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India’s drug regulator has directed all pharmaceutical manufacturers to comply with international quality standards by January 2025, rejecting industry requests for more time following a series of child deaths linked to contaminated cough syrups. The order was issued by the Central Drugs Standard Control Organisation (CDSCO) on Friday, Reuters reported. The government had earlier instructed drugmakers to upgrade facilities to World Health Organization (WHO)-recommended norms, including stricter measures to prevent contamination and enable batch-level testing. The move came after India-made cough syrups were tied to the deaths of more than 140 children across Africa and Central Asia, severely denting the country’s image as the “pharmacy of the world,” Reuters said. While large pharmaceutical firms had already complied with the June 2024 deadline, smaller manufacturers were previously granted time until December 2025. Industry bodies had since sought further extensions, warning that the cost of compliance could drive small companies into bankruptcy. However, following the deaths of 24 children in central India due to contaminated cough syrup, the regulator decided not to extend the deadline further. The CDSCO notice, signed by Drugs Controller General Rajeev Singh Raghuvanshi, stated that the revised manufacturing norms under “Schedule M” would apply to all pharmaceutical units starting January 1. “In case any manufacturing unit is found non-complying with the requirements of revised Schedule M during inspections, strict action shall be initiated,” the notice said. Raghuvanshi directed state drug regulators to conduct immediate inspections and treat the matter as a “top priority.” An association representing small and medium-scale pharmaceutical companies warned that enforcing the directive without additional time could force several units to shut down, potentially leading to job losses and higher medicine prices.
