The Union Health Ministry on Sunday banned the export of the drugs Tapentadola and Carisoprodol manufactured by Aveo Pharmaceuticals, Mumbai, to West African countries.
The Central Drugs Standard Control Organisation (CDSCO), in collaboration with state regulators, had done a focused audit of firms manufacturing and exporting Narcotic Drugs and Psychotropic Substances (NDPS) medicines over alleged circulation of unlicensed drugs.
The action was taken after reports that unapproved combinations of Tapentadola and Carisoprodol drugs were driving an opioid crisis in West African countries.
CDSCO conducted inspections of drug manufacturing and testing firms in December 2022, following which actions were taken against 694 units after the inspection. About 900 units were inspected by the officials.
The actions taken included Stop Production Orders (SPO), Stop Testing Orders (STO), license suspensions/cancellations, warning letters, and showcase notices, depending on the severity of non-compliance.
The drug manufacturing firms and their practices came under scanner after reports of unlicensed drug exports surfaced.
The Tapentadola and Carisoprodol drugs are individually approved by CDSCO. Tapentadol is approved in 50, 75, and 100 mg tablet forms, as well as 100, 150, and 200 mg extended-release tablets.
However, the combination of the drugs is not approved in India. Also, neither of these drugs is included in the NDPS list in India.
"The government will ensure smooth export operation for legitimate medicines to be used to support healthcare globally and strongly control these aberrations through swift and strong actions," said the Ministry of Health in a statement.
Around 1.3 crore tablets and 26 batches of APIs (Active Pharmaceutical Ingredients) of Tapentadol and Carisoprodol were detained by CDSCO to prevent further distribution.
Also, export NOCs and manufacturing licenses granted for the combination of Tapentadol and Carisoprodol were withdrawn.
The health officials also seized an export consignment of Tapentadol 125 mg + Carisoprodol 100 mg, destined for Ghana, in Mumbai airport.
"Going forward, CDSCO is updating the Export NOC checklist, to ensure that either the Product Registration Certificate from the importing country's National Regulatory Agency (NRA) or approval from the Indian Regulatory Authority (CDSCO) is required for all medicines being exported from India," read the statement.
