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Date: 2014-12-09 Category: Not Applicable State: Union Government Country: India

Drugs Alert for the month of November 2014

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 November 2014.
  • The list includes the name of the product, batch number, manufacturing and expiry dates, manufacturer details, reason for failure, details of the testing laboratory, and the testing report number.

Key Changes

  • A total of 24 products are listed as non-compliant.
  • The reasons for failure include misbranding, dissolution issues, disintegration issues, particulate matter, description discrepancies, assay failures, and non-conformity to tests.
  • The listed products include Paracetamol Syrups and Tablets, Rabcam-20 Tablets, Roxycept-150 Tablets, Fenela – P Tablet, Flexon Tablets, Boss-OZ Tablets, PMO-650 Tablets, Oflomin-OZ Tablets, Cyanocobalamine Injection IP, Sulbactomax (Ceftriaxone/Sulbactum for Injection), Roller Bandage, Dexon (Dexamethasone Sodium Phosphate Injection IP), Centradol 100 (Tramadol Hydrochloride Injection), Nirsal-BR Syrup, Zepara-XT Tablets, Cardem-30 (Ditliazem Tablets IP), Fruron Tablets (Frusemide and Spironolactone Tablets), Digestive Enzyme B-Complex with L-Lysine (Xzyme Syrup), Sodium Valproate & Valproic Acid Controlled Release Tablets® (SV CHRONO-300), Ondansetron Tablets IP (OND-MIN-8), Cefpodoxime Tablets IP (Zextil-200), and Ciprofloxacin Hydrochloride Tablets IP (Cipmah-500).
  • The products were tested by various CDSCO zones and CDL/RDTL laboratories.
  • Manufacturers listed are from various states including Gujarat, Uttarakhand, Himachal Pradesh, Assam, Madhya Pradesh, Sikkim, Delhi, West Bengal, Tamil Nadu, and Jammu & Kashmir.

Impact Analysis

Manufacturers

  • Action Item: Conduct a thorough internal audit of manufacturing processes and quality control systems to identify and rectify deficiencies.

Distributors/Retailers

  • Action Item: Implement a system to quickly identify and remove recalled products from shelves.

Consumers

  • Action Item: Raise awareness among consumers about the risks associated with substandard drugs and the importance of purchasing from trusted sources.

Regulatory Authorities

  • Action Item: Strengthen post-market surveillance and testing to identify and prevent the circulation of substandard drugs.

