Drugs in CDSCO samples Counterfeit, not ours, say leading pharma companies
New Delhi: After a series of media articles announcing the results of the Monthly CDSCO drug alert report and pointing how major pharma samples had failed to qualify the quality test, Drug majors, including Sun Pharma, Alkem, Glenmark and Torrent Pharma, termed the medicines flagged in the central drug regulatory authority's report as "counterfeits" and not manufactured by them while asserting that their products conform to quality standards.
The Central Drugs Standard Control Organisation (CDSCO) has listed samples of more than 50 drugs, including paracetamol, Pan D, calcium and vitamin D3 supplements, and anti-diabetes pills, as "not of standard quality" in its latest report.
All the companies have come out with a sort of common response stating that these batches were spurious
What Alkem Said
Alkem Laboratories Ltd., denied claims that batches of its products Pan-D and Clavam 625 are not-of-standard quality (NSQ), as reported by several media publications and channels based on a list issued by the Central Drugs Standard Control Organization (CDSCO).
" 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 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 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. 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. 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." the company stated
What Torrent Said
Referring to the recent media articles as well as the CDSCO report, Torrent also called the batches as non-genuine and counterfeit.
"To verify the genuineness of the sample collected by CDSCO, a comparative evaluation was carried out with our controlled sample of the same batch. The outcome of the analysis concluded that the sample seized by CDSCO is not manufactured by Torrent and is in fact non-genuine and spurious. As anti-counterfeit measures, Torrent has implemented QR codes on Shelcal, displaying batch manufacturing details to verify its authenticity, which was found to be lacking in the sample seized by CDSCO.Our assessment of establishing authenticity of samples including physical appearance, QR code and labelling text comparison establishes that the NSQ sample is non-genuine and counterfeit, whereas our controlled sample matches with pre-defined specifications. Torrent has already submitted a formal response along with assessment report, concluding the seized sample as spurious to CDSCO." the company stated
"Each and every batch manufactured is also subjected to strict quality testing. We assure that all products manufactured and marketed by Torrent follow Good Manufacturing Practices (GMP) and are controlled through pre-established specifications and/or regulatory norms," the company added
Sun Pharma classified the batches as spurious.
When contacted, a Sun Pharma spokesperson said the company has investigated the matter and found that Pulmosil (Sildenafil Injection), batch no KFA0300; Pantocid (Pantoprazole Tablets IP), batch no SID2041A and Ursocol 300 (Ursodeoxycholic Acid Tablets IP), batch no GTE1350A are spurious.
"The said batches tested by the regulatory authority are not manufactured by Sun Pharma," it stated.
The company is taking several steps to ensure patient safety, it added.
"Some of our leading medicine brands now come with QR codes printed on the label, allowing patients to easily verify their authenticity by scanning them. Additionally, we have incorporated a 3D security strip for further protection," the drug maker noted.
Glenmark's Response
A Glenmark spokesperson said: "At the outset, we would like to categorically state that the product mentioned in the list is counterfeit and has not been manufactured or distributed by Glenmark. This has been confirmed by the regulatory authorities in the list you are referring to."
As a responsible organisation, the drug firm has always prioritised patient safety and the quality of products, the spokesperson said.
"To deal with the menace and tackle this issue of counterfeit products, we have implemented advanced security measures to ensure the authenticity of our products," the spokesperson said.
"In light of these issues, we urge all pharmacy outlets to ensure they source Glenmark products exclusively from our authorised stockists. This is crucial for maintaining the integrity and quality of the medications provided to patients," the spokesperson added.
The CDSCO's drug alert for August included samples from batches of medications such as Shelcal, Vitamin B Complex with Vitamin C Softgels, vitamin C and D3 tablets and Ciprofloxacin tablets.
High blood pressure medications Telmisartan and Atropine Sulphate and antibiotics such as Amoxicillin And Potassium Clavulanate tablets have also been categorised as not of "not of standard quality".
While batches of some drugs failed the 'dissolution test' as per Indian Pharmacopoeia and failed the 'Assay' and 'water' test as per IP, some were identified as spurious or having uniformity of volume issues.
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