44 drug samples including Cipla Remdesivir fail to qualify CDSCO test, 1 declared misbranded
New Delhi: In its latest drug safety alert, the apex drug regulatory body, Central Drugs Standard Control Organization (CDSCO) flagged 44 medicine batches for failing to qualify a random drug sample test for the month of July, while 1 drug sample has been declared misbranded.
These drugs samples which are declared not of standard quality include Piramal Enterprises Ltd's Supradyn tablet, Syncom Healthcare's Albendazole tablets IP 400 mg (ZEEBEE-Tablet), Quest Laboratories' Domperidone Suspension I.P., Bharat Parenteral's Quinine Sulphate Tablets IP 300 mg, Swiss Garnier Biotech's STATIX-20 (Atorvastatin Tablets IP 20 mg) etc.
In addition, other popular drug samples that are declared not of standard quality include Paracetamol Tablets I.P. 500 mg (Biocin) manufactured by Danish Healthcare, Levofloxacin (Levoziv-500) Tablets I.P. 500 mg manufactured by Zee Laboratories, Brutab-400 (Ibuprofen Tablets IP 400 mg) manufactured by Neutec Healthcare, and Norfloxacin Tablets IP 400 mg manufactured by Unicure.
Apart from this, the popular covid drug Remdesivir for Injection 100 mg/vial (CIPREMI) manufactured by Cipla and Remdesivir for injection manufactured by Teena Labs Ltd. are on the list. Additionally, Bharat Serums and Vaccines' Liposomal Amphotericin B Injection 50 mg (ABHOPE INJ.) and Amphotericin B Lipid Complex Injection I.V. (AMPHOLIP 50 MG/10 ML) are also on the list.
Further, the list includes popular diabetes drugs DRMET FORTE G1 (Glimepiride & Metformin Hydrochloride SR Tablets) manufactured by Neptune Life Science Pvt. Ltd. and Glimepiride Tablets IP 1 mg manufactured by Trugen Pharmaceuticals Pvt. Ltd.
This came after analysis and tests conducted by the CDSCO Drugs Control Department on 1028 samples. Out of these, 983 samples were found to be of standard quality while 44 of them were declared as Not of Standard Quality (NSQ) and 1 drug was declared misbranded.
A few of the reasons why the drug samples tested failed were the failure of the assay, failure of the dissolution test, failure of disintegration, failure of the Vitamin D3 assay etc.
The samples collected were tested in four laboratories, namely CDL Kolkata, CDTL Mumbai, RDTL Chandigarh and RDTL Guwahati.
List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, for the Month of July – 2021
| Total number of samples tested | 1028 |
| Total number of samples declared as of Standard Quality | 983 |
| Total number of samples declared as Not of Standard Quality | 44 |
| Total number of samples declared as Spurious | 0 |
| Total number of samples declared as Misbranded | 01 |
| S.No. | Name of Drugs/medical device/cosmetic s | Batch No./Date of Manufacture/Date of Expiry/Manufactured By | Reason for failure | Drawn By | From |
| 1. | Calcium Carbonate, Magnesium Oxide, Manganese Sulphate, Zinc & Vitamin D3 Tablets | B. No.: MT191327 Mfg dt: 08/2019 Exp dt: 07/2021 Mfd by: M/s. Mascot Health Series Pvt. Ltd. Plot No. 79, 80, Sector - 6A, IIE, Sidcul, Haridwar- Uttarakhand -249403. | Assay of Vitamin D3 | CDSCO Sub-Zone, Guwahati | RDTL, Guwahati |
| 2. | Supradyn (Multivitamin Tablets with Minerals and Trace Elements) | B. No.: MH3388 Mfg dt: 10/2019 Exp dt: 09/2021 Mfd by: M/s. Piramal Enterprises Ltd., K-1, Addl., MIDC area, Mahad Maharashtra, 402302. | Disintegration | Drug Control Department Mizoram | RDTL, Guwahati |
