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Date: 2018-09-05 Category: Not Applicable State: Union Government Country: India

Drug Alert list for month of August 2018

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 August 2018.
  • The list includes the name of the product, batch number, manufacturing and expiry dates, manufacturer, reason for failure, and the source from which the sample was drawn.

Key Changes

  • A total of 34 products are listed as Not of Standard Quality/Spurious/Adulterated/Misbranded.
  • Reasons for failure include dissolution issues, assay discrepancies, particulate matter, sterility failures, description issues, total viable cell count issues, and being misbranded.
  • The listed products include tablets, injections, capsules, syrups, and creams.
  • Multiple manufacturers are implicated, primarily located in Himachal Pradesh, Uttarakhand, Gujarat and other states.
  • Testing was conducted by various CDSCO (Central Drugs Standard Control Organization) zones and Regional Drugs Testing Laboratories (RDTL).

Impact Analysis

Manufacturers

  • Action Item: Review manufacturing processes and quality control procedures to prevent future failures. Implement corrective and preventive actions (CAPA).

Distributors/Retailers

  • Action Item: Verify stock and immediately quarantine and return affected batches to manufacturers. Ensure robust tracking of product recalls.

Consumers

  • Action Item: Exercise caution and consult healthcare professionals regarding medication concerns. Report any adverse effects to regulatory authorities.

Regulatory Agencies (CDSCO, State FDAs)

  • Action Item: Enhance surveillance and inspection activities. Expedite investigations and take appropriate enforcement actions against non-compliant manufacturers.

Our Company

  • Action Item: Conduct a thorough review of our supply chain and internal quality control processes. Strengthen vendor qualification and monitoring programs.

