22 drug samples fail to qualify CDSCO test, Details
New Delhi: In its latest drug safety alert, the apex drug regulatory body, Central Drugs Standard Control Organization (CDSCO) has flagged 22 medicine batches for failing to qualify for a random drug sample test for the month of November.
These drug samples include Eurokem Laboratories' Glimepiride Tablets, Bharat Parenterals' Phytomenadione Injectoin IP 10mg/ml (Vitamin K1 Injection) 1 ml, Zee Laboratories' LECETZY (Levocetirizine Tablets I.P.), Danish Health Care's Dixogyl-400 (Metronidazole Tablets IP 400 mg), Health Biotech's Lignocaine and Adrenaline Injection IP (ACAINE ADR INJECTION) and others.
This came after analysis and test were conducted by the CDSCO, Drugs Control Departments on 1102 samples. Out of this, 1080 samples were found of standard quality while 22 of them were declared as Not of Standard Quality (NSQ).
A few of the reasons why the drug samples tested failed were the failure of Sterility test, failure of dissolution test, failure of the assay, failure of moisture content test.
The samples collected were tested in five laboratories, namely CDL Kolkata, CDTL Mumbai, RDTL Chandigarh, CDTL Hyderabad.
List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, for the Month of November – 2021
Total number of samples tested | 1102 |
Total number of samples declared as of Standard Quality | 1080 |
Total number of samples declared as Not of Standard Quality | 22 |
Total number of samples declared as Spurious | - |
Total number of samples declared as Misbranded | - |
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. | RL (Compound Sodium Lactate injection I.P. 500 ml) (Ringe Lactate Solution for Injection I.P.) | B. No.: 103111 Mfg dt: 03/2021 Exp dt: 02/2023 Mfd by: M/s. Ives Drugs (India) Pvt. Limited, Works: Ghatabillod, Distt. Dhar, Madhya Pradesh. | Sterility | Drug Control Department Madhya Pradesh | CDL Kolkata |
2. | Glimepiride Tablets I.P. 1mg | B. No.: GP108 Mfg dt: 04/2021 Exp dt: 03/2023 Mfd by: M/s. Eurokem Laboratories Pvt. Ltd., C- 25, Sidco Pharmaceuticals Complex, Alathur, Thiruporur-603110 Tamil Nadu. | Dissolution & Related Substances | CDSCO South Zone Chennai | CDL Kolkata |
3. | Mineral Supplements Tablets | B. No.: ET-210101 Mfg dt: 01/2021 Exp dt: 12/2022 Mfd by: M/s. Ethicare Laboratories, 15, Industrial Estate, Digiana, Jammu- 180010. | Description | CDSCO South Zone Chennai | CDL Kolkata |
4. | Vitamin B – Complex Tablets NFI III | B. No.: VPT801 Mfg dt: 06/2020 Exp dt: 11/2021 Mfd by: M/s. Unicure India Ltd., C- 21,22 & 23, Sector-3, Noida 201301, Dist. Gautam Budh Nagar, Uttar Pradesh. | Description, Assay of Vitamin B1 & Calcium Pantothenate | CDSCO South Zone Chennai | CDL Kolkata |
5. | Phytomenadione Injectoin IP 10mg/ml (Vitamin K1 Injection) 1 ml | B. No.: P0383 Mfg dt: 07/2020 Exp dt: 06/2022 Mfd by: M/s. Bharat Parenterals Ltd., Vill, Haripura, Ta. Savli, Dist. Vadodara-391520, Gujarat. | Description, Particulate Matter and Sterility | CDSCO Hyderabad | CDL Kolkata |
6. | MULVIT (Multi Vitamin Tablets) | B. No.: CU20003 Mfg dt: 12/2020 Exp dt: 05/2022 Mfd by: M/s. Ortin Laboratories Ltd., 275 & 278 (part), I.D.A. Pashamilaram – 502307, Telangana. | Description, Identication of Vitamin D3, Assay of Vitamin A Acetate & Vitamin D3 | CDSCO East Zone Kolkata | CDL Kolkata |
7. | Telmopac – AM (Telmisartan & Amlodipine Tablets) | B. No.: APT/04282 Mfg dt: 04/2021 Exp dt: 03/2023 Mfd by: M/s. Amkon Pharmaceuticals, Plot No. 242, Ind. Area. Phase IX, S.A.S. Nagar, Mohali – 160062(Punjab). | Dissolutoin, Related Substances and Assay | CDSCO East Zone Kolkata | CDL Kolkata |
8. | Oflopac – OZ Tablet (Ofloxacin & Ornidazole Tablets I.P.) | B. No.: APT/03047 Mfg dt: 04/2020 Exp dt: 03/2022 Mfd by: M/s. Amkon Pharmaceuticals, Plot No. 242, Phase – 9, Industrial Area, Mohali- 160062 (Punjab). | Identification of Ofloxacin, and Dissolution & Assay of Ofloxacin & Ornidazole | CDSCO East Zone Kolkata | CDL Kolkata |
