CDSCO declares 20 drug samples including Cough Syrup, Diabetes drugs as Not of Standard Quality
New Delhi: The apex drug regulatory body, Central Drugs Standard Control Organization (CDSCO) has flagged 20 drug samples as 'Not of Standard Quality' after they failed to qualify a random drug sample test for the month of June.
Total number of samples tested | 790 |
Total number of samples declared as of Standard Quality | 770 |
Total number of samples declared as Not of Standard Quality | 20 |
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. | Mometran Cream (Mometasone Furoate Cream IP) | B. No.: 716, Mfg dt: 06/2019, Exp dt: 07/2021, Mfd by: M/s. Mascot Health Series Pvt. Ltd., Plot No. 79, 80, Sector-6A, IIE Sidcul, Haridwar- 249403 (Uttarakhand). | Assay | CDSCO, West Zone, Mumbai. | CDTL, Mumbai |
2. | Eudox-100 (Doxycycline Capsules I.P.) | B. No.: EDX-1006, Mfg dt: 03/2019, Exp dt: 02/2021, Mfd by: M/s. Ultra-Chiron Pharmaceuticals Pvt. Ltd., 575, Phase-IX, Industrial Area, Mohali-160062 Punjab. | Uniformity of Weight | CDSCO, West Zone, Mumbai. | CDTL, Mumbai |
3. | Absorbent Guaze | B. No.: 304, Mfg dt: 01/2019, Exp dt: 12/2021, Mfd by: M/s. Balu Surgicals, 1/243, Labhvinayagar Kovil Street, Samusigapuram- 626102 Tamil Nadu. | Length | Drugs Control Department, Kerala. | RDTL, Guwahati |
4. | Doxyrap-100 (Doxycycline & Lactic Acid Bacillus Tablets) | B. No.: DET-02830, Mfg dt: 01/2019, Exp dt: 12/2020, Mfd by: M/s. Dr. Edwin Lab Plot No. 517, Indl. Area, Phase IX, Sas Nagar- 160059 (PB). | Uniformity of weight, Assay | Drugs Control Department, Mizoram. | RDTL, Guwahati |
5. | Bhringraj Hair oil 200 ml. (Liquid Parafin 55% vegetable oil including seasame oil, Eclipta Alba) | B. No.: A0014, Mfg dt: 05/2019, Exp dt: 04/2022, Mfd by: M/s. Ananya Herbal Pvt. Ltd., Khasra no. 6/67/8/2 min 10- village, Safiabad Dist. Sonepat Haryana-131209. | Acid value (Type 1 & Type 3) | Drugs Control Department, Bihar. | RDTL, Guwahati |
6. | Nitrobact-100 (Nitrofurantoin Capsules U.S.P.) | B. No.: A6JQS030, Mfg dt: 09/2019, Exp dt: 08/2021, Mfd by: M/s. Swiss Garnier Biotech Pvt. Ltd. 21, Ind. Area, Mehatpur, Dist. Una, Himachal Pradesh-74315. | Dissolution | CDSCO, East Zone, Kolkata. | CDL, Kolkata |
7. | Cefotaxime Sodium Injection IP 250 mg | B. No.: 0322, Mfg dt: 07/2019, Exp dt: 06/2021, Mfd by: M/s. Hindustan Antibiotics Ltd., Pimpri, Pune -411018. | Water | CDSCO, East Zone, Kolkata | CDL, Kolkata |
8. | Glicot -60 (Gliclazide Extended release Tablets 60 mg) | B. No.: MT190903, Mfg dt: 07/2019, Exp dt: 06/2021, Mfd by: M/s. Mascot Health Series Pvt. Ltd., Plot No. 79, 80, Sector 6A, IIE, SIDCUL, Haridwar -249403, India. (Uttarakhand). | Dissolution | CDSCO, East Zone, Kolkata | CDL, Kolkata |
9. | Fexcor-120 (Fexofenadine Hydrochloride Tablets I.P. 120 mg) | B. No.: OBRP01, Mfg dt: 08/2019, Exp dt: 07/2021, Mfd by: M/s. Akums Drugs & Pharmaceuticals Ltd., 19, 20, 21 Sector -6A, I.I.E, SIDCUL, Ranipur, Haridwar- 249403, India | Description | CDSCO, East Zone, Kolkata | CDL, Kolkata |
10. | Auditon-MD 8 Tablets (Ondansetron Orally Disintegrating Tablets IP 8 mg) | B. No.: RT181032, Mfg dt: 10/2018, Exp dt: 09/2020, Mfd by: M/s. Rachil Pharma, 18-19, Phase – I, Ind. Area, Sansarpur Terrace, Distt. Kangra (H.P.) – 176501. | Description & Disintegration | CDSCO, North Zone, Ghaziabad | CDL, Kolkata |
