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India Bans Production of Two Drugs Linked to West African Opioid Crisis

In a decisive move to curb the illegal export of highly addictive pharmaceutical drugs, the Drug Controller General of India (DCGI) has ordered a ban on the production of tapentadol and carisoprodol. These drugs have been implicated in fueling an opioid addiction crisis in West African nations, including Ghana and Nigeria.

• By Newsdesk
• New Delhi
• Feb 24, 2025

News

In a decisive move to curb the illegal export of highly addictive pharmaceutical drugs, the Drug Controller General of India (DCGI) has ordered a ban on the production of tapentadol and carisoprodol. These drugs have been implicated in fueling an opioid addiction crisis in West African nations, including Ghana and Nigeria.

The crackdown follows an investigative report by the BBC, which uncovered an illicit drug racket involving an Indian pharmaceutical manufacturer. The report revealed that Mumbai-based Aveo Pharmaceuticals was producing an unapproved combination of tapentadol, a potent opioid painkiller, and carisoprodol, a muscle relaxant commonly used for acute bone and muscular pain. This combination was being illegally exported to African countries, exacerbating the region’s opioid crisis.

Unlicensed Exports and Investigative Findings

According to the BBC investigation, Aveo Pharmaceuticals was manufacturing the unregulated drug combination despite it not being approved for medical use anywhere in the world. A covert operation by the BBC recorded an Aveo Pharma official admitting plans to target young individuals in Nigeria as part of their sales strategy.

The illegally exported drugs were discovered under various brand names across Nigeria, Ghana, and Côte d'Ivoire, all traced back to Aveo Pharma’s factory in India. The Central Drugs Standard Control Organization (CDSCO) issued a directive on February 21, acknowledging the significant abuse potential of the combination and confirming its widespread distribution in West Africa.

“Considering the potential for drug abuse and its harmful impact on public health, it is imperative to immediately revoke all export No Objection Certificates (NOCs) and manufacturing permissions for the combination of tapentadol and carisoprodol,” the CDSCO directive stated. It further noted that any combinations of these drugs not approved by importing countries would be subject to an immediate export ban.

Regulatory Crackdown and Further Investigations

In response to the revelations, Indian regulatory authorities have initiated an extensive probe into Aveo Pharmaceuticals and its manufacturing practices. Senior government officials confirmed that central drug regulators, in collaboration with the Maharashtra Food and Drug Administration (FDA), are scrutinizing the company’s operations.

“We are actively investigating the manufacturers and brands involved in these illicit exports,” a Maharashtra government official stated. While the combination is not marketed within India, authorities are expanding their inquiries to identify any unauthorized production of similar opioid formulations across the country.

Industry analysts suggest that Aveo Pharmaceuticals may have evaded detection due to a regulatory loophole. Neither tapentadol nor carisoprodol is currently classified under India’s Narcotic Drugs and Psychotropic Substances (NDPS) Act. Experts speculate that the company may have exploited this gap by blending the two substances to create a highly addictive product.

Attempts to obtain a response from Aveo Pharma were unsuccessful. The company’s website indicates that its manufacturing facility is located in Boisar, an industrial zone in Palghar near Mumbai. Besides West Africa, Aveo Pharma’s export markets include Russia, Kazakhstan, Ukraine, Poland, and Türkiye.

International Implications and Strengthened Monitoring

Indian authorities are now working to alert African regulatory agencies about the illicit opioid trade, urging stricter surveillance on imports of unapproved drug combinations. The government is also expected to introduce more stringent regulations to close existing loopholes and prevent future occurrences of such illicit pharmaceutical exports.

The ban on tapentadol and carisoprodol production underscores India’s commitment to addressing global concerns about drug abuse and unauthorized pharmaceutical exports. As investigations continue, regulatory agencies worldwide will be closely monitoring further developments in this high-profile case.