After Torrent, Alkem refutes claims of its drugs failing CDSCO test

Company claims samples of Pan-D, Clavam 625 tested were spurious, not manufactured by it

Mumbai-based Alkem Laboratories on Friday refuted claims that batches of its products Pan-D and Clavam 625 had failed quality tests by the Central Drugs Standard 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 each of Pan-D and Clavam 625, to be Not of Standard Quality (NSQ) in its monthly drug alert for August 2024.

While Pan-D is a prescription medicine used to treat acid reflux, indigestion, and gastritis, Clavam 625 tablets are an antibiotic used to treat bacterial infections of the lungs, ear, nasal sinus, urinary tract, skin, and soft tissue.

 

Based on internal investigations, the company has claimed that the samples tested by the central drug regulator were not manufactured by it and were spurious in nature.

With this, Alkem became the second company after Ahmedabad-based Torrent Pharma to refute claims of its drugs failing quality tests, calling the samples tested by CDSCO spurious.

One batch of Torrent’s Shelcal 500 tablets, a dietary supplement used for managing vitamin D and calcium deficiency, was also found to be NSQ in the apex drug regulator’s monthly update.

“Alkem conducted a thorough investigation by comparing the samples collected by the CDSCO with the actual batches of both products manufactured by Alkem and found that the samples picked by the CDSCO were spurious and not manufactured by Alkem,” the company stated in its regulatory filing.

The conclusion, Alkem said, was based on the differences observed between the CDSCO samples and the actual batches manufactured by Alkem in terms of physical appearance, colour, and text in the labelling of the two products.

“Alkem has incorporated unique features and QR codes in its packaging of both Pan-D and Clavam 625, which differentiate the genuine products from the spurious ones,” the company added.

The company has also submitted a response to the CDSCO, along with the assessment report, which confirmed that the samples collected by CDSCO are spurious and not manufactured by Alkem.