CDSCO declares 37 drug samples including Ibuprofen, Vitamin B-Complex as Not of Standard Quality
New Delhi: The nodal drug regulatory body, the Central Drugs Standard Control Organization (CDSCO) has declared batches of 37 drugs including Ibuprofen, Vitamin B-Complex, Cefpirome Injection, others as not of standard quality in a random drug sample test.
This came after analysis and test conducted by the CDSCO, Drugs Control Departments, on 1121 drug samples. Out of this, 1158 samples were found of Standard quality while 37 of them were declared as Not of Standard Quality (NSQ).
Notable drugmakers including Macleods Pharma, Bal Pharma, Intas Pharma, others are involved in the manufacture of the drug samples that were collected for testing.
Samples of Eptoin 300 ER (Phenytoin Sodium Extended-Release Tablets 300 mg), Ciprofloxacin Tablets IP 250 mg, Metronidazole Tablets I.P. 400 mg, Vitamin B-Complex Tablets NF, Ramizim - 2.5 (Ramipril Tablets I.P. 2.5 mg), Pantoprazole Enteric Coated Tablets 40 mg and others were picked for testing.
The drug samples tested failed due to the presence of Dissolution, Assay, pH, Identification of Vitamin D3 & Cyanocobalam in and Assay of Calcium Carbonate Calculated as Calcium, Disintegration & Uniformity of Dispersion, Disintegration, Description
and Disintegration, Content of Lactic Acid Bacillus, Water-soluble and Ethersoluble substances and others.
The samples collected were tested in four laboratories namely CDTL Mumbai, CDTL Chennai, RDTL Chennai, CDL Kolkata, RDTL Guwahati.
List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, for the month of November 2019 reads;
| 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. | Pantoprazole Gastro Resistant Tablets I.P. | B. No.: T-7172 Mfg dt: 10/2018 Exp dt: 09/2020 Mfd by: M/s Kwality Pharmaceuticals Ltd. Nag Kalan, Majitha Road, Amritsar. | Dissolution | Drugs Control Department, Assam. | RDTL, Guwahati |
| 2. | Ibuprofen Tablets I.P. 400 mg. | B. No.: 01019-BJA36 Mfg dt: 01/2019 Exp dt: 12/2020 Mfd by: M/s Biogenetic Drugs Pvt. Ltd. Vill- Jharmajri, Baddi, Dist- Solan H.P-174103 | Dissolution | Drugs Control Department, Arunachal Pradesh. | RDTL, Guwahati |
| 3. | Pantoprazole Enteric Coated Tablets 40 mg. | B. No.: T-7224 Mfg dt: 11/2018 Exp dt: 10/2020 Mfd by: M/s Kwality Pharmaceuticals Ltd. Nag Kalan, Majitha Road, Amritsar | Dissolution | Drugs Control Department, Arunachal Pradesh. | RDTL, Guwahati |
| 4. | Telmisartan Tablets I.P. 40mg. (Telziver-40) | B. No.: LVT-28800 Mfg dt: 04/2018 Exp dt: 03/2020 Mfd by: M/s Life Vision Healthcare, Plot No. 140- 141, E.P.I.P, Phase-I, Jharmajri, Baddi, Dist- Solan, H.P.-174103 | Dissolution | Drugs Control Department, Assam. | RDTL, Guwahati |
| 5. | Levocetirizine Dihydrochloride Tablets I.P. 5mg. | B. No.: LC18004 Mfg dt: 04/2018 Exp dt: 03/2020 Mfd by: M/s Life Max Cancer Laboratories Plot No. 106 & 106A, Sector-6A, I.I.E., SIDCUL, Haridwar, Uttarakhand-249403 | Dissolution | Drugs Control Department, Assam. | RDTL Guwahati |
