Drug alert:35 Drug Samples Fail To Clear CDSCO Test, 1 Declared spurious
New Delhi: In its latest drug safety alert, the apex drug regulatory body, Central Drugs Standard Control Organization (CDSCO) has flagged 35 medicine batches for failing to qualify for random drug sample tests for the month of April, while one drug sample has been declared spurious.These drugs samples which are declared not of standard quality include Skymap Pharmaceuticals' Metopal – 50...
New Delhi: In its latest drug safety alert, the apex drug regulatory body, Central Drugs Standard Control Organization (CDSCO) has flagged 35 medicine batches for failing to qualify for random drug sample tests for the month of April, while one drug sample has been declared spurious.
These drugs samples which are declared not of standard quality include Skymap Pharmaceuticals' Metopal – 50 XL (Metoprolol Succinate Extended Release Tablets IP), Alkem Health Science's Pantoprazole gastro- resistant and domperidone prolonged-release capsules IP Pan-D, Zee laboratories' Paracetamol oral suspension IP 60 ml. (for Paediatric use), Hindustan Antibiotic's Diclofenac Sodium Injection and others.
In addition to this, Ziten Tablets (Teneligliptin Tablets IP 20 mg) manufactured by Glenmark Pharmaceuticals, Urimax D (Tamsulosin Hydrochloride & Dutasteride Tablets) manufactured by Cipla are also on the list of drug samples not of standard quality.
The list came after analysis and tests were conducted by the CDSCO, Drug Control Departments on 895 samples. Out of this, 859 samples were found of standard quality and 35 of them were declared as Not of Standard Quality (NSQ) and one of them was declared as spurious.
A drug shall be deemed to be spurious if it is manufactured under a name that belongs to another drug, if it is an imitation of another drug or if it has been substituted wholly or partly by another drug, or if it wrongly claims to be the product of another manufacturer.
A few of the reasons why the drug samples tested failed were the failure of assays, failure of the dissolution test, failure of the disintegration test, failure of pH and identification test, failure of clarity test, failure of specific assay of drug test, and others.
The samples collected were tested in CDTL Kolkata, RDTL Chandigarh, CDTL Hyderabad, CDTL Chennai, and RDTL Guwahati.
List of Drugs, Medical Devices, and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded for the Month of April – 2023.
Total number of samples tested | 895 |
Total number of samples declared as of Standard Quality | 859 |
Total number of samples declared as Not of Standard Quality | 35 |
Total number of samples declared as Spurious | 1 |
Total number of samples declared as Misbranded | NIL |
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. | Losartan Tablets I.P. 25 mg | B. No.: 3803821 Mfg dt: 11/2021 Exp dt: 10/2024 Mfd by: M/s. Karnataka Antibiotics and Pharmaceuticals Limited, Plot No.14, II Phase, Peenya, Bengaluru - 560058. | Dissolution | CDSCO East Zone Kolkata | CDL Kolkata |
2. | Omitan – 20 (Olmesartan Medoxomil Tablets I.P.) | B. No.: T-3567 Mfg dt: 04/2022 Exp dt: 03/2024 Mfd by: M/s. Jackson Laboratories Pvt. Ltd., 22-34, Majitha Road, Bye Pass, Amritsar – 143 001 (India) Punjab. | Dissolution & Assay | CDSCO East Zone Kolkata | CDL Kolkata |
