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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) Alert.” Among them were Shelcal 500 manufactured 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.
Alkem 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.
They 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.”