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, responsible for testing and analyzing drug samples. Drugs and Cosmetics Act, 1940: The primary legislation governing the import, manufacture, distribution, and sale of drugs and cosmetics in India (Implied). VIP Pharmaceuticals (P) Ltd.: One of the manufacturers listed with multiple products failing quality tests. Goa Antibiotics & Pharmaceuticals Ltd.: One of the manufacturers listed with products failing quality tests. Sain Medicaments Private Limited: One of the manufacturers listed with products failing quality tests. Theon Pharmaceuticals ltd.: One of the manufacturers listed with products failing quality tests. Civron Pharmaceuticals: One of the manufacturers listed with products failing quality tests. SGS Pharmaceuticals Pvt. Ltd.: One of the manufacturers listed with products failing quality tests. Conscaff India: One of the manufacturers listed with products failing quality tests. Sunvet Healthcar: One of the manufacturers listed with products failing quality tests. Unital Formlations: One of the manufacturers listed with products failing quality tests. Trugen Pharmaceuticals Pvt. Ltd.: One of the manufacturers listed with products failing quality tests. Cosmas Research Lab Ltd.: One of the manufacturers listed with products failing quality tests. CMG Biotech Pvt. Ltd.: One of the manufacturers listed with products failing quality tests. Mercury Laboratories Ltd.: One of the manufacturers listed with products failing quality tests. Stanford Laboratories Pvt. Ltd.: One of the manufacturers listed with products failing quality tests. Syncom Healthcare Ltd: One of the manufacturers listed with products failing quality tests. Signature Phytochemical Industries: One of the manufacturers listed with products failing quality tests. Sanctus Drugs and Pharmaceuticals Pvt. Ltd.: One of the manufacturers listed with products failing quality tests. Pachim Banga Pharmaceutical: One of the manufacturers listed with products failing quality tests. Biogenetic Drugs Pvt. Ltd.: One of the manufacturers listed with products failing quality tests. Halewood Laboratories Pvt. Ltd.: One of the manufacturers listed with products failing quality tests. Ronak Life Care Pvt. Ltd.: One of the manufacturers listed with products failing quality tests. Wilcure Remedies Pvt. Ltd.: One of the manufacturers listed with products failing quality tests. Neutec Healthcare Pvt. Ltd.: One of the manufacturers listed with products failing quality tests. Zee Laboratories: One of the manufacturers listed with products failing quality tests. Kanha Biogentic: One of the manufacturers listed with products failing quality tests. Athens Life Sciences: One of the manufacturers listed with products failing quality tests. Drakt Pharmaceuticals Pvt. Ltd.: One of the manufacturers listed with products failing quality tests. Anglo-French Drugs & Industries Ltd.: One of the manufacturers listed with products failing quality tests. Herb Edge Health Care Pvt. Ltd.: One of the manufacturers listed with products failing quality tests.
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List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, For the Month of August, 2018 Sl. Name of Batch No./Date of Reason for failure Drawn By From No. Drugs/medical Manufacture/Date of device/cosmetics Expiry/Manufactured By 1. Telkonol-20 B. No.: HT-3049, Dissolution CDSCO, CDTL, Tablets Mfg dt: 11/2017, South-Zone, Chennai (Telmisartan Exp dt: 10/2019, Chennai Tablets IP 20mg) Mfd by: M/s. VIP Pharmaceuticals (P) Ltd., Vill. Manpura Tehsil Nalagarh, Distt. Solan-174101 (HP) 2. Ceftriaxone (Powder for Injection) Calrity of Solution CDSCO, CDL, Injection I.P. 1.0 g B. No.: 911805, & Particulate Visakhapatnam Kolkata Mfg dt: 03/2018, Matter Exp dt: 02/2020, Mfd by: M/s. Goa Antibiotics & Pharmaceuticals Ltd., Near Tuem Industrial Estate, Tuem, Pernem – Goa, (Water for Injection) B. No.: WB7L20, Mfg dt: 12/2017, Exp dt: 11/2020, Mfd by: Aurya Healthcare, Plot No. 80E, EPIP Phase 1, Jharmajri, Baddi, HP, India 3. PB Lac Capsules B. No.: PBL-123, Description, Total CDSCO, CDL, (Pre and Probiotic Mfg dt: 02/2017, viable cell count of Sub-Zone, Kolkata Blends) Exp dt: 07/2018, Bifidobacterium Hyderabad Mfd