Health Ministry bans the export of few drugs
Context:
The Union Health Ministry recently banned the export of a few unauthorised drug combinations containing tapentadol and carisoprodol.
Relevance:
GS-02 (Government policies and interventions)
Key Highlights:
- Regulatory Crackdown: The Health Ministry and CDSCO inspected Aveo Pharmaceuticals, issuing a stop activity order and revoking licenses for unauthorised drug combinations.
- Massive Drug Seizure: 1.3 crore tablets/capsules and 26 batches of APIs were confiscated to prevent further distribution.
- Wider Compliance Drive: Since December 2022, 905 pharmaceutical units have been inspected, leading to 694 regulatory actions, including shutdowns and license cancellations.
Why Ban Tapentadol-Carisoprodol Combination?
- Unapproved Combination: Although tapentadol (painkiller) and carisoprodol (muscle relaxant) are individually approved, their combination lacks approval due to potential risks.
- Misuse Potential: Tapentadol is an opioid, which could be used for drug abuse and addiction. And Carisoprodol enhances its effects, increasing the risk of dependence.
- Regulatory Violations: The export of unapproved formulations undermines drug safety regulations and could damage India’s pharmaceutical credibility.
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