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Date: 2019-12-10 Category: Not Applicable State: Union Government Country: India

Drug Alert list for month of November 2019

Issued by Ministry of Health and Family Welfare · Central Drugs Standard Control Organization

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Executive Summary & Key Takeaways

What it means

  • The gazette notification lists drugs, medical devices, and cosmetics declared as Not of Standard Quality, Spurious, Adulterated, or Misbranded for November 2019.
  • A total of 1158 samples were tested.
  • 1121 samples were declared as of Standard Quality.
  • 37 samples were declared as Not of Standard Quality.
  • 0 samples were declared as Spurious.
  • 0 samples were declared as Misbranded.

Key Changes

  • 37 samples failed quality tests related to dissolution, assay, disintegration, identification, pH, content, uniformity of weight, water-soluble and ether-soluble substances, loss on drying, and condensation products.
  • Specific drugs that failed include Pantoprazole, Ibuprofen, Telmisartan, Levocetirizine Dihydrochloride, Albendazole, Cedoxil, Amlodipine, Carbamazepine, Albendazole Vet. Oral Suspension, Prebiotic and Probitic Capsules, Suspension of Calcium, Vitamin B12 and Vitamin D3, Ferrous Ascorbate, Folic, Zinc and Cynocobalamin Syrup, Cetrizine Dihydrochloride Tablets, Ramipril Tablets, Trypsin Chymotrypsin Tablets, Vitamin B-Complex Tablets, Phenytoin Sodium Tablets, Doxycycline & Lactic Acid Bacillus Capsules, Omeprazole Capsule, Crepe Bandage, Metronidazole Tablets, Zinc Sulphate Tablets, Bacitracin Zinc, Ciprofloxacin Tablets, Cycloserine Capsules, Rabeprazole Sodium and Domperidon SR Capsules, Phenytoin Sodium Extended Release Tablets and Cefpirome Injection.
  • Reasons for failure include issues with dissolution, assay, disintegration, identification, pH, content of lactic acid bacillus, uniformity of filled weight, identification of Vitamin D3 & Cyanocobalamin and Assay of Calcium Carbonate, identification of Folic Acid and Cynaocobalamin and Assay of Ferrous Ascorbate, description and disintegration, water-soluble and Ether-soluble substances, loss on drying, condensation Products and Negative Identification for Amoxycillin and Clavulanic acid.

Impact Analysis

Impact on Manufacturers

  • Manufacturers will need to investigate the root cause of the quality failures and implement corrective and preventive actions (CAPA) to avoid future occurrences.

Impact on Retailers/Distributors

  • Retailers and distributors should verify the quality certificates and authenticity of products from manufacturers to avoid stocking substandard drugs.

Impact on Consumers

  • Consumers should verify the authenticity and quality of drugs before consumption and report any adverse effects to healthcare professionals and regulatory authorities.

Impact on Regulatory Authorities

  • Authorities should strengthen post-market surveillance to detect and address substandard drugs in the market.

Suggested Action Items

  • Regulatory Authorities: Increase inspections, strengthen post-market surveillance, and enforce stricter penalties for non-compliance.

