CDSCO declares 36 samples of Atorvastatin, Metformin, Paracetamol, others as Not of Standard Quality
New Delhi: The nodal drug regulatory body, the Central Drugs Standard Control Organization (CDSCO) has declared batches of 36 drugs as not of standard quality in a random drug sample test.
This came after analysis and test conducted by the CDSCO on 1163 drug samples. Out of this, 1127 samples were found of Standard quality while 36 of them were declared as Not of Standard Quality (NSQ).
Notable drugmakers including Glaxo Smith Kline (GSK), Macleods Pharma, Lupin, Synokem Pharma manufactured the drugs samples that were collected for testing.
Samples of Paracetamol Tablets I.P, Ibuprofen Tablets I.P. 400 mg, Ciprofloxacin Tablets IP 500 mg, Atorvastatin Tablets IP 10 Mg, Metformin Hydrochloride sustained-release Tablets IP (MEFMED-SR 500 TABLETS), Betamethasone Valerate and Neomycin Skin Cream (BETNOVATE-N CREAM) and others were picked for testing.
The drug samples tested failed due to the presence of Dissolution, Assay and pH, Identification and Assay, Uniformity of Volume, Description and Assay, Dissolution and Assay, Uniformity of dispersion and Disintegration, Uniformity of weight, Identification of Betamethasone Valerate eq. to Betamethasone and Assay of Clioquinol, Identification Betamethasone Valerate and Neomycin Sulphate, Particulate Matter, Description and Sterility, Description and Assay of Levodopa and Carbidopa, Test for Water, Dissolution, Assay, Sterility.
The samples collected were tested in four laboratories namely CDTL Mumbai, CDTL Chennai, RDTL Chandigarh, CDL Kolkata, RDTL Guwahati.
List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, for the month of October 2019 reads;
| S. N. | Name of Drugs/medical device/cosmetics | Batch No./Date of Manufacture/Date of Expiry/Manufactured By | Reason for failure | Drawn By | From |
| 1. | Paracetamol Tablets I.P. | B. No.: 821481298, Mfg dt: 03/2019, Exp dt: 02/2021, Mfd by: M/s. Bengal Chemicals & Pharmaceuticals Ltd. 84/23, Factory Area, Fazalganj, Kanpur- 208012, Uttar Pradesh. | Dissolution | Drugs Control Department, Arunachal Pradesh | RDTL, Guwahati |
| 2. | Albendazole Tablets I.P.400 mg | B. No.: 9410, Mfg dt: 01/2017, Exp dt: 12/2019, Mfd by: M/s. Orissa Drugs and Chemicals Ltd. 1, Mancheswar, Industrial Estate, Bhubaneswar, Odisha. | Dissolution | Drugs Control Department, Nagaland | RDTL, Guwahati |
| 3. | Paracetamol Tablet I.P. | B. No.: 821481296, Mfg dt: 03/2019, Exp dt: 02/2021, Mfd by: M/s. Bengal Chemicals & Pharmaceuticals Ltd. 84/23, Factory Area, Fazalganj, Kanpur- 208012, Uttar Pradesh | Dissolution | Drugs Control Department, Arunachal Pradesh | RDTL, Guwahati |
| 4. | Azithromycin Oral Suspensions I.P. 100 mg | B. No.: L-1724703, Mfg dt: 11/2017, Exp dt: 10/2019, Mfd by: M/s. Hanuchem Laboratories V.P.O: Manpura, Tehsil, Baddi, Dist-Solan-173205 (H.P.). | Assay & pH | Drugs Control Department, Arunachal Pradesh | RDTL, Guwahati |
