Regulatory Actions on Export of Unapproved Drug Combinations
The Health Ministry of India has taken significant regulatory actions following reports of unapproved drug combinations being exported by Aveo Pharmaceuticals to certain West African countries.
Details of the Case
- Drugs Involved: Tapentadol and Carisoprodol.
- Approval Status: Both drugs are approved individually in India in specific dosages but their combination is not approved.
- Legal Status: Neither drug is listed under India's Narcotic Drugs and Psychotropic Substances list.
Health Ministry's Response
- Stop Activity Order: Issued to Aveo Pharmaceuticals, ceasing all operations on site.
- Seizures: 1.3 crore tablets/capsules and 26 API batches were confiscated.
- Licence and Export NoC: Immediate withdrawal of approvals for the unapproved drug combination.
Inspections and Compliance
- Initiated risk-based inspections of drug manufacturing/testing firms since December 2022.
- Inspection Data: 905 units inspected, resulting in 694 actions including:
- Stop production/testing orders
- Licence suspensions/cancellations
- Warning letters
- Show-cause notices
Future Measures
- Export Consignment Held: A shipment bound for Ghana has been put on hold pending investigation.
- Checklist Update: CDSCO is revising the export NOC checklist to require either a Product Registration Certificate from the importing country's NRA or approval from the CDSCO.
The Health Ministry's actions aim to enhance regulatory compliance and prevent the export of unapproved drug combinations, ensuring patient safety and upholding the integrity of India's pharmaceutical industry.