On 24th October, the Central Drugs Standard Control Organisation (CDSCO) released its monthly alerts for substandard drugs. According to CDSCO’s report, drug samples were collected from sales and distribution points and sent for analysis as part of the monthly action taken against sub-par quality drugs. For September, 49 drugs failed testing and were included on the list.
This list includes Calcium Tablets Life Max by Cancer Laboratories, Paracetamol Paediatric by Vivimed Labs Limited, Cetiriz-P Syrup by Arrow Pharma, among others. Two batches each of Hepathin 5000 Injection and Monocef-O 200 also failed the tests. The list below only contains drug and company names, not batch numbers.
- Metronidazole Tablets I.P. 400 mg by Hindustan Antibiotics Ltd.
- Vomitel (Domperidon Suspension) by Rainbow Life Sciences Pvt. Ltd.
- Oxytocin Injection I.P. 5 IU/1 ml by Pushkar Pharma
- SPAMET GM 2 Tablets (Metformin Hydrochloride 500 mg SR & Glimepiride 2 mg Tablets IP) by Swiss Biotech Parenterals
- Diclofenac Sodium Tablets IP 50 mg by Hindustan Antibiotics Ltd.
- Calcium Gluconate Injection I.P. 10 ml by Martin & Brown Biosciences Pvt. Ltd.
- Oxytocin Injection I.P. 1 ml by Radiant Parenterals Ltd.
- Ceftriaxone Injection I.P. 1g by Zee Laboratories Ltd.
- Gentamycin Sulphate Injection I.P. 40 mg/ml by Zee Laboratories Ltd.
- Stimin (Glycopyrrolate 0.5 mg / 5ml + Neostigmine methysulfate Injection 2.5 mg / 5ml) by Celon Laboratories Pvt. Ltd.
- Nozal Cream (Ketoconazole Cream BP) by Olcare Laboratories
- Hepathin 5000 Injection 5 ml / vial (Heparin Sodium Injection IP 5000 IU / 5ml) by Protech Telelinks
- Gentagain (Gentamicin Injection I.P.) by Regain Laboratories
- Glipizide Tablets I.P. 5 mg by Zee Laboratories Ltd.
- Omerin-D Capsules (Omeprazole & Domperidone Capsules IP) by Renowned Life Sciences
- Chill Acid MPS (Dried Aluminium Hydroxide, Magnesium Hydroxide & Activated Dimethicone Suspension) by Devout Nord (I) Ltd.
- Nimuvent-P Tablets (Nimesulide & Paracetamol Tablets) by Innova Captab Limited
- Cipronir 500 (Ciprofloxacin Tablets IP 500 mg) by Celebrity Biopharma Ltd.
- SMB OZ Tablets (Ofloxacin & Ornidazole Tablets IP) by Saint Michael Biotech
- Calcium 500 mg and Vitamin D3 250 IU Tablets IP by Life Max Cancer Laboratories
- LOMJAN (Loperamide Hydrochloride Tablets I.P. 2 mg) by Arya Pharmaceuticals
- Glimepiride Tablets IP 1 mg by Life Max Cancer Laboratories
- Fexofenadine Hydrochloride Tablets I.P. by Signature Phytochemical Industries
- Glimepiride Tablets I.P. 2 mg by Life Max Cancer Laboratories
- PAN 40 (Pantoprazole Gastro-resistant Tablets IP) by Alkem Health Science
- Monocef-O 200 (Cefpodoxime Tablets IP 200 mg) by Aristo Pharmaceuticals Pvt. Ltd.
- Clavam 625 (Amoxicillin And Potassium Clavulanate Tablets I.P.) by Alkem Health Science
- Fexofenadine Hydrochloride Tablets IP by Oscar Remedies Pvt. Ltd.
- CIPRODAC 500 (Ciprofloxacin Tablets IP 500 mg) by Cadila Pharmaceuticals Limited
- Ramipril Tablets I.P. 2.5 mg by Relief Biotech Pvt. Ltd.
- Compound Sodium Lactate Injection I.P. (RL) by Paschim Banga Pharmaceuticals
- PHENERGAN (Promethazine Hydrochloride Injection I.P.) by Nitin Lifesciences Ltd.
- Paracetamol Paediatric Oral Suspension IP by Vivimed Labs Limited
- Spisam Gel (Aluminum Hydroxide, Simethicone & Magnesium Hydroxide Suspension) by Aan Pharma Pvt. Ltd.
- P-Genta Injection (Gentamicin Sulphate Injection IP) by Primus Pharmaceuticals
- Flucse – 150 (Fluconazole Tablets IP 150 mg) by Cureza Healthcare Pvt. Ltd.
- Bisalax Tablets (Bisacodyl Tablets I.P.) by Karnani Pharmaceutical Pvt. Ltd.
- Citrize-P (Cetirizine Dihydrochloride Syrup) by Arrow Pharma
- Celofos 1000 Injection (Ifosfamide for Injection IP with Mesna Injection) by Kwality Pharmaceuticals Limited
- ZERODOL-SP Tablets (Aceclofenac 100 mg, Serratiopeptidase 15 mg & Paracetamol 325 mg Tablets) by Ipca Laboratories Ltd.