| 6. | Albendazole Tablets I.P. (C-Bend) | B. No.: G002/2561 Mfg dt: 04/2019 Exp dt: 03/2021 Mfd by: M/s Elfin Drugs Pvt. Ltd. Vill-Berson, Nalagarh (H.P)-174101 | Dissolution | Drugs Control Department, Mizoram. | RDTL Guwahati |
| 7. | Albendazole Tablets I.P. 400 mg. | B. No.: 8605318, Mfg dt: 10/2018 Exp dt: 09/2021 Mfd by: M/s Karnataka Antibiotics & Pharmaceuticals Ltd. Plot No. 14, II Phase, Peenya, Bangalore- 560058 | Dissolution | Drugs Control Department, Meghalaya. | RDTL Guwahati |
| 8. | Pantoprazole Tablets I.P. (PAD-40) | B. No.: T03PA11-18 Mfg dt: 11/2018 Exp dt: 10/2020 Mfd by: M/s Adsila Organics Pvt. Ltd. Liwaspur Road, Vill-Bahalgarh-131021, Haryana | Dissolution | Drugs Control Department, Mizoram. | RDTL Guwahati |
| 9. | Cedoxil 500mg Tablets | B. No.: T-16549 Mfg dt: 03/2018 Exp dt: 02/2020 Mfd by: M/s Jackson Laboratories Pvt. Ltd. Bye Pass, Majitha Road, Amritsar-143004 | Dissolution | Drugs Control Department, Arunachal Pradesh. | RDTL Guwahati |
| 10. | Amlodipine Tablets IP 5mg | B. No.: CHT-9124 Mfg dt: 03/2019 Exp dt: 02/2021 Mfd by: M/s. Bengal Chemicals & Pharmaceuticals Ltd., NH-No.74 Roorkee- Dehradun Highway, Kisanpur, Roorkee- 247667, Uttarakhand | Assay | CDSCO, Sub Zone, Bangalore | CDL, Chennai |
| 11. | Carbamazepine | B. No.: AAB8B007 Mfg dt: 03/2018 Exp dt: 02/2020 Mfd by: Psychotropics India Limited, Plot No.- 46 & 49, Sector-6A, IIE, SIDCUL, Industrial Area, Ranipur, Haridwar-249 403 (Uttarakhand ) | Dissolution | CDSCO, | RDTL, |
| Extended Release | North Zone, | Chandigarh | |||
| Tablets IP | Ghaziabad | ||||
| (ACETOL CR-200 | |||||
| TABLETS) | |||||
| 12. | Albendazole Vet. Oral Suspension (FLUKGON ) | B. No.: 205 Mfg dt: 11/2018 Exp dt: 10/2020 Mfd by: Albro Pharmaceuticals Pvt. Ltd. GMP Certified Company Muktsar 152026, Punjab. | pH | CDSCO, North Zone, Ghaziabad | RDTL, Chandigarh |
| 13. | Prebiotic and Probitic Capsules (REPURE CAPSULES) | B. No.: HC-1805016 Mfg dt: 05/2018 Exp dt: 04/2020 Mfd by: Helax Health Care Private Limited, Khasra No. 410, Village- Karondi, Roorkee- 247667, District- Haridwar | Uniformity of filled Weight | CDSCO, North Zone, Ghaziabad | RDTL, Chandigarh |
| 14. | Suspension of Calcium, Vitamin B12 and Vitamin D3 ( CALCI-D ) | B. No.: SL-398 Mfg dt: 05/2019 Exp dt: 04/2021 Mfd by: Sridhara Life sciences Pvt. Ltd. Khasra | Identification of Vitamin D3 & Cyanocobalam in and Assay of Calcium Carbonate Calculated as Calcium | CDSCO, Sub-zone Baddi | RDTL, Chandigarh |
| No. 285,290, Village- | |||||
| Sisona, Bhagwanpur, | |||||
| Roorkee, Haridwar | |||||
| (Uttrakhand )-247661 | |||||
| 15. | Ferrous Ascorbate, Folic, Zinc and Cynocobalamin Syrup (FEROFOL-BZ) | B. No.: MSL-091 Mfg dt: 03/2019 Exp dt: 02/2021 Mfd by: Maskon Life Sciences Pvt. Ltd. Kh. No. 69& 70 Khatakheri, Bhagwanpur, Roorkee (U.K.) INDIA | Identification of Folic Acid and Cynaocobalam in and Assay of Ferrous Ascorbate Calculated as Elemental Iron | CDSCO, Sub Zone, Baddi | RDTL, Chandigarh |
