Torrent Pharmaceuticals Denies Allegations by CDSCO on Shelcal 500

Ahmedabad-based Torrent Pharmaceuticals issued a statement on Thursday refuting claims that its product, Shelcal 500, had failed a quality test conducted by the Central Drug Standards Control Organisation (CDSCO). The company made this assertion through a regulatory filing on the Bombay Stock Exchange (BSE).

According to a recent CDSCO alert for August 2024, over 50 drugs, including a batch of Shelcal 500, were marked as Not of Standard Quality (NSQ). Shelcal 500 is a supplement generally used to manage vitamin D and calcium deficiencies and contains calcium and vitamin D3 as primary ingredients.

Torrent Pharmaceuticals contested the CDSCO results, stating that the sample in question was spurious and not manufactured by them. The CDSCO’s announcement noted the manufacturer of the dubious Shelcal 500 batch as Pure and Cure Healthcare, based in Haridwar, Uttarakhand.

In its defense, Torrent confirmed it had conducted a comparative evaluation to verify the authenticity of the sample collected by CDSCO. “Our analysis concluded that the sample seized by CDSCO is not manufactured by Torrent and is in fact non-genuine and spurious,” the company asserted.

Torrent Pharmaceuticals highlighted that it has implemented QR codes on Shelcal products as an anti-counterfeiting measure. These codes display details about batch manufacturing, which the seized sample purportedly lacked.

The company further elaborated in their response to CDSCO, stating, “Our assessment of the authenticity of samples, including physical appearance, QR code, and labeling text comparison, establishes that the NSQ sample is non-genuine and counterfeit, whereas our controlled sample matches with pre-defined specifications.”

A formal response along with an assessment report was submitted by Torrent to the CDSCO, concluding their stance on the issue.

On Thursday, Torrent Pharma’s stocks experienced a decline of 0.61 percent, closing the day’s trade at Rs 3,409.75 per share on the BSE.