- UTROCLEAR-OZ Solution (Ofloxacin and Ornidazole Intra Uterine Solution Vet.) by Ramson Remedies
- Nopion 150 Tablets (Bupropion Hydrochloride Extended Release Tablets USP) by Digital Vision
- COUGH-DM Cough Syrup (Dextromethorphan Hydrobromide, Chlorpheniramine Maleate and Phenylephrine Hydrochloride Syrup) by Sunfine Healthcare
- KEFZONE-S INJECTION (Cefoperazone and Sulbactam for Injection) by ANG Lifesciences India Ltd.
- CASIDTAZ P Injection (Piperacillin and Tazobactam Injection IP) by ANG Lifesciences India Ltd.
- NUROFENS-2500 Injection (Methylcobalamin Injection 2500 mcg) by Systole Remedies Pvt. Ltd.
- Torverge-10 Tablets (Torsemide Tablets IP 10 mg) by J.M. Laboratories
These 49 drugs did not meet the required quality standards out of a total of 3,000 drug samples collected by CDSCO. Additionally, CDSCO has flagged four medicines manufactured by fake companies as spurious. These drugs are Urimax-D batch number GH30334, Shelcal 500 batch number GDCD0581, Pan-D batch number 2344507, and Deca-Durabolin 25 Injection batch number G20620.
For these drugs under investigation, CDSCO wrote, “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 subject to the outcome of the investigation.”
The batches of non-standard drugs have been recalled as per CDSCO guidelines to ensure public safety. CDSCO chief Rajeev Singh Raghuvanshi said that only around 1% of all drugs tested failed to meet the quality benchmarks, indicating that stringent monitoring measures are effectively controlling substandard drug production.
List of state drugs that failed the test
- Neurotem-NT (Pregabalin) by Catasta Pharmaceuticals (Jammu and Kashmir)
- Cefuroxime Axetil Tablets IP 500 mg by Agron Remedies Pvt Ltd (Jammu and Kashmir)
- Loperamide Hydrochloride Tablets IP by Karnani Pharmaceuticals Pvt. Ltd. (Jammu and Kashmir)
- Floxages-OZ (Ofloxacin and Ornidazole Tablets IP) by Suraksha Pharma Pvt. Ltd. (Thiruvananthapuram)
- Wintel 40 Tablets by Himalaya Meditek Pvt. Ltd. (Thiruvananthapuram)
- Moxica-250 (Amoxicillin Dispersible Tablets IP 250 mg) by Indica Pharmaceuticals (P) Ltd. (Thiruvananthapuram)
- Frusemide Injection IP 20 mg by Nestor Pharmaceuticals Ltd. (Thiruvananthapuram)
- Cloxacillin Sodium Capsules IP 250 mg by Nestor Pharmaceuticals Ltd. (Thiruvananthapuram)
- Fluorometholone Eye Drops IP by Cotec Healthcare Pvt. Ltd. (Thiruvananthapuram)
- Panlib 40 Tablets by Himalaya Meditek Pvt. Ltd. (Thiruvananthapuram)
- B-Cidal 625 by VADSP Pharmaceuticals (Thiruvananthapuram)
- Flavoshine (Trypsin, Bromelain & Rutoside Trihydrate Tablets) by Tiruvision Medcare (Thiruvananthapuram)
- C Mont LC Kid (Montelukast & Leveocetirizine Dihydrochloride syrup) by Cian Healthcare Ltd. (Thiruvananthapuram)
- Yogaraja Guggulu Tablet by Oushadhi, The Pharmaceutical Corporation (IM) (Thiruvananthapuram)
- Telmisartan Tablets IP 40 mg by Kerala Medical Services Corporation Ltd. (Thiruvananthapuram)
- Pantoprazole Injection BP 40 mg by Kerala Medical Services Corporation Ltd. (Thiruvananthapuram)
- Glimepiride Tablets IP by Kerala Medical Services Corporation Ltd. (Thiruvananthapuram)
- Cough Syrup by Kerala Medical Services Corporation Ltd. (Thiruvananthapuram)
State drug alerts are more region-specific. The state drug control authority may issue it, sometimes with CDSCO involvement, for drugs found to be substandard or potentially harmful within that particular state. The action is mostly limited to the region specified. Not all states sends the data to CDSCO on monthly basis.
Previous alerts by CDSCO warned consumers about Paracetamol, Antacid Pan-D, Levocetrizine and more
In September this year, CDSCO identified over 50 drugs as “Not of Standard Quality (NSQ) Alert” in its latest monthly report. More than 50 drugs, including those used to treat fever, diabetes, hypertension, vitamins, calcium D3 supplements, bacterial infections, and acid reflux, failed quality tests undertaken by India’s drugs regulatory authority.
CDSCO has released two lists of pharmaceuticals that did not pass quality checks: one “Not of Standard Quality” naming 48 popular drugs and another with answers from pharmaceutical companies whose products failed to meet the safety standards. Companies producing negatively rated pharmaceuticals include Hetero Drugs, Alkem Laboratories, Hindustan Antibiotics Limited (HAL), Karnataka Antibiotics & Pharmaceuticals Ltd, Meg Lifesciences, and Pure & Cure Healthcare. In addition, Hindustan Antibiotic Limited (HAL) manufactured the anti-stomach infection medicine Metronidazole, which did not meet the quality criteria.
