CDSCO withdraws export NOC, bans drugs linked to West Africa opioid crisis

The ministry added that Aveo Pharmaceuticals has been issued a Stop Activity Order, halting all operations at the company's premises after a comprehensive audit

Following reports of illegal export of unapproved drug combinations of Tapentadol and Carisoprodol, the Union health ministry on Sunday announced that it has moved for immediate withdrawal of export no-objection certificates (NOCs) and manufacturing licences for the combinations.

 

This comes after a recent BBC investigation had exposed a racket, where a Mumbai-based producer, namely Aveo Pharmaceuticals, was exporting the unlicenced addictive combination to West African countries such as Nigeria, Ghana and Cote D’Ivoire.

 

While Tapentadol is a strong opioid and is used to relieve severe pain, Carisoprodol is a muscle relaxant for painful bone conditions.

 

The ministry said that Aveo Pharmaceuticals has been issued a Stop Activity Order, halting all operations at the company’s premises after a comprehensive audit by a joint team of the Central Drug Standards Control Organisation (CDSCO) and the Maharashtra state regulatory authority.

 

 

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 Active Pharmaceutical Ingredients (APIs) of Tapentadol and Carisoprodol were detained to prevent further distribution of these potentially dangerous drugs,” the ministry stated.

 

The company, however, has termed the allegations in the BBC report as baseless and without merit, denying all claims made against it.

 

“Tafrodol is our registered trademark, which contains both Tapentadol and Carisoprodol. This combination is licenced by the relevant State Food and Drug Administration (FDA) and is exported under the necessary NOC from the Assistant Drug Controllers (ADC) and with an export licence issued by the CDSCO,” Aveo Pharmaceuticals said in a statement on their website.

 

A company spokesperson added that several companies have unlawfully been using Aveo Pharmaceuticals’ brand name and logo. “We have already filed multiple legal cases against such companies, and the matter is currently being heard in the high court,” the spokesperson said.

 

“Furthermore, the manufacturing code of Tafrodol blister shown in the BBC article does not bear the manufacturing code of our factory depicting it as having been manufactured by some other company,” the company stated.

 

The apex drugs regulator, however, states that while both Tapentadol and Carisoprodol are individually approved by CDSCO in India, a combination of both is not approved.

 

“Neither of these drugs is included in the Narcotic Drugs and Psychotropic Substances (NDPS) list in India,” the health ministry stated. 

 

CDSCO looking to upgrade Export NOC checklist

 

Going forward, the health ministry and CDSCO are looking at updating the export NOC checklist.

 

This will be done to ensure that either the Product Registration Certificate from the importing country’s National Regulatory Agency (NRA) or approval from the CDSCO is required for all medicines being exported from India.

 

Similarly, zonal offices and customs offices at notified ports have been informed to route all consignments of referred products through CDSCO port offices.

 

“An export consignment of Tapentadol 125 mg and Carisoprodol 100 mg, destined for Ghana, has been put on hold at Mumbai Air Cargo pending further investigation,” the ministry said.