The Centre has clamped down on opioid painkiller Tapentadol and muscle-relaxant Carisoprodol, and its combinations, following a recent report of abuse of these drugs in West African countries.
In a communication, the Central Drugs Standard Control Organisation (CDSCO) asked State and Union Territories’ drug control authorities to withdraw the NOC (no objection certificate) for export and manufacture of these products in combination. Additionally, State / UT authorities were also also asked to withdraw NOCs for the export and manufacture of all combinations involving the two drugs, independently – that was not approved by the importing country. The directive is with immediate effect.
“Significant potential for abuse”
The action follows a BBC report that mentions the combination drug and its “significant potential for abuse”, exported to West African countries from India, CDSCO said. The report alleges that Mumbai-based Aveo Pharmaceuticals was packaging and exporting these opioid pills. These exports were causing a public health crisis in Ghana, Nigeria and the Ivory Coast, the report alleged.
A query on this development was sent to Aveo Pharmaceuticals by businessline, and a response is awaited.
Meanwhile, pharma industry-insiders said the company was not part of their main associations. Pointing out that the combination was potent, an industry insider explained, such products usually have high levels of scrutiny and require meticulous documentation.
The incident comes against the backdrop of the contaminated cough syrup issues that were reported from Gambia and Uzbekistan (2022), where products from two companies in India were potentially linked to deaths reported among children. Following these incidents, authorities in India had mandated the testing of these products, before they were exported. In the domestic market, top 300 brands had also been mandated to have track and trace codes, with regulatory authorities indicating that the scope of the directive was set to increase.