CDSCO declares 16 drug samples including Clopidogrel, Aspirin Tablets as Not of Quality Standard
New Delhi: The apex drug regulatory body, Central Drugs Standard Control Organization (CDSCO) has flagged 16 drug samples including Clopidogrel and Aspirin Tablets as 'Not of Standard Quality' after they failed to qualify a random drug sample test for the month of January.
These drug samples included popular formulations and brands such as Diclofenac Gastro Resistant Tablets I.P. 50 mg (Regunac -50); Omecot Capsules (Omperazole Capsules IP); Clopidogrel and Aspirin Tablets; Amitriptyline Tablets I.P., Nitzo - 2.6 (Controlled-Release Tablets of Nitroglycerin) and others.
This came after the analysis and test conducted by the CDSCO, Drugs Control Departments, on 1001 drug samples. Out of this 985 samples were found of Standard quality while 16 of them were declared as 'Not of Standard Quality'.
A few of the causes why the drug samples failed to clear the test include Dissolution test failure, Microbial contamination, Particulate Matter & Clarity of Solution test failure, Assay of Ethyl Alcohol failure, and others.
The collected samples were tested in three laboratories namely CDL Kolkata, RDTL Chandigarh, CDTL Mumbai.
Total number of samples tested | 1001 |
Total number of samples declared as of Standard Quality | 985 |
Total number of samples declared as Not of Standard Quality | 16 |
Total number of samples declared as Spurious | 0 |
Total number of samples declared as Misbranded | 0 |
List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, for the Month of January 2021
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. | Omnikacin – 250 (Amikacin Injection I.P.) | B. No.: C2VAR02 Mfg dt: 01/2020 Exp dt: 12/2021 Mfd by: M/s. Akums Drugs & Pharmaceuticals Ltd., 2, 3, 4 & 5, Sector 6-B, I.I.E., SIDCUL, Ranipur, Haridwar- 249403 Uttarakhand. | Assay | CDSCO, South Zone | CDL, Kolkata |
2. | Ontic Syrup (Ondansetron Oral Solution I.P- 30 ml) | B. No.: CL19136 Mfg dt: 10/2019 Exp dt: 09/2021 Mfd by: M/s. Corona Remedies Pvt. Ltd., Vill. Jatoli, P.O. Oachghat, Tehsil: Solan, Dist. Solan Himachal Pradesh - 173223. | Description | CDSCO, Hyderabad | CDL, Kolkata |
3. | Tolvat 30 (Tolvaptan Tablets 30 mg) | B. No.: BRA02174D Mfg dt: 02/2020 Exp dt: 01/2023 Mfd by: M/s. MSN Laboratories Private Limited, Plot No. 42, Anrich Industrial Estate, Bollaram, Sangareddy District-502325, Telangana. | Dissolution | CDSCO, Hyderabad | CDL, Kolkata |
4. | Disilox MPS (Aluminium, Magnesium & Simethicone Oral Suspension I.P.) | B. No.: C20C92 Mfg dt: 06/2019 Exp dt: 05/2022 Mfd by: M/s. Stadmed Private Limited, 15, Jawpore Road, Kolkata-700074. | Microbial Contamination (Total Aerobic Viable Count) | CDSCO, East Zone, Kolkata | CDL, Kolkata |
5. | Nitzo - 2.6 (Controlled Release Tablets of Nitroglycerin) | B. No.: 419-1544 Mfg dt: 11/2019 Exp dt: 10/2021 Mfd by: M/s. Zee Laboratories, 47, Industrial Area, Paonta Sahib – 173025, Himachal Pradesh. | Assay of Glyceryl Trinitrate | CDSCO, East Zone, Kolkata | CDL, Kolkata |
6. | Diclofenac Gastro Resistant Tablets I.P. 50 mg (Regunac -50) | B. No.: FZ57K801 Mfg dt: 10/2018 Exp dt: 09/2021 Mfd by: M/s. Zim Laboratories Ltd., B-21/22, MIDC Area, Kalmeshwar, Nagpur, Maharashtra. | Description | CDSCO, East Zone, Kolkata | CDL, Kolkata |
7. | Amlor -2.5(Amlodipine Besylate Tablets I.P. 2.5 mg) | B. No.: KN20001 Mfg dt: 05/2020 Exp dt: 04/2022 Mfd by: M/s. Ortin Laboratories Ltd., 275 & 278 (Part), I.D.A. Pashamylaram -502307, Sangareddy Dist. T.S., Telangana. | Dissolution, Related Substances and Assay | CDSCO, East Zone, Kolkata | CDL, Kolkata |
8. | Amitriptyline Tablets I.P. | B. No.: TAMF-026 Mfg dt: 03/2020 Exp dt: 02/2022 Mfd by: M/s. Medipol Pharmaceutical India Pvt. Ltd., 1199/3, Bhud, Baddi, Dist. Solan, Himachal Pradesh. | Description | CDSCO, East Zone, Kolkata | CDL, Kolkata |
9. |
I.P.)
