The CDSCO has noted that Spurious or Quality or Adulterated or Misbranded of Drugs products, medical devices and Cosmetic products are formulations manufactured concealing the true identity of the product and made to resemble another such product, especially any popular brand, to deceive the customer and cash in on the popularity of the original. The products may or may not contain active ingredients. Spurious or adulterated drugs and cosmetics products are usually manufactured by unlicensed anti-social elements but sometimes licensed manufacturers may also be involved. Such adulterated products are those products which are found to contain an adulterated or substituted product or contaminated with filth rendering it injurious to health. By taking into consideration, on 17th October, CDSCO (Central Drug Standard Control Organisation[1]) issued a list of Drugs, Medical Devices, and Cosmetics declared as Spurious or Quality or Adulterated or Misbranded for the month of September 2022. In this blog, we will discuss a list of Drugs, Medical Devices, and Cosmetics declared as Spurious or Quality or Adulterated or Misbranded for the month of September 2022, issued by CDSCO.
Total Number of Samples tested by CDSCO – List of Drugs, Medical Devices, and Cosmetics issued by CDSCO
Below is the table showing a total number of samples tested by CDSCO in the month of September 2022:
| Particulars | Number of Samples |
| Total Number of Samples Tested | 1456 |
| Total No. of Samples declared as Not of Standard Quality | 59 |
| Total No. of Samples declared as of Standard Quality | 1397 |
| Total No. of Samples declared as Misbranded | _ |
| Total No. of Samples declared as Spurious | _ |
Detailed List of Drugs, Medical Devices, and Cosmetics issued by CDSCO for the Month of September 2022
Following is the list of Drugs, Medical Devices, and Cosmetics declared as Spurious or not of Standard Quality or Misbranded or Adulterated issued by CDSCO for the Month of September 2022:
| Name of Medical Devices or Cosmetics or Drugs | Reason for Failure |
| Pantoprazole Sodium Gastro Resistant Tablets I.P. Pantofer-40 Tablets | Dissolution (Buffer Stage) |
| Ocean-OZ (Ofloxacin & Ornidazole Tablets) | Dissolution |
| Ornigyl-O (Ofloxacin and Ornidazole Tablets I.P.) | Dissolution |
| Paracetamol Tablets IP (Larkin) | Dissolution |
| NTP-650 (Paracetamol Tablets I.P. 650 mg.) | Dissolution |
| Paracetamol Tablets IP 650 mg | Dissolution |
| Dried Ferrous Sulphate & Folic Acid Tablets IP | Description |
| Montelukast Sodium & Levocetirizine Dihydrochloride Tablets IP (Viznil) | Description |
| ALCIFLOX 500 (Ciprofloxacin Tablets IP) | Dissolution |
| Rabeprazole Gastro Resistant Tablets I.P. 20 mg | Assay |
| Ascorbic Acid Tablets IP 500 mg | Description |
| WARCETIZ (Cetirizine Hydrochloride Tablets IP) | Description |
| KOOCAL-500 (Calcium with Vitamin D Tablets IP) | Identification & Assay of Vitamin D3 |
| Glimepiride Tablets IP 1 mg. Glimvale-1 Tablets | Dissolution |
| Levocetirizine Dihydrochloride Syrup | pH |
| OMECAP (Omeprazole Capsules IP 20 mg) | Dissolution |
| Ranitidine Tablets IP 150 mg (ACILOC 150) | Description |
| IM-OK-(Levocetirizine Hydrochloride Tablets IP) | Dissolution |
| Co-trimoxazole Tablets IP SS | Disintegration |
| Rosuvastatin Calcium Tablets IP 10 mg | Dissolution |
