Torrent Pharmaceuticals refutes claim of Shelcal 500 failing CDSCO test

Company claims sample tested was spurious and not manufactured by it

Ahmedabad-based Torrent Pharmaceuticals on Thursday refuted claims that one of its products, 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.

Shelcal 500 is a dietary supplement primarily used for managing vitamin D and calcium deficiency. It contains calcium and vitamin D3 as its main ingredients.

The company claimed that the sample seized by the drug regulatory body was spurious and not manufactured by Torrent.

The CDSCO notification states the manufacturer of the seized batch of Shelcal 500 to be Pure and Cure Healthcare, based in Haridwar, Uttarakhand.

Torrent also claimed to have carried out a comparative evaluation to verify the genuineness of the sample collected by CDSCO. “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,” it stated.

The company added that Torrent 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.

On Thursday, Torrent Pharma’s stocks were down by 0.61 per cent, ending the day’s trade at Rs 3,409.75 apiece on the BSE.