In what can be termed as a major embarrassment, India’s reputation as a global pharma hub has taken a severe beating now. The World Health Organisation (WHO) medical product alert for four ‘contaminated’ cough and cold syrups, manufactured and exported by a Haryana-based pharmaceutical firm, has turned the spotlight on India’s drug regulatory system. The syrups have been ‘potentially linked’ to the deaths of 66 children in Gambia, a tiny West African nation. According to the WHO, the products in question have so far been detected only in Gambia, linked to acute kidney injury in children, but there is a possibility that these may have been supplied to other countries.
The global health body has asked various nations to detect and remove these products from circulation to prevent further harm. It is a cause for concern that the tentative results of the laboratory analysis of one of the cough syrups have confirmed ‘unacceptable’ amounts of diethylene glycol and ethylene glycol, both toxic chemicals that can cause acute kidney injury, in four of the 23 samples tested. The syrups were manufactured by Maiden Pharmaceuticals, based in Sonipat, a company that was under the scanner in the past in Kerala, Gujarat, Jammu & Kashmir and Bihar for producing poor quality medicines. The Central Drugs Standard Control Organisation has initiated an investigation in collaboration with Haryana’s drug control agency. The chemical contaminants in the solvent used in the syrups are toxic to humans and can also lead to acute kidney injury that may be fatal in children. The matter needs to be thoroughly probed in a time-bound manner as it will have a bearing on India’s image as an international pharma hub.