Export to West African Nations Suspended; Pharma Firm Under Investigation
Mumbai: The Union Health and Family Welfare Ministry has issued a Stop Activity Order against Aveo Pharmaceuticals after a joint audit by the Central Drugs Standard Control Organisation (CDSCO) and the Maharashtra FDA uncovered the export of unapproved drug combinations containing Tapentadol and Carisoprodol.
The audit, conducted on February 21-22, resulted in the seizure of 1.3 crore tablets/capsules and 26 batches of Active Pharmaceutical Ingredients (APIs) to prevent further distribution of these potentially unsafe drugs. The Maharashtra FDA also issued a Stop Production Order on February 22, effectively shutting down Aveo Pharmaceuticals’ operations.
Export Consignment to Ghana Halted
An export consignment of Tapentadol 125 mg + Carisoprodol 100 mg, bound for Ghana, has been put on hold at Mumbai Air Cargo pending further investigation. Additionally, the government has revoked all Export No Objection Certificates (NOCs) and manufacturing licenses for this combination, instructing all State Drugs Control Authorities, Zonal Offices, and Customs officials to prevent similar violations in the future.
CDSCO Strengthens Export Regulations
To enhance regulatory oversight, CDSCO is updating its Export NOC checklist to mandate that all exported medicines either have:
- A Product Registration Certificate from the importing country’s National Regulatory Agency (NRA)
- Approval from the Indian Regulatory Authority (CDSCO)
Drug Combination Not Approved in India
Although Tapentadol (an opioid analgesic) and Carisoprodol (a muscle relaxant) are individually approved in India, their combination has never been authorised by CDSCO.
- Tapentadol is approved in doses of 50 mg, 75 mg, and 100 mg tablets, as well as 100 mg, 150 mg, and 200 mg extended-release tablets.
- However, the combination of Tapentadol and Carisoprodol is not approved for use in India.
Authorities continue to investigate the matter, reinforcing India’s commitment to strict pharmaceutical compliance and patient safety.