| 3. | Ramipril Tablets IP (ORMIPRO-2.5) | B. No.: KM19001 Mfg dt: 11/2019 Exp dt: 10/2021 Mfd by: M/s. Ortin Laboratories Ltd. 275 & 278 (part) I.D.A. Pashamailaram Medak Distt. Telangana -502307. | Assay | Drug Control Department N.F. Railway Lumding | RDTL, Guwahati |
| 4. | Albendazole tablets IP 400 mg (ZEEBEE - Tablet) | B. No.: JDT0047 Mfg dt: 08/2018 Exp dt: 07/2021 Mfd by: M/s. Syncom Healthcare Ltd., Dehradun, Uttarakhand- | Dissolution | Drug Control Department Tezpur, Sonitpur | RDTL, Guwahati |
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| 248197. |
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| 5. | DRMET FORTE G1 (Glimepiride & Metformin Hydrochloride SR Tablets) | B. No.: TN-2830 Mfg dt: 01/2020 Exp dt: 12/2021 Mfd by: M/s. Neptune Life Science Pvt. Ltd., 100-B, EPIP, Phase-II, Thana, Baddi-173205, Himachal Pradesh. | Assay & Dissolution of Glimepiride | Drug Control Department Mizoram | RDTL, Guwahati |
| 6. | Domperidone Suspension I.P. | B. No.: L6002 Mfg dt: 12/2019 Exp dt: 11/2021 Mfd by: M/s. Quest Laboratories Pvt. Ltd., Plot No. 45, Sector –III, Pithampur, Dist. - Dhar, 454775, Madhya Pradesh. | Assay | Drug Control Department Nagaland | RDTL, Guwahati |
| 7. | Calcium & Vitamin D3 Tablets I.P. (CALGIO-D3) | B. No.: LTA-6957 Mfg dt: 03/2020 Exp dt: 08/2021 Mfd by: M/s. Lifevision Healthcare, Plot No. 140- 141, E.P.I.P., Phase-1, Jharmajri, Baddi, Dist.- Solan, Himachal Pradesh - 174103. | Assay of Vitamin D3 | Drug Control Department Assam | RDTL, Guwahati |
| 8. | Brutab-400 (Ibuprofen Tablets IP 400 mg) | B. No.: BRU18007 Mfg dt: 03/2019 Exp dt: 02/2022 Mfd by: M/s. Neutec Healthcare Pvt. Ltd., E-698, DSIIDC Industrial Area, Narela, Delhi- 110040. | Dissolution | Drug Control Department Nagaland | RDTL, Guwahati |
| 9. | (Levoziv -500) Levofloxacin Tablets I.P. 500 mg | B. No.: 420-1087 Mfg dt: 07/2020 Exp dt: 06/2023 Mfd by: M/s. Zee Laboratories Ltd. Behind 47, Industrial Area, Paonta Sahib, Himachal Pradesh - 173025. | Dissolution | Drug Control Department Nagaland | RDTL, Guwahati |
| 10. | Paracetamol Tablets I.P. 500 mg (Biocin) | B. No.: BCN2002 Mfg dt: 01/2020 Exp dt: 12/2021 Mfd by: M/s. Danish | Dissolution | Drug Control Department Nagaland | RDTL, Guwahati |
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| Healthcare (P) Ltd. 76/27-28, Industrial Estate, Maxi Road, Ujjain, Madhya Pradesh – 456010. |
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| 11. | Amlodipine Besilate Tablets IP 5 mg (AMLORACE-5) | B. No.: GLL19018 Mfg dt: 03/2019 Exp dt: 02/2022 Mfd by: M/s. IBN Herbals, Khasra No 63, Vill- Juddi Kalan, Baddi-173205, Dist- Solan, Himachal Pradesh. | Assay | Drug Control Department Nagaland | RDTL, Guwahati |
| 12. | Methylergometrin e Tablets IP 0.125 mg | B. No.: 1166-01 Mfg dt: 05/2020 Exp dt: 04/2022 Mfd by: M/s. Hab Pharmaceuticals & Research Limited, 10, Pharmacity, SIDCUL, Selaqui, Dehradun- 248011, Uttarakhand. | Assay | CDSCO Sub-Zone Guwahati | RDTL, Guwahati |
| 13. | Cefixime Dispersible Tablets IP (Cefimax-100 DT) | B. No.: 20D-BT016 Mfg dt: 07/2020 Exp dt: 06/2022 Mfd by: M/s. Orison Pharma International, Khari, Mauza-Ogli, Kala Amb, Himachal Pradesh - 173030. | Uniformity Of Dispersion | CDSCO Sub-Zone Guwahati | RDTL, Guwahati |