Key Entities Referenced

Drugs RDTL, Guwahati: Drugs Regional Drugs Testing Laboratory, Guwahati. One of the testing facilities that identified the drugs as Not of Standard Quality. Drugs Control Department, Assam/Arunachal Pradesh/Meghalaya/Mizoram: State-level regulatory bodies responsible for drug quality control in their respective states. CDSCO: Central Drugs Standard Control Organization, the national regulatory body for pharmaceuticals and medical devices in India. CDL, Kolkata/Chennai/Ahmedabad: Central Drugs Laboratory, Kolkata, Chennai and Ahmedabad. Central government drug testing laboratories. RDTL, North Zone, Chandigarh: Regional Drugs Testing Laboratory, North Zone, Chandigarh. Another testing facility that identified the drugs as Not of Standard Quality. CDTL, Sub Zone, Mumbai/Indore: Central Drugs Testing Laboratory, Sub Zone, Mumbai and Indore. Central government drug testing laboratories. CDTL, West Zone, Mumbai: Central Drugs Testing Laboratory, West Zone, Mumbai. Central government drug testing laboratory. Drugs Inspector CDSCO, Goa: Drugs Inspector from CDSCO, Goa.
Official Source Record View Original Source →
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List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, for the Month of November 2019 Total number of samples tested 1158 Total number of samples declared as of Standard Quality 1121 Total number of samples declared as Not of Standard Quality 37 Total number of samples declared as Spurious 0 Total number of samples declared as Misbranded 0 S.No. Name of Batch No./Date of Reason for Drawn By From Drugs/medical Manufacture/Date of failure device/cosmetics Expiry/Manufactured By 1. Pantoprazole B. No.: T-7172 Dissolution Drugs RDTL, Gastro Resistant Mfg dt: 10/2018 Control Guwahati Exp dt: 09/2020 Department, Tablets I.P. Mfd by: M/s Kwality Assam. Pharmaceuticals Ltd. Nag Kalan, Majitha Road, Amritsar. 2. Ibuprofen Tablets B. No.: 01019-BJA36 Dissolution Drugs RDTL, I.P. 400 mg. Mfg dt: 01/2019 Control Guwahati Exp dt: 12/2020 Department, Mfd by: M/s Biogenetic Arunachal Drugs Pvt. Ltd. Vill- Pradesh. Jharmajri, Baddi, Dist- Solan H.P-174103 3. Pantoprazole B. No.: T-7224 Dissolution Drugs RDTL, Enteric Coated Mfg dt: 11/2018 Control Guwahati Exp dt: 10/2020 Tablets 40 mg. Department, Mfd by: M/s Kwality Arunachal Pharmaceuticals Ltd. Pradesh. Nag Kalan, Majitha Road, Amritsar 4. Telmisartan Tablets B. No.: LVT-28800 Dissolution Drugs RDTL, I.P. 40mg. Mfg dt: 04/2018 Control Guwahati Exp dt: 03/2020 Department, (Telziver-40) Mfd by: M/s Life Vision Assam. Healthcare, Plot No. 140- 141, E.P.I.P, Phase-I, Jharmajri, Baddi, Dist- Solan, H.P.-1741035. Levocetirizine B. No.: LC18004 Dissolution Drugs RDTL Dihydrochloride Mfg dt: 04/2018 Control Guwahati Exp dt: 03/2020 Tablets I.P. 5mg. Department, Mfd by: M/s Life Max Assam. Cancer Laboratories Plot No. 106 & 106A, Sector-6A, I.I.E., SIDCUL, Haridwar, Uttarakhand-249403 6. Albendazole Tablets B. No.: G002/2561 Dissolution Drugs RDTL I.P. (C-Bend) Mfg dt: 04/2019 Control Guwahati Exp dt: 03/2021 Department, Mfd by: M/s Elfin Drugs Mizoram. Pvt. Ltd. Vill-Berson, Nalagarh (H.P)-174101 7. Albendazole Tablets B. No.: 8605318, Dissolution Drugs RDTL I.P. 400 mg. Mfg dt: 10/2018 Control Guwahati Exp dt: 09/2021 Department, Mfd by: M/s Karnataka Meghalaya. Antibiotics & Pharmaceuticals Ltd. Plot No. 14, II Phase, Peenya, Bangalore- 560058 8. Pantoprazole B. No.: T03PA11-18 Dissolution Drugs RDTL Tablets I.P. Mfg dt: 11/2018 Control Guwahati Exp dt: 10/2020 Department, (PAD-40) Mfd by: M/s Adsila Mizoram. Organics Pvt. Ltd. Liwaspur Road, Vill-Bahalgarh-131021, Haryana 9. Cedoxil 500mg B. No.: T-16549 Dissolution Drugs RDTL Tablets Mfg dt: 03/2018 Control Guwahati Exp dt: 02/2020 Department, Mfd by: M/s Jackson Arunachal Laboratories Pvt. Ltd. Pradesh. Bye Pass, Majitha Road, Amritsar-143004 10. Amlodipine Tablets B. No.: CHT-9124 Assay CDSCO, CDL, IP 5mg Mfg dt: 03/2019 Sub Zone, Chennai Exp dt: 02/2021 Bangalore Mfd by: M/s. Bengal Chemicals & Pharmaceuticals Ltd., NH-No.74 Roorkee-Dehradun Highway, Kisanpur, Roorkee- 247667, Uttarakhand. 