India Proposes Immediate Licence Suspension for Makers of Substandard Drugs
What Happened
India's Health Ministry has proposed amendments to the Drugs Rules, 1945, that would allow regulators to immediately suspend manufacturing licences for drugs found to be "Not of Standard Quality" (NSQ) on critical parameters such as assay, dissolution, impurities and sterility. The proposal has been issued for public consultation and aims to eliminate delays caused by the current show-cause notice process.
Key Takeaways
The proposed rules would give regulators faster powers to stop the manufacture and distribution of substandard medicines, reducing the risk of defective drugs remaining in circulation while enforcement proceedings are underway. The changes are currently draft proposals and have not yet come into force.