Homeā€ŗ Indiaā€ŗ Ministry of Health and Family Welfareā€ŗ Drug Alert list for month of December 2015...
Date: 2016-01-05 Category: Not Applicable State: Union Government Country: India

Drug Alert list for month of December 2015

Issued by Ministry of Health and Family Welfare Ā· 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 the month of December 2015.
  • The listed products failed to meet quality standards based on various tests conducted by CDSCO (Central Drugs Standard Control Organization) and State Drug Control Departments.

Key Changes

  • A total of 15 products are listed as Not of Standard Quality/Spurious/Adulterated/Misbranded.
  • The products include tablets, capsules, injections, and absorbent cotton wool.
  • Reasons for failure include Dissolution, Assay, Uniformity of weight, Identification, Disintegration, Surface Active Substances, Sulphated Ash, Fluorescence, Particulate Matter, Clarity of Solution, pH, and Description.
  • Manufacturers of the substandard products are located across India, including Himachal Pradesh, Sikkim, Madhya Pradesh, Assam, and West Bengal.
  • Several products were tested by CDSCO through its zonal offices (South Zone, Chennai; North Zone, Ghaziabad; East Zone, Kolkata) and CDL (Central Drugs Laboratory), Kolkata, as well as by State Drugs Control Departments.

Impact Analysis

Manufacturers

  • Action Item: Manufacturers should immediately investigate the causes of the quality failures and implement corrective and preventive actions (CAPA) to prevent recurrence. They should also engage with regulatory authorities to address the findings.

Consumers/Patients

  • Action Item: Healthcare providers should be informed about the listed products and advise patients accordingly. A system for reporting adverse events related to these products should be strengthened.

Regulatory Authorities (CDSCO & State Drug Control Departments)

  • Action Item: Regulatory authorities should enhance collaboration and information sharing to improve the effectiveness of drug quality control. They should also expedite the process of testing and declaring substandard drugs.

Distributors/Retailers

  • Action Item: Distributors and retailers should implement a robust system for verifying the authenticity and quality of drugs before stocking them. They should also cooperate with regulatory authorities in the recall process.

