduces an acknowledgment-based system for import of all drugs in small quantities for analytical and non-clinical testing purposes,”

The ministry emphasized that this reform would reduce regulatory hurdles for startups and research institutions, enabling them to begin testing without delays. It added that the change is expected to cut compliance costs and allow industries to initiate experiments more swiftly.

Shelf-Life Norms Adjusted for Inventory Efficiency

A separate proposal alters the requirement for imported drugs to have at least 60% of their shelf life remaining at the point of entry. Instead, a uniform minimum residual shelf life of twelve months is now proposed. The health ministry stated that this adjustment ensures sufficient time for distribution and use before expiration, potentially boosting inventory utilization and optimizing supply chains.

“By ensuring that imported drugs have a minimum remaining shelf life of twelve months upon entry into the country, the proposal provides sufficient time for distribution and consumption before expiry,”

The ministry also noted that the reform could lower expenses and improve the accessibility of critical medications.

Public Feedback Period Open

The draft notifications are currently open for 30 days of public comments. In addition to these changes, health officials revealed that the Centre has revoked manufacturing licenses for Jackson Laboratories’ facilities in Punjab and Himachal Pradesh. This decision follows an investigation into reports connecting the company’s oxytocin injections to maternal deaths in Rajasthan.