by: M/s. Sain Medicaments Species, Private Limited, P-2/4, I.D.A Lactobacillus Uppal, Hyderabad-500039 Species and Saccharomyces boulardii 4. Diclofenac Sodium B. No.: GT171481, Assay of CDSCO, RDTL, with Mfg dt: 11/2017, Thiocolchicoside Sub-Zone, Chandigarh Thiocolchicoside Exp dt: 10/2019, Baddi Tablets Mfd by: M/s. Theon (THEOMOVE-4 Pharmaceuticals ltd., Vill. Saini TABLETS) Majra, Teh. Nalagarh Distt. Solan (H.P)-1741015. ORTHO SOL B. No.: 170402, Assay of Vitamin Distt. Kangra, RDTL, TABLETS Mfg dt: 04/2017, D3 H.P. State Chandigarh Exp dt: 09/2018, Mfd by: M/s. Civron Pharmaceuticals, Plot No. 13, Industrial Area, Phase-III, Sansarpur, Terrace, Distt. Kangra (H.P)-176501 6. Methylcobalamin, B. No.: HC-730, Disintegration CDSCO, RDTL, Alpha Lipoic Acid, Mfg dt: 12/2017, Sub-Zone, Chandigarh Folic Acid, Exp dt: 08/2019, Baddi. Thiamine Mfd by: M/s. VIP Mononitrate and Pharmaceuticals (P) Ltd., Vill, Pyridoxine Manpura, Tehsil Nalagarh, Capsules (MECOL Dist.Solan-174101 (H.P) PLUS CAPSULES) 7. Amikacin Sulphate B. No.: AJT17373SR, Particulate matter Drugs & Food RDTL, Injection IP Mfg dt: 10/2017, Control Chandigarh (AMIJECT 500 Exp dt: 09/2019, Organisation, INJECTION) Mfd by: M/s. SGS Srinagar, Pharmaceuticals Pvt. Ltd., 162/1, Kashmir Puhana Iqbalpur Road, Nanhera, Roorkee-247667 (Uttarakhand) 8. Ferrous Ascorbate, B. No.: Cl342-T, Assay of Folic CDSCO, RDTL, Folic Acid and Mfg dt: 05/2018, Acid Sub-Zone, Chandigarh Zinc Sulphate Exp dt: 10/2019, Baddi Tablets Mfd by: M/s. Conscaff India, (FERISCO-XT Nahan Road, Kala-Amb, Distt. TABLETS) Sirmour (H.P)-173030 9. Pantoprazole and B. No.: SC-2163, Assay of DFCO, J&K RDTL, Domperidone SR Mfg dt: 08/2017, Pantoprazole Chandigarh Capsules Exp dt: 07/2019, Sodium (OMENTUM-DSR Mfd by: M/s. Sunvet Healthcar, Sesquihydrate CAPSULES) Village Shambhuwala, Paonta Calculated as Road, Distt. Sirmour-173001 Pantoprazole (H.P) 10. Rabeprazole B. No.: UGI-180012, Sterility CDSCO, RDTL, Injection IP Mfg dt: 05/2018, Sub-Zone, Chandigarh (BIOZOLE-20 Exp dt: 10/2019, Baddi INJECTION) Mfd by: M/s. Unital Formlations, 114-B, EPIP, Phase-1, Jharmajri, Baddi, Solan (H.P)11. Fexofenadine B. No.: TPT-7565, Assay of CDSCO, RDTL, Hydrochloride and Mfg dt: 09/2017, Montelukast North-Zone, Chandigarh Montelukast Exp dt: 08/2019, Sodium calculated Ghaziabad Sodium Tablets Mfd by: M/s. Trugen as Montelukast (ALLR-X Pharmaceuticals Pvt. Ltd., Vill. TABLETS) Tejjupur, Near Chodiala Rly. Station, Roorkee, Distt. Haridwar, Uttarakhand-247661 12. Amoxycillin and B. No.: DB170039, Assay of CDSCO, RDTL, Potassium Mfg dt: 03/2017, Amoxycillin Sub-Zone, Chandigarh Clavulanate Oral Exp dt: 08/2018, Trihydrate Baddi Suspension IP Mfd by: M/s. Cosmas Research calculated as (HGICLAV DRY Lab Ltd., Village: Gaunspura Amoxycillin, SYRUP) P.O.: Noorpur Bet, Hambran, Potassium Ludhiana-141008. Clavulanate Diluted calculated as Clavulanic Acid 13. Tacrolimus B. No.: CC-017019, Assay CDSCO, RDTL, Capsules IP Mfg dt: 07/2017, of Sub-Zone, Chandigarh (NEFGRAF 0.5 Exp dt: 06/2019, Tacrolimus Baddi CAPSULES) Mfd by: M/s. CMG Biotech Pvt. Ltd., 58, Industrial Area, Phase- III, Sansarpur Terrace, H.P.- 176501 14. GENTAMICIN B. No.: 16300710, Particulate matter CDSCO, RDTL, INJECTION I.P Mfg dt: 12/2016, South-Zone, Chandigarh Exp dt: 11/2018, Chennai Mfd by: M/s. Mercury Laboratories Ltd., Unit No. 1, 2/13-14, Gorwa Industrial Estate, Gorwa, Vadodara- 390016. 15. Multivitamin with B. No.: C3081717, Assay of Calcium CDSCO, RDTL, 200 mg Elemental Mfg dt: 09/2017, Pantothenate North-Zone, Chandigarh Iron Capsules Exp dt: 02/2019, Ghaziabad (EIDO-FE FORTE Mfd by: M/s. Stanford CAPSULES) Laboratories Pvt. Ltd., 8, Industrial Area, Mehatpur, (H.P.) 174315, India. 16. Domperidone B. No.: SHT7339, Assay CDSCO, CDTL, Tablets IP Mfg dt: 10/2017, Sub-Zone, Mumbai Exp dt: 09/2020, Indore Mfd by: M/s. Syncom Healthcare Ltd, D-42, UPSIDC, Industrial Area, Selaqui, Dehradhun-248197.17. Es-Prozole B. No.: 47-002, Dissolution and CDSCO, CDTL, (Esomeprazole Mfg dt: 11/2017, Assay West-Zone, Mumbai Magnesium Tablets Exp dt: 10/2019, Mumbai I.P.) Mfd by: M/s. Signature Phytochemical Industries, 122, MI, Selaqui Industrial Area Dehradhun-248197. 