| 14. | Linezolid Tablets IP | B. No.: GT200808 Mfg dt: 06/2020 Exp dt: 05/2022 Mfd by: M/s. Theon Pharmaceuticals Ltd. Vill. Saini Majra, Teh. Nalagarh, Dist. Solan, Himachal Pradesh - 174101. | Dissolution | CDSCO Sub-Zone Guwahati | RDTL, Guwahati |
| 15. | Cosmic-AZ Tablets | B. No.: MT-1911208 Mfg dt: 11/2019 Exp dt: 10/2021 Mfd by: M/s. Medox Lifesciences, Plot No- 222-223, Phase- III, Ind. Area, Sansarpur- Terrace, Distt. Kangra, Himachal Pradesh - | Disintegration | Drug Control Department Jharkhand | RDTL, Guwahati |
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| 176501. |
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| 16. | Norfloxacin Tablets IP 400 mg | B. No.: NT-802 Mfg dt: 10/2020 Exp dt: 09/2022 Mfd by: M/s. Unicure India Ltd. C-21, 22 & 23, Sector- 3, Noida, Uttar Pradesh - 201301. | Dissolution | CDSCO Sub-Zone Guwahati | RDTL, Guwahati |
| 17. | Quinine Sulphate Tablets I.P. 300 mg | B. No.: T8296 Mfg dt: 10/2018 Exp dt: 09/2021 Mfd by: M/s. Bharat Parenterals Ltd. Vill Haripura, Ta. Savil, Dist.- Vadodara - 391520, Gujarat. | Dissolution | Drug Control Department Assam |
RDTL, Guwahati |
| 18. | Natural Sunshine Hand Sanitizer (100ml) Chlorhexidine Gluconate Solution IP 2.5% Ethnol IP70% | B. No.: 007 Mfg dt: 03/2020 Exp dt: Best before 24 months Mfd by: M/s. SHREE ENTERPRISES Plot No 1, Near Star Talkies, Burmamines, Jamshedpur, Jharkhand -831007. | Assay of Ethanol (Misbranded) 'Mfg. Lic No.'' is not mentioned on the Label. Hence, Misbranded. | Drug Control Department Jharkhand | RDTL, Guwahati |
| 19. | Amoxycillin Capsule IP 500 mg | B. No.: YAT91042 Mfg dt: 10/2019 Exp dt: 09/2021 Mfd by: M/s. Yoluri Formulation Pvt. Ltd. Sy No.: 296/7/6, I.D.A., Bollaram, Sangareddy Dist: 502325, Telengana. | Assay | Drug Control Department Assam | RDTL, Guwahati |
| 20. | Norfloxacin Tablets IP 400 mg (Ridnor-400) | B. No.: RID-1925 Mfg dt: 02/2020 Exp dt: 01/2023 Mfd by: M/s. RIDLEY LIFE SCIENCE PVT. LTD. D- 1651, DSIDC, Indl. Complex, Narela, Delhi- 110040. | Dissolution | Drug Control Department Assam | RDTL, Guwahati |
| 21. | TEMPNIL-500 (Paracetamol Tablets IP 500 | B. No.: 20NT0404 Mfg dt: 04/2020 Exp dt: 03/2022 Mfd by: M/s. Nuclotec | Dissolution | Drug Control Department Assam | RDTL, Guwahati |
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| mg) | Remedies Pvt. Ltd. 14, Milestone, Rudrapur- Kashipur Road, Gadarpur, Distt.-U.S. Nagar, Uttarakhand – 263152.. |
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| 22. | Rabeprazole Sodium Gastro Resistant Tablets IP (RABGIO-20) | B. No.: LTA-7123 Mfg dt: 04/2020 Exp dt: 03/2022 Mfd by: M/s. Lifevision Healthcare (a WHO-GMP Certified Company) Plot no.140-141, E.P.I.P. Phase-1, Jharmajri, Baddi, dist. Solan, Himachal Pradesh -174103. | Dissolution | Drug Control Department Assam | RDTL, Guwahati |
| 23. | Glimepiride Tablets IP 1 mg | B. No.: T20053 Mfg dt: 05/2020 Exp dt: 04/2022 Mfd by: M/s. Trugen Pharmaceuticals Pvt. Ltd. Vill-Tejjupur, Near Chodiala Rly Station, Roorkee, Distt. Haridwar, Uttarakhand -247661. | Dissolution | Drug Control Department Assam | RDTL, Guwahati |
| 24. | Cefixime Dispersible Tablets I.P. (Cefexi-100) | B. No.: BIG -137 Mfg dt: 03/2019 Exp dt: 02/2022 Mfd by: M/s. Indo-Gulf Pharmaceuticals (unit of I.G. Pharma Ltd.), 12.4 km, Meerut Road, Roorkee, Distt- Haridwar, Uttarakhand. | Uniformity of dispersion and Water content | CDSCO Sub-Zone Guwahati | RDTL, Guwahati |
