Health Ministry bars export of unapproved drug combination

Representational file image.
| Photo Credit: Reuters

Following reports about the export of unapproved combination drugs containing Tapentadol and Carisoprodol by Aveo Pharmaceuticals, Mumbai, to certain countries in west Africa, the Health Ministry on Sunday issued a stop activity order and immediate withdrawal of export no-objection certificate (NoC) and manufacturing licences for the combinations.

“Both Tapentadol and Carisoprodol are individually approved by the Central Drugs Standard Control Organisation [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. Neither of these drugs is included in the Narcotic Drugs and Psychotropic Substances list in India,’’ noted the Health Ministry.

In a release issued on Sunday, the Health Ministry said that to ensure regulatory compliance across the pharmaceutical sector, the CDSCO, in collaboration with State regulators, initiated risk-based inspections of drug manufacturing and testing firms in December 2022. 

As of now, 905 units have been inspected, resulting in 694 actions being taken. These actions include stop production orders, stop testing orders, licence suspensions/cancellations, warning letters, and show-cause notices, depending on the severity of non-compliance. 

Comprehensive audit

Listing the actions taken by the Health Ministry, the release said a joint team from the CDSCO and the State Regulatory Authority conducted a comprehensive audit of Aveo Pharmaceuticals between February 21 and 22. The findings from the audit led to the issuance of a stop activity order, halting all operations at the company’s premises.

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 seized to prevent further distribution of these potentially dangerous drugs.

The Maharashtra FDA issued a stop production order on February 22 and issued communications to all State Drugs Control Authorities and Zonal Offices to immediately withdraw export NoCs and manufacturing licences granted for any combination of Tapentadol and Carisoprodol. 

“The same communication has also been sent to all Customs offices at notified ports to route all consignments of referred products through CDSCO port offices. 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,’’ noted the Ministry.

It added that the 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. This update of the checklist will address the root cause of the problem, said the Ministry.