 "Alkem Laboratories denies quality test failures, claiming CDSCO’s samples of Pan-D and Clavam 625 are spurious and not theirs.")
Alkem Laboratories, based in Mumbai, has denied reports that its products Pan-D and Clavam 625 failed quality tests by the Central Drugs Standard Control Organisation (CDSCO). This follows a CDSCO alert stating that these drugs were found to be Not of Standard Quality. Alkem claims that the tested samples were not their products but instead were spurious. The company conducted an internal investigation and highlighted differences in labeling and appearance between its actual products and the samples collected. Alkem has added unique features and QR codes to its packaging to help identify genuine products. A response with an assessment report has been submitted to the CDSCO, reinforcing Alkem’s position.
Title: Alkem Laboratories Addresses Quality Test Concerns
Mumbai-based Alkem Laboratories has recently issued a statement to refute allegations involving the quality of its products, Pan-D and Clavam 625. This response comes after the Central Drugs Standard Control Organisation (CDSCO) listed these products among over 50 drugs flagged for being Not of Standard Quality (NSQ) in their August 2024 drug alert.
Alkem asserts that the samples tested were not produced by them but were instead identified as spurious. This claim follows a similar defense by Torrent Pharma, another prominent company, which also contested the findings of counterfeit products. Alkem emphasized that its internal investigations delineated significant differences between the CDSCO samples and their actual products, indicating variations in physical appearance and labeling.
Both Pan-D, utilized for treating conditions like acid reflux, and Clavam 625, an antibiotic for a variety of bacterial infections, are said to be uniquely packaged with QR codes to help consumers distinguish genuine products from fakes. Alkem has communicated its findings to the CDSCO, providing an assessment report to support its claims.
In light of these developments, Alkem’s commitment to product integrity remains at the forefront, advocating for consumer safety and trust in its pharmaceutical offerings.
Tags: Alkem Laboratories, Pan-D, Clavam 625, CDSCO, pharmaceutical news, quality control, drug safety, health news
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What are the claims made against Alkem’s drugs?
Some reports suggested that Alkem’s drugs did not pass tests conducted by the CDSCO, which is India’s drug regulatory authority. -
How did Alkem respond to these claims?
Alkem strongly denied the claims, stating that their drugs meet all necessary safety and quality standards. -
What is the CDSCO?
The CDSCO is the Central Drugs Standard Control Organization in India, responsible for evaluating and approving drugs and ensuring they are safe for public use. -
Are Alkem’s drugs still available in the Market?
Yes, Alkem has confirmed that its drugs are safe and continue to be available for sale. - What does this mean for patients using Alkem products?
Patients can be assured that Alkem’s products have passed regulatory standards and are safe to use.
