Regulatory Gaps

Cough syrup deaths have exposed the deep cracks in India's drug safety net and highlighted the need for systemic change in quality control mechanisms

- By NAINI THAKER

AT LEAST 19 CHILDREN UNDER the age of five have died in Madhya Pradesh's Chhindwara district after consuming a contaminated batch of Coldrif cough syrup, triggering a nationwide investigation into pharmaceutical safety standards. Manufactured by Tamil Nadu-based Sresan Pharmaceuticals, the syrup contained diethylene glycol (DEG)—a toxic industrial solvent—at nearly 500 times the permissible limit. The company's owner was arrested on October 9, according to Reuters. Praveen Soni, the doctor who prescribed the syrup, has been arrested for negligence, though Indian medical groups blame regulators for inadequate testing and oversight, according to a BBC report.

Health officials attributed the deaths to acute kidney failure caused by DEG poisoning. The Central Drugs Standard Control Organisation (CDSCO) has recalled the product and sealed the company's Tamil Nadu manufacturing unit. A Special Investigation Team has been formed, and the World Health Organization has requested details on whether the batch was exported.

The Coldrif incident has prompted a broader review of paediatric syrups sold in India. Two additional products—Respifresh (Rednex Pharmaceuticals) and ReLife (Shape Pharma)—manufactured by Gujarat-based firms, have also been flagged for DEG contamination, though not yet linked to fatalities. Both have been recalled, and state drug controllers have been instructed to intensify testing of all syrups currently in circulation.