Home / Health / India Simplifies Drug Import for R&D
India Simplifies Drug Import for R&D
26 Jun
Summary
- Importing drugs for testing now uses an acknowledgement system.
- Shelf life for imported drugs revised to 12 months.
- Rules aim to boost pharma R&D and reduce industry burden.
The Union Health Ministry has proposed amendments to the Drugs Rules, 1945, to streamline drug import procedures for examination, testing, and analysis. A new acknowledgement-based system will now permit the import of small quantities of drugs for analytical and non-clinical testing purposes upon prior intimation.
This simplified procedure, effective from January 2026 following similar amendments to the New Drugs and Clinical Trials Rules, 2019, aims to significantly reduce the compliance burden. It is expected to deregulate the R&D sector and provide a seamless gateway for startups and industries.
Further amendments propose revising the residual shelf-life requirement for imported drugs from over 60% to a minimum of 12 months at the time of import. This change promotes ease of doing business, enhances supply chain efficiency, and optimizes inventory utilization while ensuring medicine quality.
