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Date: 2020-03-06 Category: Not Applicable State: Union Government Country: India

Drug Alert list for month of Feb 2020

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

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Executive Summary & Key Takeaways

What it means

  • This gazette notification lists drugs, medical devices, and cosmetics declared as Not of Standard Quality, Spurious, Adulterated, or Misbranded for February 2020.
  • It provides details such as the name of the product, batch number, manufacturing and expiry dates, manufacturer, reason for failure, and the zone from which the sample was drawn.

Key Changes

  • A total of 1271 samples were tested in February 2020.
  • 1233 samples were declared to be of Standard Quality.
  • 38 samples were declared as Not of Standard Quality.
  • 0 samples were declared as Spurious.
  • 0 samples were declared as Misbranded.
  • The notification lists 38 products that failed quality tests, citing reasons such as Assay, Dissolution, Water Content, Particulate Matter, Description, Sterility, Related Substances, Identification, and Bacterial Endotoxins Test failures.
  • Manufacturers include both domestic and international companies, including those from China.
  • Testing was conducted by CDSCO (Central Drugs Standard Control Organization) and various RDTLs (Regional Drugs Testing Laboratories).

Impact Analysis

Impact on Pharmaceutical Companies

  • Action Item: Review manufacturing processes and quality control procedures to prevent future occurrences. Conduct internal audits and address any identified gaps.

Impact on Healthcare Providers

  • Action Item: Review inventory and quarantine any affected products. Inform patients who may have received these products and advise them on appropriate actions.

Impact on Patients/Consumers

  • Action Item: Consult healthcare providers if they have concerns about medications they are taking. Report any adverse events to the appropriate authorities.

Impact on Regulatory Agencies (CDSCO/State FDA)

  • Action Item: Conduct thorough investigations of the manufacturers and take appropriate enforcement actions. Enhance collaboration between central and state regulatory bodies.

Impact on International Trade

  • Action Item: Strengthen import controls and collaborate with international regulatory agencies to ensure the quality of imported pharmaceutical products.

