Regulatory Lapses Revealed in Coldrif Cough Syrup Investigation

In a shocking development, an investigation into the Coldrif cough syrup by the Kanchipuram-based Sresan Pharma has exposed critical lapses by the Tamil Nadu Food and Drug Administration (TNFDA). Sources from the Central Drugs Standard Control Organisation (CDSCO) have revealed that the company ran unchecked operations for years, flouting regulatory norms and jeopardizing drug safety.

Licensed in 2011, Sresan Pharma failed to adhere to Good Manufacturing Practices as highlighted by a recent CDSCO inspection. The state FDA's lack of communication and oversight regarding the company has led to confusion and calls for stringent action. The CDSCO has been pushing for the cancellation of Sresan Pharma's manufacturing license while considering criminal action against the company.

To address the serious situation, Union Health Secretary Punya Salila Srivastava has undertaken a review of drug quality norms with an emphasis on rationalizing the use of pediatric cough syrups nationwide. Ongoing communication breakdowns between TNFDA and CDSCO and failure to manage a centralized product database have further complicated regulatory enforcement.