Following a recent exposé where illegal shipments of unlicensed opioid drugs were sent from India to West Africa, the Indian government has prohibited the production and export of two drugs—tapentadol and carisoprodol—whose combination was alleged to have contributed to an increasing opioid crisis in the region. This bold action comes in the wake of a BBC World Service documentary, India's Opioid Kings, which exposed how Indian pharmaceuticals are fueling public health emergencies in nations such as Nigeria and Ghana.
Tapentadol is a centrally active analgesic administered for the relief of acute and chronic moderate to severe pain, especially for disorders such as neuropathic pain, musculoskeletal pain, and post-operative pain. Its analgesic action results from a two-component mechanism of action: through a μ-opioid receptor agonist, thus opioid-induced analgesia, and norepinephrine reuptake inhibition (NRI), resulting in enhancing descending pain inhibitions. This dual action makes it more potent than traditional opioids for some pain types while minimizing the risk of opioid-induced gastrointestinal side effects such as nausea and constipation.
Tapentadol has been found to have a lower abuse potential than more potent opioids such as oxycodone but still poses a risk of dependence, necessitating careful use and monitoring. It shares common side effects of drowsiness, dizziness, nausea, headache, and constipation, and sudden stoppage can precipitate withdrawal effects. Carisoprodol, however, is a centrally acting skeletal muscle relaxant that is mainly utilized for the short-term treatment of acute musculoskeletal pain and discomfort. It acts by regulating the neuronal activity of the central nervous system, especially at the spinal cord and brainstem, resulting in relaxation of the muscles and blunted perception of pain.
After being metabolized in the liver, it is broken down into meprobamate, a sedative and anxiolytic drug, which is responsible for its effectiveness but also for its potential for abuse and dependence. Due to its potential for addiction and withdrawal, carisoprodol is usually prescribed for brief periods (2-3 weeks) and must not be suddenly withdrawn from patients who have become physically dependent. The most common side effects are drowsiness, dizziness, headache, and, in certain individuals, compromised cognitive and motor function, making it inappropriate for use with activities requiring alertness, including driving. Because of its potential for abuse, carisoprodol is regulated as a controlled substance in various nations, and its prescription is generally limited to instances where other muscle relaxants or pain control methods are inadequate.
The documentary directly implicated a Maharashtra-based pharmaceutical firm, Aveo Pharmaceuticals Pvt Ltd, in the manufacturing and exportation of a highly effective mixture of tapentadol, a powerful opioid drug, and carisoprodol, a highly addictive muscle relaxer. This mixture, not approved for use anywhere in the world, has been packaged as authentic medicine and exported to West African countries, leading to mass addiction and health emergencies. In reaction, state and central drug inspectors carried out a joint raid on Aveo's warehouse and factory in Boisar, Palghar district, confiscating the entire inventory and stopping further production. [2]
Subsequent to these revelations, the Central Drugs Standard Control Organisation (CDSCO) ordered all states to cancel the no-objection certificates (NOCs) and manufacturing and export licenses of tapentadol, carisoprodol, and related products. The Ministry of Health has also launched more stringent surveillance mechanisms to track pharmaceutical exports and avert such infractions in the future.
Aveo Pharmaceuticals has denied any wrongdoing, stating that they have strictly followed all guidelines for manufacturing and export. One of the company’s spokespersons said, "We have always followed the regulations and rules set by different regulatory bodies for export and manufacturing." In spite of such statements, authorities have discovered discrepancies in Aveo's manufacturing and sales records, which has resulted in stricter scrutiny and enforcement measures. [2]
The opioid crisis in West Africa has been worsening over the past decade, with drugs like tramadol, tapentadol, and other synthetic opioids being smuggled into the region. These drugs, often used without medical supervision, have led to severe addiction, overdoses, and increased crime rates. Public health experts have welcomed India's crackdown, stating that such measures are crucial in preventing further devastation in affected countries.
References
BBC World Service. India’s Opioid Kings: The drugs fueling addiction in West Africa. Available at: https://www.bbc.com/news/world-africa-68274210
United Nations Office on Drugs and Crime (UNODC). At the Crossroads of Licit and Illicit: Tramadol Trafficking in West Africa. Available at: https://www.unodc.org/conig/uploads/documents/Tramadol_Trafficking_in_West_Africa.pdf
(Input from various sources)
(Rehash/Pragati Sakhuja/MSM)