The Enforcement Directorate (ED) has launched searches at seven locations in Chennai in connection with the Coldrif cough syrup case, which has resulted in the deaths of at least 22 children, primarily under the age of five. The searches are being conducted under the Prevention of Money Laundering Act (PMLA) and are linked to Sresan Pharma, the manufacturer of the banned syrup. The company’s owner, G Ranganathan, was taken into custody by Madhya Pradesh Police on October 9.
Investigations have revealed serious lapses by the Tamil Nadu Food and Drug Administration (TNFDA) in enforcing regulatory norms. Despite being licensed in 2011, Sresan Pharma continued to operate unchecked for over a decade, with poor infrastructure and multiple violations of national drug safety regulations. A recent inspection by the Central Drugs Standard Control Organisation (CDSCO) found gross non-compliance with Good Manufacturing Practices (GMP) and deplorable working conditions at the facility.
The TNFDA failed to inform the CDSCO about Sresan Pharma, leaving it absent from central regulatory databases. The company also failed to register its approved products on the national ‘Sugam’ portal, a mandatory requirement for monitoring pharmaceutical manufacturing in India. Even when the TNFDA audited Sresan Pharma in early October, the information was not shared with the CDSCO.
The CDSCO has recommended cancelling Sresan Pharma’s manufacturing license and initiating criminal proceedings. However, no action was taken by the TNFDA, and the arrest of the company’s owner was carried out by Madhya Pradesh Police. The ED’s searches are aimed at uncovering the financial trail and possible money laundering activities related to the case.
The incident has raised concerns about the regulatory framework and the lack of coordination between state and central agencies. The TNFDA’s failure to enforce regulatory norms and its delayed action have been criticized, and the case has highlighted the need for stricter oversight and monitoring of pharmaceutical manufacturing in India. As a reliable and trusted news source, it is essential to provide accurate and timely information about such incidents to ensure public awareness and accountability.