In a shocking revelation, India’s top drug regulator, the Central Drugs Standard Control Organisation (CDSCO), has flagged over 50 commonly used medications for failing to meet safety and quality standards. This list includes household names like Paracetamol and antacid Pan D, raising significant concern among consumers and healthcare professionals alike. The flagged medications are not obscure drugs, but essentials found in millions of homes across the country. From vitamins and calcium D3 supplements to antiacid Pan-D and diabetes and blood pressure medications, these drugs have been deemed “not of standard quality” by the CDSCO.
The CDSCO, the sole authority granting no-objection certificates to pharmaceutical companies for exporting drugs, revealed the findings in an August alert. The list encompasses over 50 popular drugs failing quality standards, ranging from pain relievers and antibiotics to supplements from major pharmaceutical manufacturers.
Among the flagged medications are Paracetamol 500 mg tablets, the anti-diabetic drug Glimepiride, and high blood pressure medication Telma H (Telmisartan 40 mg). Acid reflux treatment Pan D and calcium supplements Shelcal C and D3 were also on the list. Additionally, the widely prescribed antibiotic Metronidazole, produced by Hindustan Antibiotics Limited, and Shelcal, distributed by Torrent Pharmaceuticals but produced by Pure & Cure Healthcare in Uttarakhand, did not meet quality standards.
A Kolkata-based lab found that antibiotics Clavam 625 and Pan D, produced by Alkem Health Science, were substandard. This same lab also flagged Cepodem XP 50 dry suspension, used for treating bacterial infections in children, from Hetero as failing tests.
Further concerns were raised over Paracetamol tablets from Karnataka Antibiotics & Pharmaceuticals Ltd. Additionally, Sun Pharma’s Ursocol 300, a drug for dissolving gallstones, was labeled “spurious,” and several batches of Telmisartan, manufactured by Life Max Cancer Lab, failed to pass quality checks. Interestingly, even a non-sterile gauze roll made it onto the flagged list.
Bhaskara Vilasam Vaidyasala’s Haridrakhandam and Yogaraja Guggulu, both Ayurvedic medicines, have also come under scrutiny for failing quality tests.
This comes after the regulator previously banned 156 fixed-dose drug combinations in August, further escalating concerns about drug safety in India. These banned combinations included popular fever medications, painkillers, and allergy tablets commonly used for cold, fever, and pain relief.
Several pharmaceutical companies have denied responsibility for producing the drugs that were flagged in the CDSCO’s quality tests. Many manufacturers have claimed that the flagged batches were not manufactured by them and are likely spurious. Companies like Sun Pharma and Glenmark have echoed similar denials.
Sun Pharma, which had three drugs—Pulmosil (for erectile dysfunction), Pantocid (for acid reflux), and Ursocol 300—fail the tests, stated they were not responsible for the production of the flagged batches. Likewise, Glenmark rejected claims that their hypertension drug Telma H (Telmisartan) was part of the substandard findings. Additionally, Macleods Pharma faced allegations over its arthritis medication Defcort 6, which was flagged as failing quality tests.
The pharmaceutical companies maintain their stance that the drugs in question were either counterfeit or spurious, as investigations continue.
Monitoring drug quality alerts from regulatory bodies is crucial for safeguarding public health. These alerts help identify harmful or ineffective drugs, reducing risks of adverse reactions, treatment failures, and serious health complications. Staying informed can ensure patient safety and maintain trust in the healthcare system.
