India to enforce pharma compliance after children’s deaths – Reuters
India will enforce new standards on the pharmaceutical industry in the country despite its appeal to extend a compliance deadline, according to Reuters. The refusal to allow companies more time comes following a spate of children's deaths linked to cough-syrup in September and October.
The Central Drugs Standard Control Organization is said to have issued a notice stating that all pharmaceutical manufacturers must adhere to revised standards under Schedule M from January 1, and has instructed state regulators to start conducting inspections, the outlet reported.
The move comes after toxic cough syrup was linked to more child deaths since September. More than 20 children in Chhindwara district, Madhya Pradesh died from consuming cough syrup adulterated with diethylene glycol (DEG), according to a report by the Indian Journal of Medical Ethics.
Several deaths were also reported in the neighboring state of Rajasthan, where authorities ordered an inquiry and banned dextromethorphan hydrobromide syrup along with all 19 of its formulations.
The Indian-made cough syrups were also previously tied to the deaths of more than 140 children in Africa and Central Asia.
In 2023, a Business Standard report stated that New Delhi had instructed drug manufacturers to upgrade their facilities to meet World Health Organization standards, which include implementing measures to prevent cross-contamination and conduct batch testing.
While larger pharmaceutical companies met a June 2024 deadline to upgrade their facilities, smaller manufacturers were granted an extension until December 2025, the report added. Industry groups, however, requested additional time, citing concerns that compliance costs could financially devastate smaller businesses.
India’s SME Pharma Industries Confederation expressed concern that the mandate could lead to the closure of many factories, resulting in job losses and increased medicine prices.
