The Ministry of Health and Family Welfare has taken swift and decisive action following reports of unapproved combination drugs containing Tapentadol and Carisoprodol being exported by Indian pharmaceutical manufacturer M/s Aveo Pharmaceuticals, Mumbai, to West African countries. A press release on this development was issued on February 23, 2025
Immediate Actions Taken
Stop Activity Order: A joint team from the Central Drugs Standard Control Organization (CDSCO) and the State Regulatory Authority conducted a comprehensive audit of the pharmaceutical company, leading to the issuance of a Stop Activity Order, halting all operations at the company’s premises.
Seizure of Materials: Authorities seized all raw materials, in-process materials, and finished products, including approximately 1.3 crore tablets/capsules and 26 batches of Active Pharmaceutical Ingredients (APIs) of Tapentadol and Carisoprodol.
Stop Production Order: The Maharashtra Food and Drug Administration (FDA) issued a Stop Production Order to M/s Aveo Pharmaceuticals, effectively halting the manufacturing of the concerned drug combinations.
Withdrawal of Export NOCs: Communications have been sent to all State Drugs Control Authorities and Zonal Offices to immediately withdraw Export No Objection Certificates (NOCs) and Manufacturing Licenses granted for any combination of Tapentadol and Carisoprodol. Similar communications have been sent to Customs offices at notified ports to route all consignments of these products through CDSCO Port offices.
Seizure of Export Consignment: An export consignment of Tapentadol 125 mg + Carisoprodol 100 mg, destined for Ghana, has been placed on hold at Mumbai Air Cargo pending further investigation.
Updating Export NOC Checklist: The CDSCO is updating the Export NOC checklist to require either a Product Registration Certificate from the importing country’s National Regulatory Agency (NRA) or approval from the Indian Regulatory Authority (CDSCO) for all medicines being exported from India.
Background and Context
Tapentadol and Carisoprodol are individually approved by CDSCO in India, but their combination is not. Neither drug is listed under the Narcotic Drugs and Psychotropic Substances (NDPS) Act in India.
The CDSCO, in collaboration with state regulators, has been conducting risk-based inspections of drug manufacturing and testing firms since December 2022, resulting in significant regulatory actions.
During late January of 2025, the CDSCO conducted focused audits of firms manufacturing and exporting NDPS drugs.
Ministry’s Commitment
The Ministry of Health and Family Welfare and the CDSCO have reiterated their commitment to maintaining the highest standards of drug safety and regulatory compliance. The ministry’s actions reflect a zero-tolerance policy towards the illegal or unethical export of unapproved and potentially harmful drugs.
