Centre Suggests Banning 'Coldrif' Cough Syrup Maker; Ball In Tamil Nadu FDA's Court

The central government has recommended cancellation of license of Tamil Nadu-based Sresan Pharmaceuticals, which manufactures 'Coldrif' cough syrup, and it is up to the state drug regulator to decide its action, Health Ministry sources told NDTV.

The 'Form 25' or license to manufacture common formulation allopathic drugs is given by the state drug controllers and are governed by them.

The Central Drugs Standard Control Organisation (CDSCO) under the Directorate General of Health Services of the Ministry of Health and Family Welfare, has already recommended cancellation of license for Sresan Pharma after the Diethylene Glycol presence in 'Coldrif' was confirmed, sources said.

The cancellation too has to be done by the Tamil Nadu Food Safety and Drug Administration Department, they said.

A CDSCO inspection found unbilled containers of DEG, a highly toxic chemical, at Srisan Pharma's factory. The company was adding 46-48% of DEG to cough syrup against the permitted limit of only 0.1%, thye news report said.

Coldrif is at the centre of the controversy behind the death of over a dozen children in Madhya Pradesh this week. The syrup contains salts banned for use in children under the age of four, according to a 2023 order accessed by NDTV.

Prescribed in children to treat symptoms of cold and cough, including runny nose, sneezing and sore throat and watery eyes, Coldrif contains Chlorpheniramine Maleate, Paracetamol and Phenylephrine.

On Oct. 2, the Tamil Nadu drug control authorities declared that the Coldrif syrup sample they tested was adulterated.

The Madhya Pradesh Police has filed a criminal case against a government paediatrician and the directors of Sresan Pharma. They have been booked under sections 105 (culpable homicide not amounting to murder) and 276 (adulteration of drugs) of the Bharatiya Nyaya Sanhita, as well as section 27(A) of the Drugs and Cosmetics Act, 1940.