11. | Telmisartan Tablets I.P. 20 mg | B. No.: TLMT703, Mfg dt: 07/2019, Exp dt: 06/2021, Mfd by: M/s. Unicure India Ltd., C-21, 22 & 23 Sector - 3, Noida-201301, Distt. Gautam Budh Nagar (U.P.). | Dissolution | CDSCO, North Zone, Ghaziabad | CDL, Kolkata |
12. | Setnorm – 4 (Ondansetron Tablets IP 4 mg) | B. No.: SMT610Z, Mfg dt: 02/2019, Exp dt: 01/2021, Mfd by: M/s. Unicure India Ltd., C-21, 22 & 23 Sector - 3, Noida-201301, Distt. Gautam Budh Nagar (U.P.). | Description | CDSCO, Goa | CDL, Kolkata |
13. | Ocupol Dx. (Polymyxin B Sulphate, Chloramphenicol & Dexamethasone Eye/Ear Drops) | B. No.: CB013, Mfg dt: 07/2019, Exp dt: 12/2020, Mfd by: M/s. Centaur Pharmaceuticals Pvt. Ltd., At. Vidhyanagar, Margao, Goa-403601. | Assay of Chloramphenicol | CDSCO, Hyderabad | CDL, Kolkata |
14. | Pioglitazone & Metformin Hydrochloride (Prolonged Release) Tablets | B. No.: CT9620, Mfg dt: 08/2019 Exp dt: 01/2022, Mfd by: M/s. Cian Healthcare Ltd., Kh. No. 248, Village Sisona, Bhagwanpur, Roorkee, Haridwar, Uttarakhand, India. | Dissolution of Metformin Hydrochloride | CDSCO, Ahmedabad | CDL, Kolkata |
15. | Dextromethorphan hydrobromide and Chlorpheniramine Maleate Syrup (Heel-DX Syrup) | B. No.: YHL-39, Mfg dt: 08/2019, Exp dt: 07/2021, Mfd by: M/s. Yashwin Healthcare, Village Shahpur Taga, Ganaur, Sonipat- 131001 (HR.). | Assay of Dextromethorphan Hydrobromide and Chlorpheniramine Maleate | Drug Control, Haryana | RDTL, Chandigarh |
16. | Thyroxine Sodium Tablets IP 50 mcg (Thyroute 50 Tablets) | B. No.: LTA-4081, Mfg dt: 11/2019, Exp dt: 10/2021, Mfd by: M/s. Life Vision Healthcare, Plot No.140- 141, E.P.I.P., Phase-I, Jharmajri, Baddi, Distt.Solan (H.P.)-174103. | Uniformity of content | CDSCO Sub Zone, Badd, Himachal Pradesh | RDTL, Chandigarh |
17. | Sustained Release Capsules of Ferrous Sulphate with Folic Acid (Folron Capsules) | B. No.: F921K901, Mfg dt: 10/2019, Exp dt: 09/2021, Mfd by: M/s. ZIM LABORATORIES LTD., B- 21/22, MIDC, Area, Kalmeshwar-441501, Dist.Nagpur, Maharashtra. | Assay of Folic Acid | CDSCO Sub-Zone, Baddi, Himachal Pradesh | RDTL, Chandigarh |
18. | Amoxycillin and Potassium Clavulanate Tablets IP | B. No.: 18A310, Mfg dt: 09/2018, Exp dt: 08/2020, Mfd by: M/s. Astam Healthcare Pvt. Ltd., Vill. Theda, Teh. Nalagarh, Distt. Solan-174101 (H.P.). | Identification of Potassium Clavulanate and Assay of Amoxycillin Trihydrate and Potassium Clavulanate | Drug Control, Himachal Pradesh | RDTL, Chandigarh |
19. | Calcium And Vitamin D3 Tablets IP | B. No.: CVDT-1384, Mfg dt: 04/2019, Exp dt: 03/2021, Mfd by: M/s. Wings Biotech 43 & 44 HPSIDC, Industrial Area, Baddi-173205 (H.P.). | Dissolution of Calcium Carbonate | CDSCO Sub-Zone, Baddi, Himachal Pradesh | RDTL, Chandigarh |
20. | Calcium And Vitamin D3 Tablets IP | B. No.: CVDT-1653, Mfg dt: 07/2019, Exp dt: 06/2021, Mfd by: M/s. Wings Biotech 43 & 44 HPSIDC Industrial Area, Baddi-173205 (H.P.). | Dissolution of Calcium Carbonate | CDSCO (North- Zone), Ghaziabad | RDTL, Chandigarh
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