| 5. | 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 |
| 6. | Moxiford Eye Drops (Moxifloxacin Eye Drops I.P.) | B. No.: LHL-2692, Mfg dt: 08/2018, Exp dt: 07/2020, Mfd by: M/s. Park Pharmaceuticals, Vill.- Kalujhanda, Near Nanakpura, Teh. Baddi, Distt. Solan (H.P.) – 174103. | Description & Assay | CDSCO, North Zone, Ghaziabad | CDL, Kolkata |
| 7. | Tobotor Eye Drops 5 ml (Tobramycin Sulphate Opthalmic Solution) | B. No.: ETB-045, Mfg dt: 10/2018, Exp dt: 09/2020, Mfd by: M/s. Appasamy Occular Devices (P) Ltd., Plot No. 74-D, Katha, Baddi, Distt. Solan (H.P.) – 173205. | Uniformity of Volume | CDSCO, Hyderabad | CDL, Kolkata |
| 8. | CLEO Fresh Glutathione 70000 mg | B. No.: G2A06.530, Mfg dt: Not Stated Exp dt: 10/2021 Mfd by: M/s. Laboratories Filorga 75008, Paris France. | Identification & Assay | CDSCO, South Zone, Chennai | CDL, Kolkata |
| 9. | CLEO Fresh Glutathione 70000 mg | B. No.: G2A05.529 Mfg dt: Not Stated Exp dt: 10/2019 Mfd by: M/s. Laboratories Filorga 75008, Paris France | Identification & Assay | CDSCO, South Zone, Chennai | CDL, Kolkata |
| 10. | New Erythrocin 500 (Erythromycin Stearate Tablets I.P. 500 mg) | B. No.: MBD0214, Mfg dt: 11/2018, Exp dt: 04/2020, Mfd by: Medibios Laboratories Pvt. Ltd., Plot No. J-76, MIDC Tarapur, Boisar, Taluka: Palghar, Distt. Thane - 401506 | Dissolution | CDSCO, East Zone, Kolkata | CDL, Kolkata |
| 11. | Erythrocin 500 (Erythromycin Stearate Tablets I.P. 500 mg) | B. No.: MBE0082 Mfg dt: 05/2019 Exp dt: 04/2021 Mfd by: M/s. Medibios Laboratory Pvt. Ltd., Plot No. J-76, MIDC Tarapur, Palghar – 401506. | Dissolution | CDSCO, East Zone, Kolkata | CDL, Kolkata |
| 12. | Ciprofloxacin Tablets IP 500 mg | B. No.: 2095 Mfg dt: 11/2019 Exp dt: 12/2021 Mfd by: Hindustan Antibiotics Ltd. Pimpri, Pune-411018, Maharashtra, India | Dissolution | CDSCO, North Zone, Ghaziabad | RDTL, Chandigarh |
| 13. | Betamethasone Dipropionate Cream IP | B. No.: RD459 Mfg dt: 04/2019 Exp dt: 03/2021 Mfd by: Curetech Skincare Plot No.33-34, Phase-IV, Bhatoli Kalan, Baddi-173205, Distt. Solan (HP). | Assay | Drugs Control Office, Rohtak. | RDTL, Chandigarh |
| 14. | Amoxycillin and Potassium Clavulanate Tablets IP (ICLAVE-625 TABLETS ) | B. No.: TG19-32 Mfg dt: 07/2019 Exp dt: 12/2020 Mfd by: GNB Medica Labs Village Neehli Dhang, Jagat Khana, Tehsil Nalagarh, Distt, Solan (H.P.)-174101 | Dissolution and Assay | CDSCO, Sub Zone, Baddi | RDTL, Chandigarh |
| 15. | Atorvastatin Tablets IP 10 Mg | B. No.: RLT-005 Mfg dt: 11/2018 Exp dt: 10/2020 Mfd by: Revat Laboratories Pvt. Ltd 12- 321.Opp. I.D.A, Kurnool Road, Pernamitta, Ongole-523002, Andhra Pradesh | Dissolution | CDSCO, North Zone, Ghaziabad | RDTL, Chandigarh |
