Torrent Pharmaceuticals Limited refutes claims of Shelcal 500 allegedly failing CDSCO quality test
Ahmedabad, September 26th 2024: Recent articles have been issued in media with reference to the Central Drugs Standard Control Organization (CDSCO) East Zone, Kolkata report referring to one batch (GDXD0581) sample of Product Shelcal 500, amongst other drugs marketed by various pharmaceutical companies, allegedly being non-standard quality (NSQ).
To verify the genuineness of the sample collected by CDSCO, a comparative evaluation was carried out with our controlled sample of the same batch. The outcome of the analysis concluded that the sample seized by CDSCO is not manufactured by Torrent and is in fact non-genuine and spurious.
As anti-counterfeit measures, Torrent has implemented QR codes on Shelcal, displaying batch manufacturing details to verify its authenticity, which was found to be lacking in the sample seized by CDSCO.
Our assessment of establishing 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 has already submitted a formal response along with assessment report, concluding the seized sample as spurious to CDSCO.
Each and every batch manufactured is also subjected to strict quality testing. 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.
