Home› India› Ministry of Health and Family Welfare› Drug Alert list for month of June 2015...
Date: 2015-07-07 Category: Not Applicable State: Union Government Country: India

Drug Alert list for month of June 2015

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

Research with AI Agent Chat with Document Generate Summary Translate Helpful Share Add to Project Create Task

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 June 2015.
  • The listed items failed quality checks for various reasons, including particulate contamination, dissolution issues, assay discrepancies, description deviations, uniformity of dispersion problems, and seal test failures.

Key Changes

  • Six products are listed as non-compliant.
  • Two batches of Cefotaxime Sodium Injections (DP-699 and DP-726) manufactured by M/s. Pharma Tripura Impex Laboratories Pvt. Limited failed due to particulate contamination.
  • One batch of Glimekem (Glimeprimide Tablets I.P.) (GMT/3004C) manufactured by M/s. Alkem Laboratories Pvt. Ltd. failed due to dissolution and assay issues.
  • One batch of Ranitidine Tablets I.P. 150 mg (11 Ran 14 15) manufactured by M/s. IDPL (TN) Ltd. failed due to description issues.
  • One batch of K-Dox-200 (Cefpodoxime Dispersible Tablets 200 mg) (BLT-058) manufactured by M/s. Affine Formulations Pvt. Ltd. failed due to uniformity of dispersion issues.
  • One batch of Protolyte ORS 21.8 g (Oral Rehydration Salts I.P.) (1422) manufactured by M/s. Zenith Drugs (P) Ltd. failed the seal test.

Impact Analysis

Impact on Manufacturers

  • All manufacturers: Implement corrective and preventive actions (CAPA) to prevent recurrence of these quality issues. Review and strengthen quality control processes.

Impact on Consumers/Patients

  • Pharmacies should immediately stop selling the listed drugs and return them to the distributors/manufacturers.

Impact on Regulatory Authorities

  • Review of manufacturing licenses and potential penalties for manufacturers found to be producing substandard drugs.

Suggested Action Items

  • Enhance collaboration between CDSCO and State Drug Control Departments.

Key Entities Referenced

RDTL, Guwahati: Drugs Regional Drugs Testing Laboratory, Guwahati CDSCO, CDL, Kolkata Ahmedabad Zone: Central Drugs Standard Control Organization, Central Drugs Laboratory, Kolkata, Ahmedabad Zone CDSCO, CDL, Kolkata East Zone: Central Drugs Standard Control Organization, Central Drugs Laboratory, Kolkata, East Zone M/s. Pharma Tripura Impex Laboratories Pvt. Limited: Manufacturer of Cefotaxime Sodium Injections M/s. Alkem Laboratories Pvt. Ltd.: Manufacturer of Glimekem (Glimeprimide Tablets I.P.) M/s. IDPL (TN) Ltd.: Manufacturer of Ranitidine Tablets I.P. 150 mg M/s. Affine Formulations Pvt. Ltd.: Manufacturer of K-Dox-200 (Cefpodoxime Dispersible Tablets 200 mg) M/s. Zenith Drugs (P) Ltd.: Manufacturer of Protolyte ORS 21.8 g (Oral Rehydration Salts I.P.)
Official Source Record View Original Source →
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: JUNE 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. Cefotaxime Sodium B. No.: DP-699 Particulate Drugs RDTL, Guwahati Injections Mfg dt: 11/2014, contamination Control Exp dt: 10/2016 Department, Mfd by: M/s. Pharma Tripura Impex Laboratories Pvt. Limited, 620, D. H. Road, Kolkata, 700034, West Bengal 2. Cefotaxime Sodium B. No.: DP-726 Particulate Drugs RDTL, Guwahati Injections Mfg dt: 12/2014, contamination Control Exp dt: 11/2016 Department, Mfd by: M/s. Pharma Tripura Impex Laboratories Pvt. Limited, 620, D. H. Road, Kolkata, 700034, West Bengal 3. Glimekem B. No.: GMT/3004C Dissolution & CDSCO, CDL, Kolkata (Glimeprimide Mfg dt: 10/2013 Assay Ahmedabad Tablets I.P.) Exp dt: 09/2015 Zone Mfd by: M/s. Alkem Laboratories Pvt. Ltd., Village: Thana, Baddi, Distt. Solan, HP-173205. 4. Ranitidine Tablets B. No.: 11 Ran 14 Description CDSCO, CDL, Kolkata I.P. 150 mg Mfg dt: 03/2014 Ahmedabad Exp dt: 02/2016 Zone Mfd by: M/s. IDPL (TN) Ltd., Nandanbakkam, Chennai – 600089. 5. K-Dox-200 B. No.: BLT-058 Uniformity of CDSCO, CDL, Kolkata (Cefpodoxime Mfg dt: 02/2014 Dispersion East Zone Dispersible Tablets Exp dt: 01/2016 200 mg) Mfd by: M/s. Affine Formulations Pvt. Ltd., 1947/3, Vill: Bhatia, Tehsil Nalagarh, Distt. Solan, H.P. 6. Protolyte ORS 21.8 B. No.: 1422 Seal Test CDSCO, CDL, Kolkata g (Oral Rehydration Mfg dt: 02/2014 East Zone Salts I.P.) Exp dt: 01/2016 Mfd by: M/s. Zenith Drugs (P) Ltd., 35A-36, Industrial Area, Extn. Rao – 453331.

Continue your research

Related Documents from Ministry of Health and Family Welfare