Torrent Pharmaceuticals, Alkem refute claims of their drugs failing quality test

Torrent Pharmaceuticals and Alkem Laboratories reject CDSCO's claims of their drugs failing quality tests, asserting that the samples in question were "spurious" and not genuine.

Torrent Pharmaceuticals and Alkem Laboratories have issued responses following the failure of their medicines to meet quality standards in tests conducted by India's drug regulator.

The Central Drugs Standards Control Organisation (CDSCO) had declared 53 drugs as "Not of Standard Quality (NSQ)."

Among them were Shelcal 500 distributed by Torrent Pharmaceuticals and Pan-D and Clavam 625 medicines manufactured by Alkem Laboratories.

"Torrent Pharmaceuticals Limited refutes claims of Shelcal 500 allegedly failing CDSCO quality test. The sample that was seized by CDSCO is not manufactured by Torrent and is in fact non-genuine and spurious," the company's statement read.

Shelcal 500 tablet is a vitamin and mineral supplement. It contains calcium and vitamin D3 (cholecalciferol /cholecalciferol) as the main ingredient. It is manufactured by Uttarakhand-based Pure & Cure Healthcare.

Alkem also denied the "claims" made by the drug regulator that batches of its products, Pan-D and Clavam 625 are not-of-standard quality.

"The media reports refer to the CDSCO East Zone, Kolkata’s update that mentioned one batch of Pan-D capsules (Batch No. #23444296) and one batch of Clavam 625 tablets (Batch No. #23443940), among many other drugs of other pharmaceutical companies, as allegedly being not-of-standard quality," Alkem's statement read.

Pan D capsules are used in the treatment of gastroesophageal reflux disease (acid reflux), indigestion and gastritis.

Clavam 625 is an antibiotic that contains amoxycillin and clavulanic acid, to treat bacterial infections like tonsillitis, sinusitis, otitis media, respiratory tract infections, urinary tract infections, and others.

Alkem further stated that following the CDSCO's list, the company 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."

Other companies like Hetero Drugs, Hindustan Antibiotics Limited (HAL), Karnataka Antibiotics & Pharmaceuticals Ltd, Meg Lifesciences, and more were mentioned in the list.

Among the 53 drugs mentioned in the list include Paracetamol tablets IP 500 mg, anti-diabetic drug Glimepiride, high blood pressure drug Telmisartan, Montair LC K, and Nimesulide, Paracetamol and Chlorzoxazone tablets.