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Date: 2017-11-07 Category: Not Applicable State: Union Government Country: India

Drug Alert list for month of October 2017

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 that have been declared as Not of Standard Quality, Spurious, Adulterated, or Misbranded for the month of October 2017.
  • The list includes the name of the product, batch number, manufacturing and expiry dates, the reason for failure, and the name and location of the manufacturer.
  • The products were tested by various CDSCO (Central Drugs Standard Control Organization) zones and RDTLs (Regional Drugs Testing Laboratories).

Key Changes

  • A total of 31 products are listed as Not of Standard Quality/Spurious/Adulterated/Misbranded.
  • The listed products include Oxytocin Injection, Serratiopeptidase Tablets, Carbimazole Tablets, Erythromycin Stearate Tablets, Enalapril Maleate Tablets, Oxytocin Injection, Levocetirizine Tablets, Amikacin Sulphate Injection, Alpha Lipoic Acid Tablets, Dexamethasone Sodium Phosphate Injection, Triamcinolone Acetonide Injection, B-Complex with Vitamin C Capsules, Prednisolone Tablets, Gentamicin Injection, Rolled Bandages, Mefenamic Acid & Dicyclomine HCl Tablets, Cefoperazone & Sulbactam for Injection, Shaving Cream, Cefadroxil Oral Suspension, Diclofenac Potassium Tablets, Iron, Folic Acid Tablets, Cefixime and lactic Acid Bacillus Tablets, Chlorhexidine Mouthwash, Chloroquine Tablets, Diazepam Tablets, Bisacodyl Tablets.
  • Reasons for failure include Description & Particulate Matter, Disintegration & Assay, Description, Identification & Assay, Dissolution, Uniformity of Content, Dissolution & Assay, Related Substances, Disintegration, Extractable Volume, Assay of Folic Acid, Related Substances, Threads/dm (Warp/Weft), Wt. in gm/m2, Length, Foreign Matter, Fluorescence, Bacterial Endotoxins, Particulate Matter & Clarity of Solution, Total Microbial Count, Assay of Cefadroxil, Disintegration, Identification of Folic Acid, Assay of Lactic Acid Bacillus, Assay, Test for sterility.
  • The products were manufactured by various companies located across India, including in Uttar Pradesh, Uttarakhand, Punjab, Telangana, Himachal Pradesh, Gujarat, Karnataka, Delhi, Maharashtra and Madhya Pradesh.

Impact Analysis

Impact on Stakeholders

  • General Public: Reduced confidence in the pharmaceutical industry and regulatory oversight.

Suggested Action Items

  • Review of the licensing and inspection processes for pharmaceutical manufacturing facilities.

