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Date: 2016-05-10 Category: Not Applicable State: Union Government Country: India

Drug Alert list for month of April 2016

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 April 2016.
  • The list includes the name of the product, batch number, manufacturing and expiry dates, manufacturer, reason for failure, and the testing laboratories involved.

Key Changes

  • A total of 17 products are listed as Not of Standard Quality/Spurious/Adulterated/Misbranded.
  • The products include tablets and injections of various drugs like Ascorbic Acid, Erythromycin Stearate, Buprenorphine, Ceftriaxone, Cabergolina, Ondansetron, Enalapril Maleate, Diacerein, Cyproheptadine HCl, Pantoprazole, Ibuprofen and Paracetamol, Amoxycillin and Potassium Clavulanate, and Drotaverine Hcl.
  • Reasons for failure include Assay issues, Dissolution problems, presence of Particulate Matter, Clarity of Solution, Description issues, pH and Sterility concerns, Related Substances issues, Uniformity of Content problems, Disintegration issues.
  • The products were tested by various CDSCO (Central Drugs Standard Control Organization) zones and Regional Drugs Testing Laboratories (RDTL).
  • Multiple manufacturers are implicated, including M/s. Jackson Laboratories Pvt. Ltd., M/s. Minopharm Laboratories Pvt. Ltd., M/s. Rayan Laboratories Pvt. Ltd., M/s. Ultra Drugs Pvt. Ltd., Parenteral Drugs (I) Limited, M/s. Scott-Edil Pharmacia Ltd., M/s. Remedies & Chemicals, M/s. Genpharma International Pvt. Ltd, M/s. Martina Biogenics Pvt. Ltd., M/s. Laborate Pharmaceuticals India Ltd., M/s. Kausikh Therapeutics (P) Ltd., M/s. Macleods Pharmaceutical Ltd., M/s. Modi Lifecare Industries Ltd., M/s. Saibliss Drugs and Pharmaceuticals, M/s. Indian Drugs and Pharmaceuticals ltd., M/s. Sanofi India limited and M/s. R.P. Biotech Pvt. Ltd.

Impact Analysis

Distributors/Retailers

  • Action Item: Immediately remove the listed batches from shelves and return them to the manufacturers or distributors.

Manufacturers

  • Action Item: Conduct thorough investigations into the root cause of the quality failures and implement corrective and preventive actions (CAPA).

Consumers/Patients

  • Action Item: Healthcare providers should be informed to avoid prescribing the listed batches. Issue public advisory to avoid consumption of the listed drugs.

CDSCO & State Drug Controllers

  • Action Item: Intensify surveillance and testing of drugs in the market. Strengthen collaboration between central and state drug control authorities.

Our Company

  • Action Item: Conduct a comprehensive audit of our product portfolio to identify and mitigate any potential quality risks. Review and update our standard operating procedures (SOPs) for quality control.