| 16. | MDZIME – DT (Cetrizine Dihydrochloride Tablets) | B. No.: ZT-8313 Mfg dt: 01/2019 Exp dt: 12/2021 Mfd by: M/s. Zenith Healthcare Ltd., 388/34, Chandogar Ind. Estate, Sarkhej Bavla Highway, Changodar -382210 | Disintegration & Uniformity of Dispersion | CDSCO, Ahmedabad | CDL, Kolkata |
| 17. | Ramizim - 2.5 (Ramipril Tablets I.P. 2.5 mg) | B. No.: EH97M801 Mfg dt: 12/2018 Exp dt: 11/2020, Mfd by: M/s. ZIM Laboratories Limited (Unit-II), A-8/14, MIDC, Area, Kalmeshwar 441501, Dist Nagpur, Maharashtra | Dissolution & Assay | CDSCO, Ahmedabad | CDL, Kolkata |
| 18. | Trypsin Chymotrypsin Tablets | B. No.: T 53903 Mfg dt: 05/2018 Exp dt: 04/2021 Mfd by: M/s. Vardhman Exports, A-188, T. T.C., MIDC, Khairne, Navi Mumbai – 400 710. | Disintegration | CDSCO, North Zone, Ghaziabad | CDL, Kolkata |
| 19. | Ramipril Tablets I.P. 2.5 mg | B. No.: RAPT18004 Mfg dt: 12/2018 Exp dt: 11/2020 Mfd by: M/s. Ravian Life Sciences Pvt. Ltd., Plot No. 34, Sec. 8A, IIE, SIDCUL, Haridwar -249 403, UK. | Assay | CDSCO, North Zone, Ghaziabad | CDL, Kolkata |
| 20. | Cadpril 5 (Ramipril Tablets I.P) | B. No.: ZPR0037 Mfg dt: 08/2018 Exp dt: 07/2020 Mfd by: M/s. Preet Remedies Ltd., 183-186, HPSIDC, Industrial Area, Baddi, Distt. Solan – (H.P.) – 173205 | Assay | CDSCO, North Zone, Ghaziabad | CDL, Kolkata |
| 21. | Vitamin B-Complex Tablets NFI | B. No.: KA19001 Mfg dt: 01/2019 Exp dt: 06/2020 Mfd by: M/s. Ortin Laboratories Ltd., 275 & 278 (Part) I.D.A. Pashamylaram -502307, Medak, AP. | Identification & Assay of Calcium Pantothenate | Drugs Inspector CDSCO, Goa | CDL, Kolkata |
| 22. | Medtoin (Phenytoin Sodium Tablets I.P.) | B. No.: SPT190048A, Mfg dt: 01/2019 Exp dt: 12/2020 Mfd by: M/s. Salus Pharmaceuticals, 480/211, Harraipur, P.O. Gurumajra, Teh. Baddi, Distt. Solan (H.P.) – 173 205 | Description and Disintegration | CDSCO, Sub Zone, Baddi, H.P. | CDL, Kolkata |
| 23. | DOXYGUARD (Doxycycline & Lactic Acid Bacillus Capsules) | B. No.: SOC-615F Mfg dt: 01/2018 Exp dt: 12/2019 Mfd by: M/s. Symbiosis Pharmaceuticals Pvt. Ltd., (Unit-III), Trilokpur Road, Kala Amb-173030 (H.P) | Assay/Content of Lactic Acid Bacillus | CDSCO, Sub Zone, Baddi, H.P. | CDL, Kolkata |
| 24. | OMEP (Omeprazole Capsule I.P. 20mg) | B. No.: UOME 1803 Mfg dt: 02/2018 Exp dt: 01/2020 Mfd by: M/s. Bal Pharma Limited, Plot No. 1, 2, 3 & 69, Sector 4 IIE, SIDCUL, Pantnagar, Rudrapur Distt-Udham Singh Nagar, Uttarakhand, India | Dissolution | CDSCO, East Zone, Kolkata | CDL, Kolkata |
| 25. | CREPE BANDAGE (10 CMS X 4 MTRS) | B. No.: 37 Mfg dt: 10/2017 Exp dt: 3 Yrs from Mfg. Date Mfd by: M/s. Hindustan Surgical Appliances, 29, Huzuri Mull Lane, Kolkata - 700 014. | Water-soluble and Ether- soluble substances | CDSCO, East Zone, Kolkata | CDL, Kolkata |
