Over 50 drugs, including calcium and vitamin D3 supplements, diabetes, and high blood pressure medicines, have failed quality tests conducted by India’s drug regulator. The Central Drugs Standard Control Organisation has declared 53 drugs as “not of standard quality (NSQ) alerts” in its latest monthly drug quality test list. NSQ alerts are derived from random monthly sampling done by state drug authorities.

Paracetamol tablets from Karnataka Antibiotics and Pharmaceuticals Ltd were specifically mentioned for quality concerns. The report listed a total of 48 drugs in the NSQ category, including gauze roll non-sterile roller bandage. Some of the drugs were produced by companies such as Hetero Drugs, Alkem Laboratories, Hindustan Antibiotics Ltd, Karnataka Antibiotics and Pharmaceuticals Ltd, Meg Lifesciences, and Pure & Cure Healthcare.

Additionally, the CDSCO shared another list that includes five more drugs that failed the quality test. The pharmaceutical companies denied responsibility for these drugs. They claim they are “counterfeit” and a company response states, “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. The product has been reported as counterfeit; however, this is subject to the outcome of the investigation.”

Complete list of medicines and their manufacturers
Clavam 625 – M/s Alkem Health Sciences
Maxclav 625 – M/s Meg Lifesciences
Shelcal 500 – M/s Pure & Cure Healthcare Pvt. Ltd.
Glycimate-SR-500 – M/s Scott-Edil Pharmacia Ltd.
Softgels – M/s Aose Soft Caps Pvt. Ltd.
Rifaximin Tablet 550 mg – M/s Legen Healthcare
Pan D – M/s Alkem Health Sciences
Paracetamol Tablet IP 500 mg – M/s Karnataka Antibiotics & Pharmaceuticals Ltd.
Montair LC Kid – M/s Pure & Cure Healthcare Pvt. Ltd.
RL 500 ml – M/s Vision Parenteral Pvt. Ltd.
Lactulose Solution USP – M/s Athens Life Sciences
Hostranil Injection – M/s Health Biotech Ltd.
Buflam Forte Suspension – M/s Ornate Pharma Pvt. Ltd.
Cepodem XP 50 Dry Suspension – M/s Hetero Labs Ltd.
NICIP MR – M/s HSN International
Rolled Gauze (Non-Sterilized) – M/s Blazon India
Osif-500 – M/s Ornate Labs Pvt. Ltd.
Nunim-Cold – M/s Unispeed Pharmaceuticals Pvt. Ltd.
Adrenaline Injection IP Sterile 1ml – M/s Alves Healthcare Pvt. Ltd.
RL 500ml – M/s Vision Parenteral Pvt. Ltd.
Wingel XL Pro Gel – M/s Universal Twin Labs
Atropine Sulphate Injection IP 2ml – M/s Nandani Medical Laboratories Pvt. Ltd.
Todaycef 1.5g – M/s Daxin Pharmaceuticals Pvt. Ltd.
Heparin Sodium Injection IP 25000 IU/5 ml – M/s Scott-Edil Pharmacia Ltd.
Cruprime – TZ Kid Injection – M/s Cosmas Research Lab Ltd.
Atropine Sulphate Injection – M/s Priya Pharmaceuticals
Ecozil Expectorant – M/s Antilla Lifesciences Pvt. Ltd.
Diclofenac Sodium IP – M/s Sara Exports Ltd.
Clozaps-ES Tablet – M/s Digital Vision
Phenytoin Sodium Injection – M/s Health Biotech Ltd.
Cethel Cold DS Suspension – M/s Win Cure
Pharmacalcium 500mg with Vitamin D3 250 IU Tablet – M/s Life Max Cancer Laboratories
Renmega- CV 625 – M/s Malik Lifesciences Pvt. Ltd.
Olmesartan Medoxomil Tablet IP 40mg – M/s Life Max Cancer Laboratories
Infusion Set-NV – M/s Medivision Healthcare
Telmisartan Tablet IP 40mg – M/s Life Max Cancer Laboratories
Erazol-0.25 Tablet – M/s Alikem Pharmaceuticals Pvt. Ltd.
Glimepiride Tablet IP (2mg) – M/s Mascot Health Series Pvt. Ltd.
Calcium & Vitamin D3 Tablet IP – M/s Unicure India Ltd.
Metronidazole Tablet IP 400mg – M/s Hindustan Antibiotics Ltd.
Paziva-40 – M/s Gnosis Pharmaceuticals Pvt. Ltd.
Pantomed-40 – Digital Vision 176
Cefixime Oral Suspension IP (Dry Syrup) – Nestor Pharmaceuticals Ltd.
Moximed CV – Alexa Pharmaceuticals
Frusemide Injection IP 20 mg – Nestor Pharmaceuticals Ltd.
Kudajarishtam – Bala Herbals
Tab Nodosis – Steadfast Medishield Pvt. Ltd.
Haridrakhand – Bhaskar Vilasam Vaidyasala
Pantoprazole Inj. BP 40 mg – Kerala Medical Services Corporation Ltd.
Yogaraja Guggulu – Bhaskar Vilasam Vaidyasala

An official source stated that a monthly list of “not of standard quality” drugs is regularly published.

“The drug regulator actively monitors pharmaceutical products by conducting random monthly tests to ensure they meet quality and safety standards. If any drugs are found to be below standard, appropriate action is taken against the manufacturing companies,” the source explained.

According to the CDSCO, the drugs licensing authorities from Andhra Pradesh, Arunachal Pradesh, Assam, Bihar, Chhattisgarh, Goa, Gujarat, Haryana, Himachal Pradesh, Manipur, Rajasthan, Meghalaya, Mizoram, Nagaland, Odisha, Punjab, Sikkim, and Tamil Nadu have not submitted any data for the Not of Standard Quality (NSQ) Alert for August 2024.

Additionally, no data was provided by Pondicherry, Telangana, Delhi, Uttarakhand, West Bengal, Andaman and Nicobar Islands, Dadra and Nagar Haveli, Daman and Diu, and Lakshadweep.

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