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The Central Drugs Standard Control Organisation (CDSCO), India's central drug regulatory authority, has released a report highlighting a concerning issue: over 50 drugs, including common medications like paracetamol, have been classified as 'not of standard quality.' This revelation, based on samples tested in August, underscores the crucial importance of ensuring the quality and safety of medications available to the public. The affected drugs encompass a wide range, including anti-diabetes pills, calcium and vitamin D3 supplements, and antibiotics like Amoxicillin and Potassium Clavulanate.
The CDSCO's report identifies several pharmaceutical companies whose batches of drugs failed to meet quality standards. Among them are Alkem Laboratories, Hindustan Antibiotics Limited, Hetero Labs Limited, Karnataka Antibiotics and Pharmaceuticals Ltd, Nestor Pharmaceuticals Ltd, Priya Pharmaceuticals, and Scott-Edil Pharmacia Ltd. The report specifies that some batches failed dissolution tests according to the Indian Pharmacopoeia, while others failed assays, water tests, or exhibited uniformity of volume issues. The CDSCO's August drug alert also included samples of medications like Shelcal, Vitamin B Complex with Vitamin C Softgels, vitamin C and D3 tablets, and Ciprofloxacin tablets, all of which were flagged as not of standard quality.
The CDSCO emphasizes its commitment to ensuring the quality and safety of drugs in India. The organization routinely monitors drugs and conducts random testing of samples every month. When irregularities are found, appropriate action is taken against the manufacturing firms. Notably, the report reveals that several states have not yet submitted data regarding the Not of Standard Quality (NSQ) Alert for August 2024, including Andhra Pradesh, Arunachal Pradesh, Assam, Bihar, Chhattisgarh, Goa, Gujarat, Haryana, Himachal Pradesh, Manipur, Rajasthan, Meghalaya, Mizoram, Nagaland, Odisha, Punjab, Sikkim, Tamil Nadu, Pondicherry, Telangana, Delhi, Uttarakhand, West Bengal, Andaman and Nicobar, Dadar and Nagar Haveli, Daman and Diu, and Lakshadweep. The CDSCO will likely be working to collect this data and assess the full scope of the situation.
Source: Over 50 drugs, including paracetamol, ‘not of standard quality’, says CDSCO report