Key Entities Referenced

CDSCO: Central Drugs Standard Control Organization, the national regulatory authority for pharmaceuticals and medical devices in India. RDTL: Regional Drugs Testing Laboratory CDL: Central Drugs Laboratory, Kolkata Drugs and Cosmetics Act: The primary legislation governing the quality, safety, and efficacy of drugs, cosmetics, and medical devices in India (Implied).
Official Source Record View Original Source ā†’
See Full Document Text
Annexure List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded for the Month of December -2015 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. Roxitec 150 B. No.: ROTD4B1 Dissolution CDSCO, CDTL, Tablets Mfg dt: 04/2014 South Zone, Chennai (Roxithromycin Exp dt: 03/2016 Chennai Tablet IP 150mg) Mfd by: M/s. United Biotech (P) Limited, Begbania, Baddi- Nalagarh Road, Dist, Solan (HP)-174101 2. Sirolimus Tablets B. No.: ESA14001 Assay CDSCO, NZ, RDTL, (Rocas) Mfg dt: 02/2014 Ghaziabad Chandigarh Exp dt: 01/2016 Mfd by: M/s. Swiss Garnier Life Sciences, 21-23, Industrial Area., Mehatpur, District-Una, Himachal Pradesh-174315 3. Atorvastatin and B. No.: APA14143 Dissolution CDSCO, NZ, RDTL, Aspirin Capsules Mfg dt: 08/2014 Ghaziabad Chandigarh (ECOSPRIN-AV75 Exp dt: 01/2016 CAPSULES) Mfd by: M/s. Accent Pharma, Block-D, EPIP, Kartholi, Bari Brahmma, Jammu-181133 4. Cefpodoxime and B. No.:GGCT-140031-1 Uniformity of CDSCO, NZ, RDTL, Potassium Mfg dt: 10/2014 weight Ghaziabad Chandigarh Clavulanate Tablets Exp dt: 03/2016 (PODFOX-CV Mfd by: M/s. G.G. Nutritions, TABLETS) Plot No. 19, Industrial Township, Bhatoli Kalan, Baddi, Dist. Solan (H.P.) 5. Fexofenadine HCl B. No.: OT-140904 Uniformity of CDSCO, NZ, RDTL, Tablets IP 120mg Mfg dt: 12/2014 weight, Ghaziabad Chandigarh (FOXODINE-120 Exp dt: 11/2016 Dissolution TABLETS) Mfd by: M/s. Orchid Bio-Tech and Assay Limited, 65, Peerpura-Delhi Highway, Roorkee-247667 (U.K.) 6. Aceclofenac, B. No.: FND015002AS Identification Drugs Control RDTL, Serratiopeptidase Mfg dt: 01/2015 and Assay Department, Chandigarh and Paracetamol Exp dt: 12/2016 Delhi Tablets Mfd by: M/s. Ipca Laboratories (ZERODOL-SP Ltd., 393/394, Melli Jorethang TABLETS) Road, Gom Block, Bharikhole, South District, Sikkim-737121. 7. Metronidazole B. No.: JT-097 Dissolution Drugs Control RDTL, Tablet Mfg dt: 10/2014 Department, Guwahati Exp dt: 09/2016 Meghalaya. Mfd by: M/s. Akpash Pharmaceuticals Pvt. Limited, 275, Sector ā€˜Eā€™ Sanwar Road, Indore, Madhya Pradesh- 4520158. Arteluf Tablet B. No.: T5450 Assay Drugs RDTL, Mfg dt: 07/2015 Control Guwahati Exp dt: 06/2017 Department, Mfd by: M/s. Zest Pharma, Plot Tripura No. 275, Sector ā€˜Fā€™ Sanwar Road, Indore, Madhya Pradesh- 452015 9. Odizox Tablet B. No.: ODT4016B Disintegration Drugs RDTL, Mfg dt: 10/2014 Control Guwahati Exp dt: 09/2017 Department, Mfd by: M/s. Galpha Assam Laboratories Limited, Thana, Baddi, Himachal Pradesh- 173205 10. Absorbent Cotton B. No.: 011 Surface Active CDSCO, East CDL, Wool I.P. Mfg dt: 12/2014 Substances & Zone, Kolkata Kolkata Exp dt: 11/2019 Sulphated Ash Mfd by: M/s. Prime Surgicals, Palsit, Bhaita, Burdwan 11. Absorbent Cotton B. No.: 17 Surface Active CDSCO, East CDL, Wool I.P. Mfg dt: 10/2014 Substances & Zone, Kolkata Kolkata Exp dt: 09/2017 Fluorescence Mfd by: M/s. S.N. Surgicare & Healthcare Science Pvt. Ltd. Vill: Jalsukha, P.O. Nilgunj Bazar, Kolkata- 700121 12. H-Tazo B. No.: 113L-370A Particulate CDSCO, East CDL, (Ceftriaxone & Mfg dt: 12/2013 Matter & Zone, Kolkata Kolkata Tazobactam for Exp dt: 11/2015 Clarity of Injection) Mfd by: M/s. Iskon Remedies, Solution Ogli, Kala Amb, Sirmour, HP. & & B. No.: WB 3102 Sterile water for Mfg. dt: 09/2013 Injection Exp dt: 08/2016 Mfd by: M/s. Auraya Healthcare, Jharmajri, Baddi, H.P., India. 13. Becopex ā€“ R B. No.: BC-113 Description, CDSCO, CDL, (Vitamin B Mfg dt: 10/2014 Particulate North Zone, Kolkata Complex Injection Exp dt: 03/2016 Matter Ghaziabad 10 ml) Mfd by: M/s. Regain Laboratories, 134/5, HTM Road, Raipur Lane, Hisar 125001. 14. Becopex ā€“ R B. No.: BC-108 Description, CDSCO, CDL, (Vitamin B Mfg dt: 08/2014 Particulate North Zone, Kolkata Complex Injection Exp dt: 01/2016 Matter Ghaziabad 10 ml) Mfd by: M/s. Regain Laboratories, 134/5, HTM Road, Raipur Lane, Hisar 125001. 15. Oxytocin Injection B. No.: 19, Description, CDSCO(HQ), CDL, BP Vet. Mfg dt: 06/2015 pH, Particulate New Delhi Kolkata Exp dt: 05/2017 Matter &Mfd by: M/s. U. Chem Assay Laboratory, Diwan Mohalla, Patna 800008

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