Home India Ministry of Health and Family Welfare Drugs Alert for the month of March 2015...
Date: 2015-04-06 Category: Not Applicable State: Union Government Country: India

Drugs Alert for the month of March 2015

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 March 2015.
  • The listed products failed quality tests conducted by various drug testing laboratories across India.

Key Changes

  • A total of 14 products are listed in the notification.
  • Reasons for failure include Dissolution, Particulate Matter & Clarity of Solution, Loss on Drying, Assay, Disintegration, Uniformity of Weight and being Misbranded.
  • The listed products are manufactured by various companies located in different states including Goa, West Bengal, Himachal Pradesh, Uttarakhand, Assam and Puducherry.
  • Several products failed due to dissolution issues, including Walasa 400, Aceclofenac Tablets IP, R-Livo 500, Norfloxacin Tablets and R-Panta Tablets.
  • Two batches of Norfloxacin Tablets manufactured by M/s. Viva Pharma (P) Ltd. were found to be misbranded.
  • Several products failed disintegration tests including Sinarest Tablets and Syncold Tablets.
  • Shizole (Omeprazole Capsules IP) failed Loss on Drying, Assay & Dissolution tests.

Impact Analysis

Manufacturers

  • Action Item: Engage with regulatory authorities to address concerns and demonstrate commitment to quality and compliance.

Consumers

  • Action Item: Public awareness campaigns should be conducted to inform consumers about the listed products and their potential risks. Consumers should be advised to discontinue use and consult healthcare professionals if they experience any adverse effects.

Regulatory Authorities

  • Action Item: Collaborate with other regulatory agencies and stakeholders to share information and coordinate enforcement efforts.

Distributors and Retailers

  • Action Item: Implement procedures to verify the authenticity and quality of pharmaceutical products before stocking and selling them. Ensure proper storage and handling of drugs to maintain their quality.

