New Delhi, The Drugs Controller General of India has prohibited the production and export of all combinations of pain-relief medicines tapentadol and carisoprodol over news reports that unapproved combinations of these drugs were exported to West African countries by a Mumbai-based pharma firm, causing an opioid crisis there.
In a communication, the DCGI has asked the drug control authorities of the states and Union territories to immediately withdraw all export NOCs and manufacturing licences granted for any combination of these two drugs.
Tapentadol is an opioid medication used to treat moderate to severe pain. Carisoprodol is a muscle relaxant that works on the centre of the brain and spinal cord to relieve pain.
In a statement, the Union health ministry said it has taken immediate and decisive action following news reports highlighting concerns regarding the export of unapproved combination drugs containing tapentadol and carisoprodol by Indian pharmaceutical manufacturer Aveo Pharmaceuticals to certain countries in West Africa.
It said both tapentadol and carisoprodol are individually approved by the Central Drugs Standard Control Organisation in India. Tapentadol is approved in 50, 75 and 100-mg tablet forms as well as 100, 150 and 200-mg extended-release tablets. However, a combination of tapentadol and carisoprodol is not approved in India.
Neither of these drugs is included in the NDPS list in India.
“This is in connection with a recent article from BBC whereby, it has been written that the combination drug Tapentadol and Carisoprodol has significant abuse potential and this combination is being exported to West African countries from India,” the communication sent by the DCGI on Friday said.
Looking at the potential to have a harmful impact on people, the DCGI requested for an immediate withdrawal of all export NOCs and permissions to manufacture all combinations of tapentadol and carisoprodol.
According to the ministry’s statement, a joint team from the CDSCO and Maharashtra’s state regulatory authority conducted a comprehensive audit of Aveo Pharmaceuticals between February 21 and February 22.
The findings from the audit led to the issuance of a stop-activity order, halting all operations on the company’s premises.
Meanwhile, the Maharashtra Food and Drug Administration also issued a stop-production order to Aveo on February 22, effectively halting the manufacturing of the drug combinations.
Aveo Pharmaceuticals, however, has denied the allegations and said it is fully cooperating with government authorities in the probe.
According to a statement issued by the FDA, the action was taken after the BBC’s investigative report highlighted that tapentadol and carisoprodol manufactured in India were illegally exported to African countries, where those were misused for recreational purposes.
Authorities have seized all existing stock in the company, prohibited further production and initiated stringent legal action against the firm, the FDA said.
The company has been served a show-cause notice under the Drugs and Cosmetics Act, 1940 and officials have said all necessary legal measures will be taken, without any delay, fear or favour.
According to the health ministry’s statement, 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 Is of Tapentadol and Carisoprodol were detained to prevent further distribution of these potentially dangerous drugs,” it said.
An export consignment of Tapentadol 125 mg plus Carisoprodol 100 mg, destined for Ghana, has also been put on hold at the Mumbai Air Cargo, pending further investigation.
Going forward, the CDSCO is updating the export NOC checklist to ensure that either the product registration certificate from the importing country’s National Regulatory Agency or approval from the Indian regulatory authority is required for all medicines being exported from India, the statement said.
“The Ministry of Health and Family Welfare, along with the CDSCO, remains committed to ensuring the safety and well-being of citizens in India and abroad. The steps taken in response to this issue reflect the government’s zero-tolerance policy towards illegal or unethical export of unapproved and potentially harmful drugs.
“India, as a leading global supplier of pharmaceuticals, is dedicated to maintaining the highest standards of drug safety and regulatory compliance. The Union Health Ministry assures the public and global community that the government will continue to monitor and regulate pharmaceutical exports to safeguard against any misuse of Indian-made medicines,” the statement said.
A spokesperson for Aveo Pharmaceuticals said the company has always adhered to the rules and regulations set by various regulatory authorities to manufacture and export its products.
“Tafrodol is our registered trademark, which contains both Tapentadol and Carisoprodol. This combination is licensed by the relevant state food and drug administration and exported under the necessary no-objection certificate from the assistant drug controllers and with an export licence issued by the Central Drugs Standard Control Organisation ,” he said.
He further said Aveo Pharmaceuticals is not the only company in India manufacturing a similar combination product.
“Several companies are unlawfully using our 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.
He added that the company is fully cooperating with the relevant government authorities, providing all required support and granting access to the necessary documentation for their investigation.
This article was generated from an automated news agency feed without modifications to text.