Tamil Nadu Authorities Revoke License of Pharmaceutical Firm Linked to Fatal Cough Syrup Cases

Chennai:

The Tamil Nadu Drug Control department has revoked the manufacturing licence of Sresan Pharmaceuticals, the company responsible for producing 'Coldrif' cough syrup linked to multiple child fatalities in Madhya Pradesh and Rajasthan.

The regulatory action includes complete cessation of operations and sealing of the company's warehouse facilities.

According to officials, inspections revealed over 350 significant violations at the manufacturing facility, including inadequate hygiene conditions and breaches of manufacturing protocols under the Drugs and Cosmetics Act, 1940.

"The inspection found that the company only possessed a retail pharmacy license and failed to provide valid documentation for warehouse operations," stated a drug inspector. "No refrigeration equipment for proper medicine storage was present. Despite being allowed 24 hours to provide an explanation, their response was deemed inadequate, resulting in license revocation."

The Tamil Nadu government has subsequently mandated comprehensive inspections of all pharmaceutical manufacturing facilities across the state.

An official statement from the Drug Control department indicated that disciplinary measures had previously been taken against Sresan Pharma in 2021 and 2022 for compliance failures. Due to the absence of inspections during the previous year, two drug inspectors have been suspended for dereliction of duty.

The investigation expanded on Monday when the Enforcement Directorate (ED) executed searches at seven locations in Chennai connected to Sresan Pharma.

The ED conducted raids at Ranganathan Govindan's residence in Chennai, who owns Sresan Pharma, and at the company's production facility in Kanchipuram. The Madhya Pradesh Special Investigation Team has brought Renganathan to the Kanchipuram facility for additional questioning.

Searches were also conducted at the residences and offices of key company officials and PU Karthikeyan, the Director (In-Charge) of the Tamil Nadu Food and Drug Administration, who has already been taken into custody related to this case.

The Madhya Pradesh Food and Drug Administration took decisive action against Kataria Pharmaceuticals, the authorized distributor based in Jabalpur responsible for distributing the contaminated Coldrif syrup.

Govindan, aged 75, was apprehended by Madhya Pradesh Police on October 9 at his Chennai residence following an extensive multi-state investigation. He was transported to Tamil Nadu on Sunday evening for further interrogation. Investigators are currently examining supply chain records, export information, and batch manufacturing logs to determine how the substandard cough syrup reached retail markets.

Sources indicate the ED suspects financial irregularities and potential money laundering activities connected to the sale and distribution of the substandard cough syrup batches.

A specific batch of Coldrif cough syrup was discovered to contain dangerous levels of diethylene glycol (DEG), directly causing acute kidney failure in children who consumed the medication and subsequently died.