The Food and Drug Administration (FDA) has discovered that nine additional pharmaceutical companies in and around Palghar were previously granted permission to manufacture and export a now-banned drug. This revelation follows a media exposé that linked Aveo Pharmaceuticals to the opioid crisis in West Africa, triggering a regulatory crackdown on the production of Tapentadol-Carisoprodol drug combinations.

Key Highlights:
Nine Companies Had Prior Approval for the Banned Drug:

• Seven of these companies never manufactured the drug.

• Two companies—National Pharmaceuticals and Maxwell Life Science Pvt. Ltd., both based in Boisar—had previously exported the drug to West African countries.

Company Responses and Compliance Status:

• National Pharmaceuticals could not be reached for comment.

• Maxwell Life Science Managing Director, Sanjay Surana, clarified:

“We explored the market but never proceeded with manufacturing or exporting. Now, with the ban in place, it is out of the question to produce these drugs.”

• Aveo Pharmaceuticals previously held a WHO-compliant Good Manufacturing Practice (GMP) certificate, which is required for pharmaceutical exports to many West African nations.

• Maxwell Life Science has recently re-applied for GMP certification, while National Pharmaceuticals never had one.

Seizure of Banned Drug Consignments:

• FDA seized five consignments of Tafrodol, the banned drug, which contains tapentadol (a powerful opioid painkiller) and carisoprodol (a muscle relaxant with sedative effects).

• Confiscated stock includes 90 lakh tablets worth ₹1.5 crore, along with 26 batches of raw materials classified as Active Pharmaceutical Ingredients (API).

• Investigations are ongoing to determine the intended export destinations of the remaining seven companies.

CDSCO Orders Cancellation of Approvals:

• The Central Drugs Standard Control Organisation (CDSCO) directed all states to withdraw export NoCs and manufacturing permissions for all combinations of tapentadol and carisoprodol.

• States were instructed to cancel approvals for any combinations that were not explicitly authorized by the importing country.

Regulatory Action Triggered by Media Exposé:

• A BBC investigation revealed Aveo Pharmaceuticals’ managing director, Vinod Kumar Sharma, admitting to the harmful impact of exported Tafrodol in Ghana, Nigeria, and Ivory Coast.

• Aveo denied these allegations, stating they were not the only company manufacturing similar combinations and that their exports were legally licensed by FDA, CDSCO, and Assistant Drug Controllers.

• Further investigation revealed that Aveo's official headquarters in Borivli, Mumbai, was demolished over a year ago, raising concerns about compliance and transparency.

Statements from Regulatory Authorities:
FDA Official:
“We are investigating how many of these companies exported the banned drug and ensuring that manufacturing approvals are revoked. Regulatory oversight will be tightened to prevent such incidents in the future.”The FDA and CDSCO continue to intensify their crackdown on the illicit manufacturing and export of banned opioid-based drug combinations. The case underscores the urgent need for stricter compliance, global trade monitoring, and accountability in India’s pharmaceutical sector.