Regulatory Loopholes in India Enable Surge in Illicit Tapentadol Exports to West Africa
West African states are grappling with a severe opioid crisis driven by pharmaceutical exports from India that bypassed export permits and regulatory oversight.
West African nations including Sierra Leone, Ghana, Nigeria, Togo and Senegal are confronting a severe opioid crisis driven by the illicit importation of millions of pills from India. Investigations indicate that over 320 million tablets of the painkiller tapentadol, valued at nearly USD $130 million between 2023 and 2025, were shipped to the region without valid export permits. This influx has contributed to national emergency declarations in Sierra Leone and Liberia and is described as crippling populations and straining healthcare systems.
The trade represents a sharp escalation in illicit activity, with the value of tapentadol exports rising from approximately USD $27 million between 2020 and 2022 to nearly USD $130 million in the subsequent period. More than 60 Indian suppliers have exported these drugs since 2023, with three firms—Syncom Formulations, Puizer Pharmaceuticals, and Twin Impex—dominating the market despite only two firms holding official export approval for tapentadol. A significant portion of the shipments consisted of high-strength 200mg doses, a dosage not approved for sale in India.
Ghana's Food and Drugs Authority confirmed it has issued no permits for tapentadol imports to any neighbouring country, highlighting serious gaps in export oversight and cross-border drug controls. The crisis has forced leaders in Sierra Leone and Liberia to declare national emergencies over drug use in an unprecedented decision, while experts note that porous borders and weak enforcement in West Africa facilitate the smuggling of these illicit substances.
The root of the issue lies in regulatory structures within India, where current law suggests that if a particular formulation is not sold in the domestic market, the regulator has no role in its manufacture or export. Dinesh Thakur, a public health activist, notes that while approval from the Narcotics Bureau is necessary for exporting opioids, the functioning of this process remains unclear. This lack of transparency allows manufacturers to export unapproved formulations without the requisite oversight.
Previous attempts to curb the trade, such as the seizure of stock from Aveo Pharmaceuticals following an investigation into an illegal drug mix, appear to have been circumvented by a surge in other opioid exports. Nelson Aghogho Evaborhene, a Nigerian PhD fellow, observes that while border controls exist, they are often bypassed through routes that are not effectively manned, allowing products to enter the region undetected.
Experts are now calling for improved transnational policies and joint strategies to manage the issue, suggesting that both India and West African nations must adopt better regulations and accountability measures. The situation underscores the challenges in managing the flow of generic medicines when quality and legality concerns arise, particularly when vulnerable communities in countries facing socioeconomic hardship are most at risk.