| 25. | STATIX -20 (Atorvastatin Tablets IP 20 mg) | B. No.: BPSB20093 Mfg dt: 08/2020 Exp dt: 07/2022 Mfd by: M/s. Swiss Garnier Biotech Pvt. Ltd., 21, Industrial Area, Mehatpur, Dist. Una, Himachal Pradesh – 174315. | Related Substances | CDSCO Sea Port Office Visakhapatnam Andhra Pradesh | CDL Kolkata |
| 26. | Calastravit -500 (Calcium with Vitamin D3 Tablets IP) | B. No.: MT20013 Mfg dt: 10/2020 Exp dt: 09/2022 Mfd by: M/s. Maa Pharma Tech, Survey No. 915/2, | Dissolution | CDSCO Sea Port Office Visakhapatnam Andhra Pradesh | CDL Kolkata |
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| Block Part B, Jetalpur Pirana Road, At & Post. Girmatha Village, Tal- Daskroi, Dist. Ahmedabad – 382 425, Gujarat. |
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| 27. | Cefoperazone for Injection I.P. 1000 mg | B. No.: CS-0016 Mfg dt: 04/2021 Exp dt: 03/2023 Mfd by: M/s. Sunvet Pharma Private Limited, Village: Upper Moginand, Nahan Road, Kala Amb, Distt. Sirmour 173030, Himachal Pradesh. | Description, Identification, pH, Water, Particulate Matter, Clarity of Solution, Assay | CDSCO Sub - Zone Baddi | CDL Kolkata |
| 28. | Doxycycline Hydrochloride Capsules I.P. 100 mg | B. No.: 3157 Mfg dt: 03/2020 Exp dt: 02/2022 Mfd by: M/s. Super Formulations Pvt. Ltd., 16 B & 15 F, Industrial Area, Maxi Road, Ujjain, Madhya Pradesh - 456 010. | Assay | CDSCO South Zone Chennai | CDL Kolkata |
| 29. | Folic Acid Tablets IP 5 mg | B. No.: T20072 Mfg dt: 07/2020 Exp dt: 06/2022 Mfd by: M/s. Trugen Pharmaceuticals Pvt. Ltd., Vill. Tejjupur, Near Chodiala Rly Station, Roorkee, Distt. Haridwar, Uttarakhand – 247 661. | Description & Hydrolysis Products | CDSCO South Zone Chennai | CDL Kolkata |
| 30. | Sodium Valproate Gastro Resistant Tablets IP 200 mg | B. No.: SVT871 Mfg dt: 12/2020 Exp dt: 05/2022 Mfd by: M/s. Unicure India Ltd., Noida – 201301, Uttar Pradesh. | Related Substances | CDSCO South Zone Chennai | CDL Kolkata |
| 31. | K-Life (Oral Rehydration Salts I.P.) | B. No.: KL2001 Mfg dt: 01/2020 Exp dt: 12/2021 Mfd by: M/s. Danish Healthcare (P) Ltd., 76/27- 28 Industrial Estate, Maxi Road, Ujjain – 456 010, Madhya Pradesh. | Sodium Potassium Total Chlorides and Citrate | CDSCO South Zone Chennai | CDL Kolkata |
| 32. | Telmicept 40 (Telmisartan Tablets I.P. 40 mg) | B. No.: C21T479003 Mfg dt: 09/2019 Exp dt: 08/2022 Mfd by: M/s. Concept Pharmaceuticals Ltd., A - 28/3, MIDC, Chikalthana, Aurangabad – 431 006, Maharashtra. | Dissolution | CDSCO East Zone Kolkata | CDL Kolkata |
| 33. | OZOPINE – 10 (Olanzapine Tablets IP 10 mg) | B. No.: DGTA12266 Mfg dt: 12/2020 Exp dt: 11/2022 Mfd by: M/s. Digital Vision, 176, Mauza Ogli, Nahan Road, Kala-Amb, Distt. Sirmour, Himachal Pradesh- 173 030. | Dissolution | CDSCO East Zone Kolkata | CDL Kolkata |
| 34. | RINGOLATE 500 ml (Compound Sodium Lactate Inj. I.P. 500 ml (Ringer Lactate Solution for Injection I.P) | B. No.: 2001017019 Mfg dt: 01/2020 Exp dt: 12/2022 Mfd by: M/s. Denis Chem Lab Limited, 457, Chhatral, Ta. Kalol, Dist. Gandhinagar, Gujarat – 382 729. | Potassium | CDSCO East Zone Kolkata | CDL Kolkata |
