CDSCO flags quality failures in 50 Drugs, including Paracetamol, Pantoprazole, Vitamin D3 Tablets, and more

The Central Drugs Standard Control Organization (CDSCO) has identified over 50 drugs that have failed quality tests, marking a significant concern for public health. In its latest report, the agency revealed that 50 drugs, including the widely used pain reliever Paracetamol, have been classified as “not of standard quality” (NSQ). Other drugs flagged include calcium and vitamin D3 supplements, anti-diabetes medications, and treatments for high blood pressure.

Among the specific quality concerns, Paracetamol tablets produced by Karnataka Antibiotics & Pharmaceuticals Ltd were highlighted. The report detailed a total of 48 drugs listed in the NSQ category, which also includes a Gauze Roll Non-Sterile Roller Bandage.
The alerts regarding NSQ drugs stem from monthly random sampling conducted by state drug officers. Notably, some of the implicated medicines were manufactured by reputable companies, including Hetero Drugs, Alkem Laboratories, Hindustan Antibiotics Limited (HAL), and Meg Lifesciences, raising concerns about quality control in the pharmaceutical industry.

In addition to the 50 drugs listed, the CDSCO also released a supplementary list of five additional drugs that failed quality tests. Pharmaceutical companies have denied responsibility for these drugs, claiming they are “spurious.” One manufacturer stated, “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.”

Among the drugs that did not meet the required standards are:

• Amoxicillin And Potassium Clavulanate Tablets IP (Clavam 625) – M/s. Alkem Health Science
• Amoxicillin & Potassium Clavulanate Tablets (Mexclav 625) – M/s. Meg Lifesciences
• Calcium And Vitamin D3 Tablets IP (Shelcal 500) – M/s. Pure & Cure Healthcare Pvt. Ltd.
• Metformin Hydrochloride Sustained-release Tablets IP (Glycimet-SR-500) – M/s. Scott-Edil Pharmacia Ltd.
• Vitamin B Complex with Vitamin C Softgels – M/s. Asoj Soft Caps Pvt. Ltd.
• Rifmin 550 (Rifaximin Tablets 550 mg) – M/s. Legen Healthcare
•  Pantoprazole Gastro-Resistant and Domperidone Prolonged-Release Capsules IP (Pan – D) – M/s. Alkem Health Science
• Paracetamol Tablets IP 500 mg – M/s. Karnataka Antibiotics and Pharmaceuticals Ltd.
•  Montair LC Kid (Montelukast Sodium & Levocetirizine Hydrochloride Dispersible Tablets) – M/s. Pure & Cure Healthcare Pvt. Ltd.
•  Compound Sodium Lactate Injection IP (Ringer Lactate Solution for Injection) (RL 500 ml) – M/s. Vision Parenteral Pvt. Ltd.
•  Fexofenadine Hydrochloride Tablets IP 120 mg – M/s. Maxtar Bio-Genics
•  Laxnorm Solution (Lactulose Solution USP) – M/s. Athens Life Sciences
• Heparin Sodium Injection 5000 Units (Hostranil Injection) – M/s. Health Biotech Ltd.
•  Buflam Forte Suspension (Ibuprofen & Paracetamol Oral Suspension) – M/s. Ornate Pharma Pvt. Ltd.
•  Cepodem XP 50 Dry Suspension (Cefpodoxime Proxetil and Potassium Clavulanate Oral Suspension) – M/s. Hetero Labs Limited
•  Nimesulide, Paracetamol and Chlorzoxazone Tablets (NICIP MR) – M/s. HSN International
• Rolled Gauze (Non-Sterilized) – M/s. Blazon India
•  Ciprofloxacin Tablets IP 500 mg (Ocif-500) – M/s. Ornate Labs Pvt. Ltd.
• Nimesulide, Phenylephrine Hydrochloride & Levocetirizine Dihydrochloride Tablets (Nunim-Cold) – M/s. Unispeed Pharmaceuticals Pvt. Ltd.
• Adrenaline Injection IP Sterile 1 ml – M/s. Alves Healthcare Pvt. Ltd.
•  Compound Sodium Lactate Injection IP (Ringer Lactate Solution for Injection) RL 500ml – M/s. Vision Parenteral Pvt. Ltd.
• Vingel XL Pro Gel (Diclofenac Diethylamine, Linseed Oil, Methyl Salicylate, and Menthol Gel) – M/s. Universal Twin Labs
• Atropine Sulphate Injection IP 2 ml – M/s. Nandani Medical Laboratories Pvt. Ltd.
• Cefoperazone & Sulbactam For Injection (Todaycef 1.5 G) – M/s. Daxin Pharmaceuticals Pvt. Ltd.
•  Heparin Sodium Injection IP 25000 IU / 5ml – M/s. Scott-Edil Pharmacia Ltd.
• Cefepime & Tazobactam for Injection (Crupime – TZ Kid Injection) – M/s. Cosmas Research Lab. Ltd.
•  Atropine Sulphate Injection IP (Atropine Sulphate) – M/s. Priya Pharmaceuticals
•  Salbutamol, Bromhexine HCI, Guaifenesin and Menthol Syrup (Acozil Expectorant) – M/s. Antila Lifesciences Pvt. Ltd.
• Diclofenac Sodium IP – M/s. Sara Exports Ltd.
• Escitalopram and Clonazepam Tablets IP (Klozaps-ES Tablets) – M/s. Digital Vision
• Phenytoin Sodium Injection USP – M/s. Health Biotech Ltd.
•  Paracetamol, Phenylephrine Hydrochloride and Cetirizine Hydrochloride Suspension (Cethel Cold DS Suspension) – M/s. Win Cure Pharma
•  Calcium 500 mg with Vitamin D3 250 IU Tablets IP – M/s. Life Max Cancer Laboratories
• Amoxycillin and Potassium Clavulanate Tablets IP 625 mg (Renamega-CV 625) – M/s. Malik Lifesciences Pvt. Ltd.
• Olmesartan Medoxomil Tablets IP 40 mg – M/s. Life Max Cancer Laboratories
• INFUSION SET-NV – M/s. Medivision Healthcare
• Telmisartan Tablets IP 40 mg – M/s. Life Max Cancer Laboratories
• Alprazolam Tablets IP 0.25 mg (Erazol-0.25 Tablets) – M/s. Elikem Pharmaceuticals Pvt. Ltd.
•  Glimepiride Tablets IP (2 mg) – M/s. Mascot Health Series Pvt. Ltd.
•  Calcium and Vitamin D3 Tablets IP – M/s. Unicure India Ltd.
• Metronidazole Tablets IP 400mg – M/s. Hindustan Antibiotics Ltd.
• Paziva -40 – M/s. Gnosis Pharmaceuticals Pvt. Ltd.
• Pantomed -40 – M/s. Digital Vision
• Cefixime Oral Suspension IP (Dry Syrup) – M/s. Nestor Pharmaceuticals Ltd.
•  Moxymed CV – M/s. Alexa Pharmaceuticals
• Frusemide Injection IP 20 mg – M/s. Nestor Pharmaceuticals Ltd.
•  Kudajarishtam – M/s. Bala Herbals
•  Tab Nodosis – M/s. Steadfast Medishield Pvt. Ltd.
• Haridrakhanda – M/s. Bhaskara Vilasam Vaidyasala
• Pantoprazole Inj. BP 40 mg – M/s. Kerala Medical Services Corporation Ltd.
•  Yogaraja Guggulu – M/s. Bhaskara Vilasam Vaidyasala
• PANCEF-OF – M/s. Aglomed Ltd.

MT