| Sin-DSR (Rabeprazole Sodium (EC) & Domperidone Sustained Release Capsules) | Assay for Raberprazole Sodium |
| Atorvastatin Tablets IP 20 mg | Dissolution |
| Levothyroxine Sodium Tablets IP 50 mcg | Assay |
| Lvcipro 500 – tablets (Ciprofloxacin Hydrochloride Tablets IP) | Dissolution |
| Zinc Sulphate Dispersible Tablets IP 20 mg | Uniformity of Dispersion & Disintegration |
| MONTERUS-L (Montelukast Sodium & Levocetirizine Hydrochloride Tablets I.P.) | Dissolution and Description |
| Azithromycin Oral Suspension IP 200 mg/ 5 ml | Assay or Content of Anhydrous Azithromycin |
| ACILOC 150 (RANITIDINE Tablets IP 150 mg) | Description |
| Azithromycin Tablets IP 500mg AZUSTAN-500 Tablets | Dissolution |
| Moxmed-500 (Amoxycillin Capsule I.P. 500mg) | Dissolution & Array |
| Telmisartan Tablets I.P. 40 mg | Dissolution |
| AMITRYN-C (Chlordiazepoxide & Amitriptyline Hydrochloride Tablets U.S.P.) | Assay of Chlordiazepoxide |
| Thirobal -5 (Carbimazole Tablets I.P. 5 mg) | Thiamazole & other related substances |
| Secef – CV (Cefixime & Potassium Clavulanate Tablets) | Assay of Cefixime and Postassium Clavulanate |
| Misopres -200 (Misoprostol Tablets I.P. 200 mcg) | Assay |
| Misoprostol Tablets I.P. 200 mcg | Assay |
| LEVOCET Levocetirizine Tablets IP 5 mg | Description |
| BUDISON 0.5 Respules (Budenoside, Nebuliser Suspension BP (0.5 mg) – 2 ml | Assay & Related Substances |
| Clopidogrel & Aspirin Tablets I.P. | Free Salicylic Acid (Related substances for Asprin) |
| RL 500ml (Compound Sodium Lactate Injection IP) (Ringer Lactate Solution for Injection) | Bacterial Endotoxins |
| Flavosil -200 (Flavoxate Hydrochloride Tablets IP 200 mg) | Assay |
| Vildazem M 1000 (Vildagliptin 50 mg & Metformin Hydrochloride 1000 mg Tablets I.P.) | Disintegration |
| Losacon-H (Losartan Potassium & Hydrochlorothiazide Tablets I.P.) | Assay of Hydrochlorthiazide |
| Alumina, Magnesia & Simethicone Tablets U.S.P. | Assay of Simethicone |
| Propoven Injection 50ml (Propofol Emulsion for Injection IP 10mg/ml) | Free Fatty Acid and Assay |
| Propomit Injection 20 ml (Propofol Emulsion for Injection IP 10mg/ml) | Free Fatty Acid |
| NEXOFOL Injection 20 ml (Propofol Emulsion for Injection IP 10mg/ml) | Assay |
| Ciprofloxacin Tablets IP 500 mg | Test for Dissolution |
| Norfloxacin Tablets I.P. 400 mg | Dissolution Test |
| FEXOFENADINE HCL Tablets IP 120 mg (REFEXO Tablets 120 mg) | Dissolution |
| DIVALPROEX SODIUM Tablets IP 500 mg | Dissolution (Buffer Stage) |
| Prolongedrelease Sodium Valproate Tablet BP 500 mg | Description |
| Zinc Sulphate Dispersible Tablets IP | Disintegration test |
| THIOCOLCHICOSI DE CAPSULES IP 4 mg | Assay |
| POVIDONE Iodine Solution IP 10% W/V | pH & Assay |
| Propofol Emulsion for Injection IP 10 mg/ml (PROPOVEN INJECTION ) | Description, pH, Free fatty acid, Propofol dimer, Bacterial Endotoxins Sterility |
| Propofol Injection IP 1%w/v (NEOROF INJECTION ) | pH |
Conclusion
The CDSCO comes with a list of Drugs, Medical Devices, and Cosmetics which are not of standard quality or spurious or misbranded every month. In September 2020, the CDSCO declared that it had tested 1456, of which 59 were not of standard quality and 1397 as of standard quality.
Read our Article:CDSCO Medical Device Registration for Paediatrics and Neonatology
