Strict quality control is a must

India’s reputation as one of the trusted global pharma hubs is being dented by a series of incidents of death on foreign shores which are being linked to medicines supplied by Indian pharma companies. First, it was the death of 70 kids in Gambia and now it is that of 18 children in Uzbekistan linked to adulterated cough syrup manufactured by pharma companies in India. The two tragedies have dealt a serious blow to India’s reputation as a global pharma hub. It is a wake-up call for the authorities to pull up their socks and ensure strict quality control. Even before any corrective measures could be taken in the case of Haryana-based Maiden Pharmaceuticals, blamed for supplying contaminated cough syrups to the West African country, the reports of a similar tragedy in Uzbekistan have cast a shadow over the country’s drug regulatory system. While a joint inquiry is being conducted by the teams of Central Drugs Standard Control Organisation (CDSCO) and Uttar Pradesh Drugs Controlling and Licensing Authority into the case involving Noida-based Marion Biotech, linked to Uzbekistan deaths, urgent steps are needed to reform the drug regulatory system and send the right message to the world. The recent decision of the CDSCO to conduct inspections of risk-prone manufacturing units across the country jointly with state drug controllers is a much-desired course correction. Hopefully, this move will set in motion a comprehensive action to clean up the country’s drug regulatory system. The government’s clean chit to Sonepat-based Maiden Pharma, notwithstanding the WHO’s medical product alert over the Gambian deaths, apparently triggered a serious relook at the drug regulatory structure. Criminally negligent pharma unit promoters should be prosecuted. The Indian pharmaceuticals industry, ranked third worldwide by volume, must learn lessons from both tragedies, and appropriate reforms must be initiated to make the regulatory process more effective.