Torrent Pharma refutes claims product Shelcal 500, failed quality test by CDSCO

Ahmedabad-based Torrent Pharmaceuticals on Thursday refuted claims that one of its top selling product Shelcal 500, failed a quality test by the Central Drug Standards Control Organisation (CDSCO), according to the company’s regulatory filing on the Bombay Stock Exchange (BSE).

This comes after the CDSCO found over 50 drugs, including one batch of Shelcal 500, to be Not of Standard Quality (NSQ) in its monthly drug alert for August 2024.

Torrent said it has carried out a comparative evaluation to verify the genuineness of the sample collected by CDSCO.


"The sample seized by CDSCO is not manufactured by Torrent and is in fact non-genuine and spurious,” the company said.

The company said it has implemented QR codes on Shelcal as anti-counterfeit measures, displaying batch manufacturing details to verify its authenticity, which was found to be lacking in the sample seized by CDSCO.

“Our assessment of the authenticity of samples, including physical appearance, QR code, and labelling text comparison, establishes that the NSQ sample is non-genuine and counterfeit, whereas our controlled sample matches with pre-defined specifications,” Torrent added.

Torrent has submitted a formal response along with an assessment report, concluding that the seized sample is spurious, to CDSCO.

"We assure that all products manufactured and marketed by Torrent follow Good Manufacturing Practices (GMP) and are controlled through pre-established specifications and/or regulatory norms," the company said.