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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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Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751