Over 50 drugs, including paracetamol, ‘not of standard quality’, says central drug regulator in latest report

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The country’s Central drug regulatory authority 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.

The batches of medicines flagged by the Central Drugs Standard Control Organisation (CDSCO) in its drug alert for August are of 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.

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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.

According to an official source, a list of “not of standard quality” drugs is released every month.

“The drug regulator constantly monitors drugs and samples are randomly tested every month to ensure their quality as well as safety standards. When found as not of standard quality, action is taken against manufacturing firms accordingly,” the source said.

According to the CDSCO, the drugs licensing authorities of Andhra Pradesh, Arunachal Pradesh, Assam, Bihar, Chhattisgarh, Goa, Gujarat, Haryana, Himachal Pradesh, Manipur, Rajasthan, Meghalaya, Mizoram, Nagaland, Odisha, Punjab, Sikkim and Tamil Nadu, have not submitted any data regarding the Not of Standard Quality (NSQ) Alert for August 2024.

Pondicherry, Telangana, Delhi, Uttarakhand, West Bengal, Andaman and Nicobar, Dadar and Nagar Haveli, Daman and Diu and Lakshadweep have also not submitted data, it said.