Cough Syrup Deaths: Tamil Nadu Regulator’s Lapses Exposed in Coldrif Manufacturer Probe

An investigation into the Kanchipuram-based manufacturer of Coldrif cough syrup, which has been linked to child deaths in Madhya Pradesh, has brought to light critical lapses by the Tamil Nadu Food and Drug Administration (TNFDA) in upholding basic regulatory protocols, according to CDSCO sources.

Sresan Pharma, licensed by the TNFDA in 2011, continued its operations for over a decade without adequate scrutiny, despite possessing dismal infrastructure and committing numerous violations of national drug safety regulations. A recent inspection by the Central Drugs Standard Control Organisation (CDSCO) uncovered the appalling conditions at the unit and its complete failure to comply with Good Manufacturing Practices (GMP).

Sources revealed that the CDSCO had no prior involvement in audits at Sresan Pharma, and the state FDA had not shared any information about the company. This meant the manufacturer was absent from any CDSCO databases. TNFDA officials were unavailable for comment.

A CDSCO source further pointed out that Rule 84AB of the D and C Rules mandates that manufacturers update all approved products on the ‘Sugam’ portal to facilitate national monitoring. Sresan Pharma failed to register its products, a violation that the state regulator should have enforced.

Despite the CDSCO’s requests in October 2023 for manufacturers and state FDAs to share information for a centralized database, and repeated reminders in subsequent meetings, Sresan Pharma did not register, nor did the TNFDA assist the company in getting onboarded.

The TNFDA conducted an audit of Sresan Pharma on October 1 and 2 at the request of its Madhya Pradesh counterpart, but this crucial information was not shared with the CDSCO headquarters or its zonal office. The CDSCO team subsequently conducted a joint risk-based inspection (RBI) at Sresan Pharma on October 3 as part of a proactive measure to inspect units supplying medicines to affected children in Chhindwara. Despite calls for the TNFDA drug inspector to join, they did not participate. The CDSCO proceeded with the audit independently and recommended the cancellation of the manufacturing license.

Furthermore, the TNFDA failed to inform the CDSCO about the sampling and analysis of Coldrif cough syrup from Sresan Pharma. The CDSCO became aware of the test results only on the evening of October 3, when the TNFDA publicly announced that the product contained 48% DEG, far exceeding the permissible limit of 0.1%.

This lack of transparency from the TNFDA, sources noted, has created confusion regarding the sharing of results among the TNFDA, MPFDA, and CDSCO.

The CDSCO formally communicated with the TNFDA on October 4, emphasizing the gravity of the situation and recommending the cancellation of Sresan Pharma’s manufacturing license and consideration of criminal action. However, no action has been taken by the TNFDA to date, and it was the Madhya Pradesh Police who arrested the owner of Sresan Pharma on October 8.

Earlier, the CDSCO had visited Chhindwara as part of a central team. During a September 27 visit, they collected six samples, while the MPFDA collected thirteen. These nineteen samples represented various medicines, including cough syrups, antibiotics, and antipyretics, consumed by children hospitalized with similar symptoms.

In response to these developments, Union Health Secretary Punya Salila Srivastava convened a high-level meeting with states and Union territories to review drug quality norms and promote the rational use of cough syrups, especially for children. The meeting underscored the necessity for strict action.

Official sources also stated that Sresan Pharma is neither WHO GMP certified nor compliant with the Revised Schedule M requirements, as mandated by the gazette notification dated December 28, 2023.