Key Entities Referenced

CDSCO: Central Drugs Standard Control Organisation, the national regulatory body for pharmaceuticals and medical devices in India. RDTL: Regional Drugs Testing Laboratory, a laboratory that tests drugs and medical devices for quality. CDL: Central Drugs Laboratory, a national laboratory for testing and analysis of drugs and cosmetics. IP: Indian Pharmacopoeia, the official book of standards for drugs manufactured and marketed in India.
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 November, 2014 Sl. Name of Batch No./Date of Reason for failure Drawn By From No. Drugs/medica Manufacture/Date of with Report No. l Expiry/Manufactured By (in Form-13)& Date device/cosmet ics 1 Paracetamol B. No. RL-276, Misbranded CDSCO, East RDTL, Syrups D/Mfg. Apr, 2014, Report No. 09881/2014- Zone D/Exp. Mar, 2016, 15 Guwahati Mfg. By. Dated M/s Ratnamani Healthcare Pvt. 25-11-2014 Limited, Survey No. 750/1, Ahmedabad- Mehsana Highway, Vill-Indrad, Tal- Kadi, 382721, Gujarat. 2 Rabcam-20 B. No. RAB-078, Misbranded CDSCO, East RDTL, Tablets D/Mfg. Nov, 2013, Report No. 09882/2014- Zone D/Exp. Oct, 2015, 15 Guwahati Mfg. By. Dated M/s Regent Ajanta Biotech, 25-11-2014 86-87, Vill-Makhiyali Dundi, Peerpura Road, Roorkee, Uttarakhand, 247667. 3 Roxycept-150 B. No. V13A-069, Dissolution CDSCO, East RDTL, Tablets D/Mfg. Jan, 2013, Report No. 09811/2014- Zone D/Exp. Dec, 2014, 15 Guwahati Mfg. By. Dated M/s Venus Biosciences Pvt. Ltd., 07-11-2014 116, Export Promotion Indl Park, Phase-I, Jharmajri, Baddi, Dist-Solan, 173205, Himachal Pradesh. 4 Paracetamol B. No. 060114, Dissolution Report No. CDSCO, East RDTL, Tablets D/Mfg. Jan, 2014, 09832/2014-15 Zone D/Exp. Dec, 2016, Dated Guwahati Mfg. By. 14-11-2014 M/s Veejay Laboratories, EPIP Zone, Amingaon, Guwahati- 781031, Assam. 5 Paracetamol B. No. 010114, Dissolution CDSCO, East RDTL, Tablets D/Mfg. Jan, 2014, Report No. 09833/2014- Zone D/Exp. Dec, 2016, 15 Guwahati Mfg. By. Dated M/s Veejay Laboratories, 14-11-2014 EPIP Zone, Amingaon, Guwahati- 781031, Assam. 6 Fenela – P B. No. EIG-1307, Disintegration Report No. CDSCO, East RDTL, Tablet D/Mfg. Jul, 2013, 09866/2014-15 Zone D/Exp. Jun, 2015, Dated Guwahati Mfg. By. 20-11-2014 M/s Everest Formulations, Saproon, Solan, 173211, Himachal Pradesh. 7 Flexon Tablets B. No. MM26K553, Disintegration Report No. CDSCO, East RDTL, D/Mfg. Oct, 2013, 09867/2014-15 Zone D/Exp. Sep, 2016, Dated Guwahati Mfg. By. 20-11-2014 M/s Aristo Pharmaceuticals Pvt. Limited, Plot No. 208, Dist-Raisen, Madhya Pradesh.8 Boss-OZ B. No. D30145, Disintegration Report No. CDSCO, East RDTL, Tablets D/Mfg. Apr, 2013, 09865/2014-15 Zone D/Exp. Mar, 2015, Dated Guwahati Mfg. By. 20-11-2014 M/s Arion Healthcare. Vill-Kishanpura, Baddi, Dist-Solan, 174101. 9 PMO-650 B. No. LPMT-13001S, Dissolution Report No. CDSCO, East RDTL, Tablets D/Mfg. Mar, 2013, 09879/2014-15 Zone D/Exp. Feb, 2016, Dated Guwahati Mfg. By. 25-11-2014 M/s Indchemie Health Specialities Pvt. Limited, Vill-Kumerk, Rangpo, East-Sikkim, 737132, Sikkim. 10 Oflomin-OZ B. No. RAB-111, Disintegration Report No. CDSCO, East RDTL, Tablets D/Mfg. Apr, 2014, 09883/2014-15 Zone D/Exp. Mar, 2016, Dated Guwahati Mfg. By. 25-11-2014 M/s Regent Ajanta Biotech, 86-87, Vill-Makhiyali Dundi, Peerpura Road, Roorkee, Uttarakhand, 247667. 