The Central Drug Regulatory Authority has found samples of four drugs, including widely used calcium supplement Shelcal 500 and Pan D, as spurious, while samples of 49 drugs were listed as not of standard quality.
The samples of 49 drugs include paracetamol, Pan D, calcium and vitamin D3 supplements, Oxytocin, Metronidazole and fluconazole as "Not of Standard Quality" in its monthly drug alert report for September.
Some of the batches of drugs which have been listed as not of standard quality are by companies like Alkem Health Science, Aristo Pharmaceuticals, Camila Pharmaceuticals, Innova Captain, Hindustan Antibiotics and Ipca Laboratories.
Drug Controller General of India (DCGI) Rajeev Singh Raghuvanshi said the inspections are carried out periodically to bring down the percentage of less efficacious drugs.
"Vigilant action and monitoring of drugs by CDSCO (Central Drugs Standard Control Organisation) drastically brings down the percentage of less efficacious drugs," he said.
"Out of nearly 3,000 samples tested, 49 drugs were asked to be recalled as they were found less efficacious (NSQ). Only nearly 1.5 per cent of the total drugs sampled found to be less efficacious," Raghuvanshi said.
The failure of a drug sample of any specific batch to meet the quality standards does not mean that all drugs being sold by that name are sub-standard. Only that specific batch is considered not of standard quality, an official source said.
The Central Drug Regulatory Authority in its August report had listed samples of over 50 drugs, including widely used paracetamol, Pan D, calcium and vitamin D3 supplements and anti-diabetes pills as "Not of Standard Quality".
Here is full list-
- Metronidazole Tablets I.P. 400 mg
- Vomitel (Domperidon Suspension)
- Oxytocin Injection I.P. 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 I.P. 10 ml
- Oxytocin Injection I.P. 1 ml
- Ceftriaxone Injection I.P. 1g
- Gentamycin Sulphate Injection I.P. 40 mg/ml
- Stimin (Glycopyrrolate 0.5 mg / 5ml + Neostigmine methysulfate Injection 2.5 mg / 5ml)
- Nozal Cream (Ketoconazole Cream BP)
- Hepathin 5000 Injection 5 ml / vial (Heparin Sodium Injection IP 5000 IU / 5ml)
- Gentagain (Gentamicin Injection I.P.)
- Glipizide Tablets I.P. 5 mg
- Omerin-D Capsules (Omeprazole & Domperidone Capsules IP)
- Chill Acid MPS (Dried Aluminium Hydroxide, Magnesium Hydroxide & Activated Dimethicone Suspension)
- Nimuvent-P Tablets (Nimesulide & Paracetamol Tablets)
- Cipronir 500 (Ciprofloxacin Tablets IP 500 mg)
- SMB OZ Tablets (Ofloxacin & Ornidazole Tablets IP)
- Calcium 500 mg and Vitamin D3 250 IU Tablets IP
- LOMJAN (Loperamide Hydrochloride Tablets I.P. 2 mg)
- Glimepiride Tablets IP 1 mg
- Fexofenadine Hydrochloride Tablets I.P.
- Glimepiride Tablets I.P. 2 mg
- PAN 40 (Pantoprazole Gastro-resistant Tablets IP)
- Monocef-O 200 (Cefpodoxime Tablets IP 200 mg)
- Clavam 625 (Amoxicillin And Potassium Clavulanate Tablets I.P.)
- Fexofenadine Hydrochloride Tablets IP
- CIPRODAC 500 (Ciprofloxacin Tablets IP 500 mg)
- Ramipril Tablets I.P. 2.5 mg
- Compound Sodium Lactate Injection I.P. (RL)
- PHENERGAN (Promethazine Hydrochloride Injection I.P.)
- Paracetamol Paediatric Oral Suspension IP
- Spisam Gel (Aluminum Hydroxide, Simethicone & Magnesium Hydroxide Suspension)
- P-Genta Injection (Gentamicin Sulphate Injection IP)
- Flucse – 150 (Fluconazole Tablets IP 150 mg)
- Bisalax Tablets (Bisacodyl Tablets I.P.)
- Citrize-P (Cetirizine Dihydrochloride Syrup)
- Celofos 1000 Injection (Ifosfamide for Injection IP with Mesna Injection)
- ZERODOL-SP Tablets (Aceclofenac 100 mg, Serratiopeptidase 15 mg & Paracetamol 325 mg Tablets)
- UTROCLEAR-OZ Solution (Ofloxacin and Ornidazole Intra Uterine Solution Vet.)
- Nopion 150 Tablets (Bupropion Hydrochloride Extended Release Tablets USP)
- COUGH-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 Prostate Hyperplasia (BPH) or enlargement of the prostate gland, and Deca-Durabolin 25 Injection, used to treat osteoporosis in postmenopausal women are the other drugs flagged as spurious in CDSCO’s recent monthly update for September. As per the regulator, the four medicines were being made by fake companies.
The regulator's monthly action against false medications also listed 49 drugs and formulations, manufactured by 40 companies, as not of standard quality (NSQ). NSQ drugs are those that do not meet the quality standards set by national or international authorities. These 49 were out of the 3,000 drugs, which have been recalled batch-wise 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 includes 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 picked by the CDSCO were spurious and not manufactured by Alkem. He stated that the company is committed to offering quality drugs to patients.
“We have informed the regulator of the same and will continue to work with the authorities to help curb the spurious drug menace in the country,” media reports 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 under various degrees of counts. These include seven drugs manufactured out of Uttarakhand and five from Kerala, including four drugs manufactured by the Kerala Medical Services Corporation.
