Cough syrup deaths: CDSCO probe reveals TNFDA lapses in monitoring Coldrif manufacturer

Madhya Pradesh: The investigation into Sresan Pharma, the Kanchipuram-based manufacturer of Coldrif cough syrup linked to the deaths of children in Madhya Pradesh, has exposed major failures by the Tamil Nadu Food and Drug Administration (TNFDA) in enforcing drug safety norms, according to Central Drugs Standard Control Organisation (CDSCO) sources.

Licensed in 2011, Sresan Pharma continued operations for over a decade without adequate oversight, despite poor infrastructure and repeated non-compliance with national safety standards. A recent CDSCO inspection found the facility in “appalling” condition, violating Good Manufacturing Practices (GMP) and lacking basic regulatory compliance.

Sources revealed that the CDSCO had never audited the company, as the TNFDA failed to notify it or list the firm in national databases. Under Rule 84AB of the Drugs and Cosmetics Rules, manufacturers must register their products on the ‘Sugam’ portal to ensure proper oversight. Sresan Pharma did not comply, and the TNFDA did not enforce this rule.

In October 2023, the CDSCO instructed all manufacturers and state regulators to share information through a centralised database, but Sresan Pharma was not registered. Despite repeated reminders in review meetings, the TNFDA neither ensured compliance nor informed CDSCO of its local inspections.

When the CDSCO team conducted a risk-based inspection of the unit on 3 October, TNFDA officials failed to participate despite multiple requests. The CDSCO completed the audit independently and recommended cancellation of Sresan Pharma’s manufacturing licence.

The TNFDA also did not share test results of Coldrif syrup samples, which it later revealed publicly on the evening of 3 October. The analysis showed the syrup contained 48 per cent diethylene glycol (DEG), vastly exceeding the 0.1 per cent permissible limit. This lack of coordination among TNFDA, Madhya Pradesh FDA, and CDSCO created confusion in official communication and response.

On 4 October, CDSCO formally advised TNFDA to cancel the company’s licence and initiate criminal proceedings. No action was taken by the state authority, while the Madhya Pradesh Police arrested Sresan Pharma’s owner on 8 October.

The central team had earlier visited Chhindwara and Nagpur on 27 September, collecting 19 samples of various drugs—including cough syrups and antibiotics—used by affected children.

On Friday, Union Health Secretary Punya Salila Srivastava held a review meeting with all states and Union Territories, calling for stricter enforcement of drug quality standards and rational use of paediatric cough syrups.

Officials confirmed that Sresan Pharma lacked WHO GMP certification and did not meet Revised Schedule M requirements under the December 2023 notification, underscoring long-standing gaps in pharmaceutical oversight.
(With PTI inputs)