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Tapentadol-Carisoprodol Drug
Context:
The Health Ministry has issued a stop activity order against Aveo Pharmaceuticals, Mumbai, following reports of exporting unapproved combination drugs containing Tapentadol and Carisoprodol to West African countries.
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- A joint team from CDSCO and the Maharashtra State Regulatory Authority performed a comprehensive audit from February 21-22.
- The audit uncovered serious issues, prompting swift regulatory actions.
- Export No-Objection Certificates (NoCs) and manufacturing licenses for these drug combinations have been immediately withdrawn.
Tapentadol & Carisoprodol
- Tapentadol is approved in India in various tablet forms:
- 50 mg, 75 mg, 100 mg (regular tablets)
- 100 mg, 150 mg, 200 mg (extended-release tablets)
- Carisoprodol is also approved for use individually.
- However, the combination of Tapentadol and Carisoprodol is not approved in India.
- Neither of these drugs is classified under India’s Narcotic Drugs and Psychotropic Substances (NDPS) list.
Large-Scale Pharma Compliance Inspections
- The Central Drugs Standard Control Organisation (CDSCO) and State regulators launched risk-based inspections in December 2022 to ensure pharmaceutical regulatory compliance.
- 905 drug manufacturing and testing units have been inspected.
- 694 enforcement actions have been taken, including:
- Stop production/testing orders
- Licence suspensions/cancellations
- Warning letters and show-cause notices
Enforcement Actions Against Aveo Pharmaceuticals
- A joint audit of Aveo Pharmaceuticals by the CDSCO and Maharashtra FDA was conducted on February 21-22, 2024.
- The audit revealed regulatory violations, leading to:
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- Immediate halt of all operations at Aveo Pharmaceuticals.
- Seizure of raw materials, in-process materials, and finished products.
- Confiscation of approximately 1.3 crore tablets/capsules and 26 batches of Active Pharmaceutical Ingredients (APIs) of Tapentadol and Carisoprodol.
Regulatory Measures & Export Restrictions
- On February 22, the Maharashtra FDA issued a stop production order for Aveo Pharmaceuticals.
- All State Drug Control Authorities and Zonal Offices were directed to withdraw export NoCs and manufacturing licenses for any Tapentadol-Carisoprodol combination.
- Customs offices at all notified ports were alerted to route all consignments of these drugs through CDSCO port offices.
- A shipment of Tapentadol 125 mg + Carisoprodol 100 mg bound for Ghana was put on hold at Mumbai Air Cargo pending further investigation.
Strengthening Drug Export Regulations
- The CDSCO is updating its export NoC checklist to prevent future regulatory lapses.
- The new checklist will mandate:
- A Product Registration Certificate from the importing country’s National Regulatory Agency (NRA) OR
- Approval from the Indian Regulatory Authority (CDSCO) before a drug can be exported.
- This measure aims to prevent unauthorised drug exports and strengthen pharmaceutical regulatory compliance.
