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Joint CDSCO and Maharashtra Regulatory Team Conducts Thorough Audit
Stop Activity and Stop Production Orders Issued
Export NOCs and Manufacturing Licenses for Tapentadol-Carisoprodol Combinations Withdrawn
23 FEB 2025
The Union Ministry of Health and Family Welfare has taken immediate action in response to reports regarding the export of unapproved drug combinations containing Tapentadol and Carisoprodol by M/s Aveo Pharmaceuticals, Mumbai, to certain West African nations.
As part of its ongoing efforts to ensure regulatory compliance in the pharmaceutical sector, the Central Drugs Standard Control Organization (CDSCO), in collaboration with state regulators, has been conducting risk-based inspections of drug manufacturing and testing facilities since December 2022. A total of 905 units have been inspected, leading to 694 regulatory actions, including Stop Production Orders (SPO), Stop Testing Orders (STO), license suspensions and cancellations, warning letters, and show-cause notices. These efforts have significantly improved compliance within the industry.
Focused Audit of NDPS Drug Manufacturers
In late January 2025, CDSCO and State Regulators conducted a focused audit of firms engaged in manufacturing and exporting NDPS (Narcotic Drugs and Psychotropic Substances) drugs. The findings led to decisive regulatory actions aimed at strengthening oversight on the export of such drugs from India.
Unapproved Drug Combination in Question
Both Tapentadol and Carisoprodol are individually approved by CDSCO for use in India. Tapentadol is authorized in 50 mg, 75 mg, and 100 mg tablet forms, as well as 100 mg, 150 mg, and 200 mg extended-release tablets. However, the combination of Tapentadol and Carisoprodol has not been approved in India. While neither drug is listed under India’s NDPS Act, their combination raises regulatory concerns.
Actions Taken by the Union Health Ministry
- Audit and Inspection: A joint team from CDSCO and the Maharashtra State Regulatory Authority conducted an extensive audit of M/s Aveo Pharmaceuticals between February 21 and 22, 2025. Based on their findings, a Stop Activity Order was issued, halting all operations at the firm’s premises.
- Seizure of Materials: Investigators seized all raw materials, in-process substances, and finished products related to the unapproved combination. Approximately 1.3 crore tablets/capsules and 26 batches of Active Pharmaceutical Ingredients (APIs) were detained to prevent further distribution.
- Stop Production Order: On February 22, 2025, the Maharashtra FDA issued a Stop Production Order against M/s Aveo Pharmaceuticals, effectively ceasing the manufacture of the concerned drug combinations.
- Withdrawal of Export NOCs: Instructions have been sent to all State Drugs Control Authorities and Zonal Offices to immediately withdraw Export NOCs and Manufacturing Licenses granted for the combination of Tapentadol and Carisoprodol. Customs offices at designated ports have also been directed to route all related consignments through CDSCO Port Offices for additional scrutiny.
- Seizure of Export Consignment: An export consignment containing Tapentadol 125 mg + Carisoprodol 100 mg tablets, destined for Ghana, has been halted at Mumbai Air Cargo pending further investigation.
- Updating Export NOC Checklist: CDSCO is revising the Export NOC checklist to mandate that either a Product Registration Certificate from the importing country’s National Regulatory Authority (NRA) or approval from the Indian Regulatory Authority (CDSCO) is obtained before medicines are exported from India. This measure aims to prevent future regulatory lapses and ensure compliance.
The Union Government is committed to maintaining a balance between facilitating the legitimate export of essential medicines and preventing unauthorized pharmaceutical trade. By taking swift and stringent actions against regulatory violations, the government upholds its zero-tolerance policy towards the export of unapproved and potentially unsafe drugs.
As a leading global pharmaceutical supplier, India remains dedicated to ensuring the highest standards of drug safety and regulatory compliance. The Ministry of Health and Family Welfare assures both domestic and international stakeholders that robust monitoring mechanisms will continue to be enforced to prevent misuse of Indian-manufactured medicines.
Disclaimer:
This news article is based on official statements and reports from the Ministry of Health and Family Welfare. Any legal or regulatory developments following this publication should be verified from official sources.
