Govt bans production, export of drugs containing tapentadol and carisoprodol

The Indian authorities has taken rapid and decisive motion to manage the export of unapproved mixture medicine containing Tapentadol and Carisoprodol manufactured by Aveo Prescribed drugs, Mumbai, to sure international locations in West Africa, the ministry of well being and household welfare stated in a press release.

The ministry stated that in January, the Central Medicine Commonplace Management Organisation (CDSCO), in collaboration with state regulators, had centered on auditing companies manufacturing and exporting medicine coated by the Narcotic Medicine and Psychotropic Substances Act 1985.

“Primarily based on evaluation of observations from the audit, essential choices have been taken to strengthen regulatory oversight on export of NDPS medicine from India,” the well being ministry stated in its assertion.

As a part of the train, a joint workforce from the CDSCO and the state regulatory authorities carried out a complete audit of Aveo Prescribed drugs between 21 and 22 February 2025. The audit’s findings led to the issuance of a Cease Exercise Order, halting all operations on the firm’s premises.

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Following the audit, the investigation workforce seized all uncooked supplies, in-process supplies, and completed merchandise, in response to the well being ministry. Roughly 1.3 crore tablets/capsules and 26 batches of APIs (Lively Pharmaceutical Substances) of Tapentadol and Carisoprodol have been confiscated to stop additional distribution of those probably harmful medicine.

In the meantime, the Maharashtra Meals & Medicine Administration issued a Cease Manufacturing Order to Aveo Prescribed drugs on Saturday, successfully halting the manufacturing of the drug mixtures in query, the ministry stated. 

“Communications have been despatched to all State Medicine Management Authorities and Zonal Places of work to instantly withdraw Export NOCs and Manufacturing Licenses granted for any mixture of Tapentadol and Carisoprodol. The identical communication has additionally been despatched to all customs workplaces at notified ports to route all consignments of referred merchandise by way of CDSCO port workplaces.” 

The federal government has additional seized export consignments associated to those two medicine. “An export consignment of Tapentadol 125 mg + Carisoprodol 100 mg, destined for Ghana, has been placed on maintain at Mumbai Air Cargo pending additional investigation,” the ministry stated.

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“Relating to the particular problem at hand, each Tapentadol and Carisoprodol are individually accredited by CDSCO in India. Tapentadol is accredited in 50, 75, and 100 mg pill kinds, in addition to 100, 150, and 200 mg extended-release tablets. Nonetheless, the mixture of Tapentadol and Carisoprodol just isn’t accredited in India, and neither of those medicine is included within the NDPS listing,” the well being ministry acknowledged.

It has additionally been deliberate that going ahead, CDSCO will replace the Export NOC guidelines, to make sure that both the Product Registration Certificates from the importing nation’s nationwide regulatory company (NRA) or approval from the Indian regulatory authority or CDSCO is required for all medicines being exported from India.

The pharma trade welcomed the transfer, saying it was time the medicine have been faraway from the export listing. Devesh Malladi, chairman of the NDPS Committee on the Indian Medicine Producers Affiliation (IDMA) stated, “This explicit mixture of Tapentadol and Carisoprodol is irrational and odd. It isn’t accredited wherever on the earth. It might be manufactured by small pharma corporations, not the larger ones. I do not suppose there may be any monetary implication on the producers over the ban on this mix. It’s good that DCGI has banned the mixture.”

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He added that it’s a matter of investigation to find out how these medicine have been exported and the way the importing nation allowed the import.

“This updation of the guidelines will deal with the basis reason behind the issue and settle the difficulty as soon as and for all. The federal government will guarantee easy export operation for authentic medicines to help healthcare globally and strongly management these aberrations by way of swift and powerful motion as demonstrated by way of its current choices and actions,” the well being ministry stated.

The ministry added that the federal government has a zero-tolerance coverage in direction of unlawful or unethical export of unapproved and probably dangerous medicine.

In December 2022, the federal government initiated risk-based inspections of drug manufacturing and testing companies to make sure regulatory compliance throughout the pharmaceutical sector. As of now, 905 models have been inspected, leading to motion being taken in 694 circumstances. 

These actions embody Cease Manufacturing Orders (SPO), Cease Testing Orders (STO), license suspensions/cancellations, warning letters, and showcase notices, relying on the severity of non-compliance. This initiative has supplied worthwhile insights into the bottom actuality of producing practices and has led to corrective actions, main in noticeable enhancements within the regulatory framework.

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India, as a number one international provider of prescription drugs, is devoted to sustaining the best requirements of drug security and regulatory compliance. The federal government will proceed to observe and regulate pharmaceutical exports to safeguard in opposition to any misuse of Indian-made medicines, the ministry added.