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 22 drug samples as 'Not of Standard Quality' after they failed to qualify a random drug sample test for the month of August.
These drug samples included popular formulations and brands like Folic Acid Tablets I.P. 5mg, Diclofenac gel B.P. 1% w/w, Hypodermic Syringe 2ml, Herpivir-800 Tablets, RYAAL, Vibpure Hand Sanitizer, Ulcon Tablets, Allyn Instant Dry Hand Rub, Amzeclav-625 Tablets, and others.
This came after analysis and test conducted by the CDSCO, Drugs Control Departments, on 843 drug samples. Out of this, 821 samples were found of Standard quality while 22 of them were declared as Not of Standard Quality (NSQ).
A few of the causes why the drug samples tested failed included Sterility, Assay, Dissolution, Description & Particulate Matter, Uniformity of weight, Assay of Isopropyl Alcohol, Assay of Ethyl Alcohol, and so on.
The samples were collected by the Drugs Control Department of Gujarat, Assam, Govt .of N.C.T of Delhi, Himachal Pradesh, and Srinagar Further CDSCO Ahmedabad, Ghaziabad, and Kolkata also picked up samples. Tests were conducted in three laboratories namely CDL Kolkata, RDTL Chandigarh, RDTL Guwahati.
List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, for the Month of August 2020
Total number of samples tested | 843 |
Total number of samples declared as of Standard Quality | 821 |
Total number of samples declared as Not of Standard Quality | 22 |
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. | Diclofenac gel B.P. 1% w/w | B. No.: 8916 Mfg dt: 09/2019 Exp dt: 08/2020 Mfd by: M/s. Syncom Healthcare Ltd.D-42,IIE SIDCUL, Selaqui, Dehradun-248197, U.K. | ASSAY | Drugs Control Department, Assam | RDTL, Guwahati |
2. | Folic Acid Tablets I.P. 5mg. | B. No.: T9125 Mfg dt: 05/2019 Exp dt: 04/2022 Mfd by: M/s. Bharat Parenterals Ltd. ViLL- Haripura, TA. Savli, Dist- Vadodara-391520, Gujarat. | ASSAY | Drugs Control Department, Assam | RDTL, Guwahati |
3. | Hypodermic Syringe 2ml. | B. No.: 19501 Mfg dt: 12/2019 Exp dt: 11/2021 Mfd by: M/s. Gurumangalam International Rancharda-382115 (TA, Kalol, Dist-Gandhinagar). | Sterility | Drugs Control Department, Gujarat | RDTL, Guwahati |
4. | Hypodermic Syringe 2ml. | B. No.: 19503 Mfg dt: 12/2019 Exp dt: 11/2021 Mfd by: M/s. Gurumangalam International Rancharda-382115 (TA. Kalol, Dist-Gandhinagar). | Sterility | Drugs Control Department, Gujarat | RDTL, Guwahati |
5. | Hypodermic Syringe 5ml. | B. No.: 19703 Mfg dt: 12/2019 Exp dt: 11/2021 Mfd by: M/s. | Sterility | Drugs Control Department, Gujarat | RDTL, Guwahati |
Gurumangalam International Rancharda-382115 (TA. Kalol, Dist-Gandhinagar). | |||||
6. | Winpress-XL 5mg (Prazosin Hydrochloride Sustained Release Tablets) | B. No.: PST9001 Mfg dt: 02/2019 Exp dt: 01/2021 Mfd by: M/s. Vivimed Labs Limited, D-125 &128, Phase III, IDA, Jeedimetla, Hyderabad-500055, Telangana. | Dissolution | CDSCO, East Zone, Kolkata | CDL, Kolkata |
7. | Halopar (Haloperidol Injection IP 5mg/ml) 1ml. | B. No.: DP9004 Mfg dt: 01/2019 Exp dt: 12/2020 Mfd by: M/s. Divine Laboratories Pvt. Ltd., Block No. 471, Dabhasa, Ta.: Padra. Dist. Vadodara. | Description & Particulate Matter | CDSCO, Ahmedabad | CDL, Kolkata |
8. | Aciclovir Tablets IP (Herpivir-800 Tablets) | B. No.: DVT197055 Mfg dt: 07/2019 Exp dt: 06/2021 Mfd by: M/s. Digital Vision 176, Mauza Ogli, Nahan Road, Kala-Amb, Distt. Sirmour (H.P.)-173030. | Uniformity of weight | CDSCO North- Zone, Ghaziabad (UP) | RDTL, Chandigarh |
9. | Advanced Hand Rub 70% Alcohol (RYAAL) | B. No.: BO208586 Mfg dt: 03/2020 Exp dt: 02/2022 Mfd by: M/s. Bo International A91, Wazirpur Industrial Area, New Delhi- 110052. | Assay of Isopropyl Alcohol and Chlorhexidine Gluconate Solution | Drug Control, Department, Govt .of N.C.T of Delhi, | RDTL, Chandigarh |
10. | Isopropyl Alcohol and Chlorhexidine Gluconate Hand Sanitizer (Vibpure Hand Sanitizer) | B. No.: 231H Mfg dt: 06/2020 Exp dt: 05/2022 Mfd by: M/s. Haustus Biotech Pvt. Ltd. 44-45, Ind. Area, Tahliwal, Distt. Una (H.P.). | Assay of Isopropyl Alcohol | Drug Control, Department, Himachal Pradesh | RDTL, Chandigarh |