| B. No.: 13018A Mfg dt: 03/2019 Exp dt: 02/2021 Mfd by: M/s. Osper Formulations Pvt. Ltd., Plot No. 134-B, Export Promotion Industrial Park, Phase- 1, Jharmajri Baddi, Dist. Solan, Himachal Pradesh. B. No.: 1902022 Mfg dt: 02/2019 Exp dt: 01/2022 Mfd by: M/s. legency Remedies Pvt. Ltd., P.O. Baddi, Dist. Solan Himachal Pradesh. | Particulate Matter & Clarity of Solution | CDSCO, Sub Zone, Baddi | CDL, Kolkata |
10. | VEDARK INSTANT HAND SANITIZER | B. No.: A-142 Mfg dt: 05/2020 Exp dt: 04/2022 Mfd by: M/s. Gladios Products Pvt. Ltd., 31, Virat industrial Estate, Dhanot Gandhinagar-382721 Gujarat. | Identification of Chlorhexidine Gluconate | CDSCO North Zone | RDTL, Chandigarh |
11. | DAYS 2X HAND SANITIZER | B. No.: BYHS29 Mfg dt: 09/2020 Exp dt: 08/2023 Mfd by: M/s. Yadav's Health & Beauty Herbal Products Plot No.25, EPIP, Phase-2, Thana, Baddi, Distt. Solan, Himachal Pradesh -173205. | Assay of Ethyl Alcohol | Drug Control Departmen t Himachal Pradesh | RDTL, Chandigarh |
12. | Doxycycline and Lactic Acid Bacillus Capsules (Mesodox LB Capsules) | B. No.: HBC-4052 Mfg dt: 02/2020 Exp dt: 07/2021 Mfd by: M/s. Haustus Biotech Pvt. Ltd. 44-45, Indl.Area, Tahliwal, Distt.Una Himachal Pradesh. | Uniformity of filled weight | CDSCO North Zone | RDTL, Chandigarh |
13. | Hand Sanitizer | B. No.: V20EL011 Mfg dt: 04/2020 Exp dt: 08/2022 Mfd by: M/s. Vowcare Products Plot No.77, Zone 4th, I.G.C., SIDCO Lassipora, Dist. Pulwama Jammu & Kashmir 192305. | Assay of Isopropyl Alcohol Hydrogen Peroxide Glycerol | Drug Control Departmen t Srinagar | RDTL, Chandigarh |
14. | (Omeprazole Capsules I.P.) 20 mg | B. No.: 5703320 Mfg dt: 06/2020 Exp dt: 05/2022 Mfd by: M/s. Karnataka Antibiotics & Pharmaceuticals Ltd., (A Govt. of India Enterprise), Plot No.14, II Phase, Peenya, Bengaluru - 560 058 Karnataka. | Dissolution (Acid Stage) | CDSCO, West Zone Mumbai | CDTL, Mumbai |
15. | Omecot Capsules (Omperazole Capsules IP) | B. No.: MC 19235 Mfg dt: 08/2019 Exp dt: 07/2021 Mfd by: M/s. Mascot Health Series Pvt Ltd., Plot No. 79, 80, Sector 6 A, IIE, Sidcul, Haridwar 249 403, Uttarakhand. | Assay & Dissolution | CDSCO, West Zone Mumbai | CDTL, Mumbai |
Also Read:CDSCO Declares 14 Drug Samples Including BP, dyslipidemia Drug As Not Of Standard Quality
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