The CDSCO has also identified 67 additional medications that were classified as Not of Standard Quality (NSQ) due to their failure to meet established quality standards or specifications.
New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has flagged 71 medicines including commonly used Pan D and Shelcal 500 as either “spurious” or “not of standard quality” (NSQ). The list also includes drugs like antibiotics, cough syrups, diabetes medications, and blood pressure pills, according to the reports.
The central organisation in its report also highlighted issues with cough syrups, labour-induction medications, paracetamol, anti-inflammatory eye drops, calcium and vitamin D3 supplements, anti-diabetes pills, and blood pressure drugs.
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Spurious drugs
The Central Drugs Standard Control Organisation (CDSCO) found common gastric medication, a drug for treating non-cancerous prostate enlargement, a dietary supplement essential for bone health, and a medication used by women for anaemia and osteoporosis after menopause to be
Spurious.
The spurious drugs identified include:
PAN-D: Pantoprazole Gastro-Resistant and Domperidone Prolonged-Release Capsules, commonly used to treat acid reflux and other gastric issues.
Urimax-D: Used for managing non-cancerous prostate enlargement.
Shelcal 500: Calcium and Vitamin D3 Tablets, a dietary supplement critical for maintaining bone health.
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Nandrolone Decanoate Injection IP 25 mg/ml (Deca-Durabolin 25 Inj.), often used for managing anaemia and osteoporosis in postmenopausal women.
The CDSCO reported that these medications were flagged as spurious after manufacturers confirmed they had not produced the batches in question. A CDSCO representative commented, “The product is purported to be spurious; however, this is subject to the outcome of ongoing investigations.”
NSQ drugs
The CDSCO has also identified 67 additional medications that were classified as Not of Standard Quality (NSQ) due to their failure to meet established quality standards or specifications.
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These drugs are:
- Antibiotics: Drugs such as Metronidazole, Cefuroxime Axetil, Ceftriaxone, Ciprofloxacin, and others used for bacterial infections were flagged by several laboratories, including CDL Kolkata, RDTL Guwahati, and Drugs Testing Laboratory Thiruvananthapuram.
- Diabetes Medications: Medications like Metformin & Glimepiride, Glipizide, and multiple batches of Glimepiride tablets were found to be NSQ.
- These drugs, produced by companies such as Swiss Biotech Parenterals and Zee Laboratories Ltd., were tested at CDL Kolkata, RDTL Guwahati, and other labs.
- APain Relief/Anti-inflammatory Drugs: Diclofenac Sodium and Aceclofenac & Paracetamol, were identified as NSQ. They were primarily manufactured by Hindustan Antibiotics Ltd. and Innova Captab Limited, with lab testing by CDL Kolkata, RDTL Chandigarh, and others.
- Heart/Blood Pressure Medications: Ramipril and Telmisartan, used to manage hypertension, were flagged by RDTL Guwahati and Drugs Testing Laboratory Thiruvananthapuram.Relief Biotech Pvt. Ltd. and Kerala Medical Services Corporation are the main manufacturers.
- Diuretics: Frusemide Injection and Torsemide Tablets, used for treating edema and hypertension, were identified as NSQ.Produced by Nestor Pharmaceuticals Ltd. and J.M. Laboratories, they were tested at Drugs Testing Laboratory Thiruvananthapuram and RDTL Chandigarh.
- Gastrointestinal Medications: Omeprazole & Domperidone and Pantoprazole tablets for acid reflux treatment were tested NSQ by CDL Kolkata and other labs.Key manufacturers include Renowned Life Sciences and Alkem Health Science.
- Electrolyte Replenishment: Compound Sodium Lactate Injection by Paschim Banga Pharmaceuticals was found non-compliant and tested by RDTL Guwahati.
- Vitamin/Mineral Supplements: Injections like Calcium Gluconate, Calcium & Vitamin D3, and Methylcobalamin were marked as NSQ.Tested at CDL Kolkata and RDTL Chandigarh, these supplements are manufactured by Martin & Brown Biosciences Pvt. Ltd. and Life Max Cancer Laboratories.
- Cough/Cold/Allergy Medications: Dextromethorphan & Chlorpheniramine Syrup, Fexofenadine, and Cetirizine Dihydrochloride were identified as NSQ by RDTL Chandigarh and other labs.Main manufacturers include Sunfine Healthcare and Signature Phytochemical Industries.
- Antiemetic for Nausea: Domperidone Suspension, produced by Rainbow Life Sciences Pvt. Ltd., failed quality checks at CDL Kolkata.
- Hormonal Therapy: Oxytocin Injection, used to induce labour, was flagged by CDL Kolkata. Manufacturers include Pushkar Pharma and Radiant Parenterals Ltd.
- Eye Care: Fluorometholone Eye Drops from Cotec Healthcare Pvt. Ltd. were found NSQ at Drugs Testing Laboratory Thiruvananthapuram.
- Antifungal Medications: Ketoconazole Cream and Fluconazole Tablets were identified as NSQ by CDL Kolkata and CDTL Mumbai.Produced by Olcare Laboratories and Cureza Healthcare Pvt. Ltd.
- Urinary Tract Infection Treatment: Ciprofloxacin by Celebrity Biopharma Ltd. was identified as NSQ by RDTL Guwahati.
- Laxatives: Bisacodyl Tablets from Karnani Pharmaceutical Pvt. Ltd. were found non-compliant at CDTL Mumbai.
- Chemotherapy: Ifosfamide with Mesna from Kwality Pharmaceuticals Ltd. was flagged by RDTL Chandigarh.
- Antihistamines for Allergic Rhinitis: Fexofenadine and Cetirizine from Signature Phytochemical Industries and other companies were found NSQ by RDTL Guwahati and other labs.
- Enzyme Therapy: Trypsin, Bromelain & Rutoside Tablets by Tiruvision Medcare were tested as NSQ at Drugs Testing Laboratory Thiruvananthapuram.
- Antidepressants: Bupropion Hydrochloride Extended-Release Tablets from Digital Vision were identified as NSQ by RDTL Chandigarh.
- Blood Thinners: Heparin Sodium by Protech Telelinks failed quality checks at CDL Kolkata.
