New Delhi: The investigation conducted against the Kancheepuram-based manufacturer of Coldrif cough syrup in the case of child deaths in Madhya Pradesh has revealed negligence in implementing basic regulatory norms by the Tamil Nadu Food and Drug Administration (TNFDA), sources in the Central Drug Standard Control Organization have informed.
Srisan Pharma, which got its license in 2011, continued to operate without any restrictions for more than a decade despite its poor infrastructure and several violations of the National Drug Safety Rules.
A recent inspection by the CDSCO revealed the appalling condition of the unit and complete non-compliance of the manufacturing process.
“CDSCO has not been involved in any audit of Srisan Pharma. The state FDA (Food and Drug Administration) did not inform CDSCO about this company in any way, hence this company was not part of any database of CDSCO,” a source said.
Meanwhile, there was no reaction from TNFA officials on the matter.
“The company did not register its products on the database. Thus, it did not comply with the rule. It is the responsibility of the state regulator to implement this rule in the state,” the source said.