Key Entities Referenced

CDSCO: Central Drugs Standard Control Organization, the national regulatory body for pharmaceuticals and medical devices in India. RDTL: Regional Drugs Testing Laboratory, a network of laboratories responsible for testing and analyzing drug samples. Drugs and Cosmetics Act: The primary legislation governing the regulation of drugs, cosmetics, and medical devices in India. (Implicitly referenced through the listing of drugs and cosmetics) IP: Indian Pharmacopoeia, the book of standards for drugs manufactured and marketed in India
Official Source Record View Original Source →
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0List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, for the Month of February 2020 Total number of samples tested 1271 Total number of samples declared as of Standard Quality 1233 Total number of samples declared as Not of Standard Quality 38 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. Serratiopeptidase B. No.: SET8002, Assay CDSCO, CDL, Tablets IP 10 mg Mfg dt: 10/2017, South Zone, Kolkata Exp dt: 09/2020, Chennai. Mfd by: M/s. Sai Mirra Innopharm Pvt. Ltd., 288 & 299, SIDCO Estate, Ambattur, Chennai – 600 098. 2. Glyjack – 1 (Glimepiride B. No.: T–19598, Dissolution CDSCO, CDL, Tablets I.P.) Mfg dt: 05/2019, East Zone, Kolkata Exp dt: 04/2021, Kolkata. Mfd by: M/s. Jackson Laboratories Pvt. Ltd., 22-24, Majitha Road, Bye Pass, Amritsar – 143 001, Punjab. 3. Ondansetron Injection B. No.: ONI1923, Description and CDSCO, CDL, I.P. 2 mg/ml, 2 ml Mfg dt: 06/2019, Particulate Matter East Zone, Kolkata Exp dt: 05/2021, Kolkata. Mfd by: M/s. Modern Laboratories, 45-47, Sector D – 2, Sanwer Road, Indore, Madhya Pradesh – 452 015. 4. Oxytetracycline B. No.: Y51806089W, Water Content CDSCO, CDL, Hydrochloride (VET) Mfg dt: 01/06/2018, Ahmedabad Kolkata Exp dt: 31/05/2022, Zone. IP/EP/USP Mfd by: M/s. Hebei Jainmin Starch GlucoseCo. Ltd., Industrial Development Zone, Ningjin Country, Hebei, China. 5. Oxytetracycline B. No.: Y2-1904082-3, Water Content CDSCO, CDL, Hydrochloride I.P. Mfg dt: 08/04/2018, Ahmedabad Kolkata Exp dt: 07/04/2022, Zone. Mfd by: M/s. Hebei Shengxue Dacheng Pharmaceuticals Co. Ltd., No. 50, Shengxue Road, Luancheng, Shijiazhuang Hebei, Province, China. 6. Fexodil 120 mg B. No.: T–18839, Dissolution CDSCO, CDL, (Fexofenadine Mfg dt: 02/2019, East Zone, Kolkata Exp dt: 01/2021, Kolkata. Hydrochloride Tablets) Mfd by: M/s. Jackson Laboratories Pvt. Ltd., 22-24, Majitha Road, Bye Pass, Amritsar – 143 001, Punjab. 7. Tymolytic AP B. No.: LVC–6286, Assay of Trypsin CDSCO, CDL, (Aceclofenac, Mfg dt: 12/2018, Chymotrypsin South Zone, Kolkata Exp dt: 11/2020, Chennai. Paracetamol & Trypsin Mfd by: M/s. Life Vision Chymotrypsin Capsules) Healthcare, Plot No. 140, EPIP, Phase – 1, Jharmajri, Baddi, Solan Himachal Pradesh. 8. Cecon – XT Tablets B. No.: SRDT – 1207, Assay/Content of CDSCO, CDL, (Ferrous Ascorbate, Mfg dt: 05/2019, ‘Folic Acid, Sub Zone, Kolkata Exp dt: 10/2020, Baddi. Folic Acid, Vitamin B12 Elemental Iron Mfd by: M/s. Spas & Zinc Tablets) and Elemental Remedise, Vill Bersan, Zinc P.O. Lodhi Majra, Teh Baddi, Distt. Solan Himachal Pradesh – 173 205. 9. Phenytoin Sodium B. No.: T–18909, Assay and CDSCO, CDL, Tablets I.P. 100 mg Mfg dt: 02/2019, Description Subzone Kolkata Exp dt: 01/2021, Goa. Mfd by: M/s. Jackson Laboratories Pvt. Ltd., No. 22 – 24, Majitha Road, Bye Pass, Amritsar – 143 001 Punjab.10. Cyanocobalamin Inj. I.P. B. No.: CY2902, Particulate Matter CDSCO, CDL, 1 ml Mfg dt: 01/2019, and Description Ahmedabad Kolkata Exp dt: 12/2020, Zone. Mfd by: M/s. Nandini Medical Laboratories Pvt Ltd., 221/5, Bicholi Hapsi, Kanadia Road, Indore. 