Govt Proposes Immediate Suspension of Drug Manufacturing Licences for Specified Quality Failures
New Delhi, Nov. 5 -- The government has proposed rules requiring regulators to immediately suspend manufacturing licences for medicines that fail specified quality tests, tightening oversight of pharmaceutical manufacturing and drug safety.
Under the draft rules, immediate suspension would apply when government laboratories find that medicines fail prescribed standards for impurities, sterility, assay or dissolution. These tests assess contamination, sterility, active ingredient content and the release of the active ingredient, Reuters reported.
The Health Ministry said existing rules require regulators to issue a show-cause notice before suspending or cancelling a manufacturing licence, potentially delaying action against drugs declare...
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