18. Compound Sodium B. No.: R-1/18/109, Particulate Drugs Control RDTL, Lactate Injection Mfg dt: 03/2018, Contamination Department, Guwahati I.P. (RL) Exp dt: 02/2020, Meghalaya Mfd by: M/s. Sanctus Drugs and Pharmaceuticals Pvt. Ltd., Plot No. 251, Sector-1, Pithempur, Dist-Dhar, M.P. 19. Compound Sodium B. No.: 03BF0390, Sterility Test Drugs Control RDTL, Lactate Injection Mfg dt: 06/2017, Department, Guwahati I.P. (RL) Exp dt: 05/2020, Assam Mfd by: M/s. Pachim Banga Pharmaceutical NH-31, Tin Mile Hat, Sonapur Hat, P.S. Chopra, Dist-Uttar Dinajpur-733214 20. Compound Sodium B. No.: 03BF0205, Bacterial Drugs Control RDTL, Lactate Injection Mfg dt: 10/2016, Endotoxin Test Department, Guwahati I.P. (RL) Exp dt: 09/2019, Assam Mfd by: M/s. Pachim Banga Pharmaceutical NH-31, Tin Mile Hat, Sonapur Hat, P.S. Chopra, Dist-Uttar Dinajpur-733214 21. Terbutaline B. No.: 05126-BJA3, Assay of Drugs Control RDTL, Sulphate, Mfg dt: 12/2016, Terbutaline Department, Guwahati Bromhexine Exp dt: 11/2018, Sulphate & Assay Assam Hydrochloride and Mfd by: M/s. Biogenetic Drugs of Bromhexine Guaiphenesin Pvt. Ltd., Vill-Jharmazri, Baddi- Hydrochloride Syrup(4x100 ml.) 174103, Dist-Solan, H.P. Bottles 22. Ibuprofen Tablets B. No.: BR8005, Dissolution Drugs Control RDTL, I.P. 400mg Mfg dt: 01/2018, Department, Guwahati Exp dt: 12/2019, Assam Mfd by: M/s. Halewood Laboratories Pvt. Ltd., 312, Phase-II, G.I.D.C., Vatva, Ahmedabad-382445 23. Azithromycin B. No.: RL-234, Assay & Drugs Control RDTL, Tablets I.P. 500mg Mfg dt: 07/2017, Dissolution Department, Guwahati (Zolid 500) Exp dt: 06/2019, Mizoram Mfd by: M/s. Ronak Life Care Pvt. Ltd., R.S. No. 41 (Part),Vill. Rajpur T.A. & Dist. Patan- 384265, Ahmedabad, Gujarat 24. Cefowil Dry Syrup B. No.: BD-012, Assay Drugs Control RDTL, Mfg dt: 06/2017, Department, Guwahati Exp dt: 11/2018, Meghalaya Mfd by: M/s. Wilcure Remedies Pvt. Ltd., Ph. No. 10, Gram Mirzapur, Dist. Indore-452020 25. Ibuprofen Tablets B. No.: BR8004, Dissolution Drugs Control RDTL, I.P. 400mg Mfg dt: 01/2018, Department, Guwahati Exp dt: 12/2019, Assam Mfd by: M/s. Halewood Laboratories Pvt. Ltd., 319, Phase-II, G.I.D.C., Vatva, Ahmedabad-382445 26. Ibuprofen Tablets B. No.: NT17007, Dissolution Drugs Control RDTL, I.P. 400mg Mfg dt: 04/2017, Department, Guwahati Exp dt: 03/2020, Meghalaya Mfd by: M/s. Neutec Healthcare Pvt. Ltd., E-698, DSIDC Narela, Industrial Area, Delhi-110040 27. Atorvastatin B. No.: GT161736, Dissolution Drugs Control RDTL, Tablets I.P. 20mg Mfg dt: 12/2016, Department, Guwahati Exp dt: 11/2018, Tripura Mfd by: M/s. Theon Pharmaceutical Ltd., Vill-Saini Majra, Tehsil Nalagarh Dist. Solan, H.P. 28. Chlorhexidine B. No.: 374, Assay Drugs Control RDTL, Cream 1% w/w Mfg dt: 05/2017, Department, Guwahati Exp dt: 04/2019, Assam Mfd by: M/s. Zee Laboratories 47, Industrial Area, Paonta Sahib-173025 29. Iron Sucrose B. No.: 316-440, Assay of Iron Drugs Control RDTL, Injection U.S.P Mfg dt: 10/2016, Department, Guwahati Exp dt: 09/2018, Meghalaya Mfd by: M/s. Zee Laboratories 47, Industrial Area, Paonta Sahib-173025, (H.P) 30. Ezisartan 80 B. No.: 1710017, Dissolution Drugs Control RDTL, Tablets Mfg dt: 10/2017, Department, Guwahati Exp dt: 09/2019, Meghalaya Mfd by: M/s. Kanha Biogentic Plot No. 1, E.P.I.P., Phase-1 Jharmajri, Baddi, Dist. Solan, H.P.31. Ezisartan 40 B. No.: VT18-5696, Dissolution Drugs Control RDTL, Tablets Mfg dt: 02/2018, Department, Guwahati Exp dt: 01/2020, Mizoram Mfd by: M/s. Athens Life Sciences, Mauza Rampur Jattan, Nahan Road, Kala Amb, Dist- Sirmour, H.P.173030 32. Panda Tablets B. No.: PP-034, Misbranded Drugs Control RDTL, Mfg dt: 12/2017, Department, Guwahati Exp dt: 11/2019, Assam Mfd by: M/s. Drakt Pharmaceuticals Pvt. Ltd. 76-B, Mukut Nagar, Manjusar, Taluka-Savli, Dist-Baroda, Gujarat 33. Paracetamol B. No.: 10708P, Dissolution Drugs Control RDTL, Tablets I.P. 500mg Mfg dt: 10/2017, Department, Guwahati Exp dt: 09/2020, Assam Mfd by: M/s. Anglo-French Drugs & Industries Ltd., Plot No. 4, Phase II, Peenya, Banglore-560058 34. Paracetamol B. No.: M-9706, Dissolution Drugs Control RDTL, Tablets I.P. 500mg Mfg dt: 03/2018, Department, Guwahati Exp dt: 02/2020, Assam Mfd by: M/s. Herb Edge Health Care Pvt. Ltd., 81,82,86,87, Industrial Area, Nagziri, Dewas Road, Ujjain-456010

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