11. | (Allyn Instant Dry Hand Rub) | B. No.: PKE-06 Mfg dt: 06/2020 Exp dt: 05/2023 Mfd by: M/s. P.K.COSMETICS C-152, | Assay of Ethyl Alcohol | Drug Control, Department, Govt. of N.C.T. of Delhi | RDTL, Chandigarh |
Sector-2, DSIIDC, Bawana Industrial Area, Delhi- 110039. | |||||
12. | Clidinium Bromide, Chlordiazepoxide and Magnesium Hydroxide Tablets (Ulcon Tablets) | B. No.: ULGT20031 Mfg dt: 01/2020 Exp dt: 12/2021 Mfd by: M/s. UNIMARCK HEALTHCARE LTD. Plot No.25 & 37, Sector-6A, SIDCUL, Haridwar-249403 (Uttarakhand). | Assay of Clidinium Bromide | CDSCO North- Zone, Ghaziabad (UP) | RDTL, Chandigarh |
13. | Ethanol Hand Sanitizer (Instawash Hand Sanitizer) | B. No.: 247H Mfg dt: 06/2020 Exp dt: 05/2022 Mfd by: M/s. Haustus Biotech Pvt. Ltd. 44-45, Ind. Area, Tahliwal, Distt. Una (H.P.). | Assay of Ethanol | Drug Control, Department, Himachal Pradesh | RDTL, Chandigarh |
14. | Ethyl Alcohol Solution 70% (Handzon Instant Hand Sanitizer) | B. No.: HDZC-016 Mfg dt: 05/2020 Exp dt: 04/2022 Mfd by: M/s. RPL (India) Pharmaceuticals Pvt. Ltd., D-8/5 & D-8/6, Okhla, Industrial Area, Phase-1, New Delhi-110020. | Assay of Ethanol | Drug Control, Department, Govt of N.C.T. of Delhi | RDTL, Chandigarh |
15. | (Allyn Instant Dry Hand Rub) | B. No.: PKEA-07 Mfg dt: 07/2020 Exp dt: 07/2023 Mfd by: M/s. P.K.COSMETICS C-152, Sector-2, DSIIDC, Bawana Industrial Area, Delhi- 110039. | Assay of Ethyl Alcohol | Drug Control, Department, Govt. of N.C.T. of Delhi | RDTL, Chandigarh |
16. | Cefixime Dispersible Tablets (Micfox-100 Dt Tablets) | B. No.: FBT19-186B Mfg dt: 06/2019 Exp dt: 05/2021 Mfd by: M/s. Athens Life Sciences Mauza Rampur Jattan, Nahan Road, Kala Amb, Distt.Sirmour, H.P.173030. | Assay | Drug Control, Department, Govt .of N.C.T. of Delhi | RDTL, Chandigarh |
17. | Amoxycillin & Potassium Clavulanate | B. No.: KPT-3348 Mfg dt: 11/2019 Exp dt: 04/2021 | Dissolution (Amoxycillin Trihydrate | Drug Control, Department, Govt .of N.C.T. | RDTL, Chandigarh |
Tablets IP 625 mg (Amzeclav-625 Tablets) | Mfd by: M/s. G NINE BIOCEUTICALS PVT. Ltd, 208-F, Sector-3, HSIDC, Industrial Estate, Karnal- 132001 (Haryana). | of Delhi | |||
18. | New Fame N Love Fairness Cream | B. No.: 5 Mfg dt: 07/2020, Exp dt: 06/2023, Mfd by: M/s. P.C.COSMETICS | Total Aerobic Microbial Count, Total yeast and Mould Count, Pseudomonas aeruginosa per gram | Drug Control, Department, Govt .of N.C.T. of Delhi | RDTL, Chandigarh |
19. | Vitamin C, Vitamin B-12, Folic Acid and Niacinamide Injection ( Eldervit- 12 Im/Iv Drip) | B. No.: 20NI0210 Mfg dt: 02/2020, Exp dt: 01/2022, Mfd by: M/s. Nuclotec Remedies Pvt. Ltd. 14-Mile Stone, Rudrapur-Kashipur Road, Gadarpur, Distt- U.S.Nagar, (Uttarakhand)- 263152. | Particulate Matter | CDSCO North- Zone, Ghaziabad (UP) | RDTL, Chandigarh |
20. | Vitamin C, Vitamin B-12, Folic Acid and Niacinamide Injection (Eldervit-12 Im/Iv Drip) | B. No.: 20NI0212 Mfg dt: 02/2020 Exp dt: 01/2022 Mfd by: M/s. Nuclotec Remedies Pvt. Ltd. 14-Mile Stone, Rudrapur-Kashipur Road, Gadarpur, Distt- U.S.Nagar, (Uttarakhand)- 263152. | Sterility A, Sterility B | CDSCO (North- Zone), Ghaziabad (UP) | RDTL, Chandigarh |
21. | Ethyl Alcohol, Isopropyl Alcohol and Niacinamide Hand Sanitizer Gel ( Tanzo) | B. No.: SM041 Mfg dt: 03/2020 Exp dt: 02/2022 Mfd by: M/s. Swiss Biotech Parentrals Kewat No.1138, VPO-Kachhwa, Karnal 132001 (Haryana). | Assay of Ethyl Alcohol, Isopropyl Alcohol | Drug Control, Department, Govt .of N.C.T. of Delhi | RDTL, Chandigarh |
22. | Instant Hand Sanitizer Original Alcohol Based (Safe Me Sanitizer) | B. No.: SM/2020/508 Mfg dt: 02/2020 Exp dt: 01/2022 Mfd by: M/s. KDM GOLDSTAR CO. NewDelhi-110019. | Identification for Alcohol (Ethyl Alcohol) | Drug Control, Department, Srinagar | RDTL, Chandigarh |
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