Key Entities Referenced

CDSCO: Central Drugs Standard Control Organization, the national regulatory body for pharmaceuticals and medical devices in India. CDTL: Central Drugs Testing Laboratory RDTL: Regional Drugs Testing Laboratory Drugs and Cosmetics Act, 1940: The primary legislation governing the import, manufacture, distribution, and sale of drugs and cosmetics in India. (Implicitly referenced through the identification of drugs as 'Not of Standard Quality/Spurious/Adulterated/Misbranded')
Official Source Record View Original Source →
See Full Document Text
List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, For the Month of April, 2016 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. Ascorbic Acid B. No.:T-6455, Assay CDSCO, CDTL, Tablet IP 100mg Mfg dt: 06/2014 East-Zone, Chennai (Vitamin-C) Exp dt: 05/2016 Kolkata Mfd by: M/s. Jackson Laboratories Pvt. Ltd., Majitha Road, Bye Pass, Amristar- 143004 2. Erythromycin B. No.: ES-169, Dissolution CDSCO, CDTL, Stearate Tablets IP Mfg dt: 11/2015 South-Zone, Chennai 250mg Exp dt: 10/2017 Chennai Mfd by: M/s. Minopharm Laboratories Pvt. Hyderabad- 500073 3. X-Gesic B. No.: RL-14325, Description & CDSCO, CDL, (Buprenorphine Mfg dt: 12/2014, Particulate North-Zone, Kolkata Injection I.P.) Exp dt: 11/2016 Matter Ghaziabad Mfd by: M/s. Rayan Laboratories Pvt. Ltd., Khasra No. 390, Vill: Matlabpur, Roorkee, Distt, Haridwar (Uttarakhand). 4. i) Tecef (Ceftriaxone B. No.: UDD-5001B, Particulate CDSCO, CDL, Injection I.P. 500 Mfg dt: 01/2015 Matter & North-Zone, Kolkata mg) Exp dt: 12/2016 Clarity of Ghaziabad Mfd by: M/s. Ultra Drugs Pvt. Solution Ltd., Manpura, Nalagarh, Solan (H.P.) & ii) Sterile water for B. No.: 4W-221, Injection I.P. 5 ml Mfg dt: 10/2014 Exp dt: 09/2017 Mfd by: Parenteral Drugs (I) Limited, Bhud, Baddi (H.P.). 5. Monoscot B. No.: DC5014, Particulate CDSCO, CDL, (Ceftriaxone Mfg dt: 01/2015, Matter & North-Zone, Kolkata Injection I.P.) Exp dt: 12/2016 Clarity of Ghaziabad Mfd by: M/s. Scott-Edil Solution Pharmacia Ltd., 56, EPIP, Phase I, Jharmajri – 173205 (H.P.). 6. N-Norphin Injection B. No.: 749, Description, CDSCO, CDL, (Buprenorphine Mfg dt: 06/2015, Particulate North-Zone, Kolkata Injection I.P.) Exp dt: 05/2017 Matter, pH & Ghaziabad Mfd by: M/s. Remedies & Sterility Chemicals, NH-22, PNB Building, Parag, Solan Brewery - 1732147. Prolactolina B. No.: AMB1401, Related CDSCO, CDL, (Cabergolina 0.5 mg Mfg dt: Not Mentioned, Substances West-Zone, Kolkata Tablets) Exp dt: 09/2016 Mumbai Mfd by: M/s. Genpharma International Pvt. Ltd, India. 8. Martixone 1 gm B. No.: E411816, Particulate CDSCO, CDL, (Ceftriaxone Mfg dt: 05/2014, Matter & East-Zone, Kolkata Injection I.P.) Exp dt: 04/2016 Clarity of Kolkata Mfd by: M/s. Martina Biogenics Solution Pvt. Ltd., Dareer Road, Chowhati, Rajpur, Kolkata 700151 9. Ondansetron Tablets B. No.: EBOT-002, Dissolution & CDSCO, CDL, I.P. 4 mg, Mfg dt: 06/2014, Related East-Zone, Kolkata Exp dt: 05/2016 Substances Kolkata Mfd by: M/s. Laborate Pharmaceuticals India Ltd., Unit - 2, 31, Rajban Road, Nariwala, Ponta Sahib (H.P.). 10. Enalapril Maleate B. No.: K0215033, Assay, CDSCO, CDL, Tablets I.P. 5 mg, Mfg dt: 02/2015, Uniformity of Hyderabad Kolkata Exp dt: 01/2018 Content & Zone Mfd by: M/s. Kausikh Dissolution Therapeutics (P) Ltd., Plot No. 6 & 7, Door No.- 728 Kakkanji Cross Street, Paraniputhur Road, Gerugambakkam, Chennai- 600128. 11. Orcerin (Diacerein B. No.: ADA325A, Related CDSCO, CDL, Capsules I.P. 50 mg) Mfg dt: 06/2013, Substances Ahmedabad Kolkata Exp dt: 05/2017, Zone Mfd by: M/s. Macleods Pharmaceutical Ltd., Vill- Theda, P.O. Lodhimajra, Baddi, Solan, H.P – 174101. 12. Aptidin 4 B. No.: 140694, Uniformity of CDSCO, CDL, (Cyproheptadine Mfg dt: 06/2014, Content Ahmedabad Kolkata HCl Tablets I.P. 4 Exp dt: 05/2017 Zone mg) Mfd by: M/s. Modi Lifecare Industries Ltd., 27, GIDC, Opp. Creata Cold Storage, Odhav, Ahmedabad – 382415, Gujarat. 13. Para Tablets B. No.: PR-2020, Dissolution & Drugs RDTL, Mfg dt: 05/2015, Assay Control Guwahati Exp dt: 04/2017 Department, Mfd by: M/s. Saibliss Drugs and Arunachal Pharmaceuticals, 66/67, Pradesh Gondpur Industrial Area, Paonta Sahib, H.P. 14. Pantoprazole Tablets B. No.:PZT-1415, Dissolution CDSCO, RDTL, IP 40mg Mfg dt: 09/2015 North-Zone, Chandigarh Exp dt: 08/2017 Ghaziabad Mfd by: M/s. Indian Drugs and Pharmaceuticals ltd., Dundahera Gurgaon-122016, Haryana15. Ibuprofen and B. No.:A150682, Disintegration CDSCO, RDTL, Paracetamol Tablets Mfg dt: 06/2015 North-Zone, Chandigarh (Combiflam Tablets) Exp dt: 05/2018 Ghaziabad Mfd by: M/s. Sanofi India limited, 3501, 3503-15, 6310, B- 14, GIDC Estate, Ankleshwar- 393002 16. Amoxycillin and B. No.:3909, Assay U.T., RDTL, Potassium Mfg dt: 01/2016 Chandigarh Chandigarh Clavulanate Tablets Exp dt: 06/2017 IP (Stanclav 625 Mfd by: M/s. R.P. Biotech Pvt. Tablets) Ltd., 61, Ind. Focal Point, Batala 17. Drotaverine Hcl B. No.:T-10270, Assay CDSCO, RDTL, Tablets (D-Vir Mfg dt: 11/2015 Sub-Zone, Chandigarh Tablets) Exp dt: 10/2017 Chandigarh Mfd by: M/s. Jackson Laboratories Pvt. Ltd., Bye Pass, Majitha Road, Amritsar-143004

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