| 16. | Cefixime Dispersible Tablets (SAMCEF- 200DT TABLETS) | B. No.: TF19-88 Mfg dt: 06/2019 Exp dt: 05/2021 Mfd by: GNB Medica Labs Village Neehli Dhang, Jagat Khana, Tehsil Nalagarh, Distt, Solan (H.P.)-174101 | Uniformity of dispersion and Disintegration | CDSCO, Sub Zone, Baddi | RDTL, Chandigarh |
| 17. | Luliconazole 1 % w/w Cream (LUZOLE) | B. No.: 393 Mfg dt: 05/2019 Exp dt: 04/2021 Mfd by: Algen Healthcare Limited 134/2, Vill. Khara Khari, Sadhaura Road, Kala Amb, Distt. Sirmour H.P.-173030 | Assay | CDSCO, Sub Zone, Baddi | RDTL, Chandigarh |
| 18. | Calcium Carbonate Tablets IP | B. No.: CBRT-1041 Mfg dt: 04/2019 Exp dt: 03/2021 Mfd by: Wings Biotech 43 & 44 HPSIDC Industrial Area, Baddi-173205, H.P | Uniformity of weight | CDSCO, North Zone, Ghaziabad | RDTL, Chandigarh |
| 19. | Albendazole Tablets IP 400 mg | B. No.: RALB-1841 Mfg dt: 06/2018 Exp dt: 05/2020 Mfd by: Revat Laboratories Pvt. Ltd 12- 321. Opp. I.D.A, Kurnool Road, Pernamitta, Ongole-523002, Andhra Pradesh. | Uniformity of weight | CDSCO, North Zone, Ghaziabad | RDTL, Chandigarh |
| 20. | Clindamycin Phosphate Gel USP 1% w/w | B. No.: 08073 Mfg dt: 06/2018 Exp dt: 05/2020 Mfd by: Rhydburg Pharmaceuticals Ltd. C-2 & 3, S.I.E.I, Seaqui, Dehradun, Uttarakhand, India | Assay | CDSCO, Sub Zone, Jammu | RDTL, Chandigarh |
| 21. | Amoxycillin and Potassium Clavulanate with Lactic Acid Bacillus Tablets (ANUMOX- CV-LB TABLETS) | B. No.: TG19-36 Mfg dt: 07/2019 Exp dt: 12/2020 Mfd by: GNB Medica Labs Village Neehli Dhang, Jagat Khana, Tehsil Nalagarh, Distt, Solan (H.P.)- 174101 | Assay | CDSCO, Sub Zone, Baddi | RDTL, Chandigarh |
| 22. | Metformin Hydrochloride Sustained release Tablets IP (MEFMED-SR 500 TABLETS) | B. No.: M500SRT-1901 Mfg dt: 01/2019 Exp dt: 12/2020 Mfd by: Titanes Pharma, Vill, Bathu, Tehsil Haroli, Distt. Una (H.P)-174507 | Assay | CDSCO, Sub Zone, Baddi | RDTL, Chandigarh |
| 23. | Clobetasol Propionate, Neomycin Sulphate and Miconazole Nitrate Cream (PANDERM ++CREAM) | B. No.: PCF901A Mfg dt: 02/2019 Exp dt: 01/2021 Mfd by: Macleods Pharmaceuticals Ltd. Khasra No. 21, 22, 66, 67 & 68, Aho-Yangtam, Namchepung, PO: Ranipool, Sikkim-737135. | Identification | Drugs Control Office, N.C.T Delhi | RDTL, Chandigarh |
| 24. | Betamethasone and Clioquinol Cream BP (BETNOVATE-C SKIN CREAM) | B. No.: NG980 Mfg dt: 04/2019 Exp dt: 03/2021 Mfd by: GlaxoSmithKline Pharmaceuticals Limited A-10, M.I.D.C., Ambad- Pathardi Block, Nashik- 422010, Maharashtra, India | Identification of Betamethasone Valerate eq. to Betamethasone & Assay of Clioquinol | Drugs Control Office, N.C.T Delhi | RDTL, Chandigarh |
| 25. | Betamethasone Valerate and Neomycin Skin Cream (BETNOVATE-N CREAM) | B. No.: EZ277 Mfg dt: 01/2019 Exp dt: 06/2020 Mfd by: GlaxoSmithKline Pharmaceuticals Limited, At: Plot No. C-1, Madkaim Industrial Estate, Madkaim, Post Mardol, Ponda, Goa 403404. | Identification Betamethasone Valerate and Neomycin Sulphate | Drugs Control Office, N.C.T Delhi | RDTL, Chandigarh |
