CDSCO investigation uncovers TNFDA regulatory lapses in monitoring Sresan Pharma.
Coldrif cough syrup contained 48% diethylene glycol, far exceeding safety limits.
Union Health Secretary urges stricter compliance and rational use of paediatric cough syrups.
The investigation into the Kanchipuram-based manufacturer of Coldrif cough syrup, linked to the deaths of children in Madhya Pradesh, has exposed serious lapses by the Tamil Nadu Food and Drug Administration (TNFDA) in enforcing regulatory norms, according to sources from the Central Drugs Standard Control Organisation (CDSCO).
Licensed in 2011, Sresan Pharmaceutical continued operations for over a decade despite inadequate infrastructure and repeated violations of national drug safety rules. A recent CDSCO inspection revealed the unit’s complete non-compliance with Good Manufacturing Practices (GMP).
According to PTI, the CDSCO was not involved in prior audits, and the TNFDA did not share any information about the company, leaving Sresan Pharma unlisted in CDSCO databases. Rule 84AB of the Drugs and Cosmetics Rules, which requires manufacturers to update approved products on the ‘Sugam’ portal to aid national monitoring, was also not complied with by the company.
Sources told PTI that despite a 2023 CDSCO initiative to create a centralised database, which included communications and reminders to the TNFDA and manufacturers, Sresan Pharma neither registered its products nor did the state FDA facilitate the process.
The TNFDA conducted an audit of Sresan Pharma on October 1-2 at the request of Madhya Pradesh authorities but did not inform CDSCO headquarters or zonal offices. During a joint risk-based inspection by CDSCO on October 3, the TNFDA did not participate despite multiple requests. CDSCO subsequently recommended cancellation of the company’s manufacturing licence.
PTI reported that TNFDA also delayed sharing the analysis of Coldrif cough syrup, which revealed 48 per cent diethylene glycol (DEG)—far above the permissible limit of 0.1 per cent—creating confusion between TNFDA, MPFDA, and CDSCO.
Sources said CDSCO advised TNFDA on October 4 to cancel Sresan Pharma’s licence and consider criminal action. No action had been taken by TNFDA, with the Madhya Pradesh Police arresting the company owner on October 8.
Earlier, CDSCO collected six medicine samples from Chhindwara, and MPFDA collected 13, covering cough syrups, antibiotics, antipyretics, and ondansetron, all consumed by affected children.
Union Health Secretary Punya Salila Srivastava has also convened a high-level meeting with states and Union territories on Friday to review compliance with drug quality norms and emphasise rational use of cough syrups in paediatric populations.
Official sources confirmed that Sresan Pharma is neither WHO GMP certified nor compliant with Revised Schedule M requirements, as per the gazette notification of December 28, 2023.
(With inputs from PTI)
