Vitamin D3 Calcium Tablets 47 Others Fail CDSCO Quality Tests Full List of Latest Updates – India TV

The Central Drug Regulatory Authority has declared samples of four drugs, including widely used calcium supplements Shelcal 500 and Pan D, as counterfeit, while samples of 49 drugs were listed as not of standard quality.

The samples of 49 drugs included paracetamol, Pan D, calcium and vitamin D3 supplements, Oxytocin, Metronidazole and fluconazole as “Not of Standard Quality” in the monthly drug alert report for September.

Some batches of medicines listed as not of standard quality are from companies like Alkem Health Science, Aristo Pharmaceuticals, Camila Pharmaceuticals, Innova Captain, Hindustan Antibiotics and Ipca Laboratories.

Drugs Controller General of India (DCGI) Rajeev Singh Raghuvanshi said the inspections are being conducted periodically to reduce the percentage of less effective drugs.

“Vigilant action and monitoring of drugs by CDSCO (Central Drugs Standard Control Organization) is drastically reducing the percentage of less effective drugs,” he said.

“Out of nearly 3,000 samples tested, 49 drugs were asked to be recalled as found to be less effective (NSQ). Only nearly 1.5 percent of the total drugs sampled were found to be less effective,” Raghuvanshi said.

Just because a drug sample from a specific batch does not meet quality standards does not mean that all drugs sold under that name are substandard. Only that particular batch is considered not to be of standard quality, an official source said.

The Central Drug Regulatory Authority in its August report had listed samples of more than 50 drugs, including commonly used paracetamol, Pan D, calcium and vitamin D3 supplements and anti-diabetes pills, as “not of standard quality”.

Here is the full list-

• Metronidazole Tablets IP 400 mg
• Vomitel (Domperidone suspension)
• Oxytocin injection IP 5 IU/1 ml
• SPAMET GM 2 tablets (Metformin hydrochloride 500 mg SR & Glimepiride 2 mg tablets IP)
• Diclofenac Sodium Tablets IP 50 mg
• Calcium Gluconate Injection IP 10 ml
• Oxytocin Injection IP 1 ml
• Ceftriaxone Injection IP 1g
• Gentamycin sulphate injection IP 40 mg/ml
• Stimin (Glycopyrolate 0.5 mg / 5 ml + Neostigmine methyl sulfate injection 2.5 mg / 5 ml)
• Nozal Cream (Ketoconazole Cream BP)
• Hepathin 5000 injection 5 ml / vial (heparin sodium injection IP 5000 IU / 5 ml)
• Gentagain (Gentamicin Injection IP)
• Glipizide tablets IP 5 mg
• Omerin-D Capsules (Omeprazole and Domperidone Capsules IP)
• Chill Acid MPS (dried aluminum hydroxide, magnesium hydroxide and activated dimethicone suspension)
• Nimuvent-P tablets (nimesulide and paracetamol tablets)
• Cipronir 500 (Ciprofloxacin Tablets IP 500 mg)
• SMB OZ tablets (ofloxacin and ornidazole tablets IP)
• Calcium 500 mg and vitamin D3 250 IU tablets IP
• LOMJAN (Loperamide hydrochloride tablets IP 2 mg)
• Glimepiride tablets IP 1 mg
• Fexofenadine Hydrochloride Tablets IP
• Glimepiride tablets IP 2 mg
• PAN 40 (Pantoprazole gastro-resistant tablets IP)
• Monocef-O 200 (Cefpodoxime Tablets IP 200 mg)
• Clavam 625 (amoxicillin and potassium clavulanic acid tablets IP)
• Fexofenadine Hydrochloride Tablets IP
• CIPRODAC 500 (Ciprofloxacin Tablets IP 500 mg)
• Ramipril tablets IP 2.5 mg
• Compound Sodium Lactate Injection IP (RL)
• PHENERGAN (Promethazine Hydrochloride Injection IP)
• Paracetamol oral suspension for children IP
• Spisam gel (aluminum hydroxide, simethicone and magnesium hydroxide suspension)
• P-Genta Injection (gentamicin sulfate injection IP)
• Flucse – 150 (Fluconazole tablets IP 150 mg)
• Bisalax Tablets (Bisacodyl Tablets IP)
• Citrize-P (Cetirizine dihydrochloride syrup)
• Celofos 1000 Injection (Ifosfamide for Injection IP with Mesna Injection)
• ZERODOL-SP tablets (aceclofenac 100 mg, serratiopeptidase 15 mg and paracetamol 325 mg tablets)
• UTROCLEAR-OZ solution (ofloxacin and ornidazole intrauterine solution, vet)
• Nopion 150 Tablets (Bupropion Hydrochloride Extended Release Tablets USP)
• CUGH-DM Cough Syrup (Dextromethorphan Hydrobromide, Chlorpheniramine Maleate and Phenylephrine Hydrochloride Syrup)
• KEFZONE-S INJECTION (Cefoperazone and Sulbactam for Injection)
• CASIDTAZ P Injection (Piperacillin and Tazobactam Injection IP)
• NUROFENS-2500 Injection (Methylcobalamin Injection 2500 mcg)
• Torverge-10 tablets (Torsemide tablets IP 10 mg)

Urimax D, used to treat benign prostatic hyperplasia (BPH) or enlargement of the prostate gland, and Deca-Durabolin 25 Injection, used to treat osteoporosis in postmenopausal women, are the other drugs included in CDSCO’s recent monthly update for September have been classified as false. According to the regulator, the four drugs were made by fake companies.

The regulator’s monthly drive against counterfeit medicines also listed 49 medicines and formulations, manufactured by 40 companies, as not of standard quality (NSQ). NSQ drugs are drugs that do not meet quality standards established by national or international authorities. These 49 were among the 3,000 drugs recalled in batches by CDSCO.

Antibiotic Clavam 625 and antacid Pan 40 tablets, manufactured by Alkem Health Science, are some of these drugs on the list. It also contains other antibiotics Monocef and Ciprodac 500, manufactured by Aristo Pharmaceuticals and Cadila Pharmaceuticals respectively.

A spokesperson for Alkem Laboratories reportedly defended the company, stating that the drug samples selected by the CDSCO were counterfeit and not manufactured by Alkem. He stated that the company is committed to providing quality medicines to patients.

“We have informed the regulator about this and will continue to work with authorities to help curb the counterfeit drug menace in the country,” the media quoted the spokesperson as saying.

Further, the regulatory body also released a state list of 18 drugs manufactured by 14 companies that were found to be NSQ to varying degrees. These include seven medicines manufactured from Uttarakhand and five from Kerala, including four medicines manufactured by the Kerala Medical Services Corporation.