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Date: 2016-08-02 Category: Not Applicable State: Union Government Country: India

Drugs Alert for the month of July 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 the month of July 2016.
  • The list includes the name of the drug/medical device/cosmetic, batch number, manufacturing and expiry dates, manufacturer details, reason for failure, and the zone/location where the sample was drawn.

Key Changes

  • A total of 13 items are listed in the notification.
  • The listed items include tablets, injections, suspensions and eye/ear drops.
  • Reasons for failure include: Related Substances, Particulate Matter & Description, Dissolution, Does not conform to IP 2014 standard with respect to the test for Salicylic Acid in Aspirin Gastro-Resistant Tablet I.P., Does not conform to IP 2014 standard with respect to the test for Extractable Volume, Spurious and Misbranded, pH, Bet Test & Assay, and Assay.
  • Several drugs manufactured by different companies located across India have been declared as substandard.
  • M/s. AIMS International, M/s. Saibliss Drugs & Pharmaceuticals and M/s. Vardhman Pharma have had products declared as 'Spurious'
  • CDSCO (Central Drugs Standard Control Organization) zones including East Zone (Kolkata), North Zone (Ghaziabad), South Zone (Chennai), and West Zone (Mumbai) are involved in drawing samples and testing.

Impact Analysis

Impact on Manufacturers

  • Potential legal action and penalties.

Impact on Consumers

  • Need for increased awareness among consumers about checking drug quality and authenticity.

Impact on Regulatory Bodies

  • Indicates potential gaps in the drug regulatory system that need to be addressed.

Suggested Action Items

  • Review and update of drug regulations to ensure compliance with international standards.

Key Entities Referenced

CDSCO: Central Drugs Standard Control Organization. Responsible for regulating drugs and cosmetics in India. CDL: Central Drugs Laboratory. A drug testing laboratory. CDTL: Central Drugs Testing Laboratory. A drug testing laboratory. RDTL: Regional Drugs Testing Laboratory. A drug testing laboratory. IP: Indian Pharmacopoeia. A book of standards for drugs manufactured and marketed in India. Drugs and Cosmetics Act: The primary legislation governing drugs and cosmetics in India.
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 July, 2016 S. Name of Batch No./Date of Reason for failure Drawn By From No Drugs/medical Manufacture/Date of . device/cosmetics Expiry/Manufactured By 1. Dexlysone B. No.: T141047, Related Substances CDSCO, East CDL, (Dexamethasone Mfg dt: 10/2014, Zone, Kolkata Kolkata Tablets I.P.) Exp dt: 09/2016, Mfd by: M/s. Lycon Healthcare Pvt. Ltd., Khasra No. 37, Makkanpur, Bhagwanpur, Roorkee, Dist. Haridwar. 2. Adrecid B. No.: 610601, Particulate Matter CDSCO, North CDL, (Adrenaline Mfg dt: 02/2016, & Description Zone, Kolkata Tartrate Injection Exp dt: 01/2017, Ghaziabad I.P. 1 ml) Mfd by: M/s. Ravi Pharmaceuticals Pvt. Ltd., 69/1, GIDC, Kansari – 388 630, Khambhat (Cambay), Gujarat. 3. Paracetamol B. No.: 9102, Dissolution CDSCO South CDTL, Tablets IP 500 mg Mfg dt: 04/2015, Zone, Chennai Chennai Exp dt: 03/2018, Mfd by: M/s. Orissa Drugs & Chemicals Limited, A unit of India Drugs & Pharmaceuticals Ltd 1, Mancheswar Industrial Estate, Bhubaneswar, Odisha 4. Stromix A 75 B. No.: SA-1393, Does not conform CDSCO South CDTL, (75mg+75mg) Mfg dt: 11/2014, to IP 2014 Zone, Chennai Mumbai (Clopidogrel & Exp dt: 10/2016, standard with Aspirin Capsules) Mfd by: M/s. Mapro respect to the test Pharmaceuticals Pvt. Ltd., (Unit for Salicylic Acid II), Q Road, Phase IV, G.I.D.C., in Aspirin Gastro- Wadhwan City-363035, Resistant Tablet Dist. Surendra Nagar, Gujarat, I.P. India 5. Zenil B. No.: ZN1501, Does not conform CDSCO West CDTL, (Pheniramine Mfg dt: 08/2015, to IP 2014 Zone, Mumbai Mumbai Maleate Injection Exp dt: 07/2017, standard with I.P.) Mfd by: M/s. Pharmax India Pvt. respect to the test Ltd., 9 Kurla Industrial Estate, for Extractable Ghatkopar (W), Mumbai-400086 Volume 6. Amika 100 B. No.: AM2020, Spurious And Drugs Control RDTL, Injections Mfg dt: 05/2015, Misbranded Department, Guwahati Mizoram. Exp dt: 04/2017, Mfd by: M/s. AIMS International, Dehradun Road, Rampur Ghat, Paonta Sahib, H.P.7. Esthrocin B. No.: ET-2020, Spurious Drugs Control RDTL, Suspensions Mfg dt: 05/2015, Department, Guwahati Arunachal Exp dt: 04/2017, Pradesh. Mfd by: M/s. Saibliss Drugs & Pharmaceuticals, 66/67, Gondpur Indstl. Area, Paonta Sahib 8. Gentamicin B. No.: GT-2020, Spurious Drugs Control RDTL, Injection Mfg dt: 04/2015, Department, Guwahati Arunachal Exp dt: 03/2017, Pradesh. Mfd by: M/s. Vardhman Pharma, 32 Indl. Area, Trilokpur Road, Kala-Amb, Dist-Sirmour H.P 9. Gentamicin B. No.: 8189, pH Drugs Control RDTL, Eye/Ear Drops Mfg dt: 09/2015, Department, Guwahati Arunachal Exp dt: 02/2017, Pradesh. Mfd by: M/s. Ramson Remedies, 186-187 Indl. Focal Point, Malabar Hill, Mumbai. 10. Oxytocin B. No.: H204, Bet Test & Assay Drugs Control RDTL, Injection Mfg dt: 01/2015, Department, Guwahati Arunachal Exp dt: 12/2016, Pradesh. Mfd by: M/s. JMD Pharmaceuticals, A.T. Road, Barauni-851112 11. Norfloxacin & B. No.: GT50605, Assay Drugs Control RDTL, Tinidazole Mfg dt: 10/2015, Department, Guwahati Assam. Tablets Exp dt: 09/2017, Mfd by: M/s. Omega Biotech Ltd., 7th Mile Stone, Roorkee, Uttarakhand-247667. 12. Paracetamol B. No.: 561115, Dissolution Drugs Control RDTL, Tablets Mfg dt: 11/2015, Department, Guwahati Assam. Exp dt: 10/2017, Mfd by: M/s. Veejay Laboratories, Unit of Grace Laboratories Pvt. Ltd., EPIP Zone, Amingaon, Guwahati, Assam-781031 13. Aciclovir Tablets B. No.: TPVR4-008, Assay Drugs Control RDTL, Mfg dt: 02/2015, Department, Guwahati Assam. Exp dt: 01/2017, Mfd by: M/s. Medipol Pharmaceuticals Pvt. Ltd., 1199/3, Bhud Baddi, Dist-Solan, H.P.

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