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NEW DELHI: Torrent Pharmaceuticals has strongly denied claims that a batch of its widely used Shelcal 500 failed a quality test conducted by the Central Drugs Standard Control Organization (CDSCO).
The company clarified that the sample in question, seized by CDSCO, was not manufactured by Torrent and was identified as counterfeit.
Recent media reports cited a CDSCO East Zone, Kolkata report, which listed Shelcal 500, along with products from other companies, as being of “non-standard quality” (NSQ).
The disputed sample belonged to batch number GDXD058. Torrent Pharmaceuticals promptly conducted a comparative analysis with its own controlled sample from the same batch.
The investigation confirmed that the seized sample was not genuine and lacked Torrent’s QR code, a security feature used to verify product authenticity.
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Torrent has implemented anti-counterfeit measures such as QR codes on Shelcal 500, which display essential manufacturing details for verification.
The QR code was absent in the counterfeit sample seized by CDSCO. The company has submitted a formal response along with an assessment report to CDSCO, concluding that the seized sample is spurious.
“We assure that all products manufactured and marketed by Torrent follow Good Manufacturing Practices (GMP) and are controlled through pre-established specifications and regulatory norms,” the company stated.
This clarification comes after CDSCO’s monthly drug alert for August 2024 listed over 50 drugs, including one batch of Shelcal 500, as Not of Standard Quality (NSQ)2.
Torrent Pharmaceuticals’ swift response aims to reassure consumers and stakeholders about the quality and safety of its products.
The company further confirmed that all genuine products meet pre-defined specifications and comply with Good Manufacturing Practices (GMP).
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Torrent Pharmaceuticals is a leading pharmaceutical company based in Ahmedabad, India, known for its commitment to quality and innovation in healthcare.
It is a leader in the Indian pharmaceutical market, generating annual revenues exceeding ₹10,700 crores, with total group revenues of ₹41,000 crores.
Ranked 5th in India, the company leads in key therapeutic segments including cardiovascular, gastrointestinal, and central nervous system treatments.
Torrent operates in over 50 countries and has eight manufacturing facilities, five of which are USFDA-approved.