11. STECLIN INJECTION B. No.: STIR19113, Bacterial CDSCO, CDL, Veterinary 50 mg/ml Mfg dt: 08/2019, Endotoxins Test South Zone, Kolkata Exp dt: 07/2021, (Oxytetracycline Chennai. Mfd by: M/s. Zydus Hydrochloride Injection Animal Health, A I.P. 30 ml) Division of Cadila Healthcare Ltd., At. Plot No. 69/1, G.I.D.C. Kansari Khambhat, Dist. Anand 388 630, Gujarat. 12. Everolimus B. No.: 201812021, Assay, Water and CDSCO, CDL, Mfg dt: 12/2018, Chromatographic Ahmedabad Kolkata Exp dt: 12/2023, Purity Zone Mfd by: M/s. Zhejiang Medicines & Health Products Import & Export Co. Ltd., China. 13. Albendazole Tablets I.P. B. No.: GLL18001, Dissolution Drugs RDTL, 400mg. (Zenebend) Mfg dt: 01/2018, Control Guwahati Exp dt: 12/2020, Department, Mfd by: M/s. IBN Arunachal Herbals Khasra No. 63, Pradesh Vill-Juddikalan Baddi, Dist- Solan, Himachal Pradesh. 14. Albendazole 400mg. B. No.: BBT19329A, Dissolution Drugs RDTL, Tablets I.P. Mfg dt: 08/2019, Control Guwahati Exp dt: 07/2021, Department, Mfd by: M/s. Biomax Arunachal Biotechnics (P) Ltd. Pradesh 261, HSHDC, Industrial Estate Alipur, Barwala, Haryana-134118. 15. Ferrous Sulphate and B. No.: ELB-1901, Disintegration Drugs RDTL, Folic Acid Tablets I.P. Mfg dt: 07/2019, Control Guwahati Exp dt: 06/2021, Department, Mfd by: M/s. HLL Arunachal Lifecare Ltd. 11/A-1 & Pradesh 12/C-1, Sector-E, Industrial Area, Sanwer Road, Indore-45201Madhya Pradesh. 16. Pantoprazole Sodium B. No.: T-7105, Dissolution Drugs RDTL, Tablets I.P. Mfg dt: 09/2018, Control Guwahati Exp dt: 08/2020, Department, Mfd by: M/s. Kwality Arunachal Pharmaceuticals Ltd. Pradesh Nag Kalan, Majitha Road, Amritsar Punjab. 17. Pantoprazole Gastro B. No.: T-7159, Dissolution CDSCO, RDTL, Resistant Tablets I.P.40 Mfg dt: 10/2018, Subzone, Guwahati Exp dt: 09/2020, mg. Guwahati Mfd by: M/s. Kwality Pharmaceuticals Ltd. Nag Kalan, Majitha Road, Amritsar, Punjab. 18. Pantoprazole Gastro B. No.: T-7156, Dissolution Drugs RDTL, Resistant Tablets I.P.40 Mfg dt: 10/2018, Control Guwahati Exp dt: 09/2020, mg. Department, Mfd by: M/s. Kwality Assam. Pharmaceuticals Ltd. Nag Kalan, Majitha Road, Amritsar, Punjab. 19. Amoxycillin Capsules B. No.: HCB709L, Assay Drugs RDTL, I.P. (Amoxytor-250) Mfg dt: 11/2017, Control Guwahati Exp dt: 10/2020, Department, Mfd by: M/s. Himalaya Arunachal Medical Pvt. Ltd. Plot Pradesh No. 35 & 36, Pharmacity, Selaqui, IndL. Area, Dehradun- 248197 Uttarakhand. 20. Pantoprazole Tablets B. No.: OPT-48, Dissolution Drugs RDTL, I.P. (PANTA-40) Mfg dt: 05/2018, Control Guwahati Exp dt: 04/2020, Department, Mfd by: M/s.Orison Meghalaya. Pharmaceuticals 51, Industrial Estate, Ambala Cantt-133006 Haryana. 21. Albendazole Tablets I.P. B. No.: ABT18042, Dissolution Drugs RDTL, 400 mg. Mfg dt: 12/2018, Control Guwahati Exp dt: 11/2020, Department, Mfd by: M/s. Vivek Assam. Pharmachem (India) Ltd. NG-8, Chimanpura, Amer, Jaipur-303102 Rajasthan. 22. Domperidone B. No.: 1801, Assay Drugs RDTL, Suspension (Dom-H) Mfg dt: 03/2018, ControlExp dt: 02/2020, Department, Guwahati Mfd by: M/s. Harsh Arunachal Healthcare 100, Pradesh. Industrial Area Rau- 453331, Madhya Pradesh. 23. Albendazole 400 mg. B. No.: BBT19326A, Dissolution Drugs RDTL, Tablets I.P. Mfg dt: 08/2019, Control Guwahati Exp dt: 07/2021, Department, Mfd by: M/s. Biomax Arunachal Biotechnics (P) Ltd. 261, Pradesh. HSHDC, Indsutrial Estate Alipur, Barwala, Haryana- 134118. 24. Albendazole 400 mg. B. No.: BBT19331A, Dissolution Drugs RDTL, Tablets I.P. Mfg dt: 08/2019, Control Guwahati Exp dt: 07/2021, Department, Mfd by: M/s. Biomax Arunachal Biotechnics (P) Ltd. 261, Pradesh. HSHDC, Indsutrial Estate Alipur, Barwala, Haryana- 134118. 