11. Carbamazepine B. No.: AAB8B007 Dissolution CDSCO, RDTL, Extended Release Mfg dt: 03/2018 North Zone, Chandigarh Exp dt: 02/2020 Tablets IP Ghaziabad Mfd by: Psychotropics (ACETOL CR-200 India Limited, Plot No.- TABLETS) 46 & 49, Sector-6A, IIE, SIDCUL, Industrial Area, Ranipur, Haridwar-249 403 (Uttarakhand ) 12. Albendazole Vet. B. No.: 205 pH CDSCO, RDTL, Oral Suspension Mfg dt: 11/2018 North Zone, Chandigarh Exp dt: 10/2020 (FLUKGON ) Ghaziabad Mfd by: Albro Pharmaceuticals Pvt. Ltd. GMP Certified Company Muktsar 152026, Punjab. 13. Prebiotic and B. No.: HC-1805016 Uniformity of CDSCO, RDTL, Probitic Capsules Mfg dt: 05/2018 filled Weight North Zone, Chandigarh Exp dt: 04/2020 Ghaziabad (REPURE Mfd by: Helax Health CAPSULES) Care Private Limited, Khasra No. 410, Village- Karondi, Roorkee- 247667, District- Haridwar 14. Suspension of B. No.: SL-398 Identification of CDSCO, RDTL, Calcium, Vitamin Mfg dt: 05/2019 Vitamin D3 & Sub-zone Chandigarh Exp dt: 04/2021 Cyanocobalam Baddi B12 and Vitamin D3 Mfd by: Sridhara Life in and Assay ( CALCI-D ) sciences Pvt. Ltd. Khasra of Calcium Carbonate No. 285,290, Village- Calculated as Sisona, Bhagwanpur, Calcium Roorkee, Haridwar (Uttrakhand )-247661 15. Ferrous Ascorbate, B. No.: MSL-091 Identification of CDSCO, RDTL, Folic, Zinc and Mfg dt: 03/2019 Folic Acid and Sub Zone, Chandigarh Cynocobalamin Exp dt: 02/2021 Cynaocobalam Baddi Syrup Mfd by: Maskon Life in and Assay (FEROFOL-BZ) Sciences Pvt. Ltd. Kh. of Ferrous No. 69& 70 Khatakheri,Bhagwanpur, Roorkee Ascorbate (U.K.) INDIA Calculated as Elemental Iron 16. MDZIME – DT B. No.: ZT-8313 Disintegration CDSCO, CDL, (Cetrizine Mfg dt: 01/2019 & Uniformity of Ahmedabad Kolkata Dihydrochloride Exp dt: 12/2021 Dispersion Tablets) Mfd by: M/s. Zenith Healthcare Ltd., 388/34, Chandogar Ind. Estate, Sarkhej Bavla Highway, Changodar -382210 17. Ramizim - 2.5 B. No.: EH97M801 Dissolution & CDSCO, CDL, (Ramipril Tablets Mfg dt: 12/2018 Assay Ahmedabad Kolkata I.P. 2.5 mg) Exp dt: 11/2020, Mfd by: M/s. ZIM Laboratories Limited (Unit-II), A-8/14, MIDC, Area, Kalmeshwar 441501, Dist Nagpur, Maharashtra 18. Trypsin B. No.: T 53903 Disintegration CDSCO, CDL, Chymotrypsin Mfg dt: 05/2018 North Zone, Kolkata Exp dt: 04/2021 Tablets Ghaziabad Mfd by: M/s. Vardhman Exports, A-188, T. T.C., MIDC, Khairne, Navi Mumbai – 400 710. 19. Ramipril Tablets I.P. B. No.: RAPT18004 Assay CDSCO, CDL, 2.5 mg Mfg dt: 12/2018 North Zone, Kolkata Exp dt: 11/2020 Ghaziabad Mfd by: M/s. Ravian Life Sciences Pvt. Ltd., Plot No. 34, Sec. 8A, IIE, SIDCUL, Haridwar -249 403, UK. 20. Cadpril 5 (Ramipril B. No.: ZPR0037 Assay CDSCO, CDL, Tablets I.P) Mfg dt: 08/2018 North Zone, Kolkata Exp dt: 07/2020 Ghaziabad Mfd by: M/s. Preet Remedies Ltd., 183-186, HPSIDC, Industrial Area, Baddi, Distt. Solan – (H.P.) – 17320521. Vitamin B-Complex B. No.: KA19001 Identification & Drugs CDL, Tablets NFI Mfg dt: 01/2019 Assay of Inspector Kolkata Exp dt: 06/2020 Calcium CDSCO, Mfd by: M/s. Ortin Pantothenate Goa Laboratories Ltd., 275 & 278 (Part) I.D.A. Pashamylaram -502307, Medak, AP. 22. Medtoin (Phenytoin B. No.: SPT190048A, Description CDSCO, CDL, Sodium Tablets I.P.) Mfg dt: 01/2019 and Sub