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New Delhi: The investigation against the Kanchipuram-based manufacturer of Coldrif cough syrup, linked to the deaths of children in Madhya Pradesh, has brought to light lapses by the Tamil Nadu Food and Drug Administration in enforcing basic regulatory norms, CDSCO sources said.

Licensed in 2011 by the Tamil Nadu Food and Drug Administration (TNFDA), Sresan Pharma continued operations unchecked for over a decade despite its dismal infrastructure and multiple violations of national drug safety rules, they said.

A recent inspection by the Central Drugs Standard Control Organisation (CDSCO) exposed the unit’s appalling conditions and total non-compliance with Good Manufacturing Practices (GMP), the sources said.

“The CDSCO has not been involved in any of the audits at Sresan Pharma. Since the CDSCO was not involved and the state FDA did not inform the CDSCO about this company in any way, this company was not part of any of the CDSCO databases,” a source said.

TNFDA officials could not be reached for comment.

Another source at the CDSCO highlighted that Rule 84AB of D and C Rules requires manufacturers to update all of their approved products on the ‘Sugam’ portal.

The rule was notified to prepare a national database of all the approved products in the country to support better monitoring.

“The company did not register its products on the database. Thus, it did not comply with this rule. It is the state regulator’s responsibility to get the rule executed in the state,” the source said.

Further, with the intent of making a centralised database of pharmaceutical manufacturers, the CDSCO sent communication to all manufacturers and the TNFDA in October 2023, requesting them to share their information through a Google form.

Subsequently, this point was reiterated in every monthly review meeting and other interactions with the state FDA. However, neither Sresan Pharma registered during this campaign nor did the state FDA help the manufacturer get onboarded, the source said.

The TNFDA conducted an audit of Sresan Pharma on October 1 and 2 on a request from its Madhya Pradesh counterpart, but this information was also not shared with the CDSCO headquarters or zonal office, the source said.

As part of the proactive exercise to conduct risk-based inspections (RBI) of all units which had supplied the medicines consumed by the affected children in Chhindwara, the CDSCO team went for a joint RBI inspection at Sresan Pharma on the morning of October 3.

“Since it was a joint inspection, as a system, the team called the TNFDA drug inspector to join. Unfortunately, despite multiple requests, they did not join. The CDSCO did the audit on its own and sent a recommendation for manufacturing license cancellation,” the source said.

The TNFDA also did not inform the CDSCO about sampling and analysis of Coldrif cough syrup from Sresan Pharma.

The CDSCO came to know about the analysis when the TNFDA publicly released the results of the analysis in the late evening on October 3, stating that the product had 48 per cent DEG content as against the permissible limit of 0.1 per cent.

“This information blackout on the part of TNFDA has created confusion in the system about result sharing by TNFDA, MPFDA and CDSCO,” the source said.

According to the sources, the CDSCO wrote to the TNFDA on October 4, saying that looking at the gravity of the situation, Sresam Pharma’s manufacturing license should be cancelled and initiation of criminal action against it should be considered.

“No action in this regard has yet been taken. It was MP Police that arrested the owner of Sresan Pharma on October 8,” the source said.

Earlier, the CDSCO visited Chhindwara as part of a central team, which was deputed to the city and Nagpur.

During the visit on September 27, the CDSCO picked six samples from Chhindwara and the MPFDA picked 13 samples. The 19 samples were of 19 different medicines that were consumed by children hospitalised with similar symptoms.

The samples included cough syrups, antibiotics, antipyretics and ondansetron etc.

On Friday, Union Health Secretary Punya Salila Srivastava, convened a high-level meeting with all states and Union territories to review compliance with drug quality norms and promote the rational use of cough syrups, especially in paediatric populations.

In the meeting, the need for strict action in this regard was underlined.

Official sources said that Sresan Pharma is neither WHO GMP certified nor meets the requirements of Revised Schedule M, as is required by the gazette notification dated December 28, 2023.