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Over 50 generic drugs including paracetamol fail quality test: CDSCO issues drug alert for August 2024

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CDSCO’s August 2024 alert lists over 50 common drugs, including paracetamol, Pan D, and anti-diabetes pills, as substandard. Key pharmaceutical companies are implicated in the production of these faulty medications.

 

The Central Drugs Standard Control Organisation (CDSCO) has flagged over 50 widely used medicines, including paracetamol, Pan D, calcium, vitamin D3 supplements, and anti-diabetes tablets, as “not of standard quality” in its August 2024 drug alert.

 

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Notable pharmaceutical companies such as Alkem Laboratories, Hindustan Antibiotics Limited, Hetero Labs Limited, Karnataka Antibiotics and Pharmaceuticals Ltd, Nestor Pharmaceuticals Ltd, Priya Pharmaceuticals, and Scott-Edil Pharmacia Ltd are reportedly involved in the production of these substandard drugs.

 

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Each month, the CDSCO conducts rigorous testing and publishes a list of drugs that fail to meet quality standards. This initiative ensures the public has access to safe and effective medications. The latest alert also highlights that high blood pressure medications like Telmisartan and Atropine Sulphate, as well as antibiotics such as Amoxicillin and Potassium Clavulanate, have been classified as substandard.

 

 

The failed drugs have encountered various issues, including non-compliance with the ‘dissolution test’, ‘assay’ test, and ‘water content’ test, as per Indian Pharmacopoeia standards. Some drugs were even identified as spurious or suffering from uniformity issues in volume.

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An official source explained, “The CDSCO conducts monthly random tests to monitor drug quality and ensure safety standards. When a drug is found to be substandard, appropriate actions are taken against the manufacturing companies.”

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It is also noted that several states and territories, including Andhra Pradesh, Assam, Gujarat, Punjab, and Tamil Nadu, among others, have not yet provided data for the August 2024 NSQ Alert. Similarly, Union Territories such as Pondicherry, Telangana, Delhi, and West Bengal, along with several others, have also failed to submit their reports.

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