9. | LECETZY (Levocetirizine Tablets I.P.) | B. No.: 420-1286 Mfg dt: 10/2020 Exp dt: 09/2022 Mfd by: M/s. Zee Laboratories, 47, Industrial Area, Paonta Sahib- 173025, Himachal Pradesh. | Dissolution and Assay | CDSCO East Zone Kolkata | CDL Kolkata |
10. | Ashialben 300 (Albendazole 300 mg Bolus) | B. No.: ALT-9096 Mfg dt: 08/2021 Exp dt: 07/2025 Mfd by: M/s. Ashish Lifesciences Pvt. Ltd., J- 137, MIDC, Tarapur | Moisture content | CDSCO West Zone Mumbai | CDTL Mumbai |
Maharashtra, India. | |||||
11. | Ashialben 300 (Albendazole 300 mg Bolus) | B. No.: ALT-8958 Mfg dt: 05/2021 Exp dt: 04/2025 | Moisture content | CDSCO West Zone Mumbai | CDTL Mumbai |
Mfd by: M/s. Ashish Lifesciences Pvt. Ltd., J- 137, MIDC, Tarapur, Maharashtra, India | |||||
12. | Ashialben 600 (Albendazole Bolus 600 mg) | B. No.: ALT-8703 Mfg dt: 12/2020 Exp dt: 11/2024 | Moisture content | CDSCO West Zone Mumbai | CDTL Mumbai |
Mfd by: M/s. Ashish Lifesciences Pvt. Ltd., J- 137, MIDC, Tarapur, Maharashtra, India. | |||||
13. | Ashialben 300 (Albendazole 300 mg Bolus) | B. No.: ALT-9090 Mfg dt: 08/2021 Exp dt: 07/2025 | Moisture content | CDSCO West Zone Mumbai | CDTL Mumbai |
Mfd by: M/s. Ashish Lifesciences Pvt. Ltd., J- 137, MIDC, Tarapur Maharashtra, India. | |||||
14. | Dixogyl-400 (Metronidazole Tablets IP 400 mg) | B. No.: DLY2101 Mfg dt: 01/2021 Exp dt: 12/2022 | Uniformity of weight | CDSCO Sub Zone Indore | CDTL Mumbai |
Mfd by: M/s. Danish Health Care (P) Ltd., 76/27-28, Industrial Estate, Maxi Road, Ujjan 456010, Madhya Pradesh. | |||||
15. | CLOPIDOGREL & ASPIRIN TABLETS IP (PILOGRELTM_ A75) | B. No.: ALA21002 Mfg dt: 02/2021 Exp dt: 01/2023 Mfd by: M/s. Psychotropics India Ltd. Plot No. 46 & 49, | Description | CDSCO Zonal Office Hyderabad | CDTL Hyderabad |
Sector-6A, IIE SIDCUL, | |||||
Ranipur, Haridwar- | |||||
249403, Uttarakhand. | |||||
16. | Diclofenac Sodium Prolonged Release Tablets IP (FENCO-100 SR) | B. No.: IDM20020 Mfg dt: 05/2020 Exp dt: 04/2023 Mfd by: M/s IBN Herbals, {A unit of Curetech Formulations (P) Ltd.}, Khasra No. 63, Vill.- Juddi | Dissolution | Drug Control Department Kohima | RDTL Guwahati |
Kalan, Baddi, Dist.- Solan Himachal Pradesh. | |||||
17. | ATENOLOL AND AMLODIPINE TABLETS | B. No.: Z20-660 Mfg dt: 05/2020 Exp dt: 04/2022 | Assay of Amlodipine | CDSCO Sub-Zone Baddi | RDTL Chandigarh |
Mfd by: M/s. Zee Laboratories Ltd. Behind 47, Industrial Area, Paonta Sahib -173205, Himachal Pradesh. | |||||
18. | Lignocaine and Adrenaline Injection IP (A- CAINE ADR INJECTION) | B. No.: HILR2006F Mfg dt: 11/2020 Exp dt: 10/2022 Mfd by: M/s. Health Biotech Ltd. Village: Sandoli, Nalagarh Road, Baddi, Distt. Solan, Himachal Pradesh - 173205. | Assay of Adrenaline | Drug Control Department Himachal Pradesh | RDTL Chandigarh |
19. | Amlodipine Besylate and Atenolol Tablets (CARDINOL PLUS TABLETS) | B. No.: 1154-12 Mfg dt: 05/2021 Exp dt: 04/2024 Mfd by: M/s. Hab Pharmaceuticals & Research Limited 10, Pharmacity, SIDCUL, Selaqui, Dehradun- 248011, Uttarakhand. | Assay of Amlodipine | Drug Control Department Himachal Pradesh | RDTL Chandigarh |
20. | Atorvastatin Calcium Tablets IP 10 mg | B. No.: CATO009001 Mfg dt: 09/2020 Exp dt: 08/2022 | Related Substances | CDSCO Sub Zone Jammu | RDTL Chandigarh |
Mfd by: M/s. Celebrity Bipharma Ltd. Vill. Panga, Jharmajri, Hill Top Estate, Barotiwala, Distt. Solan H.P. 174103. | |||||
21. | Ofloxacin and Metronidazole Suspension (OFLOX OZ SUSPENSION ) | B. No.: CLOF1014 Mfg dt: 09/2021 Exp dt: 08/2023 Mfd by: M/s. CREST LIFESCIENCES PVT. | Assay of Ofloxacin & Metronidazole | CDSCO Sub-Zone Baddi | RDTL Chandigarh |
LTD. Plot No. 127-128, | |||||
EPIP Phase-1, Jharmajri, | |||||
Tehsil Baddi, Dist. Solan, | |||||
Himachal Pradesh - | |||||
174103. |
22. | NORFLOXACIN TABLETS IP 400 mg | B. No.: RJNL-17 Mfg dt: 06/2021 Exp dt: 05/2024 Mfd by: M/s. Combitic Global Caplet Pvt. Ltd., M- 15, D-2, D-3, Ind.Area, Sonepat-131001, Haryana. | Dissolution | CDSCO North Zone | RDTL Chandigarh |
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