The pharmacy of the global South is facing a reputation crisis, and recent incidents have put India’s pharmaceutical industry under intense scrutiny. The deaths of children in The Gambia, Uzbekistan, and Cameroon due to contaminated cough syrups, and cases of blindness and fatalities in the United States due to tainted Indian-made eye drops, have raised serious concerns about drug safety and regulatory oversight.
The latest revelation, uncovered by a BBC Eye investigation, further tarnishes this image, exposing criminal malpractice by Aveo Pharmaceuticals, a Maharashtra-based firm. Aveo Pharmaceuticals was found to be manufacturing and exporting unapproved, highly addictive opioid drug combinations to West Africa, despite these drugs having no legal clearance in India. The company produced a mix of tapentadol (a strong opioid) and carisoprodol (a muscle relaxant), which is not approved as a combination by India’s Central Drugs Standard Control Organization (CDSCO). Even if the State drug authority had granted approval, such a move would still be illegal, as only the CDSCO has the authority to clear new fixed-dose combination (FDC) drugs.
While India previously denied the World Health Organization’s report on the contaminated cough syrup crisis, the swift action taken by the CDSCO and the State drug authority in response to the BBC’s irrefutable video evidence shows a willingness to hold violators accountable. The seizure of 13 million tablets and 26 batches of active pharmaceutical ingredients points to the scale of this illicit trade, making it imperative that criminal action follows.
The Indian pharmaceutical industry is globally recognized for its high-quality generic drugs, and it is the responsibility of regulators to ensure that this reputation remains intact. Strict enforcement, stringent penalties, and an unwavering commitment to drug safety are necessary to prevent the industry from becoming synonymous with dangerous synthetic opioids. The integrity of India’s pharma sector must not be compromised for illicit profits.
