Paracetamol, Pan-D Among 50+ Drugs Flagged As 'Not Of Standard Quality' | Full List

The Central Drugs Standards Control Organization (CDSCO) raised serious safety concerns by declaring over 50 medications as "not of standard quality" in its recent monthly report. The list includes widely-used drugs such as paracetamol, Pan D, and calcium supplements.

The CDSCO’s August 2024 report categorized several medications under its “Not of Standard Quality (NSQ Alert)” list, which included vitamin C and D3 tablets, Shelcal, the antacid Pan-D, paracetamol tablets, vitamin C softgels, the anti-diabetic drug Glimepiride, vitamin B complex, and the high blood pressure medication Telmisartan.

These NSQ alerts are based on random monthly samples collected by state drug officers and emphasize the potential risks posed by substandard medications.

The failures were linked to poor manufacturing practices, contamination during production, and insufficient quality control. The issue is further compounded by inconsistent levels of active pharmaceutical ingredients (APIs) in these drugs.

These products were manufactured by various companies, including Unicure India Ltd, Health Biotech Ltd, Hindustan Antibiotics Limited (HAL), Life Max Cancer Laboratories, Hetero Drugs, Pure & Cure Healthcare, Alkem Laboratories, and Meg Lifesciences.

The central drug regulator issued two lists in August 2024: one containing 48 drugs that failed quality tests, and another listing five drugs classified as "Spurious/Adulterated/Misbranded."

The drugs 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 (Defcort 6 Tablets)

Batch numbers and manufacturing dates can be checked for further details.

Drugs Declared 'Not Of Standard Quality': Full List

According to the CDSCO report, “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."

Below is the complete list of 48 drugs declared "not of standard quality" in the CDSCO's August 2024 report. You can check the batch numbers and manufacturing dates of these drugs.

• Amoxicillin And Potassium Clavulanate Tablets IP (Clavam 625)

• Amoxycillin & Potassium Clavulanate Tablets (Mexclav 625)

• Calcium And Vitamin D3 Tablets IP Shelcal 500 (Shelcal)

• Metformin Hydrochloride Sustained-release Tablets IP (Glycimet-SR-500

• Vitamin B Complex with Vitamin C Softgels

• Rifmin 550 (Rifaximin Tablets 550 mg)

• Pantoprazole Gastro-Resistant and Domperidone Prolonged-Release Capsules IP (Pan-D)

• Paracetamol Tablets IP 500 mg

• Montair LC Kid (Montelukast Sodium & Levocetirizne 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

• Laxnorm Solution (Lactulose Solution USP)

• Heparin Sodium Injection 5000 Units (Hostranil Injection)

• Buflam Forte Suspension (Ibuprofen & 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 I.P. 500 mg (Ocif-500)

• Nimesulide, Phenylephrine Hydrochloride & Levocetirizine Dihydrochloride Tablets (Nunim-Cold)

• Adrenaline Injection I.P. Sterile 1 ml

• Compound Sodium Lactate Injection I.P. (Ringer Lactate Solution for Injection) RL 500ml

• Vingel XL Pro Gel (Diclofenac Diethylamine, Linseed Oil, Methyl Salicylate and Menthol Gel)

• Atropine Sulphate Injection IP 2 ml

• Cefoperazone & Sulbactam For Injection (Todaycef 1.5 G)

• Heparin Sodium Injection IP 25000 IU / 5ml

• Cefepime & Tazobactam for Injection (Crupime - TZ Kid Injection)

• Atropine Sulphate Injection I.P. (Atropine Sulphate)

• Atropine Sulphate Injection I.P. (Atropine Sulphate)

• Atropine Sulphate Injection I.P. (Atropine Sulphate)

• Atropine Sulphate Injection I.P. (Atropine Sulphate)

• Salbutamol, Bromhexine HCI, Guaifenesin and Mentho Syrup(Acozil Expectorant)

• Diclofenac Sodium IP

• Escitalopram and Clonazepam Tablets IP (Klozaps-ES Tablets)

• Phenytoin Sodium Injection USP

• Paracetamol, Phenylephrine Hydrochloride and Cetirizine Hydrochloride Suspension (Cethel Cold DS Suspension)

• Calcium 500 mg with Vitamin D3 250 IU Tablets IP

• Amoxycillin 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 Tablets IP 0.25 mg (Erazol-0.25 Tablets)

• GLIMEPIRIDE TABLETS IP (2 mg)

• Calcium and Vitamin D3 Tablets I.P.

• Metronidazole Tablets IP 400mg

In August 2024, the CDSCO also banned over 156 fixed-dose drug combinations nationwide due to potential risks to human health.