Union Health Ministry in India wants to shake up Drugs Rules, 1945. Goal: simplify drug imports for examination, testing, or analysis. They're rolling out an acknowledgment-based system letting small drug quantities in for testing without prior licensing,except certain drug types.
Applicants will file a prior intimation form,then get acknowledgment to proceed with import. This tweak aims to lighten compliance load, especially for start-ups and R&D industries. One senior official says it could open up R&D sector for faster testing and analysis.
These changes build on tweaks from January 2026 to New Drugs and Clinical Trials Rules, 2019,which set up similar system for domestic test licenses. Extending this to imports should cut red tape and speed things up.
But some drugs still need prior licensing. Sex hormones, cytotoxic drugs,beta-lactams, biologics with live microorganisms,and narcotics or psychotropics stay tightly regulated for safety .
Aside from import rules,Ministry has floated draft to amend Rule 31 of Drugs Rules, 1945. Idea is to ease shelf-life requirement for imported drugs. Current rule demands over 60% shelf life left at import; proposal drops it to 12 months,except for biologicals and radiopharmaceuticals.
This change looks to streamline pharma supply chain,ensuring imported drugs have enough usable shelf life. Aim: cut waste, optimize inventory,reduce costs,and boost access to key meds .
With 12-month shelf life, Ministry hopes drugs can be distributed and used before expiration. Key for keeping medicine quality and access stable for patients nationwide.
Draft notification's open for public comments now. Ministry says these changes only tweak shelf-life rules,leaving quality,safety,and efficacy standards from Drugs and Cosmetics Act,1940, and Drugs Rules, 1945,untouched. What feedback will emerge from stakeholders…?
