Health Ministry acts against Mumbai's Aveo Pharmaceuticals over export of unapproved Tapentadol-Carisoprodol combination to West Africa
The Union Health Ministry said on 23 February 2025 that CDSCO and Maharashtra regulators had stopped operations at Aveo Pharmaceuticals, Mumbai, and moved to withdraw export NOCs for the unapproved Tapentadol-Carisoprodol combination exported to West Africa.
Summary
On 23 February 2025 the Union Health Ministry said a joint team of the Central Drugs Standard Control Organization (CDSCO) and the Maharashtra regulator had audited Aveo Pharmaceuticals, Mumbai, on 21-22 February after news reports on its export of unapproved Tapentadol-Carisoprodol combination drugs to West African countries. A Stop Activity Order halted all operations, about 1.3 crore tablets and capsules and 26 batches of APIs were detained, and the Maharashtra FDA issued a Stop Production Order on 22 February. CDSCO asked all state drug controllers to withdraw export NOCs and manufacturing licences for any Tapentadol-Carisoprodol combination. Both drugs are individually approved in India but the combination is not, and neither is on India's NDPS list.
Key facts
- Firm
- Aveo Pharmaceuticals, Mumbai
- Combination
- Tapentadol + Carisoprodol (not approved in India)
- Exported to
- West African countries
- Audit
- 21-22 February 2025, CDSCO and Maharashtra regulator
- Detained
- About 1.3 crore tablets/capsules and 26 API batches
- NDPS status
- Neither drug is on India's NDPS list
Practice MCQs 2 questions
The Health Ministry's action against Aveo Pharmaceuticals in February 2025 concerned the export of an unapproved combination of Tapentadol with which drug?
Show answer
Correct answer: D — Carisoprodol
The firm exported unapproved combinations of Tapentadol and Carisoprodol to West African countries.
Consider the following statements about Tapentadol and Carisoprodol, as stated by the Health Ministry in February 2025: 1. Both drugs are individually approved by CDSCO in India. 2. Both drugs are included in India's NDPS list. Which of the statements given above is/are correct?
Show answer
Correct answer: A — 1 only
The Ministry said both drugs are individually approved by CDSCO but their combination is not, and neither is included in the NDPS list, so only the first statement is correct.