Maharashtra FDA Issues Urgent Warning Against Coldrif Syrup After Child Deaths in MP and Rajasthan
Pune, 6th October 2025: The Maharashtra Food and Drug Administration (FDA) has issued an urgent advisory to citizens and drug dealers across the state, directing them to immediately stop the use and sale of ‘Coldrif Syrup’ following reports of child deaths in Madhya Pradesh and Rajasthan allegedly linked to the medicine.
According to Maharashtra Drug Controller D. R. Gahane, preliminary tests revealed the presence of Diethylene Glycol (DEG) — a highly toxic chemical compound known to cause severe poisoning and, in extreme cases, death.
The advisory pertains to Coldrif Syrup (Phenylephrine Hydrochloride and Chlorpheniramine Maleate), Batch No. SR-13, manufactured in May 2025 with an expiry date of April 2027 by Sertion Pharma, based in Kanchipuram district, Tamil Nadu.
“All licensed drug dealers and citizens are instructed to immediately stop the sale, distribution, or consumption of this batch,” said Gahane. “Anyone who has already purchased the syrup should inform the local drug control authority without delay.”
The FDA has also directed its inspectors and assistant commissioners to carry out immediate inspections, seize existing stocks, and coordinate with the Tamil Nadu Drug Control Authority to trace the distribution network of the affected batch.
Meanwhile, the FDA has also taken cognizance of reports from Madhya Pradesh and Rajasthan where children allegedly died after consuming cough syrups manufactured by Kesan Pharma Company based in Jaipur. Following this, the FDA has directed all drug sellers and distributors in Maharashtra to halt the sale and use of Kesan Pharma’s cough syrups, including Coldrip and Nextro-DS Syrup, with immediate effect.
Girish Hukare, Joint Commissioner of the FDA, Pune Division, has issued letters to drug sellers’ associations in Pune, Satara, Sangli, Solapur, and Kolhapur districts under provisions of the Drugs and Cosmetics Act, 1940 and Rules, 1945. The letter instructs pharmacists to report any available stock of Kesan Pharma products to the FDA.
“To ensure public safety, we have initiated state-wide checks and instructed chemists to cooperate fully. Appropriate action will be taken as per law,” said Hukare.
Responding to the alert, Anil Belkar, Secretary of the Chemist Association of Pune District, said, “We understand the gravity of the incidents linked to these cough medicines. There is no stock of Kesan Pharma products in Pune district at present.”
In light of these incidents, the Union Ministry of Health and Family Welfare has issued updated national guidelines on the use of cough and cold medicines for children. The advisory states that children below the age of two should not be given any cough or cold medication, and such medicines are generally not recommended for children below five years of age, as most cases of acute cough and cold in children resolve without drug intervention.
The ministry has instructed all state and union territory health departments to ensure that only high-quality cough medicines manufactured under Good Manufacturing Practices (GMP) are procured for government health centers, clinics, and hospitals. These directives are to be implemented immediately across district hospitals, community and primary health centers, and medical education institutions.
The Maharashtra FDA has appealed to citizens to remain cautious and to report any suspicious or unsafe medicines via its toll-free helpline 1800-222-365 or by email at [email protected].