Key Entities Referenced

CDSCO: Central Drugs Standard Control Organization, the national regulatory body for pharmaceuticals and medical devices in India. RDTL: Regional Drugs Testing Laboratories, responsible for testing and analyzing drug samples to ensure quality and compliance. Drugs and Cosmetics Act: The primary legislation governing the import, manufacture, distribution, and sale of drugs and cosmetics in India. It defines standards for quality, safety, and efficacy. I.P.: Indian Pharmacopoeia, the official book of standards for drugs manufactured and marketed in India.
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List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, For the Month of October, 2017 Sl. Name of Batch No./Date of Reason for Drawn By From No. Drugs/medical Manufacture/Date of failure device/cosmetics Expiry/Manufactured By 1. Oxytocin Injection B. No.: OX-1616, Description & CDSCO, CDL, I.P. 1 ml Mfg dt: 12/2016, Particulate Matter South Zone, Kolkata Exp dt: 11/2018, Chennai Mfd by: M/s. Systochem Laboratories Ltd, B-75, Roop Nagar, Indl Area, Loni – 201 102(U.P) 2. Serratiopeptidase B. No.: N1604042, Disintegration & CDSCO, CDL, Tablets I.P. 10 mg Mfg dt: 04/2016, Assay South Zone, Kolkata Exp dt: 03/2018, Chennai Mfd by: M/s. Talent Healthcare, 66-67, Sector 6A, SIDCUL, IIE, Haridwar 249 403, (Uttarakhand) 3. Carbimazole B. No.: T-12112, Description, CDSCO, CDL, Tablets I.P. 5 mg Mfg dt: 08/2016, Identification & South Zone, Kolkata Exp dt: 07/2018, Assay Chennai Mfd by: M/s. Jackson Laboratories Pvt. Ltd., 22-24, Majitha Road, Bye Pass, Amritsar 143 001 4. Erythromycin B. No.: ES-1602, Dissolution CDSCO, CDL, Stearate Tablets Mfg dt: 04/2016, South Zone, Kolkata Exp dt: 03/2018, Chennai I.P. 250 mg Mfd by: M/s. Minopharm Laboratories Pvt. Ltd., Hyderabad 500 073, Works: Opp. I.D.A, Pernamitta - 523002 5. ELPRIL 2.5 B. No.: AP6109, Uniformity of CDSCO, CDL, (Enalapril Maleate Mfg dt: 03/2016, Content, East Zone, Kolkata Exp dt: 02/2018, Dissolution & Kolkata Tablets I.P.) Mfd by: M/s. Affy Assay Parenterals, Village: Gullerwala, P.O. Baddi, Solan 173 205 (H.P.) 6. ELPRIL 5 B. No.: AP7042, Uniformity of CDSCO, CDL, (Enalapril Maleate Mfg dt: 02/2017, Content, East Zone, Kolkata Exp dt: 01/2019, Dissolution & Kolkata Tablets I.P.) Mfd by: M/s. Affy Assay Parenterals, Village: Gullerwala, P.O. Baddi, Solan 173 205 (H.P.). 7. Oxymac (Oxytocin B. No.: OT-16010, Description & CDSCO, CDL, Injection I.P.) Mfg dt: 03/2016, Particulate Matter East Zone, Kolkata Exp dt: 02/2018, Kolkata Mfd by: M/s. Macin Remedies India Ltd, B-21, Ind. Focal Point, Moga-142001 8. Levocetirizine B. No.: 9700717, Related CDSCO, CDL, Tablets I.P. 5 mg Mfg dt: 05/2017, Substances East Zone, Kolkata Exp dt: 04/2020, Kolkata Mfd by: M/s. Karnataka Antibiotics &Pharmaceuticals Limited, Plot No. 14, II Phase, Peenyar, Bangalore 560 068 9. Amikacin Sulphate B. No.: P7171, Description & CDSCO, CDL, Injection I.P. Mfg dt: 04/2017, Particulate Matter East Zone, Kolkata Exp dt: 03/2019, Kolkata 250mg/ml Mfd by: M/s. Bharat Parenterals Ltd., Vill. Hariupra, Ta. Savli, Dist- Vadodara - 391520, Gujarat. 