TN body ‘lapses’ enabled cough syrup firm: Centre

The central government on Friday accused Tamil Nadu’s drug authority of a series of regulatory lapses that enabled Sresan Pharma to operate unchecked for over a decade, manufacturing the contaminated cough syrup that killed 22 children.

- Rhythma Kaul and Divya Chandrababu

Tamil Nadu officials defended their record and said they would providea detailed response on Saturday, while pointing to their cooperation in the arrest of the company owner.

Speaking on condition of anonymity, Union government officials accused Tamil Nadu of enabling noncompliance, failing to share critical information, and delaying action after contamination was confirmed.

“CDSCO (the central drugs standards organisation) has not been involved inany of the auditsat Sresan Pharma. Since CDSCO was not involved and state FDA did not inform CDSCO about this company in any way, this company was not part of any of the CDSCO databases,” an official said, questioning how the Kancheepuram facility— found during recent inspections to be substandard—and allowed to continue operating.

The new disclosures comes ata time when questions have been raised of the policies and enforcement mechanisms that failed: of central drugs control standards and monitoring that allowed toxic DEG to contaminate, of state authorities in Madhya Pradesh who did not raise an alarm on the poisonings as cases began trickling in over three weeks, and of Tamil Nadu officials where the drugmaker's unit was based.