India's drug regulator, the Central Drugs Standards Control Organisation (CDSCO), has flagged 53 medicines as "Not of Standard Quality (NSQ)" in its latest monthly report. The list includes popular medications such as calcium and vitamin D3 supplements, anti-diabetic drugs, and high blood pressure medicines, raising significant concerns about drug safety and quality.
Among the affected drugs are widely used brands like Shelcal Vitamin C and D3 tablets, Pan-D antacid, Glimepiride for diabetes, and Telmisartan for hypertension. These medications were found to be below quality standards and are produced by well-known companies including 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 HAL, was also flagged for failing to meet quality standards. The company claims that the batch in question is spurious and was not produced by them, though the matter remains under investigation.
A drug-testing lab in Kolkata labeled Alkem Health Science's antibiotics Clavam 625 and Pan D as spurious, while Hetero's Cepodem XP 50 Dry Suspension, commonly used for severe bacterial infections in children, was found to be substandard. Paracetamol tablets from Karnataka Antibiotics & Pharmaceuticals Ltd were also cited for quality issues.
Additionally, prominent pharma companies like Sun Pharma, Glenmark Pharmaceuticals, and Macleods Pharmaceuticals are now under government scrutiny. The CDSCO report listed adulterated products such as Pulmosil, Pantocid, and Ursocol from Sun Pharma, which are believed to be spurious based on the manufacturer's statement. Similar concerns have been raised for Telma H medicines from Glenmark and Deflazacort tablets from Macleods Pharmaceuticals.
The CDSCO's report highlighted that several state drug licensing authorities, including those from Andhra Pradesh, Tamil Nadu, Delhi, and other regions, have not submitted any data concerning the NSQ Alert, raising questions about the regulatory oversight in these areas.
Other flagged drugs include Pantomed-40, Cefixime, and Pantoprazole injections. Traditional medicines like Haridrakhandam and Yogaraja Guggulu from Bhaskara Vilasam Vaidyasala have also failed quality tests, particularly for not meeting pH standards as per the Ayurvedic Pharmacopoeia of India.
ome important drug-list read as under:-
Paracetamol Tablets (500 mg) Telmisartan (multiple batches from Life Max Cancer Lab, Haridwar) Ursocol 300 (gallstone dissolution medication, manufactured by Sun Pharma Laboratories) Defcort 6 (arthritis treatment, manufactured by Macleods Pharma) Clavam 625 (antibiotic, manufactured by Alkem Health Science) Metronidazole (antibiotic, manufactured by Hindustan Antibiotics Limited) Cepodem XP 50 (dry suspension for severe bacterial infections in children, produced by Hetero) Pan D (acid reflux medication) Shelcal C and D3 (calcium supplements) Shelcal (distributed by Torrent Pharmaceuticals, produced by Pure & Cure Healthcare, Uttarakhand) Glimepiride (anti-diabetic drug)A number of other pharmaceutical companies, such as Gnosis Pharmaceuticals, Digital Vision, Nestor Pharma, Alexa Pharma, Bala Herbals, Steadfast Medishield, and Aglomed Ltd, have also seen one or more products failing to meet quality standards.
The CDSCO plays a critical role in regulating the import of drugs, approving new medications, and overseeing clinical trials. Staying updated on such drug alerts is crucial to ensure public health safety, preventing health risks like adverse reactions, toxicity, or treatment failures.
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