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India bans 2 painkillers allegedly creating serious opioid addiction in African countries, Palghar based company accused of making combination drug without approval

The combination of the two drugs tapentadol and carisoprodol is not licensed for use anywhere in the world including India as it is highly addictive and has harmful side effects which include death from overdose. The opioid is popular in West African countries because of its cheap price and wide availability.

India has banned the production of two highly addictive painkillers after a BBC report revealed that an Indian pharmaceutical company based in Palghar, Maharashtra had been involved in the export of the drugs to certain African countries causing a health crisis there. The Drug and Controller General of India, Dr Rajeev Singh Raghuvansi said on Friday (21st February) that permission to produce and export the two drugs – tapentadol and carisoprodol – has been withdrawn.

The decision came after an investigative report by the BBC exposed that an Indian pharmaceutical company named Aveo Pharmaceuticals was exporting a mix of the two drugs in countries like Ghana, Nigeria and Cote D’Ivoire. Reportedly, the combination drug caused serious opioid addiction in those countries. Tapentadol is a strong opioid and is used to relieve severe pain, while carisoprodol is a muscle relaxant used in acute cases or painful bone conditions.

The investigation found that Aveo Pharmaceuticals was manufacturing the Tafrodol brand as a combination of the two drugs without any approval. In a sting operation by BBC India, company officials admitted that they targeted teenagers in Nigeria and other African countries to sell the drug.

While the drug is sold in different brand names in Nigeria, Ghana, Cote D’Ivoire etc countries, they were traced back to Aveo Pharmaceuticals.

Subsequently, Maharashtra’s Food and Drug Administration (FDA) issued a show-cause notice to the company on Sunday (23rd February) under the Drugs and Cosmetics Act, 1940. A joint team of drug inspectors from the centre and the state government raided the company’s factory in Mumbai and seized the entire stock. The company has been prohibited from producing the drug.

An advisory was issued by the Centre on Friday directing all state governments to withdraw the export NOC (No Objection Certificate) for all unapproved combinations of Tapentadol and Carisoprodol and revoke manufacturing permissions for these drugs to prevent their misuse. The Central Drugs Standard Control Organization said the combination of tapentadol and carisoprodol had significant abuse potential.

The company denies allegations

Aveo Pharmaceuticals has denied the allegations and assured full cooperation with the government authorities. In a statement on its website, the company states, “In response to the allegations made against us in the BBC film dated 21st February 2025, we categorically deny all claims. The allegations against us are entirely baseless and without merit. We have always adhered to the rules and regulations set by various regulatory authorities to manufacture and export our products.”

It further adds, “Tafrodol is our registered trademark, which contains both Tapentadol and Carisoprodol. This combination is licensed by the relevant State Food and Administration and is exported under the necessary No Objection Certificate (NOC) from the Assistant Drug Controllers (ADC) and with an export license issued by the Central Drugs Standard Control Organisation (CDSCO),” a company spokesperson was quoted as saying.

Claiming that Aveo is not the only company to manufacture the combination, the spokesperson alleged that several companies have been illegally using Aveo’s brand name and logo to produce the combination. “We have already filed multiple legal cases against such companies, and the matter is currently being heard in the High Court,” he added.

Aveo Pharmaceuticals is based in Boisar, Palghar industrial zone near Mumbai.

The BBC Investigation

The BBC World Service reportedly found packets of the drugs with the Aveo logo being publicly sold in Nigeria and Cote D’Ivoire. As part of its investigation, the BBS sent an undercover operative posing as an African businessman inside one of Aveo’s factories in India. The operative met one of Aveo’s directors Vinod Sharma. He told Sharma that he was looking to supply opioids to Nigeria. The entire conversation was recorded on camera.

The drugs are banned in Europe and regulated in the US

Tapentadol, a powerful opioid, and Carisoprodol, a muscle relaxant, are highly addictive. Carisoprodol is banned in Europe and is approved for use in the US for short periods. The withdrawal symptoms of the drug are said to include anxiety, insomnia and hallucinations. The combination of the two drugs is reportedly not licensed for use anywhere in the world because of its harmful side effects which include death from overdose. The combination is not sold in India, and the company was selling it only in Africa. The opioid is popular in West African countries because of its cheap price and wide availability.

Notably, both the drugs are not included in the list of Narcotic Drugs and Psychotropic Substance (NDPS), and that is how the company was able to produce and export it.

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OpIndia Staffhttps://www.opindia.com
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