3. | Paracetamol Tablets I.P. 500 mg | B. No.: 2505122 Mfg dt: 02/2022 Exp dt: 01/2025 Mfd by: M/s. Karnataka Antibiotics & Pharmaceuticals Limited, Plot No. 14, II Phase, Peenya Industrial Area, Bengaluru-560058. | Description | CDSCO East Zone Kolkata | CDL Kolkata |
4. | Metopal – 50 XL (Metoprolol Succinate Extended Release Tablets IP) | B. No.: JD22036 Mfg dt: 06/2022 Exp dt: 05/2024 Mfd by: M/s. Skymap Pharmaceuticals Skymap Pharmaceuticals Pvt. Ltd., B-3, Dev Bhoomi | Dissolution & Assay of Metoprolol Succinate | CDSCO East Zone Kolkata | CDL Kolkata |
Industrial Estate, Puhana Iqbalpur Road, Roorkee- 247667, Uttarakhand. | |||||
5. | Paracetamol Tablets I.P. 500 mg | B. No.: 2510922 Mfg dt: 04/2022 Exp dt: 03/2025 Mfd by: M/s. Karnataka Antibiotics & Pharmaceuticals Limited, Plot No. 14, II Phase, Peenya Industrial Area, Bengaluru-560058.. | Description & Dissolution | CDSCO East Zone Kolkata | CDL Kolkata |
6. | Astrazol (Zoledronic Acid Injection IP 4 mg) | B. No.: L22ZL09A1 Mfg dt: 09/2022 Exp dt: 08/2024 Mfd by: M/s. Medion Biotech Pvt. Ltd., Village – Kaundi, Baddi, Solan, Himachal Pradesh 173205. | Particulate Matter | CDSCO Hyderabad | CDL Kolkata |
7. | Astrizo-2.5 Tablets (Letrozole Tablets I.P. 2.5 mg) | B. No.: SPT220701 Mfg dt: 03/2022 Exp dt: 02/2024 Mfd by: M/s. Salus Pharmaceuticals, 480/211, Harraipur, P.O. Gurumajra, Teh. Baddi, Distt. Solan, Himachal Pradesh- 173205. | Dissolution | CDSCO Hyderabad | CDL Kolkata |
8. | Cefo-S (Cefoperazone & Sulbactam for Injection) | B. No.: I220044B Mfg dt: 07/2022 Exp dt: 06/2024 Mfd by: M/s. Astrica Healthcare Pvt. Ltd., First Floor, Plot No. 9-18/5, Bharathi Nagar, Temple Alwal, Medchal Hyderabad – 10, Works At: Vill. Gaunspura, P.O. Noorpur Bet, Hambran, Ludhiana -141008, Punjab. | Assay of Sulbactam | CDSCO Hyderabad | CDL Kolkata |
9. | Misoprostol Tablets IP | B. No.: ATH-517 Mfg dt: 08/2022 | Assay | CDSCO Hyderabad | CDL Kolkata |
200 mcg (Misovent- 200) | Exp dt: 07/2024 Mfd by: M/s. Astrica Healthcare Pvt. Ltd., Works at: 440/3, Village Katha, Baddi, Distt. Solan, Himachal Pradesh – 173 205. | ||||
10. | Vitasurge Syrup 200ml (Multivitamin & Minerals Syrup) | B. No.: CVS-22011 Mfg dt: 09/2022 Exp dt: 02/2024 Mfd by: M/s. Ceego Labs Pvt. Ltd. S. No. 84/1A1, 86/3A1, 86/3A2, 86/3B1, Manjamedu Village, Thenneri Post 631604, Kancheepuram Taluk & District, Tamilnadu, India. | Assay of Vitamin A and Cholecalcifer ol | CDSCO South Zone Chennai | CDL Kolkata |
11. | Urimax D (Tamsulosin Hydrochloride & Dutasteride Tablets) | B. No.: GH20067 Mfg dt: 01/2022 Exp dt: 12/2023 Mfd by: M/s. Cipla Ltd., Verna Indl. Estate, Goa 403722, India. | Identification & Assay of Tamsulosin Hydrochloride and Dutasteride The sample is deemed to be Spurious | Drug Control Department Odisha | CDL Kolkata |
12. | Irinotecan Injection IP | B. No.: 01220013E Mfg dt: 03/2022 Exp dt: 02/2024 Mfd by: M/s. Cosmas Research Laboratories Ltd., Village – Gaunspura, P.O. Noorpur Bet. Hambran, Ludhiana- 141008 Punjab. | Description, Ph Extractable volume & Particulate matter | Drug Control Department Odisha | CDL Kolkata |
13. | SOCOF - BR (Terbutaline Sulphate, Bromhexine HCl, Guaiphenesin & Menthol Syrup) 100 ml | B. No.: MH22-166 Mfg dt: 10/2022 Exp dt: 09/2024 Mfd by: M/s. Mahys Pharmaceuticals, Satulur – 522 549, Andhra Pradesh. | Assay of Menthol | Drug Control Department Andhra Pradesh | CDL Kolkata |
