After the Central Drugs Standard Control Organization (CDSCO) 53 commonly used medicines for failing quality tests, several pharmaceutical companies have come forward to defend the quality the medicines manufactured by them.
According to the alert, more than 50 drugs have been declared Not of Standard Quality (NSQ) or substandard. The list includes essential medicines manufactured by several top pharma firms, including Torrent Pharma, Hetero Drugs, Alkem Laboratories, Hindustan Antibiotics Limited (HAL), Karnataka Antibiotics & Pharmaceuticals Ltd. etc.
The list has revealed that Pharma firm Alkem Health Science’s antibiotic drugs Clavam 625 and Pan D have been found spurious by a drug-testing laboratory in Kolkata. Meanwhile, Alkem denies claims that batches of its products Pan-D and Clavam 625 are not-of-standard quality (NSQ).
“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,” the company informed in its exchange filing.
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.
“The conclusion is 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,” it added.
Alkem has already submitted a response to the CSDCO, along with the assessment report which confirmed that samples collected by CDSCO are spurious and not manufactured by Alkem, the company said.
“Alkem remains committed to following the highest quality standards and the current good manufacturing practices (cGMP) for all its products. To tackle the spurious drugs issues, Alkem has incorporated unique features and QR codes in its packaging of both Pan-D and Clavam 625, which separates the genuine products from the spurious ones,” it stated.