| 35. | Fexofenadine Tablets I.P. 120 mg | B. No.: CT-8321220 Mfg dt: 12/2020 Exp dt: 11/2022 Mfd by: M/s. Clevus Lifesciences, Near Apple Terminal Market, Sector - 6, Parwanoo, Himachal Pradesh – 173 220. | Dissolution | CDSCO East Zone Kolkata | CDL Kolkata |
| 36. | Absorbent Gauze | B. No.: 09 Mfg dt: 01/2021 Exp dt: 3 Yrs from Mfg. Date Mfd by: M/s. Sri Sanjeevi Natchiyar Surgicals, 2/181- D, Vayakattu Street, Samusigapuram – 626 102 (via), Rajapalyam, Tamilnadu. | Weight in gm / m2, Length, Width, Foreign Matter and Flourescence | CDSCO Sub - Zone Bangalore | CDL Kolkata |
| 37. | FloxidinTM VET – 100 ml (Enrofloxacin Injection I.P. 10% VET) | B. No.: FN2220046 Mfg dt: 11/2020 Exp dt: 10/2022 Mfd by: M/s. Samrudh Pharmaceuticals Pvt. Ltd., Plot No. J-174, J-168 & J- 168/1 MIDC, Tarapur, Thane – 401 506, Maharashtra. | pH | Drug Control Department Bangalore | CDL Kolkata |
| 38. | Remdesivir for Injection | B. No.: BREMD210001 Mfg dt: 04/2021 Exp dt: 03/2024 Mfd by: M/s. Teena Labs Ltd. Plot No. 41,S.V. Co- Operative Industrial Estate, Bachupally (V & M), Medchal-Malkajgiri, District Telangana State-500090. | Water and Residue on ignition | CDSCO Hyderabad | CDTL Mumbai |
| 39. | Ampicillin 500 mg (Ampicillin Capsules I.P.) | B. No.: 475 Mfg dt: 02/2020 Exp dt: 01/2022 Mfd by: M/s. Super Pharma Products., 13 A & C, Industrial Area, Maksi Road, Ujjain, Madhya Pradesh. | Assay | CDSCO West Zone Mumbai | CDTL Mumbai |
| 40. | Orvastin-40 (Atorvastatin Tablets I.P. 40 mg) | B. No.: P-0C0154 Mfg dt: 03/2020 Exp dt: 08/2022 Mfd by: M/s. Morepen Laboratories Ltd., Plot No. 12B, Sector-2, Parwanoo, Dist. Solan, Himachal Pradesh – 173220. | Dissolution | CDSCO West Zone Mumbai | CDTL Mumbai |
| 41. | Closantel 15% Oral Solution (WORM- GO ORAL SOLUTION) | B. No.: CLP-443 Mfg dt: 03/2020 Exp dt: 02/2022 Mfd by: M/s. Saibliss Drugs & Pharmaceuticals 66-67, Ind.Area, Ponta Sahib, Distt. Sirmour, Himachal Pradesh. | Identification (Negative for Closantel Sodium Dihydrate) | Drug Control Department Srinagar | RDTL Chandigarh |
| 42. | Liposomal Amphotericin B Injection 50 mg (ABHOPE INJ.) | B. No.: A18021003 Mfg dt: 02/2021 Exp dt: 01/2024 Mfd by: M/s. Bharat Serums and Vaccines Ltd. Plot No. K-27, Anand Nagar, Add.MIDC, (E) Ambernath-421501, Taluka: Ambernath City, District: Thane-Zone 6, Maharashtra. | Identification (Negative for Amphotericin B) | Drug Control Department Delhi | RDTL Chandigarh |
| 43. | Remdesivir for Injection 100 mg/vial (CIPREMI) | B. No.: R310019 Mfg dt: 03/2021 Exp dt: 11/2021 Mfd by: M/s. CIPLA LTD. Plot No. G-84/1, Tarapur, M.I.D.C., Boisar, Dist, Palghar, Maharashtra- 401506. | Identification (Negative for Remdesivir) | Drug Control Department Delhi | RDTL Chandigarh |
| 44. | Amphotericin B Lipid Complex Injection I.V. (AMPHOLIP 50 MG/10 ML) | B. No.: R310019 Mfg dt: 03/2021 Exp dt: 10/2022 Mfd by: M/s. BHARAT SERUMS AND VACCINS LIMITED Plot No. K-27, Additional M.I.D.C., Ambernath (E) 421501, Maharashtra. | Identification (Negative for Amphotericin B) | Drug Control Department Delhi | RDTL Chandigarh |
| 45. | Enalapril Maleate Tablets IP (GNAP-2.5 TABLETS) | B. No.: CT-201041 Mfg dt: 12/2020 Exp dt: 11/2022 Mfd by: M/s. CMG BIOTECH PVT. LTD 58, Industrial Area, Phase III, Sansarpur Terrace, Himachal Pradesh - 176501. | Assay | Drug Control Department Himachal Pradesh | RDTL Chandigarh |
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