14. | Mucotrol – LS Cough Syrup (Levosalbutamol, | B. No.: MH22-154 Mfg dt: 10/2022 Exp dt: 09/2024 | Description, Assay of Levosalbuta | Drug Control Department | CDL Kolkata |
Ambroxol HCl and Guaiphenesin Cough Expectorant) 100 ml | Mfd by: M/s. Mahys Pharmaceuticals, Survey No. 519 - C3A2, Satuluru -522549, Andhra Pradesh. | mol & Ambroxol Hydrochloride | Andhra Pradesh | ||
15. | BETACID (Aluminia, Magnesia and Simethicone Oral Suspension U.S.P.) | B. No.: BC-10222 Mfg dt: 10/2022 Exp dt: 09/2024 Mfd by: M/s. Alapati Pharma, 467, Pernamitta – 523 233, Andhra Pradesh. | Assay of Polydimethyl -siloxane | Drug Control Department Andhra Pradesh | CDL Kolkata |
16. | Nihar Naturals Coconut Hair Oil (Type 3 Hair Oil) | B. No.: Not Stated Mfg dt: Not Stated Exp dt: Not Stated Mfd by: M/s. Not Stated | Description and Acid Value. | Drug Control Department Jharkhand | CDTL Chennai |
17. | MEENA SHRI BELPAAT SINDUR | B. No.: Not Stated Mfg dt: Not Stated Exp dt: Not Stated Mfd by M/s. Meena Chemical Products, Ranchi-1 | Test for Fineness | Drug Control Department Jharkhand | CDTL Chennai |
18. | MEENA SHRI PUJA ROLI SINDUR | B. No.: Not Stated Mfg dt: Not Stated Exp dt: Not Stated Mfd by: M/s. Meena Chemical Products, Ranchi-1 | Test for Fineness | Drug Control Department Jharkhand | CDTL Chennai |
19. | Ziten Tablets (Teneligliptin Tablets IP 20 mg) | B. No.: 18220672 Mfg dt: 09/2022 Exp dt: 08/2024 Mfd by: M/s. Glenmark Pharmaceuticals Ltd., Samlik Marchak, Industrial Growth Centre, East Sikkim, Sikkim – 737135. | Dissolution | CDSCO Hyderabad | CDTL Chennai |
20. | Amoxycillin, Cloxacillin & Lactic Acid Bacillus Capsules (MoxiSpin®-D) | B. No.: SPL-220225 Mfg dt: 02/2022 Exp dt: 01/2024 Mfd by: M/s. Preet Remedies Ltd., 183-186, HPSIDC, Industrial Area, Baddi- 173205, Himachal | Assay of Cloxacillin | Drug Control Department Bihar | RDTL Guwahati |
Pradesh. | |||||
21. . | Pantoprazole gestro- resistant and domperidone prolonged- release capsules ip pan-d | B. No.: 21442024 Mfg dt: 07/2021 Exp dt: 06/2023 Mfd by: M/s. ALKEM ALKEM HEALTH SCIENCE, A unit of Alkem Laboratories Limited, Unit-2 Samardung, Karek Block, P.O.: Namthang, South Sikkim-737137. | Assay of Pantoprazole and Domperidone | Drug Control Department Assam | RDTL Guwahati |
22. | Paracetamol oral suspension i.p. 60 ml. (for Paediatric use) | B. No.: 622-412 Mfg dt: 07/2022 Exp dt: 06/2024 Mfd by: M/s. Zee laboratories, 47, Industrial Area, Paonta Sahib – 173025 Himachal Pradesh. | Assay | CDSCO Sub-Zone Guwahati | RDTL Guwahati |
23. | Calcizen Suspension (Calcium Phosphate Vitamin D3 & B12 Suspension) | B. No.: 21216 Mfg dt: 08/2022 Exp dt: 01/2024 Mfd by: M/s. Zenith Drugs Pvt. Ltd. (A WHO-GMP Certified Company) 72/5, Muradpura (Orangpura) Dhar Road, Near Kalaria, Indore 453001, Madhya Pradesh- India. | Assay of Vitamin D3 | Drug Control Department Bihar | RDTL Guwahati |
24. | FINAVIV-1 Tablets (Finasteride Tablets) | B. No.: AT22070978 Mfg dt: 07/2022 Exp dt: 06/2024 Mfd by: M/s. Accura Care Pharmaceuticals Pvt. Ltd., Vill. Moginand Nahan Road, Kala Amb, Distt-Sirmour, Himachal Pradesh – 173030. | Dissolution | Drug Control Department Jharkhand | RDTL Guwahati |