10. L-BEX-OD (Alpha B. No.: LBDT16003, Disintegration CDSCO, CDL, Lipoic Acid, Mfg dt: 08/2016, East Zone, Kolkata Exp dt: 01/2018, Kolkata Pyridoxine Mfd by: M/s. Ravian Life Hydrochloride Science Pvt. Ltd., Plot No. 34, Methylcobalamin, Sector-8A, IIE, SIDCUL, Folic Acid & Haridwar-249403 Vitamin D 3 Tablets) 11. Anodex B. No.: FN-231, Description, CDSCO, CDL, (Dexamethasone Mfg dt: 11/2016, Particulate Matter East Zone, Kolkata Exp dt: 10/2018, Kolkata Sodium Phosphate Mfd by: M/s. COAX Injection I.P. Bioremedies Pvt. Ltd., 4mg/ml ) 83, Sec-28, Industrial Area, Delhi Road, Hisar 125 044 12. Tramicort 40 B. No.: VI7074, Extractable CDSCO, CDL, mg/ml Mfg dt: 05/2017, Volume Head Kolkata Exp dt: 04/2019, Quarter, New (Triamcinolone Mfd by: M/s. Scott-Edil Delhi Acetonide Injection Pharmacia Limited, 56, I.P. 1 ml) E.P.I.P, Phase - I, Jharmajri 173 205 13. Becomax Forte B. No.: HL0099, Assay of Folic CDSCO, CDL, (B-Complex with Mfg dt: 12/2016, Acid Head Kolkata Exp dt: 05/2018, Vitamin C Quarter, New Mfd by: M/s. Hindustan Capsules) Delhi Laboratories, Plot No. 5-9, Survey No. 38/2, Aliyali Village, Palghar (W), Dist. Palghar-401404 14. Prednisolone B. No.: AT17077, Related CDSCO, CDL, Tablets I.P Mfg dt: 05/2017, Substances Head Kolkata Exp dt: 04/2020, Quarter, New Mfd by: M/s. Arbro Delhi Pharmaceuticals Pvt Ltd, 6/14, Kirti Nagar, IndustrialArea, New Delhi-110015 15. Gentamicin B. No.: 5000816, Description, CDSCO, CDL, Injection I.P. 2 ml Mfg dt: 05/2016, Particulate Matter North Zone, Kolkata Exp dt: 04/2018, Ghaziabad Mfd by: M/s. Karnataka Antibiotics &Pharmaceuticals Limited , Plot No 14, II Phase, Peenyar, Bangalore- 560058 16. Amikacin Sulphate B. No.: 7901616, Description, CDSCO, CDL, Injection I.P. 500 Mfg dt: 05/2016, Particulate Matter North Zone, Kolkata Exp dt: 04/2018, Ghaziabad mg - 2 ml Mfd by: M/s. Karnataka Antibiotics &Pharmaceuticals Limited , Plot No 14, II Phase, Peenyar, Bangalore- 560058 17. Ajanta Brand B. No.: B.420, Threads/dm CDSCO, CDL, Rolled Bandages Mfg dt: 05/2017, (Warp/Weft), Wt. North Zone, Kolkata Exp dt: 04/2020, in gm/m2, Length, Ghaziabad (Non Sterilized) 20 Mfd by: M/s. Ajanta Surgical Foreign Matter, x 14 Superfine Industries, Kanth Fluorescence (Moradabad, U.P). 18. Dexamethasone B. No.: HLI612H, Description, CDSCO, CDL, Sodium Phosphate Mfg dt: 08/2016, Particulate Matter North Zone, Kolkata Exp dt: 07/2018, & Bacterial Ghaziabad Injection I.P 2ml Mfd by: M/s. Himalaya Endotoxins Mediteck Private Ltd., Plot No. 35 & 36, Pharmacity, Selaqui, Industrial Area, Dehradun - 248197 19. Dysmeril – Spas B. No.: JBT-2843, Disintegration CDSCO, CDL, (Mefenamic Acid Mfg dt: 04/2016, Hyderabad Kolkata Exp dt: 03/2018, Zone & Dicyclomine Mfd by: M/s. J. B. Remedies HCl Tablets) Pvt. Ltd., 11th Mile Stone, Roorkee Road, KH. No. 298, Vill. Kurdi, Manglaur, Roorkee, Haridwar - 247 667 (U.K.). 