Not business as usual: On upholding India’s reputation for quality drugs.

India’s reputation for high-quality generic drugs should not be put at risk.

The pharmacy of the global South is facing a crisis of reputation. After cough syrups made by pharmaceutical companies based in India, which had unacceptable amounts of diethylene glycol and/or ethylene glycol, killed 66 children in the Gambia, 65 children in Uzbekistan in 2022, and 12 children in Cameroon in 2023, and India-made eye drops contaminated by drug-resistant bacteria killed three persons and blinded eight in the U.S., again in 2023, the spotlight is back on Indian drug companies for all the wrong reasons. A BBC Eye investigation has brought to light the criminal actions of Aveo Pharmaceuticals, a Maharashtra-based company, which was manufacturing and exporting unapproved, highly addictive opioid drug combinations to West Africa. The “medicines” contain tapentadol, a powerful opioid, and carisoprodol, a highly addictive muscle relaxant. While the Indian drug regulator has approved tapentadol and carisoprodol as standalone drugs, the combination has no clearance. Even if the company’s claim that the drug combination has been approved by the State drug authority turns out to be correct, it is still illegal as only the Central Drugs Standard Control Organization (CDSCO) can approve any novel fixed dose combination (FDC) drugs for safety and efficacy. It is only after this approval that State drug authorities can issue a manufacturing licence. The Health Ministry routinely banning FDCs is only because the State drug authorities ignore this provision in the law with impunity. 

India questioned and denied the World Health Organization’s report about the lethal cough syrup sent to Gambia, but in the latest case, CDSCO and the State regulatory authority swung into action even in the absence of any complaint by West African countries. The reason: the BBC investigation’s irrefutable video evidence that the company was in the “business” of manufacturing and exporting the dangerous combination drug despite knowing the harmful effects. The seizure of nearly 13 million “medicines” and 26 batches of active pharmaceutical ingredients of tapentadol and carisoprodol are clinching evidence for taking criminal action against the company. While the moves by the authorities — to issue a ‘ stop activity’ order, withdraw the manufacturing licence and permission to export the drugs by any company, and a show cause notice — inspire some confidence, only stringent punishment can serve as a deterrent. Indian pharmaceutical companies are known in the global South for their high-quality generic drugs. It is for the drug regulator to ensure that India continues to be famous for this and not gain notoriety for producing and exporting deadly synthetic opioids as drugs. Manufacturing synthetic opioid drugs cannot be any pharmaceutical company’s “business”.