India’s drug regulator, the Central Drugs Standards Control Organisation (CDSCO), has listed more than 50 drugs as “Not of Standard Quality (NSQ) Alert” in its latest monthly report. This list includes widely used medicines such as calcium and vitamin D3 supplements, anti-diabetes pills, and high blood pressure medicines.
Drugs like Shelcal Vitamin C and D3 tablets, Pan-D antacid, Glimepiride for diabetes, and Telmisartan for high blood pressure are among the 53 drugs found to be below standard.The poorly rated medicines are produced by companies like Hetero Drugs, Alkem Laboratories, Hindustan Antibiotics Limited (HAL), Karnataka Antibiotics & Pharmaceuticals Ltd, Meg Lifesciences, and Pure & Cure Healthcare.
The anti-stomach infection drug Metronidazole, manufactured by Hindustan Antibiotic Limited (HAL), also did not meet quality standards. “The actual manufacturer (as per label claim) has informed that the impugned batch of the product has not been manufactured by them and that it is a spurious drug. The product is purported to be spurious, however, the same is subjected to the outcome of investigation,” one response from the pharmaceutical companies read.
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Additionally, the report from a Kolkata drug-testing lab labeled Alkem Health Science’s antibiotics Clavam 625 and Pan D as spurious. The same lab also found Hetero’s Cepodem XP 50 Dry Suspension, often given to children with severe bacterial infections, to be substandard. Paracetamol tablets produced by Karnataka Antibiotics & Pharmaceuticals Ltd were flagged for quality issues as well.
Along with this, several leading pharma companies including the Sun Pharma, Glenmark Pharmaceuticals, Macleods Pharmaceuticals have come under the scrutiny of the government.
The Central Drugs Standard Control Organisation (CDSCO) has released a list of spurious drugs, their makers, and the reason for failure.
Medicines like Pulmosil (batch number KFA0300), Pantocid (batch number SID2041A), Ursocol (batch number GTE1350A) manufactured by Sun Pharma are adulterated, the CDCSCO report says. “The actual manufacturer (as per
label claim) has informed that the impugned batch of the product has not been manufacturer by them and that it is a spurious drug. The product is purported to be spurious, however, the same is subjected to outcome of investigation,” the drug regulator has said. In the same list are Telma H medicines (batch number 18230080) manufactured by Glenmark Pharmaceuticals and Deflazacort Tablets (batch number GDB23041A) from Macleods Pharmaceuticals.
“State Drugs Licensing Authorities of 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 & Nicobar, Dadar and Nagar Haveli; Daman and Diu, Lakshadweep have not submitted any data in respect of the Not of Standard Quality (NSQ) Alert,” the CDSCO has said.
Other medicines like Pantomed -40 (batch number GTEO230C), Cefixime (batch number CADA-02), Pantoprazole Inj. BP 40 mg (batch number D0726/24-25) have been flagged. Bhaskara Vilasam Vaidyasala’s Haridrakhandam has also come under scrutiny as it failed the test ‘pH’ as per API or the Ayurvedic Pharmacopoeia of India. Yogaraja Guggulu from the same firm has also failed the quality test.
The list of pharma companies whose one or more products have failed to meet the standards are: M/s.Gnosis Pharmaceuticals, Digital Vision 176, Nestor Pharma, Alexa Pharma, Bala Herbals, Steadfast Medishield, Aglomed Ltd.
CDSCO has a regulatory control over the import of drugs, approval of new drugs and clinical trials.
Paying attention to drug standard alerts from government bodies is crucial for ensuring safety, efficacy, and quality. These alerts notify the public about harmful or substandard drugs, contaminated batches, or improper labeling, helping to prevent health risks such as adverse reactions, toxicity, or ineffectiveness. Ignoring these alerts can lead to serious health risks, including treatment failure or severe side effects. Staying informed through these alerts helps protect public health and maintain trust in medical treatments.