| 26. | Metronidazole Tablets I.P. 400 mg | B. No.: 7596027 Mfg dt: 08/2017 Exp dt: 07/2020 Mfd by: M/s. Bengal Chemical & Pharmaceuticals Ltd., 164, Maniktala Main Road, Kolkata – 700054 | Dissolution | CDSCO, East Zone, Kolkata | CDL, Kolkata |
| 27. | Ramizim 5 (Ramipril Tablets I.P. 5 mg) | B. No.: EO82M801 Mfg dt: 12/2018 Exp dt: 11/2020 Mfd by: M/s. Zim Laboratories Limited (Unit-II), A-8/14, MIDC Area, Kalmeshwar 441501, Dist Nagpur, Maharashtra | Dissolution & Assay | CDSCO, East Zone, Kolkata | CDL, Kolkata |
| 28. | Zinc Sulphate Tablets IP 20 mg | B. No.: 05069 Mfg dt: 06/2019 Exp dt: 05/2021 Mfd by: M/s. Healthy Life Pharma Pvt. Ltd., N-31/1, M.I.D.C., Tarapur, Dist. Palghar, Boisar-401506, Maharashtra | Disintegration and Uniformity of Dispersion | CDSCO, Sub Zone, Indore. | CDTL, Mumbai |
| 29. | Bacitracin Zinc | B. No.: B190304 Mfg dt: 03/2019 Exp dt: 03/2023 Mfd by: M/s. Yancheng Youhua Pharmaceutical & Chemical Technology, Co. Ltd., China | Loss on Drying | CDSCO, Air Cargo, Mumbai | CDTL, Mumbai |
| 30. | Ciprofloxacin Tablets IP 250 mg | B. No.: (10)CITW-31 Mfg dt: 04/2019 Exp dt: 03/2021 Mfd by: M/s. Nestor Pharmaceuticals Limited, 11, Western Extension Area, Faridabad-121001 | Dissolution | CDSCO, Sub Zone, Indore. | CDTL, Mumbai |
| 31. | Cycloserine Capsules USP 250 mg | B. No.: ECB5836A Mfg dt: 07/2018 Exp dt: 06/2021 Mfd by: M/s. Macleods Pharmaceuticals Ltd., Plot No. 25-27, Survey No.366, Premier Industrial Estate, Kachigam, Daman 396210 (U.T) | Condensation Products and Assay | CDSCO, West Zone, Mumbai | CDTL, Mumbai |
| 32. | Rabiun-DSR (Enteric coated Rabeprazole Sodium and Domperidon SR Capsules) | B. No.: NY1180 Mfg dt: 05/2019 Exp dt: 04/2021 Mfd by: M/s. Intas Pharmaceuticals Limited, Samardung Road, Kabrey Block, Namthang Elaka, South Sikkim- 737 132 | Dissolution | CDSCO, West Zone, Mumbai | CDTL, Mumbai |
| 33. | Eptoin 300 ER (Phenytoin Sodium Extended Release Tablets 300 mg) | B. No.: SDE0020 Mfg dt: 03/2019 Exp dt: 02/2021 Mfd by: M/s. Sidmak Laboratories (India) Pvt. Ltd., Plot No.20, Pharma City, Selaqui Industrial Area, Dehradun-248197, Uttarakhand | Dissolution | CDSCO, Ahmedabad Zone | CDTL, Mumbai |
| 1. | Purport to contain Amoxycillin & Potassium Clavulanate equivalent to Amoxycillin 500 mg, Potassium Clavulanate Diluted IP equivalent to Clavulanic Acid 125 mg | B. No.: Not Specified Mfg dt: Not Specified Exp dt: Not Specified Mfd by: Not Specified | Negative Identification for Amoxycillin and Clavulanic Acid | CDSCO, Sub Zone, Indore. | CDTL, Mumbai |
| 1. | Cefpirome Injection (AZZICEF ) | B. No.: GS1547G Mfg dt: 08/2018 Exp dt: 07/2020 Mfd by: Not mentioned | Identification of Cefpirome Sulphate | CDSCO, North Zone, Ghaziabad | RDTL, Chandigarh |
Also Read: CDSCO declares 36 samples of Atorvastatin, Metformin, Paracetamol, others as Not of Standard Quality
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