Torrent Pharmaceuticals, Alkem refute claims their medicines failed quality tests
Torrent Pharmaceuticals and Alkem Laboratories rejected CDSCO’s claims that their medicines failed quality tests, saying the samples in question were. “Fake” and not real.
Torrent Pharmaceuticals and Alkem Laboratories have issued reactions after the failure of their medicines to meet quality standards in tests conducted by India’s drug regulator.
The Central Drugs Standard Control Organization (CDSCO) had declared 53 drugs banned as “not of standard quality (NSQ).”
These included the drugs Shelcal 500, distributed by Torrent Pharmaceuticals, and Pan-D and Clavam 625, manufactured by Alkem Laboratories.
“Torrent Pharmaceuticals Limited refutes claims of Shelcal 500 allegedly failing CDSCO quality test. The sample seized by CDSCO is not manufactured by Torrent and is in fact non-genuine and counterfeit.” Read the company’s statement.
Shelcal 500 Tablet is a vitamin and mineral supplement. It contains calcium and vitamin D3 (cholecalciferol) as main components. It is manufactured by Uttarakhand-based Pure & Cure Healthcare.
Alkem also denied the “claim” that the drug regulator said batches of its products, Pan-D and Clavam 625, are not of standard quality.
“Media reports cite an update from CDSCO East Zone, Kolkata that a batch of Pan-D Capsules (Batch No. #23444296) and a batch of Clavam 625 Tablets (Batch No. #23443940) besides several medicines from other pharmaceutical companies have been seized. companies, are reportedly not of standard quality,” Alkem’s statement read.
Pan D Capsule is used in the treatment of gastroesophageal reflux disease (acid reflux), indigestion and gastritis.
Clavam 625 is an antibiotic containing amoxicillin and clavulanic acid, which treats bacterial infections such as tonsillitis, sinusitis, otitis media, respiratory tract infections, urinary tract infections and others.
Alkem further said that following CDSCO’s listing the company conducted a thorough investigation “and compared the samples collected by CDSCO with the genuine batches of both the products manufactured by Alkem and found that the samples picked up by CDSCO were counterfeit and those manufactured by Alkem Were not.”
Hetero Drugs, Hindustan Antibiotics Ltd (HAL), Karnataka Antibiotics and Pharmaceuticals Ltd, Meg Lifesciences and other companies were mentioned in the list.
The 53 medicines mentioned in the list include Paracetamol Tablets IP 500 mg, anti-diabetic drug Glimepiride, high blood pressure drug Telmisartan, Monterey LC K, and Nimesulide, Paracetamol and Chlorzoxazone tablets.
