Cough syrup deaths: TNFDA probe reveals Coldrif manufacturer's shortcomings

According to CDSCO sources, the investigation into the Kanchipuram-based Coldrif cough syrup producer, which was connected to child fatalities in Madhya Pradesh, has shown shortcomings in the Tamil Nadu Food and Drug Administration's enforcement of fundamental regulatory standards.They said that Sresan Pharma, which was granted a license by the Tamil Nadu Food and Drug Administration (TNFDA) in 2011, carried on operating undetected for more than ten years in spite of its inadequate infrastructure and many infractions of national drug safety regulations.According to the sources, a recent examination by the Central Drugs Standard Control Organization (CDSCO) revealed the unit's terrible conditions and complete disregard for Good Manufacturing Practices (GMP).

"The CDSCO has not participated in any of Sresan Pharma's audits. This company was not included in any of the CDSCO databases since the CDSCO was not involved and the state FDA did not provide the CDSCO with any information on it, according to a source.Rule 84AB of the D and C Rules mandates that manufacturers update all of their certified items on the "Sugam" site, according to another source at the CDSCO.In order to facilitate improved monitoring, the regulation was notified to create a national database of all the authorized items in the nation. "The business failed to list its goods in the database. It did not follow this guideline as a result. According to the source, the state regulator is in charge of ensuring that the regulation is followed in the state.