ED Raids Sresan Pharma

Written By :  Parthika Patel
Published On 2025-10-13 10:30 GMT   |   Update On 2025-10-13 10:30 GMT
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Chennai: In a major regulatory crackdown following the deaths of several children in Madhya Pradesh, the Tamil Nadu government has permanently cancelled the manufacturing licence of Sresan Pharmaceuticals and ordered the company to shut down its operations.

The decision comes after Coldrif cough syrup, manufactured by the Chennai-based firm, was found contaminated with dangerously high levels of diethylene glycol (DEG) — a toxic industrial chemical linked to the deaths of more than 19 children in Ujjain and surrounding areas.

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Laboratory analysis revealed DEG concentrations nearly 500 times above permissible limits, triggering a coordinated investigation between the Madhya Pradesh FDA, the Central Drugs Standard Control Organisation (CDSCO), and the Tamil Nadu Drugs Control Department. The contaminated batch of Coldrif had reportedly been supplied to a local government hospital, where several children developed acute kidney failure symptoms after consumption.

In a sweeping enforcement action, the Enforcement Directorate (ED) has conducted raids at seven locations in Chennai, including Sresan Pharma’s factory, the residence of its proprietor G. Ranganathan, and the homes of senior Tamil Nadu drug control officials. According to The Hindu, these searches are part of a money laundering probe under the Prevention of Money Laundering Act (PMLA), aimed at uncovering possible financial irregularities and collusion with regulatory officials. The ED seized digital evidence, financial ledgers, and communication records during the operation.

As reported by The Print, the raids follow the arrest of G. Ranganathan, who was taken into custody last week by Madhya Pradesh police and later handed over to investigating authorities. Two senior Tamil Nadu drug inspectors have also been suspended for negligence, while a departmental inquiry has been launched into regulatory failures that allowed the firm to continue manufacturing despite repeated violations.

An internal audit cited by Business Standard uncovered over 300 breaches of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) at Sresan’s facility. The company had been functioning with expired approvals and without proper registration on the national “Sugam” portal — a mandatory database for pharmaceutical manufacturers. Further, LiveMint reported that the Tamil Nadu FDA had allegedly failed to share inspection reports with the central regulator, a lapse now under scrutiny by the Union Health Ministry.

The Coldrif case has reignited global concern over India’s pharmaceutical oversight, echoing earlier tragedies in Gambia and Uzbekistan, where DEG-contaminated syrups manufactured by Indian firms led to the deaths of dozens of children. Experts stated that the recurring pattern underscores systemic flaws in drug testing, especially for products sold domestically. They have called for stronger coordination between the CDSCO and state drug authorities, stricter compliance audits, and mandatory third-party quality verification.

The Tamil Nadu government has sealed all manufacturing units of Sresan Pharmaceuticals, revoked its licence permanently, and directed drug inspectors to conduct surprise checks across all syrup-producing facilities in the state. Meanwhile, investigations under the Drugs and Cosmetics Act and PMLA continue, with authorities vowing to fix accountability for the regulatory lapses that allowed a tragedy of this scale.

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Article Source : with inputs

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