| 26. | Amikacin Sulphate Injection IP (AMIKACARE 500 ) | B. No.: CLI-6868 Mfg dt: 11/2018 Exp dt: 10/2020 Mfd by: Caremax Formulations Plot No. 56 & 61, Industrial Area, Phase III, Sansarpur Terrace, Distt. Kangra (H.P.)-176501 | Particulate Matter | CDSCO, North Zone, Ghaziabad | RDTL, Chandigarh |
| 27. | Ondansetron Oral Solution IP | B. No.: GNSG3-18-227 Mfg dt: 02/2019 Exp dt: 01/2021 Mfd by: Ornate Labs Pvt. Ltd., Bela Industrial Estate, Muzaffarpur - 842005, Bihar | Assay | CDSCO, Port Office, Visakhapatnam | CDTL, Chennai |
| 28. | Compound Sodium Lactate Injection IP (Ringers Lactate Solution for Injection) | B. No.: 2198 Mfg dt: 01/2019 Exp dt: 12/2021 Mfd by: Hindustan Antibiotics Ltd., Pimpri, Pune-411018, Maharashtra, India | Description & Sterility | CDSCO, South Zone, Chennai | CDTL Chennai |
| 29. | Levodopa & Carbidopa Tablets IP | B. No.: AU49 Mfg dt: 12/2018 Exp dt: 11/2020 Mfd by: Eurokem Laboratories Pvt. Ltd., C- 25, SIDCO Pharmaceuticals Complex, Alathur, Thiruporur-603110 | Description & Assay of Levodopa & Carbidopa | CDSCO, South Zone, Chennai | CDTL Chennai |
| 30. | Lansoprazole Ph. Eur | B. No.: T9004141 Mfg dt: 03/2019 Exp dt: 05/2023 Mfd by: M/s. Lupin Ltd., T-142, MIDC, Tarapur, Boisar, Palghar-401506 | Test for Water | CDSCO, West Zone, Mumbai | CDTL, Mumbai |
| 31. | Atorvastatin Calcium Tablets IP 40mg | B. No.: 19SGBT032 Mfg dt: 02/2019 Exp dt: 01/2021 Mfd by: M/s. Synokem Pharmaceutical Ltd., Plot No.-35-36, Sector-6A, Integrated Industrial Estate (SIDCUL), Ranipur (BHEL), Haridwar -249403, Uttarakhand | Dissolution | CDSCO, Sub Zone, Indore | CDTL, Mumbai |
| 32. | Moxileb Oral Suspension (Amoxicillin Oral Suspension BP) | B. No.: BS169 Mfg dt: 09/2019 Exp dt: 08/2021 Mfd by: M/s. Leben Laboratories Pvt. Ltd., Plot No. L-4, Phase-III, MIDC Akola-444104 Maharashtra. | Assay | CDSCO, West Zone, Mumbai | CDTL, Mumbai |
| 33. | Enaril (Enalapril Maleate Tablets I.P. 5mg) | B. No.: T-17395 Mfg dt: 07/2018 Exp dt: 06/2020 Mfd by: M/s. Jackson Laboratories Pvt. Ltd., Bye Pass, Majitha Road, Amritsar 143001, Punjab | Assay & Dissolution | CDSCO, West Zone, Mumbai | CDTL, Mumbai |
| 34. | Furosemide Injection I.P. 20mg / 2ml | B. No.: AV-4275 Mfg dt: 05/2019 Exp dt: 04/2021 Mfd by: M/s. Alpa Laboratories Ltd., 33/2. A.B. Road, Pigdamber 453446, Indore, Madhya Pradesh | Sterility | CDSCO, West Zone, Mumbai | CDTL, Mumbai |
| 35. | Ramipril Tablets IP 2.5mg | B. No.: STN-181394A Mfg dt: 12/2018 Exp dt: 11/2020 Mfd by: M/s. Terrace Paharmaceuticals (P) Ltd., 3-B (a), Phase-III, Industrial Area, Sansarpur terrace, Distt. Kangra (H.P.) 176501 | Assay | CDSCO, Sub Zone, Indore | CDTL, Mumbai |
Also Read: CDSCO declares 21 drug samples Not of Standard Quality
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