20. CEZOTUM(R) 1g B. No.: UP16034, Particulate Matter CDSCO, CDL, (Cefoperazone & Mfg dt: 12/2016, & Clarity of Hyderabad Kolkata Sulbactam for Exp dt: 11/2018, Solution Zone Injection) Mfd by: M/s. Unimark Remedies Ltd., At Plot No. 23, EPIP, Phase - II, Thana Baddi -173205, Dist- Solan (H.P.) & Sterile Water for B. No.: WB6L10, Injection I.P. Mfg dt: 12/2016,Exp dt: 11/2019, Mfd by: M/s. Auraya Healthcare, Plot No. 80E, E.P.I.P. Phase 1, Jharmajri, Baddi, H.P. India 21. Blue Valley B. No.: B-27, Total Microbial Drugs RDTL, Shaving Cream Mfg dt: 07/2017, Count Control Chandigarh Exp dt: 06/2020, Department Mfd by: M/s. Shree N.C.T. Delhi Sudarshan Cosmetics DSIDC Indl. Complex Narela, Delhi- 110040 22. Cefadroxil Oral B. No.: CLS1701, Assay of CDSCO, RDTL, Suspension IP Mfg dt: 02/2017, Cefadroxil Sub-Zone, Chandigarh Exp dt: 01/2019, calculated as Jammu Mfd by: M/s. Modern Anhydrous Laboratories 45-47, Sector D- Cefadroxil 2, Sanwer Road Indore (M.P)- 452015. 23. Diclofenac B. No.:T-170746 , Disintegration CDSCO, RDTL, Potassium, Mfg dt: 07/2017 Sub-Zone, Chandigarh Exp dt: 06/2019 Baddi Paracetamol and Mfd by: M/s. Medirose Drugs Serratiopeptidase & Pharmaceuticals 51, Tablets (RECOV- Industrial Area, Phase-III, SR TABLETS) Sansarpur Terrace, Distt. Kangra, Pin-176501 (H.P) 24. Iron, Folic Acid B. No.: TX-12052 , Identification of CDSCO, RDTL, Tablets IP Mfg dt: 06/2017 , Folic Acid Sub-Zone, Chandigarh Exp dt: 05/2019, Baddi (SAMFER Mfd by: M/s. Legen SMALL Healthcare, Plot No. 20, TABLETS) Sector-5, Parwanoo, Distt. Solan (H.P)-173220 25. Cefixime and lactic B. No.: THG160043, Assay of Lactic CDSCO, RDTL, Acid Bacillus Mfg dt: 09/2016 Acid Bacillus North Zone, Chandigarh Exp dt: 08/2018 Ghaziabad Dispersible Tablets Mfd by: M/s. Theon (THEOXIME –LB Pharmaceuticals Ltd., Vill. TABLETS) Saini Majra, Tehsil Nalagarh, Dist. Solan H.P.-174101 26. Chlorhexidine B. No.: 616-571, Assay CDSCO, CDTL, Mouthwash I.P. Mfg dt: 03/2016, West Zone, Mumbai Exp dt: 02/2018, Mumbai 0.2% w/v Mfd by: M/s. Zee Laboratories Ltd., Behind 47, industrial Area, Paonta Sahib- 173025 27. Chloroquine B. No.: M-9504, Assay CDSCO, CDTL, (Chloroquine Mfg dt: 03/2016, West Zone, Mumbai Exp dt: 02/2018, Mumbai Phosphate Tablet Mfd by: M/s. Herb Edge IP. 250mg) Health Care Pvt. Ltd., 81-82- 86-87, Industrial Area, Dewas Road, Ujjain-456010.28. Chloroquine B. No.: MPC 6004, Assay CDSCO, CDTL, Phosphate Tablets Mfg dt: 03/2016 Sub-Zone, Mumbai Exp dt: 02/2019 Indore IP Mfd by: M/s. Halewood Laboratories Pvt. Ltd., 319, Phase-II, G.I.D.C., Vatva, Ahmedabad-382445. 29. Diazepam Tablets B. No.: DZT409 , Related CDSCO, Sub CDTL, I.P. 5mg Mfg dt: 10/2016 Substances & Zone/Port Mumbai Exp dt: 09/2018 Decomposition Office, Goa Mfd by: M/s. Unicure India Products Ltd., C-22 &23, Sector-3, Noida, Uttar Pradesh 201301. 30. Bisacodyl Tablets B. No.: 603324, Assay CDSCO, CDTL, IP 5mg Mfg dt: 08/2016, West Zone, Mumbai Exp dt: 07/2018, Mumbai Mfd by: M/s. Ciron Drugs & Pharmaceuticals Pvt. Ltd., Plot No. 35 to 37, 43 to 45, CFC-B, Dewan Udyog Nagar, Aliyali, Palghar, Dist-Thane- 401404. 31. Amikacin Sulphate B. No.: AK1611, Test for sterility CDSCO, Sub CDTL, Injection I.P. Mfg dt: 06/2016, Zone, Indore Mumbai Exp dt: 05/2018, 100mg Mfd by: M/s. Nandani Medical Laboratories Pvt. Ltd., 221/5, Bicholi Hapsi, Kanadia Road, Indore.

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