CDSCO Flags 8 Drug Samples As Not Of Standard Quality
New Delhi: The apex drug regulatory body, Central Drugs Standard Control Organization (CDSCO) has flagged 8 drug samples as 'Not of Standard Quality' after they failed to qualify a random drug sample test for the month of October.
These drug samples included popular formulations and brands like Propylene Glycol I.P., Ondansetron Tablets I.P. 8 mg, Verticot – 8 Tablets (Betahistine DiHCL Tablets I.P.), Linezolid Tablets I.P. 600 mg, Amoxycillin Oral Suspension I.P. 125mg/5ml Dry Syrup and others.
This came after analysis and test conducted by the CDSCO, Drugs Control Departments, on 644 drug samples. Out of this, 636 samples were found of Standard quality while 8 of them were declared as Not of Standard Quality (NSQ).
A few of the causes why the drug samples tested failed included Water, Description, Assay and Dissolution, Assay of Chromium Polynicotinate.
The samples were collected by the Drugs Control Department of Himachal Pradesh, CDSCO, West Zone, Mumbai; CDSCO, South Zone, Chennai; CDSCO, Hyderabad Zone; CDSCO, North Zone, Ghaziabad; CDSCO, South Zone, Chennai.
List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, for the Month of October-2020
Total number of samples tested | 644 |
Total number of samples declared as of Standard Quality | 636 |
Total number of samples declared as Not of Standard Quality | 08 |
Total number of samples declared as Spurious | 00 |
Total number of samples declared as Misbranded | 00 |
S.No . | Name of Drugs/medical device/cosmetics | Batch No./Date of Manufacture/Date of Expiry/Manufactured By | Reason for failure | Drawn By | From |
1. | Propylene Glycol I.P. | B. No.: PG-IP/2019- 20/2123, Mfg dt: 07/2019, Exp dt: 06/2024, Mfd by: M/s. Manali Petrochemicals Limited, Plant II, 1/6, Sathangadu Village, Manali, Chennai – 600 068. | Water | CDSCO, South Zone, Chennai | CDL, Kolkata |
2. | Ondansetron Tablets I.P. 8 mg | B. No.: SMAT 703, Mfg dt: 11/2019, Exp dt: 10/2021, Mfd by: M/s. Unicure India, C – 21, 22 & 23, Sector – 3, Noida – 201 301, Distt. Gautam Budh Nagar (U.P.). | Description | CDSCO, North Zone, Ghaziabad | CDL, Kolkata |
3. | Verticot – 8 Tablets (Betahistine DiHCL Tablets I.P.) | B. No.: MT191390, Mfg dt: 08/2019, Exp dt: 07/2021, Mfd by: M/s. Mascot Health Series Pvt. Ltd., Plot No. 79, 80, Sector – 6A, IIE, Sidcul, Haridwar – 249 403, Uttarakhand. | Assay & Dissolution | CDSCO, Hyderabad Zone | CDL, Kolkata |
4. | Linezolid Tablets I.P. 600 mg | B. No.: GT200228, Mfg dt: 02/2020, Exp dt: 01/2022, Mfd by: M/s. Theon Pharmaceuticals Ltd., Vill. Saini Majara, Teh. Nalagarh, Distt. Solan (H.P.) – 174 101. | Dissolution | CDSCO, South Zone, Chennai. | CDL, Kolkata |
5. | Amoxycillin Oral Suspension I.P. 125mg/5ml Dry Syrup | B. No.: 9909619, Mfg dt: 08/2019, Exp dt: 01/2021, Mfd by: M/s. Karnataka Antibiotics & Pharmaceuticals limited (A govt. of India Enterprise) plot No. 14, II Phase, Peenya, bengaluru, 560058. | Assay | CDSCO, West Zone, Mumbai | CDTL, Mumbai |
6. | Methylcobalamin, Benfotiamine, Folic Acid, Chromium Polynicotinate, Myo- Inositol and Pyridoxine Hydrochloride Tablets ( NUHENZ TABLETS) | B. No.: T0501969, Mfg dt: 07/2019, Exp dt: 06/2021, Mfd by: M/s. Standord Laboratories Pvt. Ltd. 8, Industrial Area, Mehatpur Distt. Una, (H.P.)-174315. | Assay of Chromium Polynicotinate | Drugs Control Department, Himachal Pradesh | RDTL, Chandigarh |
7. | ISO PROPYL ALCOHOL IP | B. No.: IPA/DRM/2020/0035, Mfg dt: 02/2020, Exp dt: 01/2023, Mfd by: M/s. Deepak Fertilizers & Petro Chemicals, Maharashtra. | Water | Drugs Control Department, Himachal Pradesh | RDTL, Chandigarh |
8. | ISO PROPYL ALCOHOL IP | B. No.: IPA/GCPL/532, Mfg dt: 05/2020, Exp dt: 04/2023, Mfd by: M/s. Gujrat Chempac Pvt.Ltd. Valsad Gujarat. | Water | Drugs Control Department, Himachal Pradesh | RDTL, Chandigarh |
To view the official notice, click on the following link:
