Contaminated cough syrup probe exposes TN drug regulator lapses

An investigation report by the Central Drugs Standard Control Organisation (CDSCO) has revealed serious regulatory lapses by the Tamil Nadu Food and Drug Administration (TN FDA) in the licensing and oversight of Sresan Pharma, the manufacturer linked to the recent contaminated cough syrup incident.

- TDG NETWORK

Sresan Pharma, based in Kanchipuram, Tamil Nadu, was licensed by the Tamil Nadu State Drug Authority in 2011. Despite multiple inspections, the company failed to meet required standards, raising questions about how it was licensed and allowed to operate.

The report highlights that CDSCO was not involved in any audits of Sresan Pharma and was not informed by the TN FDA about the company's operations, resulting in the firm being excluded from CDSCO's national database. Furthermore, Sresan Pharma did not comply with Rule 84AB of the Drugs and Cosmetics Rules, which mandates manufacturers to update all approved products on the national Sugam portal. The Tamil Nadu FDA failed to enforce this regulation, allowing noncompliance.