11 Cyanocobalami B. No.: 46/B Particulate Matter & CDSCO, CDL, Kolkata ne Injection IP Mfg dt: 01/2014, Description North Zone Exp dt: 06/2015 32-1/2014-SS/ Mfd by: M/s. Good Kare Medico (P) DCA(N)-7/1663 Ltd., E-6, Industrial Estate, Delhi Dt. 17.11.2014 Road, Saharanpur, UP 12 Sulbactomax B. No.: DV3G583 Appearance after CDSCO, Sub CDL, Kolkata (Ceftriaxone/Sul Mfg dt: 07/2013 reconstitution & Zone, bactum for Exp dt: 06/2015 Particulate Matter Chandigarh Injection) Mfd by: M/s. Venus Remedies Ltd., 32-18/2014-SS/DCA(C)- Hill Top Industrial Estate, Jharmajri, 28/1664 EPIP, Phase-I Dt. 17.11.2014 (Extn.), Bhatoli, Kalan, Baddi 173205, HP. 13 Roller Bandage B. No.: 1373 Description, Threads per CDSCO, East CDL, Kolkata 10 cms x 4 mts Mfg dt: 09/2013, dm, Weight in g/m2, Zone Exp dt: 08/2016 Length, Foreign Matter, Mfd by: M/s. Atin Cottage Industries, Fluorescence 36-A, Beniapukur Road, Kolkata 700 32-8/2014-SS/ 014. DCA(E)-141/1678 Dt. 17.11.2014 14 Dexon B. No.: L13D01007 Assay of Dexamethasone CDSCO, East CDL, Kolkata (Dexamethasone Mfg dt: 08/2013 32-8/2014-SS/ Zone Sodium Exp dt: 07/2015 DCA(E)-3/1677 Phosphate Mfd by: M/s. N.I. Pharmaceutical Dt. 17.11.2014 Injection IP) Works (P) Ltd., Boral Main Road, Paschim Nischintapur, Bagher Ghole, Kolkata 700 103 15 Centradol 100 B. No.: TAM3F1 Description & Particulate CDSCO, East CDL, Kolkata (Tramadol Mfg dt: 04/2013, Matter Zone Hydrochloride Exp dt: 03/2015 32-8/2014-SS/ Injection) Mfd by: M/s. Tablets (India) Ltd., DCA(E)-253/1711 179, T.H. Road, Chennai 600081 Dt. 24.11.201416 Nirsal-BR B. No.: 8L20614 Assay of Bromhexine CDSCO, CDL, Kolkata Syrup Mfg dt: 12/2012 Hydrochloride Zonal Office, Exp dt: 11/2014 32-11/2014-SS/ Ahmedabad Mfd by: M/s. Nirma Limited DCA(A)-122/1734 (Healthcare Division), Sachana, Dt. 25.11.2014 Gujarat – 382150, India. 17 Zepara-XT B.No: 414-1247 Does not conform with CDSCO, CDTL, Tablets respect to Test For Zonal Office, Chennai Mfd. Dt: 07/2014 ( Paracetamol Dissolution Hyderabad Exp. Dt: 06/ 2016 Tablets IP 650 ( 44.9 % to 73 % of mg ) Mfd By: Zee Laboratories, Claim) 47, Industrial Area, Regn.No: CDTL/Form- Paonta Sahib, 173 025 (H.P) 18/D/641/14-15 18 Cardem-30 B.No: 03402P Does not conform with CDSCO, CDTL, (Ditliazem respect to Test For Zonal Office, Chennai Mfd. Dt: March 2014 Tablets IP) Dissolution Hyderabad Exp. Dt: August 2016 ( 35.03 % to 45.46 % of Mfd By: AFD Laboratories Pvt. Ltd, Claim) At: Plot, No.4, Phase-II, Regn.No: CDTL/Form- Peenya Industrial, Peenya, Bangalore-560 058. 18/D/703/14-15 19 Fruron Tablets B.No: ZT- 6991 Does not conform with CDSCO, CDTL, ( Frusemide and respect to Assay of Zonal Office, Chennai Mfd. Dt: 03/2014 Spironolactone Frusemide Hyderabad Exp. Dt: 02/2016 Tablets) ( 0.568 % of Claim) Mfd By: Zee Laboratories, Regn.No: CDTL/Form- 47, Industrial Area, 18/D/382/14-15 Paonta Sahib -173 025 (H.P) 20 Digestive B.No: AK1892 Assay of Thiamine CDSCO, Sub RDTL, Enzyme B- Mononitrate Zone, Mfd. Dt:- May/2014 Chandigarh Complex with Report No. Chandigarh Exp. Dt: -Oct/2015 L-Lysine LSD/RDTL/0071/14-15 (Xzyme Syrup) Mfd By: M/s. Affy Pharma Pvt. Ltd., Date:13-11-14 Village Thana, Baddi- Distt. Solan,, (H.P.) 21 Sodium B.No: LC13-249 Assay of Sodium CDSCO, Sub RDTL, Valproate & Valproate & Valproic Zone, Jammu Mfd. Dt: -08/2013 Chandigarh Valproic Acid Acid Exp. Dt: -07/2016 Controlled Report No. RDTL/845/13- Release Mfd By: - M/s. Lifecare Neuro 14 Tablets® (SV Products Ltd., 70/1, Dharampur, Near Dated:-17-11-14 CHRONO-300) EPIP-II, Baddi-173205, Himachal Pradesh. 22 Ondansetron B.No: -1122 Assay of Ondansetron CDSCO, Sub RDTL, Tablets IP Hydrochloride calculated Zone, Jammu Mfd. Dt: -Jul./2013 Chandigarh (OND-MIN-8) as Ondansetron Exp. Dt: -Jun./2015 Report No. Mfd By: - M/s. Minil Laboratories LSD/RDTL/0191/14-15 Pvt. Ltd., 26, Industrial Estate, Dated:-28-11-14 Jammu-180010.23 Cefpodoxime B.No: ZT-14103 Dissolution CDSCO, Sub RDTL, Tablets IP Report No. Zone, Mfd. Dt: -02/14 Chandigarh (Zextil-200) LSD/RDTL/0256/14-15 Chandigarh Exp. Dt: -01/16 Dated:-25-11-14 Mfd By: - M/s. Zee Laboratories, 47, Industrial Area, Paonta Sahib, Distt. Sirmour H.P.173025 24 Ciprofloxacin B.No: MAT1349 Dissolution & Assay CDSCO, RDTL, Hydrochloride LSD/RDTL/0320/14-15 North Zone Mfd. Dt: -10/13 Chandigarh Tablets IP Dated:-26-11-14 Exp. Dt: -09/15 (Cipmah-500) Mfd By:- M/s. Mediaid Health Care Pvt. Ltd., Plot No. 88, Sector-7, IIE, SIDCUL, Haridwar (U.K.)

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