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Date: 2015-10-07 Category: Not Applicable State: Union Government Country: India

Drug Alert list for month of September 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 September 2015.
  • The listed products failed quality tests conducted by various drug testing laboratories across India.

Key Changes

  • A total of 17 products are listed as Not of Standard Quality/Spurious/Adulterated/Misbranded.
  • 7 out of the 17 products are Oral Rehydration Salts (ORS) failing the seal test.
  • The ORS batches were manufactured in June 2015, April 2015 with expiry dates in November 2016 and September 2016.
  • Manufacturers of the ORS include M/s. Syndicate Pharma, M/s. Wilcure Remedies Private Limited and M/s. Dusap Pharmaceuticals.
  • Other products include IBU-400 Tablets (failed dissolution test), Pantoprazole Tablets (did not conform to IP standard for dissolution), Fenofibrate Tablets (did not conform to USP standard for dissolution), Salbutamol Sulphate Tablets (did not conform to IP standard for Assay), Salbutamol Tablets IP (failed Related Substances & Assay test), Doxycycline Hyclate Tablets (failed dissolution test), and Betamethasone Tablets IP (failed Dissolution & Related Substances test).
  • Testing was conducted by RDTL Guwahati, CDSCO West Zone Mumbai, CDSCO East Zone Kolkata, CDSCO Sub Zone Kolkata, CDL Kolkata and CDTL Mumbai.
  • Reasons for failure include seal test failure, dissolution issues, not conforming to IP/USP standards, and related substances & assay failures.

Impact Analysis

Impact on Manufacturers

  • M/s. Anrose Pharma, M/s. Aran Pharmaceuticals, M/s. Micron Pharmaceuticals, M/s. IDPL (TN) Ltd., M/s. Luxmi Pharmaceuticals Works, M/s. Elfin Drugs Pvt. Ltd., and M/s. Modi Lifecare Industrial Ltd. need to immediately cease distribution of the listed batches.

Impact on Consumers

  • Anxiety and concern among consumers regarding the quality of medicines they are taking.

Impact on Government

  • The Drugs Control Department of Meghalaya and other relevant state drug control authorities need to take action against the manufacturers.

Suggested Action Items

  • Legal teams to prepare for potential litigation and regulatory action.

