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).
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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