New Delhi [India], February 23 : After a joint team from the Central Drugs Standard Control Organisation (CDSCO) and the state regulatory authority conducted an audit of Aveo Pharmaceuticals, the Union Health and Family Welfare Ministry has issued a Stop Activity Order that halts all operations at the company's premises.
This concerns the reports of the export of unapproved combination drugs containing Tapentadol and Carisoprodol by the Mumbai-based pharmaceutical company to certain West African nations.
"Following the audit, the investigation team seized all raw materials, in-process materials, and finished products. Approximately 1.3 crore tablets/capsules and 26 batches of APIs (Active Pharmaceutical Ingredients) of Tapentadol and Carisoprodol were detained to prevent further distribution of these potentially dangerous drugs," the health ministry said in a release.
The audit was conducted between February 21-22.
The Maharashtra FDA issued a Stop Production Order to "M/s. Aveo Pharmaceuticals" on February 22, effectively halting the manufacturing of the concerned drug combinations.
"An export consignment of Tapentadol 125 mg Carisoprodol 100 mg, destined for Ghana, has been put on hold at Mumbai Air Cargo pending further investigation," the ministry said.
To prevent similar incidents in the future, the government has withdrawn all Export No Objection Certificates (NOCs) and manufacturing licenses for this combination, with a directive sent to all State Drugs Control Authorities, Zonal Offices, and Customs offices at notified ports.
"CDSCO is updating the Export NOC checklist, to ensure that either the Product Registration Certificate from the importing country's National Regulatory Agency (NRA) or approval from the Indian Regulatory Authority (CDSCO) is required for all medicines being exported from India," the ministry said.
Although Tapentadol and Carisoprodol are individually approved in India, their combination has not been authorised by CDSCO.
"Tapentadol and Carisoprodol are individually approved by CDSCO in India. Tapentadol is approved in 50, 75, and 100 mg tablet forms, as well as 100, 150, and 200 mg extended-release tablets. However, the combination of Tapentadol and Carisoprodol is not approved in India," the release read.