Zone, Kolkata Exp dt: 12/2020 Disintegration Baddi, H.P. Mfd by: M/s. Salus Pharmaceuticals, 480/211, Harraipur, P.O. Gurumajra, Teh. Baddi, Distt. Solan (H.P.) – 173 205 23. DOXYGUARD B. No.: SOC-615F Assay/Content CDSCO, CDL, (Doxycycline & Mfg dt: 01/2018 of Lactic Acid Sub Zone, Kolkata Exp dt: 12/2019 Lactic Acid Bacillus Bacillus Baddi, H.P. Mfd by: M/s. Symbiosis Capsules) Pharmaceuticals Pvt. Ltd., (Unit-III), Trilokpur Road, Kala Amb-173030 (H.P) 24. OMEP (Omeprazole B. No.: UOME 1803 Dissolution CDSCO, CDL, Capsule I.P. 20mg) Mfg dt: 02/2018 East Zone, Kolkata Exp dt: 01/2020 Kolkata Mfd by: M/s. Bal Pharma Limited, Plot No. 1, 2, 3 & 69, Sector 4 IIE, SIDCUL, Pantnagar, Rudrapur Distt-Udham Singh Nagar, Uttarakhand, India 25. CREPE BANDAGE B. No.: 37 Water-soluble CDSCO, CDL, (10 CMS X 4 Mfg dt: 10/2017 and Ether- East Zone, Kolkata Exp dt: 3 Yrs from Mfg. MTRS) soluble Kolkata Date substances Mfd by: M/s. Hindustan Surgical Appliances, 29, Huzuri Mull Lane, Kolkata - 700 014. 26. Metronidazole B. No.: 7596027 Dissolution CDSCO, CDL, Tablets I.P. 400 mg Mfg dt: 08/2017 East Zone, Kolkata Exp dt: 07/2020Mfd by: M/s. Bengal Kolkata Chemical & Pharmaceuticals Ltd., 164, Maniktala Main Road, Kolkata – 700054 27. Ramizim 5 (Ramipril B. No.: EO82M801 Dissolution & CDSCO, CDL, Tablets I.P. 5 mg) Mfg dt: 12/2018 Assay East Zone, Kolkata Exp dt: 11/2020 Kolkata Mfd by: M/s. Zim Laboratories Limited (Unit-II), A-8/14, MIDC Area, Kalmeshwar 441501, Dist Nagpur, Maharashtra 28. Zinc Sulphate B. No.: 05069 Disintegration CDSCO, CDTL, Tablets IP 20 mg Mfg dt: 06/2019 and Uniformity Sub Zone, Mumbai Exp dt: 05/2021 of Dispersion Indore. Mfd by: M/s. Healthy Life Pharma Pvt. Ltd., N-31/1, M.I.D.C., Tarapur, Dist. Palghar, Boisar-401506, Maharashtra 29. Bacitracin Zinc B. No.: B190304 Loss on Drying CDSCO, CDTL, Mfg dt: 03/2019 Air Cargo, Mumbai Exp dt: 03/2023 Mumbai Mfd by: M/s. Yancheng Youhua Pharmaceutical & Chemical Technology, Co. Ltd., China 30. Ciprofloxacin B. No.: (10)CITW-31 Dissolution CDSCO, CDTL, Tablets IP 250 mg Mfg dt: 04/2019 Sub Zone, Mumbai Exp dt: 03/2021 Indore. Mfd by: M/s. Nestor Pharmaceuticals Limited, 11, Western Extension Area, Faridabad-121001 31. Cycloserine B. No.: ECB5836A Condensation CDSCO, CDTL, Capsules USP 250 Mfg dt: 07/2018 Products and West Zone, Mumbai Exp dt: 06/2021 mg Assay Mumbai Mfd by: M/s. Macleods Pharmaceuticals Ltd., Plot No. 25-27, Survey No.366, Premier Industrial Estate, Kachigam, Daman396210 (U.T) 32. Rabiun-DSR B. No.: NY1180 Dissolution CDSCO, CDTL, (Enteric coated Mfg dt: 05/2019 West Zone, Mumbai Exp dt: 04/2021 Rabeprazole Mumbai Mfd by: M/s. Intas Sodium and Pharmaceuticals Limited, Domperidon SR Samardung Road, Capsules) Kabrey Block, Namthang Elaka, South Sikkim- 737 132 33. Eptoin 300 ER B. No.: SDE0020 Dissolution CDSCO, CDTL, (Phenytoin Sodium Mfg dt: 03/2019 Ahmedabad Mumbai Exp dt: 02/2021 Extended Release Zone Mfd by: M/s. Sidmak Tablets 300 mg) Laboratories (India) Pvt. Ltd., Plot No.20, Pharma City, Selaqui Industrial Area, Dehradun-248197, Uttarakhand1. Purport to contain B. No.: Not Specified Negative CDSCO, CDTL, Amoxycillin & Mfg dt: Not Specified Identification Sub Zone, Mumbai Exp dt: Not Specified Potassium for Amoxycillin Indore. Mfd by: Not Specified Clavulanate and Clavulanic equivalent to Acid Amoxycillin 500 mg, Potassium Clavulanate Diluted IP equivalent to Clavulanic Acid 125 mg 1. Cefpirome Injection B . N o . : G S1547G Identification of CDSCO, RDTL, (AZZICEF ) Mfg dt: 08/2018 Cefpirome North Zone, Chandigarh Exp dt: 07/2020 Sulphate Ghaziabad Mfd by: Not mentioned

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