25. Pantoprazole Gastro- B. No.: T-7166, Dissolution Drugs RDTL, Resistant Tablets I.P. Mfg dt: 10/2018, Control Guwahati Exp dt: 09/2020, Department, Mfd by: M/s.Kwality Assam. Pharmaceuticals Ltd. Nag Kalan, Majitha Road, Amritsar, Punjab. 26. Pantoprazole Gastro- B. No.: T-7165, Dissolution Drugs RDTL, Resistant Tablets I.P. Mfg dt: 10/2018, Control Guwahati Exp dt: 09/2020, Department, Mfd by: M/s. Kwality Assam. Pharmaceuticals Ltd. Nag Kalan, Majitha Road, Amritsar, Punjab. 27. Metronidazole Tablets B. No.: NZL-19002, Dissolution Drugs RDTL, I.P. 400mg. (NEUZOL- Mfg dt: 05/2019, Control Guwahati Exp dt: 04/2022, 400) Department, Mfd by: M/s. Neutec Arunachal Healthcare Pvt. Ltd. E- Pradesh. 698, DSNDC, Industrial Area, Narela, Delhi- 110040. 28. Ondansetron Tablet I.P. B. No.: 19440988, Dissolution Drugs RDTL, (ONDEM-4) Mfg dt: 05/2019, Control Guwahati Exp dt: 04/2021, Department, Mfd by: M/s. Alkem Assam. Health Sciences Unit-2,Samardung, Karak Block, P.O. Namthang, South Sikkim-737137. 29. Compound Sodium B. No.: 2194, Sterility CDSCO, CDTL, Lactate Injection IP Mfg dt: 01/2019, South Zone, Chennai Exp dt: 12/2021, (Ringers Lactate Chennai Mfd by: M/s. Hindustan Solution for Injection) Antibiotics Ltd. Pimpri, Pune-411018. 30. Biodipin 5 (Amlodipine B. No.: ZD19769, Related CDSCO, CDTL, Tablets IP) Mfg dt: 09/2019, Substances West Zone, Mumbai Exp dt: 08/2021, Mumbai Mfd by: M/s. Skymap Pharmaceuticals Pvt. Ltd., B-3, Dev Bhoomi Industrial Estate, Puhana Iqbalpur Road, Roorkee 247667 Uttarakhand. 31. Ambroxol Hydrochloride B. No.: AMB E18001 Assay & Related CDSCO, CDTL, IP 1219, Substances West Zone, Mumbai Mfg dt: 12/2019, Mumbai Exp dt: 11/2022, Mfd by: M/s. Anuh Pharma Ltd., E-17/3, 17/4 & E18, M.I.D.C., Tarapur, Maharashtra. 32. Amoxycillin and B. No.: SSB-1658, Identification of CDSCO RDTL, Potassium Clavulanate Mfg dt: 11/2019, Clavulanic Acid Sub Zone, Chandigarh Exp dt: 04/2021, Tablets IP (Angiclave- Baddi. Mfd by: M/s. Shri Sai 625 Tablets) Balaji Pharmatech Pvt. Ltd. 20 Ext. HPSIDC, Ind.Area, Baddi, Himachal Pradesh 173205. 33. Erythromycin Stearate B. No.: GT18390, Dissolution CDSCO RDTL, Tablets Ip 250 Mg Mfg dt: 09/2018, North Zone, Chandigarh Exp dt: 08/2021, Ghaziabad. Mfd by: M/s. Globela Pharma Pvt. Ltd. 357, G.I.D.C., Sachin Surat- 394230, Gujarat. 34. Mefenamic Acid and B. No.: ABM29010, Description CDSCO, RDTL, Dicyclomine Mfg dt: 07/2019, Sub-Zone, Chandigarh Exp dt: 06/2022, Hydrochloride Tablets Jammu. Mfd by: M/s. IP ( KOLISPAS Psychotropics India TABLETS) Limited Plot No. 46 &49, Sector-6A, IIE, SIDCUL, Ranipur, Haridwar-249403 Uttarakhand. 35. Enzitec Digestive B. No.: UBL19005, Identification of Drug RDTL, Enzyme Syrup Mfg dt: 01/2019, Diastase and Control Chandigarh Exp dt: 06/2020, Assay of Pepsin Department, Mfd by: M/s. Unibiotech HP. Formulations Delta Division, Vill.Katha, Baddi, Dist. Solan, Himachal Pradesh - 173205. 36. Lactulose Solution B. No.:TL-19109, Assay of CDSCO RDTL, Mfg dt: 06/2019, Lactulose North Zone, Chandigarh Exp dt: 05/2021, Ghaziabad. Mfd by: M/s. Terrace Pharmaceuticals (P) Ltd. 3-B (a), Phase-III, Industrial Area, Sansarpur, Terrace, Distt. Kangra (H.P.)- 176501. 37. Clindamycin Phosphate B. No.: O8073, Assay of CDSCO, RDTL, Gel Usp 1% w/w) Mfg dt: 06/2018, Clindamycin Sub-Zone, Chandigarh Exp dt: 05/2020, Phosphate Jammu. Mfd by: M/s. Rhydburg Pharmaceuticals Ltd. C- 2 & 3, S.I.E.L., Seaqui, Dehradun, Uttarakhand. 38. Sucralfate and B. No.: ML190359, Assay of CDSCO RDTL, Oxetacaine Suspension Mfg dt: 09/2019, Oxetacaine North Zone, Chandigarh Exp dt: 08/2021, ( SUCRACE-O Ghaziabad. Mfd by: M/s. Mascot SUSPENSION ) Health Series Pvt. Ltd. Plot No. 79, 80 Sec. 6A, IIE, SIDCUL, Haridwar- 249403.

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