Srinagar, Oct 15: The Jammu and Kashmir Drug and Food Control Organisation (DFCO) has imposed a ban on the sale, distribution, and use of three cough syrup brands, including ColdRif Syrup, RespiFresh-TR and Relif Syrup, after laboratory tests declared them “Not of Standard Quality” due to the presence of toxic impurities.
The alert was issued following a communication from the Central Drugs Standard Control Program under the Ministry of Health and Family Welfare, GoI, which found three contained Diethylene Glycol (DEG) impurities beyond permissible limits, a compound known to cause severe poisoning and linked to child deaths in Madhya Pradesh and Rajasthan.
As per the public notice issued by Office of State Drugs Controller, the affected formulations include Relif Syrup (Ambroxol HCl, Terbutaline Sulphate, Guaiphenesin & Menthol) manufactured by M/s Shape Pharma Pvt Ltd, Gujarat, and marketed by Leo Life Science Pvt Ltd, Ahmedabad; RespiFresh-TR Syrup (Bromhexine Hydrochloride, Terbutaline Sulphate, Guaiphenesin & Menthol) manufactured by M/s Rednex Pharmaceuticals Ltd, Ahmedabad, and marketed by Smartway Wellness Pvt Ltd, Sanand; and ColdRif Syrup (Paracetamol, Phenylephrine Hydrochloride & Chlorpheniramine Maleate) manufactured by M/s Sresan Pharmaceuticals, Tamil Nadu.
The notice said that the drug formulations of cough syrups have been declared as ‘Not of Standard Quality’ as they have failed to comply with the requirement of “Presence of Impurities of Diethylene Glycol is more than permissible limit” as per the Govt. Analyst, Drug Testing Laboratory, Food and Drug Administration, M.P.
In this regard, the Drug and Food Control Organisation (DFCO), in a communication marked most urgent, has asked the Director of SKIMS Soura and all Principals of Medical College Hospitals in Jammu and Kashmir to disseminate the information to all Heads of Departments (HoDs) for necessary action.
The DFCO notice said considering the seriousness of the matter, as the above-mentioned drug formulations have been observed to be linked to the deaths of children in the states of Madhya Pradesh and Rajasthan, and a need has been felt to ban the sale, distribution, and utilisation in the UT of Jammu & Kashmir of the above-referred products.
As per the notice, any stock available in the UT of Jammu & Kashmir is to be brought to the notice of the office of the J&K State Drug Controller.
Notably, many states have banned these cough syrups, while some have prohibited the use of all cough and cold syrups for children under the age of two.
On October 04, 2025, the Ministry of Health and Family Welfare issued an advisory cautioning that cough and cold medications should not be prescribed or dispensed to children below two years of age.
“Such medicines are generally not recommended for children under five and, when used in older children, must be administered only after proper clinical evaluation and under strict medical supervision,” the Ministry said.
The Directorate General of Health Services (DGHS) had issued an advisory to all States and Union Territories on the rational use of cough syrups in the paediatric population, following consumption-related deaths in Madhya Pradesh and Rajasthan.
The World Health Organization (WHO) has voiced “deep concern” over gaps in India’s drug safety regulations, following the deaths of children from contaminated cough syrups. It has also warned that such medicines could reach other countries through unregulated distribution channels.
The deaths, reported from Madhya Pradesh and Rajasthan states over the past month, have been linked to three cough syrups, samples of which have been found to contain diethylene glycol (DEG) – a toxic substance found in industrial solvents.–(RK)
