CDSCO Alerts on Quality Failures in Batches of Popular Drugs; Safety Concerns Arise Over Spurious Products

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A recent monthly drug alert from the country’s regulatory agency has flagged several widely used medications for failing quality tests. Among these are the antacid Pan D, the antibacterial drug Clavam 625, and the calcium supplement Shelcal, as well as basic medicines like paracetamol tablets from specific manufacturers.

The Central Drugs Standard Control Organisation (CDSCO) identified a total of 48 products and drug combinations from 35 companies across various locations, including Sikkim, Pune, Baddi, and Haridwar, labeling them as “not of standard quality.” As a result, the CDSCO has issued an alert.

The samples were tested by central laboratories located in Kolkata, Guwahati, Mumbai, and Chandigarh. Notably, multiple batches of Telmisartan tablets, commonly prescribed for high blood pressure, have also failed quality assessments. Additionally, one batch of Metronidazole, an antibiotic used to treat stomach infections, produced by State-owned Hindustan Antibiotics Ltd., has been flagged as “not of standard quality.”

The CDSCO report specifically noted a batch of Shelcal from Pure & Cure Healthcare, based in Uttarakhand, as having failed the tests. Batches of Alkem Health Science’s Clavam 625 and Pan D were found to be spurious, and Hetero’s Cepodem XP 50 Dry Suspension, used to treat severe bacterial infections in children, was also flagged as spurious. Paracetamol tablets from Karnataka Antibiotics & Pharmaceuticals Ltd. have been included in the alert as well.

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An Alkem spokesperson commented that the flagged products “appear to be spurious” and that the company is in discussions with the authorities regarding the issue. Hetero has not responded to inquiries, and a response from the Department of Pharmaceuticals is pending.

In addition, another 11 drugs were reported as “not of standard quality” based on findings from the State laboratory in Thiruvananthapuram.

As reported by thehindubusinessline.com, the CDSCO released a second alert list that includes five drugs produced by leading pharmaceutical companies. This marks the first time CDSCO has published two separate lists—one for products from major firms and another regular list.

Among the drugs mentioned from Sun Pharmaceuticals are Pantocid, an acid reflux medication; Pulmosil, for erectile dysfunction; and Ursocol 300, for gallstone dissolution. Glenmark’s Telma H, a popular hypertension drug, and Macleods Pharma’s arthritis medication, Defcort 6, were also noted.

In their responses, Sun Pharma, Glenmark, and Macleods stated, “The actual manufacturer (as per label claim) has informed that the impugned batch of the product was not manufactured by them and that it is a spurious drug. The product is claimed to be spurious; however, this is subject to the outcome of the investigation.”

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