Key Entities Referenced

RDTL Guwahati: Regional Drugs Testing Laboratory, Guwahati. Conducted testing for ORS samples. CDSCO: Central Drugs Standard Control Organization. CDSCO Zones (West, East, Sub Zone) conducted testing for various drug samples. CDL Kolkata: Central Drugs Laboratory, Kolkata. Conducted testing for Salbutamol and Doxycycline samples. CDTL Mumbai: Central Drugs Testing Laboratory, Mumbai. Conducted testing for Pantoprazole, Fenofibrate and Salbutamol samples. M/s. Syndicate Pharma: Manufacturer of multiple batches of Oral Rehydration Salts (ORS) declared as Not of Standard Quality. M/s. Wilcure Remedies Private Limited: Manufacturer of multiple batches of Oral Rehydration Salts (ORS) declared as Not of Standard Quality. M/s. Dusap Pharmaceuticals: Manufacturer of multiple batches of Oral Rehydration Salts (ORS) declared as Not of Standard Quality. M/s. Anrose Pharma: Manufacturer of IBU – 400 Tablets declared as Not of Standard Quality. M/s. Aran Pharmaceuticals: Manufacturer of Arpan (Pantoprazole Tablets I.P. 40mg) declared as Not of Standard Quality. M/s. Micron Pharmaceuticals: Manufacturer of Fenofibrate Tablets 200mg declared as Not of Standard Quality. M/s. IDPL (TN) Ltd.: Manufacturer of Salbutamol Sulphate Tablets I.P. 4mg declared as Not of Standard Quality. M/s. Luxmi Pharmaceuticals Works: Manufacturer of Salbut (Salbutamol Tablets IP) declared as Not of Standard Quality. M/s. Elfin Drugs Pvt. Ltd.: Manufacturer of Docox (Doxycycline Hyclate Tablets U.S.P.) declared as Not of Standard Quality. M/s. Modi Lifecare Industrial Ltd.: Manufacturer of Betsone 5 (Betamethasone Tablets IP 0.5mg) declared as Not of Standard Quality.
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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 September 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. Oral Rehydration B. No.: 815215 Seal Test Drugs RDTL, Salts Mfg dt: 06/2015 Control Guwahati Exp dt: 11/2016 Department, Mfd by: M/s. Syndicate Pharma, Meghalaya 188, Sector-F, Sanwer Road, Indore. 2. Oral Rehydration B. No.: WD - 032 Seal Test Drugs RDTL, Salts Mfg dt: 06/2015 Control Guwahati Exp dt: 11/2016 Department, Mfd by: M/s. Wilcure Remedies Meghalaya Private. Limited, P. H. No. 10, Gram Mirjapur, Indore-452020, Madhya Pradesh 3. Oral Rehydration B. No.: 815214 Seal Test Drugs RDTL, Salts Mfg dt: 06/2015 Control Guwahati Exp dt: 11/2016 Department, Mfd by: M/s. Syndicate Pharma, Meghalaya 188, Sector-F, Sanwer Road, Indore. 4. Oral Rehydration B. No.: WD - 030 Seal Test Drugs RDTL, Salts Mfg dt: 06/2015 Control Guwahati Exp dt: 11/2016 Department, Mfd by: M/s. Wilcure Remedies Meghalaya Private. Limited, P. H. No. 10, Gram Mirjapur, Indore-452020, Madhya Pradesh 5. Oral Rehydration B. No.: 815221 Seal Test Drugs RDTL, Salts Mfg dt: 06/2015 Control Guwahati Exp dt: 11/2016 Department, Mfd by: M/s. Syndicate Pharma, Meghalaya 188, Sector-F, Sanwer Road, Indore. Madhya Pradesh 6. Oral Rehydration B. No.: ORS-1800 Seal Test Drugs RDTL, Salts Mfg dt: 04/2015 Control Guwahati Exp dt: 09/2016 Department, Mfd by: M/s. Dusap Meghalaya Pharmaceuticals, 115 Dr. B. C. Roy Road, Rajpur, South 24, Parganas, Kolkata, West Bengal. 7. Oral Rehydration B. No.: 815228 Seal Test Drugs RDTL, Salts Mfg dt: 06/2015 Control Guwahati Exp dt:11/2016 Department, Mfd by: M/s. Syndicate Pharma, Meghalaya 188, Sector-F, Sanwer Road, Indore. Madhya Pradesh.8. Oral Rehydration B. No.: 815218 Seal Test Drugs RDTL, Salts Mfg dt: 06/2015 Control Guwahati Exp dt:11/2016 Department, Mfd by: M/s. Syndicate Pharma, Meghalaya Sector-F, Sanwer Road, Indore. Madhya Pradesh. 9. Oral Rehydration B. No.: ORS-1798 Seal Test Drugs RDTL, Salts Mfg dt: 04/2015 Control Guwahati Exp dt: 09/2016 Department, Mfd by: M/s. Dusap Meghalaya Pharmaceuticals, 115 Dr. B. C. Roy Road, Rajpur, South 24, Parganas, Kolkata, 700151, West Bengal 10. Oral Rehydration B. No.: ORS-1797 Seal Test Drugs RDTL, Salts Mfd by: 04/2015 Control Guwahati Exp dt: 09/2016 Department, Mfd by: M/s. Dusap Meghalaya Pharmaceuticals, 115 Dr. B. C. Roy Road, Rajpur, South 24, Parganas, Kolkata, 700151, West Bengal. 11. IBU – 400 Tablets B. No.: SMT-925 Dissolution Drugs RDTL, Mfg dt: 03/2012 Control Guwahati Exp dt: 02/2016 Department, Mfd by: M/s. Anrose Pharma, Sikkim 147, Mauza, Sansiwala, Tehsil, Kasuli, Dist.-Solan, Himachal Pradesh. 12. Arpan B. No.: 76514 Does not CDSCO, West CDTL, (Pantoprazole Mfg dt: 05/2014 conform to IP Zone, Mumbai Tablets I.P. 40mg) Exp dt: 04/2016 standard with Mumbai Mfd by: M/s. Aran respect to for Pharmaceuticals, 49 & 53, Ram Dissolution Kala Nagar, Morar, Gwalior-M.P. 474006 13. Fenofibrate B. No.: T131205 Does not CDSCO, West CDTL, Tablets 200mg Mfg dt: 12/2013 conform to USP Zone, Mumbai Exp dt: 11/2015 standard with Mumbai Mfd by: M/s. Micron respect to for Pharmaceuticals, 2117, A-2, Phase- Dissolution III, GIDC, Vapi-396195 14. Salbutamol B. No.: 1 SBL 414 Does not CDSCO, West CDTL, Sulphate Tablets Mfg dt: 03/2014 conform to IP Zone, Mumbai I.P. 4mg Exp dt: 02/2017 2010 standard Mumbai Mfd by: M/s. IDPL (TN) Ltd., A with respect to Wholly owned subsidiary of IDPL for Assay (A Government of India Undertaking), Nandambakkam, Chennai-600089 15. Salbut B. No.: 130310, Related CDSCO, East CDL, (Salbutamol Mfg dt: 11/2013 Substances & Zone, Kolkata Kolkata Tablets IP) Exp dt: 10/2015 Assay Mfd by: M/s. LuxmiPharmaceuticals Works, P-18, Kanungo Park, Kolkata – 700 084 16. Docox B. No.: GHG-14260, Dissolution CDSCO, East CDL, (Doxycycline Mfg dt: 10/2014, Zone, Kolkata Kolkata Hyclate Tablets Exp dt: 09/2016 U.S.P.) Mfd by: M/s. Elfin Drugs Pvt. Ltd., Vill: Berson, Nalagarh (H.P.) - 174101 17. Betsone 5 B. No.: 1401036, Dissolution & CDSCO, Sub CDL, (Betamethasone Mfg dt: 10/2014 Related Zone Kolkata Tablets IP 0.5mg) Exp dt: 09/2017 Substances Ahmedabad Mfd by: M/s. Modi Lifecare Industrial Ltd., 27, GIDC, Opp. Creata Cold Storage, Odhav, Ahmedabad – 382415.

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