25. | Odeflox – OZ (Ofloxacin & Ornidazole Tablets IP) | B. No.: PR-202205 Mfg dt: 02/2022 Exp dt: 01/2024 Mfd by: M/s. Park Pharmaceuticals, 272, Ind. Area, Phase-II, Panchkula-134 113. | Dissolution | Drug Control Department Assam | RDTL Guwahati |
Haryana. | |||||
26. | Pantoprazole (EC) & Domperidone (SR) Capsules I.P. GFree® - D | B. No.: CF0552 Mfg dt: 06/2022 Exp dt: 05/2024 Mfd by: M/s. SYSTOLE REMEDIES PVT. LTD. Vill. Ogli Kala Amb, The. Nahan, Distt. Sirmour, Himachal Pradesh – 173030. | Assay of Pantoprazole | Drug Control Department Jharkhand | RDTL Guwahati |
27. | AMLODIPINE AND ATENOLOL TABLETS IP (ALAMO-AT) | B. No.: MDG226D Mfg dt: 04/2022 Exp dt: 03/2024 Mfd by: M/s. M.R. Healthcare Pvt. Ltd., At: Village: Tanda Mallu, Kashipur Road, Ramnagar- 244715, Dist. Nainital, Uttarakhand (INDIA). | Dissolution and Assay | CDSCO Zonal Office Hyderabad | CDTL Hyderabad |
28. | AMLODIPINE AND ATENOLOL TABLETS IP (ALAMO-AT) | B. No.: MRT1846 Mfg dt: 12/2021 Exp dt: 11/2023 Mfd by: M/s. M.R. Healthcare pvt. Ltd., Village: Tanda Mallu, Kashipur Road, Ramnagar-244715, Dist. Nainital, Uttarakhand, (INDIA). | Dissolution and Assay | CDSCO Zonal Office Hyderabad | CDTL Hyderabad |
29. | RANTIDINE HYDROCHLORIDE TABLETS IP 150 mg | B. No.: AT22200 Mfg dt: 08/2022 Exp dt: 07/2024 Mfd by: M/s. Alves Healthcare Pvt. Ltd., Village Nangal Uperla, Swarghat Road, Tehsil, Nalagarh Dist. Solan- 174101 (H.P.). INDIA. | Uniformity of Weight | CDSCO South Zonal Chennai | CDTL Hyderabad |
30. | Diclofenac Sodium Injection IP | B. No.: DSIY-85 Mfg dt: 12/2021 Exp dt: 11/2023 Mfd by: M/s. Hindustan Antibiotics LTD., | Particulate Matter | CDSCO Sub Zone Baddi | RDTL Chandigarh |
(A Government Of India Enterprises) At 11, W.E.A. Faridabad- 121001 (Haryana). | |||||
31. | Loose Green Color Capsules (Purported to be contains Tramadol, Pregabalin and Other) | B. No.: Not mentioned Mfg dt: null Exp dt: null Mfd by: M/s. Not Mentioned. | Identification (B) of Pregabalin | Drug Control Department Himachal Pradesh | RDTL Chandigarh |
32. | Enrofloxacin Injection IP (Vet.) | B. No.: VENF-250A Mfg dt: 01/2022 Exp dt: 12/2023 Mfd by: M/s. PUSHKAR PHARMA, Bhandariwala, Kheri, Kala-Amb-173030, Himachal Pradesh. | pH | Drug Control Department Himachal Pradesh | RDTL Chandigarh |
33. | Levocetirizine Dihydrochloride Tablets IP (Svlo Tablets) | B. No.: LV20MT-672 Mfg dt: 12/2020 Exp dt: 11/2022 Mfd by: M/s. L.V. LIFE SCIENCES, VPO Gurumajra, Baddi, Distt. Solan, Himachal Pradesh- 174101. | Assay | Drug Control Department Himachal Pradesh | RDTL Chandigarh |
34. | Ibuprofen Tablets IP 200 mg | B. No.: IB-22A01 Mfg dt: 02/2023 Exp dt: 01/2025 Mfd by: M/s. Cyper Pharma, K.No. 825-827, Gullarwala, Sai Road, Baddi, Distt. Solan, Himachal Pradesh - 173205 INDIA. | Dissolution | Drug Control Department Himachal Pradesh | RDTL Chandigarh |
35. | Cefixime, Ofloxacin and Lactic Acid Bacillus Tablets (C- Cef OLB Tablets) | B. No.: SLH-2101 Mfg dt: 01/2022 Exp dt: 12/2023 Mfd by: M/s. PRAGTI REMEDIES, Plot No.- 143, G.S. Road Link, Ulubari Guwahati, Assam-781008. | Identification and Assay of Cefixime, Ofloxacin and Lactic Acid Bacillus | Drug Control Department Himachal Pradesh | RDTL Chandigarh |
Also Read:CDSCO Drug Alert: 48 drug samples flagged not of standard quality
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