New Delhi: The US Food and Drug Administration (FDA) has blamed the executive management of Torrent Pharmaceuticals Ltd for violations across multiple plants in its warning letter to the company's Indrad plant in Gujarat.
"Repeated failures at multiple sites demonstrate that executive management oversight and control over the manufacture of drugs is inadequate," the US FDA said in its warning letter issued on 8 October. The US FDA made the warning letter public late on Tuesday.
The regulator directed the company to immediately and comprehensively assess its global manufacturing operations to ensure that the manufacturing systems, processes, and products meet FDA standards.
The regulator pointed out that similar quality control violations were observed at two of its major manufacturing sites - Indrad and Dahej.
Last week, Torrent Pharma had informed stock exchanges that the US FDA has issued a warning letter to its Indrad plant following an inspection of the facility in April.
After the regulator inspected the Indrad facility in April, it had issued a Form 483 with four observations, three of which were for the finished drug product unit and one for active pharmaceutical ingredients (API) unit.
One of the observations for the finished drug unit was that the company failed to thoroughly review any unexplained discrepancy and failure of a batch, and also failed to review written procedures.
The observations were classified as 'Official Action Indicated' (OAI) in August, the company had said.
The US regulator classifies its observations as OAI when it believes that violations of current good manufacturing practices are severe and require urgent remedial measures. If the company fails to assure the regulator of undertaking remedial measures, the US FDA issues a warning letter to the plant. New product approvals are usually not given to a plant under warning letter.
In its warning letter, the regulator also pointed out plant officials not following written procedures for drug manufacturing and their inability to thoroughly review unexplained discrepancy and failure of a batch.
The US FDA had inspected the company’s other facility in Dahej in March, after which it had issued certain observations which were later categorized as OAI.
Both the plants manufacture active pharmaceutical ingredients as well as medicine formulations.
The company has hired a consultant to help resolve the issues, as per the Indrad plant warning letter.
Of the ₹7,673 crore that Torrent Pharmaceuticals generated in revenue in 2018-19 (Apr-Mar), ₹1,589 crore or 21% came from sale of medicines in the US, according to the company's annual report. The country is Torrent Pharmaceuticals’ second largest market after India.