Key Entities Referenced

CDSCO: Central Drugs Standard Control Organization, the national regulatory body for pharmaceuticals and medical devices in India. CDL: Central Drugs Laboratory, a national drug testing laboratory responsible for quality control and analysis of drugs and cosmetics. RDTL: Regional Drugs Testing Laboratory, a regional drug testing laboratory responsible for quality control and analysis of drugs and cosmetics. M/s. Wallace Pharmaceuticals Pvt. Ltd.: Manufacturer of Walasa 400 (Mesalamine Delayed Release Tablets USP 400 mg). M/s. Pharma Impex Laboratories Pvt. Ltd.: Manufacturer of Cefriaxone Injection IP 1gram. M/s. Medipol Pharmaceutical India Pvt. Ltd.: Manufacturer of Aceclofenac Tablets IP. M/s. Regent Ajanta Biotech: Manufacturer of R-Livo 500 (Levofloxacin Hemihydrate Tablets 500mg) and R-Panta Tablets. M/s. Shashi Pharma: Manufacturer of Shizole (Omeprazole Capsules IP). M/s. Centaur Pharmaceuticals Pvt. Ltd.: Manufacturer of Sinarest Tablets. M/s. Arion Healthcare: Manufacturer of Syncold Tablets and Elmox Plus Capsules. M/s. Viva Pharma (P) Ltd.: Manufacturer of Norfloxacin Tablets. M/s. Dr. Mittal Laboratories Pvt. Ltd.: Manufacturer of Sanclo Plus Tablets. M/s. Amanath Pharmaceuticals: Manufacturer of Paracetamol Phenylephrine HCl, Chlorpheniramine Maleate and Caffeine tablets (HATRIC*-3 COLD). M/s. Anrose Pharma: Manufacturer of Amoxycillin Capsules IP 250mg (CEEMOX-250).
Official Source Record View Original Source →
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Annexure List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded For the Month of: MARCH 2015 Sl. Name of Batch No./Date of Reason for failure Drawn By From No. Drugs/medical Manufacture/Date of with Report No. device/cosmetics Expiry/Manufactured By (in Form-13)& Date 1. Walasa 400 B. No.: WVA 2006 Dissolution CDSCO, CDL, (Mesalamine Mfg dt: 08/2012, Hyderabad Kolkata Delayed Release Exp dt: 07/2015 Tablets USP 400 Mfd by: M/s. Wallace Pharmaceuticals mg) Pvt. Ltd., Curti Ponda, Goa 403 409. 2. Cefriaxone B. No.: DP-394 Particulate Matter & East Zone, CDL, Injection IP 1gram Mfg dt: 03/2014, Clarity of Solution Kolkata Kolkata Exp dt: 02/2016 Mfd by: M/s. Pharma Impex Laboratories Pvt. Ltd., 620, Diamond Harbour Raod, Kolkata 34 3. Aceclofenac B. No.: TAFN-009 Dissolution East Zone, CDL, Tablets IP Mfg dt: 04/2013, Kolkata Kolkata Exp dt: 03/2015, Mfd by: M/s. Medipol Pharmaceutical India Pvt. Ltd., 1199/3, Bhud, Baddi, Distt. Solan (HP). 4. R-Livo 500 B. No.: RAB-122 Dissolution East Zone, CDL, (Levofloxacin Mfg dt: 04/2014, Kolkata Kolkata Hemihydrate Exp dt: 03/2016 Tablets 500mg) Mfd by: M/s. Regent Ajanta Biotech, 86- 87, Village Makhiyali, Dundi, Peerpura Road, Roorkee 247667, Uttarakhand 5. Shizole B. No.: 20-08-0413 Loss on Drying, West Zone, CDL, (Omeprazole Mfg dt: 04/13, Assay & Mumbai Kolkata Capsules IP) Exp dt: 2 years from the date of mfg. Dissolution Mfd by: M/s. Shashi Pharma, Vejalpur Road, Chikhodra, Godhra 389001, Distt. PMS 6. Sinarest Tablets B. No.: 5474 Disintegration Drugs Control RDTL, Mfg dt: 07/13, Department, Guwahati Exp dt: 06/16 Assam Mfd by: M/s. Centaur Pharmaceuticals Pvt. Ltd., Plant I, Plot No. 3, Tivim Industrial Estate, Karaswala, Mapusa, 403526, Goa. 7. Syncold Tablets B. No.: C40880 Disintegration Drugs Control RDTL, Mfg dt: 03/14, Department, Guwahati Exp dt: 02/16 Assam Mfd by: M/s. Arion Healthcare, Vill-Kishanpura, Baddi, Dist-Solan, 174101, Himachal Pradesh 8. Norfloxacin Tablets B. No.: FT/1405 Dissolution & Drugs Control RDTL, Mfg dt: 12/14, Misbranded Department, Guwahati Exp dt: 11/17 Assam Mfd by: M/s. Viva Pharma (P) Ltd., Jorhat, 785005, Assam 9. Norfloxacin Tablets B. No.: FT/1404 Dissolution & Drugs Control RDTL, Mfg dt: 12/14, Misbranded Department, Guwahati Exp dt: 11/17 Assam Mfd by: M/s. Viva Pharma (P) Ltd., Jorhat, 785005, Assam. 10. R-Panta Tablets B. No.: RAB-0123 Dissolution Drugs Control RDTL, Mfg dt: 11/13, Department, Guwahati Exp dt: 10/15 Arunachal Mfd by: M/s. Regent Ajanta Biotech, Pradesh 86-87, Village-Makhiyali Dundi, Peerpua Road, Roorkee, Uttarakhand, 24766711. Sanclo Plus Tablets B. No.: DMT-010 Assay Drugs Control RDTL, Mfg dt: 04/13, Department, Guwahati Exp dt: 03/15 Assam Mfd by: M/s. Dr. Mittal Laboratories Pvt. Ltd., C-10-12, Sara Industrial Estate Ltd., Vill- Rampur, Selaqui, Dehradun, Uttarakhand. 12. Elmox Plus B. No.: AE4021 Assay Drugs Control RDTL, Capsules Mfg dt: 02/14, Department, Guwahati Exp dt: 01/16 Arunachal Mfd by: M/s. Arion Healthcare, Pradesh Kishanpura, Baddi, Dist-Solan, 174101, Himachal Pradesh. 13 Paracetamol B. No.: 1068 Uniformity of CDSCO, Sub- RDTL, Phenylephrine HCl, Mfg dt: 09/14, Weight Zone, Jammu Chandigarh Chlorpheniramine Exp dt: 08/16 Maleate and Mfd by: M/s. Amanath Pharmaceuticals, Caffeine tablets R.S. No. 35/5, Phathukannu, (HATRIC*-3 Koodapakkam Village, Puducherry- COLD) 605502 14 Amoxycillin B. No.: SMX-307 Dissolution CDSCO, Sub- RDTL, Capsules IP 250mg Mfg dt: 07/14, Zone, Chandigarh (CEEMOX-250) Exp dt: 06/16 Chandigarh Mfd by: M/s. Anrose Pharma, 147, Mauza Sansiwala, Post Barotiwala, Tehsil, Kasauli, Dist. Solan, H.P.

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