Chennai, India – The Tamil Nadu government has revoked the manufacturing license of Sresan Pharmaceuticals, the company responsible for producing the cough syrup Coldrif, which has been linked to the deaths of children in Madhya Pradesh and Rajasthan. The government has also ordered the company to cease all operations.

The decision follows investigations that revealed the cough syrup was adulterated with a high concentration of diethylene glycol (DEG), a toxic industrial solvent. Testing showed the syrup contained nearly 500 times the permissible limit of the chemical. The state Drug Control Department officials found 48.6% of Diethylene Glycol (DEG) during an inspection.

At least 24 deaths have been confirmed in Madhya Pradesh, with another three reported in Rajasthan, all suspected to be linked to the consumption of the contaminated cough syrup. The children, primarily under the age of five, died due to suspected renal failure after developing complications.

Govindan Ranganathan, the 75-year-old owner of Sresan Pharmaceuticals, was arrested last week in Chennai, along with two of his employees. He faces charges including culpable homicide not amounting to murder, drug adulteration, and violations of the Drugs and Cosmetics Act.

In addition to the license revocation and shutdown, the Enforcement Directorate (ED), a financial crime-fighting agency, is conducting searches at seven premises connected to the company in Chennai, on accusations of money laundering. Some of these locations include the homes of top officials of the state's drug control office.

The Tamil Nadu government has stated that inspections of other drug manufacturing companies located in the state will be conducted. Officials found that Sresan Pharmaceuticals lacked proper good manufacturing practices (GMP) and good laboratory practices (GLP), and they recorded over 300 critical and major violations.

This incident has raised concerns about the quality control and safety of pharmaceuticals in India, a major global exporter of generic medicines. In 2023, Indian-made syrups were linked to the deaths of children in Cameroon, Gambia, and Uzbekistan.

The World Health Organization (WHO) has voiced concerns over gaps in India's drug safety regulations, warning that such medicines could reach other countries through unregulated channels. The WHO flagged India’s “regulatory gap” in screening domestically sold medicinal syrups.

Indian law requires drug makers to test each batch of raw materials and the final product, but since 2023, exports of cough syrup must undergo further testing at government-mandated laboratories. Authorities have also issued warnings against the consumption of two more cough syrups sold domestically, Respifresh and RELIFE, after they were found to contain the same toxic chemical.

The Drugs Controller General of India (DCGI) has decided that every medicine produced in India must undergo mandatory testing before approval.