The Central Drugs Standard Control Organisation (CDSCO) has raised serious safety concerns by declaring over 50 drugs as “not of standard quality” in its latest monthly report. The list includes widely used drugs such as paracetamol, Pan D and calcium supplements.
The CDSCO’s August 2024 report classified several drugs under its “not of standard quality (NSQ alert)” list, including vitamin C and D3 tablets, Shelcal, antacid Pan-D, paracetamol tablets, vitamin C softgels, anti-diabetic drug Glimepiride, vitamin B complex, and hypertension drug Telmisartan.
These NSQ alerts are based on random monthly samples collected by state drug officials and highlight the potential risks posed by substandard drugs. These failures were linked to poor manufacturing practices, contamination during production, and inadequate quality control. The problem is further compounded by inconsistent levels of active pharmaceutical ingredients (APIs) in these drugs.
These products were manufactured by various companies, including UniQure India Limited, Health Biotech Limited, Hindustan Antibiotics Limited (HAL), Life Max Cancer Laboratories, Hetero Drugs, Pure & Cure Healthcare, Alkem Laboratories and Meg Lifesciences.
The central drug regulator released two lists in August 2024: one included 48 medicines that failed quality tests, and the other list included five medicines classified as “spurious/adulterated/misbranded”.
Medicines listed as spurious/adulterated/misbranded include:
-Pulmosil (sildenafil injection)
-Pantocid (Pantoprazole Tablets IP)
-Ursocol 300 (Ursodeoxycholic Acid Tablets IP)
-Telma H (telmisartan 40 mg and hydrochlorothiazide 12.5 mg tablets IP)
-Deflazacort tablets (Deflacort 6 tablets)
Medicines declared ‘not of standard quality’: Full list
According to the CDSCO report, “The actual manufacturer (as per label claim) has informed that the disputed batch of the product is not manufactured by them and is a counterfeit drug.”
Below is the complete list of 48 medicines declared “not of standard quality” in the CDSCO report of August 2024. You can check the batch numbers and manufacturing dates of these medicines.
-Amoxicillin and Potassium Clavulanate Tablets IP (Clavum 625)
-Amoxicillin and potassium clavulanate tablets (Mexaclav 625)
-Calcium & Vitamin D3 Tablets IP Shelcal 500 (Shelcal)
-Metformin hydrochloride sustained-release tablets IP (Glycimet-SR-500
-Vitamin B Complex with Vitamin C Softgels
-Rifamin 550 (Rifaximin Tablets 550 mg)
-Pantoprazole Gastro-Resistant and Domperidone Prolonged-Release Capsules IP (Pan-D)
-Paracetamol Tablets IP 500mg
-Montair LC Kid (montelukast sodium and levocetirizine hydrochloride dispersible tablets)
-Compound Sodium Lactate Injection I.P. (Ringer Lactate Solution for Injection) (RL 500 ml)
-Fexofenadine Hydrochloride Tablets IP 120 mg
-Fexofenadine Hydrochloride Tablets IP 120 mg
-Laxanorm Solution (Lactulose Solution USP)
-Heparin Sodium Injection 5000 units (Hostranil Injection)
-Buflam Forte Suspension (Ibuprofen and Paracetamol Oral Suspension)
-Cepodem XP 50 dry suspension (cefpodoxime proxetil and potassium clavulanate oral suspension)
-Nimesulide, paracetamol and chlorzoxazone tablets (NICIP MR)
-Rolled gauze (non-sterilized)
-Ciprofloxacin Tablets IP 500mg (OCIF-500)
-nimesulide, phenylephrine hydrochloride, and levocetirizine dihydrochloride tablets (Nunim-Cold)
-Adrenaline injection I.P. sterile 1 ml
-Compound Sodium Lactate Injection I.P.(Ringer Lactate Solution for Injection) RL 500 ml
-Wingel XL Pro Gel (diclofenac diethylamine, linseed oil, methyl salicylate and menthol gel)
-Atropine Sulphate Injection IP 2 ml
-Cefoperazone and sulbactam for injection (Todacef 1.5 gm)
-Heparin Sodium Injection IP 25000 IU/5 ml
-Cefepime and tazobactam for injection (Cruapime – TZ Kid Injection)
-Atropine sulfate injection I.P. (atropine sulfate)
-Atropine sulfate injection I.P. (atropine sulfate)
-Atropine sulfate injection I.P. (atropine sulfate)
-Atropine sulfate injection I.P. (atropine sulfate)
-Salbutamol, bromhexine HCI, guaifenesin and mentho syrup (Ecogil Expectorant)
-Diclofenac Sodium IP
-Escitalopram and Clonazepam Tablets IP (Clonazepam-ES Tablets)
-Phenytoin Sodium Injection USP
-Paracetamol, phenylephrine hydrochloride and cetirizine hydrochloride suspension (Cethel Cold DS Suspension)
-Calcium 500 mg 250 IU Tablet IP with Vitamin D3
-Amoxicillin and potassium clavulanate tablets IP 625 mg (Renamega-CV 625)
-Olmesartan medoxomil tablets IP 40 mg
-infusion set-nv
-Telmisartan tablets IP 40 mg
-Telmisartan tablets IP 40 mg
-Telmisartan tablets IP 40 mg
-Telmisartan tablets IP 40 mg
-Alprazolam tablet IP 0.25 mg (Erazol-0.25 tablet)
-Glimepiride Tablets IP (2 mg)
-Calcium and Vitamin D3 Tablets I.P.
-Metronidazole Tablets IP 400 mg
