Indian authorities have initiated criminal proceedings against pharmaceutical company Sresan Pharma after toxic cough syrup produced by the firm was linked to the deaths of 14 children in Madhya Pradesh. The incident has reignited global concerns over the safety of India's drug manufacturing industry, often referred to as the "pharmacy of the world."
According to a state drug laboratory report reviewed by Reuters, a sample of the cough syrup, branded Coldrif, contained 46.28% diethylene glycol -- a toxic chemical commonly used in antifreeze and industrial products. The permitted limit is just 0.1%. The substance is known to cause severe kidney damage, vomiting, and abdominal pain, and has been linked to fatal poisoning outbreaks in the past.
Police filed criminal charges on Sunday against both the prescribing doctor and Sresan Pharma, whose manufacturing facility is located in Tamil Nadu. Madhya Pradesh's Deputy Chief Minister Rajendra Shukla confirmed that the doctor involved had been arrested. The company faces multiple charges, including culpable homicide not amounting to murder, drug adulteration, and violations under India's Drugs and Cosmetics Act.
The Central Drugs Standard Control Organisation (CDSCO) has recommended revoking Sresan Pharma's manufacturing license, while the Health Ministry said regulatory action has already been taken against one of its units. Neighboring states including Uttar Pradesh and Rajasthan have banned Coldrif as a precaution. The contaminated batch was distributed only within India, and thus did not fall under export testing requirements introduced in 2023 after similar international incidents.
India's pharmaceutical exports have been under growing scrutiny following reports that contaminated cough syrups from Indian manufacturers were tied to child deaths in Gambia, Uzbekistan, and Cameroon in recent years. In response, the Health Ministry has advised doctors to prescribe cough syrups for children only when absolutely necessary, emphasizing that most cases of cough and cold can resolve without medication.
If convicted, officials at Sresan Pharma could face heavy fines and prison sentences of up to life imprisonment. The case marks another critical moment for India's drug regulators, who are under pressure to restore global confidence in the nation's pharmaceutical industry, which supplies 40% of the generic medicines used in the United States and the majority of those in African countries.