Highlights
- A total of 53 medicines, including paracetamol and anti-diabetes pills, have failed quality tests by the CDSCO.
- Major manufacturers implicated include Alkem Laboratories and Hindustan Antibiotics Limited.
- Many companies dispute the findings, claiming the flagged products are counterfeit.
New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has released a report indicating that 53 medicines have failed quality tests, including well-known products like paracetamol, calcium, vitamin D3 supplements, and various anti-diabetes and high blood pressure medications.
The CDSCO issued a ‘Not of Standard Quality’ (NSQ) alert based on random monthly sampling conducted by state drug authorities. The list comprises two reports, with one containing 48 drugs and another adding 5 more. This includes top-selling medications such as Vitamin C, D3 tablets, and Glimepiride, used to manage diabetes.
Key manufacturers involved in the alert are Hetero Drugs, Alkem Laboratories, Hindustan Antibiotics Limited (HAL), and others. Notably, Metronidazole, used for stomach infections, and Shelcal, a calcium and vitamin D3 supplement, were also among the products that failed.
Concerns were raised over the quality of several antibiotics and high blood pressure medications. For instance, Alkem’s Clavam 625 and Pan D failed tests conducted in Kolkata, while Hetero’s Cepodem XP 50 dry suspension for children was declared substandard.
In their responses, the companies involved have rejected responsibility, claiming that the products listed are counterfeit and not produced by them. Investigations into these claims are ongoing.
Here’s the complete list of the 48 drugs that failed the quality tests as reported by the CDSCO:
Complete List of 48 Failed Medicines
- Amoxicillin and Potassium Clavulanate Tablets IP (Clavam 625)
- Amoxicillin and Potassium Clavulanate Tablets (Mexclav 625)
- Calcium and Vitamin D3 Tablets IP (Shelcal 500)
- Metformin Hydrochloride Sustained-release Tablets IP (Glycimet-SR-500)
- Vitamin B Complex with Vitamin C Softgels
- Rifaximin Tablets (Rifmin 550)
- Pantoprazole Gastro-Resistant and Domperidone Prolonged-Release Capsules IP (Pan D)
- Paracetamol Tablets IP (500 mg)
- Montair LC Kid (Montelukast Sodium & Levocetirizine Hydrochloride Dispersible Tablets)
- Compound Sodium Lactate Injection IP (Ringer Lactate Solution for Injection) (RL 500 ml)
- Fexofenadine Hydrochloride Tablets IP (120 mg)
- Laxnorm Solution (Lactulose Solution USP)
- Heparin Sodium Injection (5000 Units)
- 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)
- Ciprofloxacin Tablets IP (500 mg) (Ocif-500)
- Nimesulide, Phenylephrine Hydrochloride & Levocetirizine Dihydrochloride Tablets (Nunim-Cold)
- Adrenaline Injection IP (Sterile 1 ml)
- Vingel XL Pro Gel (Diclofenac Diethylamine, Linseed Oil, Methyl Salicylate and Menthol Gel)
- Atropine Sulfate Injection IP (2 ml)
- Cefoperazone & Sulbactam for Injection (Todaycef 1.5 G)
- Heparin Sodium Injection IP (25000 IU / 5 ml)
- Cefepime & Tazobactam for Injection (Crupime – TZ Kid Injection)
- Salbutamol, Bromhexine HCl, Guaifenesin and Menthol Syrup (Acozil Expectorant)
- Diclofenac Sodium IP
- Escitalopram and Clonazepam Tablets IP (Klozaps-ES)
- Phenytoin Sodium Injection USP
- Paracetamol, Phenylephrine Hydrochloride and Cetirizine Hydrochloride Suspension (Cethel Cold DS)
- Calcium (500 mg) with Vitamin D3 (250 IU) Tablets IP
- Amoxicillin and Potassium Clavulanate Tablets IP (625 mg) (Renamega-CV 625)
- Olmesartan Medoxomil Tablets IP (40 mg)
- Telmisartan Tablets IP (40 mg)
- Alprazolam Tablets IP (0.25 mg) (Erazol-0.25)
- Glimepiride Tablets IP (2 mg)
- Calcium and Vitamin D3 Tablets IP
- Metronidazole Tablets IP (400 mg)
- Fexofenadine Hydrochloride Tablets IP (120 mg) (listed twice)
- Diclofenac Sodium IP (listed twice)
- Amoxycillin and Potassium Clavulanate Tablets (Mexclav 625) (duplicate entry)
- Nimesulide, Paracetamol and Chlorzoxazone Tablets (NICIP MR) (duplicate entry)
- Montair LC Kid (Montelukast Sodium & Levocetirizine Hydrochloride) (duplicate entry)
- Telmisartan Tablets IP (40 mg) (duplicate entry)
- Cefepime & Tazobactam for Injection (Crupime – TZ Kid Injection) (duplicate entry)
- Heparin Sodium Injection (25000 IU / 5 ml) (duplicate entry)
- Vingel XL Pro Gel (Diclofenac Diethylamine, Linseed Oil, Methyl Salicylate and Menthol Gel) (duplicate entry)
- Salbutamol, Bromhexine HCl, Guaifenesin and Menthol Syrup (Acozil Expectorant) (duplicate entry)
- Escitalopram and Clonazepam Tablets IP (Klozaps-ES) (duplicate entry)
This latest report follows a prior action by the CDSCO in August, when over 156 fixed-dose drug combinations were banned due to concerns about potential harm to patients.
Commitment to Public Health
The CDSCO remains vigilant in its efforts to monitor the pharmaceutical market. Regular inspections and quality testing are essential to ensure that only safe, effective medicines are available to the public. The organization emphasizes its commitment to public health and safety as it investigates these alarming findings.