CDSCO Flags 22 Drug Samples As Not Of Standard Quality
New Delhi: The apex drug regulatory body, Central Drugs Standard Control Organization (CDSCO) has flagged 10 drug samples as 'Not of Standard Quality' after they failed to qualify a random drug sample test for the month of September.
These drug samples included popular formulations and brands like ISOPROPYL ALCOHOL IP, Noradrenaline Bitartrate I.P., Clopidogrel, and Aspirin Tablets, Levocetirizine Tablets I.P. 5 mg, CefiximeTablets I.P. 100 mg, Ranius – 300 (Ranitidine Tablets I.P. 300 mg) and others.
This came after analysis and test conducted by the CDSCO, Drugs Control Departments, on 646 drug samples. Out of this, 636 samples were found of Standard quality while 10 of them were declared as Not of Standard Quality (NSQ).
A few of the causes why the drug samples tested failed included Description, Limit of Salicylic Acid and Assay of aspirin, Assay, Dissolution, Description & Particulate Matter, pH, Disintegration, and Assay of Vitamin D3, Assay of Glycerin, Chlorhexidine Digluconateand so on.
The samples were collected by the Drugs Control Department of Himachal Pradesh, CDSCO Zonal Office, Hyderabad, CDSCO, East Zone, Kolkata, CDSCO, South Zone, Chennai, CDSCO, Zonal Office, Ahmedabad, CDSCO, Zonal Office, Hyderabad also picked up samples. Tests were conducted in two laboratories namely CDL Kolkata, RDTL Chandigarh.
List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, for the Month of September 2020
Total number of samples tested | 646 |
Total number of samples declared as of Standard Quality | 636 |
Total number of samples declared as Not of Standard Quality | 10 |
Total number of samples declared as Spurious | 0 |
Total number of samples declared as Misbranded | 0 |
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. | CIROPRAZ – 1 Injection – 5 ml (Midazolam Injection I.P. 1 mg/ml) | B. No.: 9B04028 Mfg dt: 04/2019 Exp dt: 03/2021 Mfd by: M/s. Ciron Drugs & Pharmaceuticals Pvt. Ltd., N - 118, 119, 113, 119/1, 119/2 & 118/1, M.I.D.C., Tarapur, Boisar, Distt. Palghar – 401 506 (Maharashtra). | Description & Particulate Matter | CDSCO, Zonal Office, Hyderabad | CDL, Kolkata |
2. | Ranius – 300 (Ranitidine Tablets I.P. 300 mg) | B. No.: VNT – 19A02 Mfg dt: 01/2019 Exp dt: 12/2020 Mfd by: M/s. Venus Biosciences Pvt. Ltd., 116, Export Promotion Industrial Park, Phase – I, Jharmajri, Baddi, Distt. Solan – 173 205, H.P. | Dissolution & Assay | CDSCO, East Zone, Kolkata | CDL, Kolkata |
3. | CefiximeTablets I.P. 100 mg | B. No.: 8513007 Mfg dt: 11/2018 Exp dt: 10/2020 Mfd by: M/s. Bengal Chemicals & Pharmaceuticals Ltd., 164, Maniktala Main Road, Kolkata – 700 054. | Description, Dissolution & Assay | CDSCO, East Zone, Kolkata | CDL, Kolkata |
4. | Levocetirizine Tablets I.P. 5 mg | B. No.: 9700719 Mfg dt: 05/2019 Exp dt: 04/2021 Mfd by: M/s. Karnataka Antibiotics & Pharmaceuticals Limited, Plot No. – 14, II Phase, Peenya, Bangalore – | Dissolution | CDSCO, East Zone, Kolkata | CDL, Kolkata |
560 058. | |||||
5. | Clopidogrel & Aspirin Tablets | B. No.: TACB-010 Mfg dt: 07/2019 Exp dt: 06/2021 Mfd by: M/s. Medipol Pharmaceutical India Pvt. Ltd., 1199/3, Bhud, Baddi, Distt. Solan (Himachal Pradesh). | Description, Limit of Salicylic Acid and Assay of aspirin | CDSCO, South Zone, Chennai | CDL, Kolkata |
6. | Noradrenaline Bitartrate I.P. | B. No.: MLPL/NABT/0220/84 Mfg dt: 02/2020 Exp dt: 01/2023 Mfd by: M/s. Medinex Laboratories Pvt. Ltd., Plot No. 2 & 3, Survey No. 277/1, Vill, Ukharla – 364 050, Distt. Bhavnagar (Gujarat). | pH | CDSCO, Zonal Office, Ahmedabad | CDL, Kolkata |
7. | ROOTCAL ((Calcium Citrate Malate & Vitamin D3 Tablets) | B. No.: RTC - 1910 Mfg dt: 10/2019, Exp dt: 09/2021, Mfd by: M/s. Concord Drugs Ltd., Survey No. 249, Brahmanapally, R.R. (DT.) TS– 501 511 Hyderabad, Telangana. | Disintegration and Assay of Vitamin D3 | CDSCO, Zonal Office, Hyderabad | CDL, Kolkata |
8. | (ISOPROPYL ALCOHOL IP) | B. No.: IPA/GCPL/532 Mfg dt: 05/2020 Exp dt: 04/2023 Mfd by: M/s. Gujrat Chempac Pvt. Ltd. Valsad Gujrat. | Refractive Index, Water | Drugs Control Department, Himachal Pradesh | RDTL, Chandigarh |
9. | (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 Gujrat. | Identification | Drugs Control Department, Himachal Pradesh | RDTL, Chandigarh |
10. | Isopropyl Alcohol, Carbopol, Triethanolamine, Glycerin and Chlorhexidine Digluconate Hand Sanitizer ( Safe And Clean Hand Sanitizer) | B. No.: C-02 Mfg dt: 04/2020 Exp dt: 03/2022 Mfd by: M/s. Cosway Pharmaceuticals Plot No.11C, Ind.Area, Tahiwal, Teh.Haroli, Distt.UNA, (H.P)-174507. | Assay of Glycerin, Chlorhexidine Digluconate | Drugs Control Department, Himachal Pradesh | RDTL, Chandigarh |
To view the official notice, click on the following link:
https://medicaldialogues.in/pdf_upload/pdf_upload-135830.pdf
