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Date: 2015-12-03 Category: Not Applicable State: Union Government Country: India

Drug Alert list for month of November 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 by the Central Drugs Laboratory (CDL), Kolkata for the month of November 2015.
  • The listed items failed quality tests conducted by the CDL and were reported by various Drugs Inspectors from CDSCO zones across India.

Key Changes

  • Eight items are listed as not of standard quality.
  • Two batches of Bromax Syrup (Bromhexine Hydrochloride Syrup) manufactured by M/s. Maxchem Pharmaceuticals Pvt. Ltd. failed due to issues with Description & Assay. Batch numbers are MS-14117 and MS-14121, both manufactured in October 2014 and expiring in September 2016.
  • One batch of Oxytocin Injection B.P. (Vet) manufactured by M/s. Neclo Chemicals Works failed due to issues with Description, Particulate Matter, pH & Assay. The batch number is 07, manufactured in March 2015 and expiring in February 2017.
  • Two batches of Chloropheniramine Maleate Tablets IP 4 mg failed due to Uniformity of Content. One batch (B. No.: 1464, Mfg dt: 08/2014, Exp dt: 07/2016) was manufactured by M/s. Deepin Pharmaceuticals Pvt. Ltd. and the other (B. No.: AH-2217, Mfg dt: 12/2014, Exp dt: 11/2016) by M/s. Azine Healthcare Pvt. Ltd.
  • One batch of Vitamin B-complex Tablets NFI manufactured by M/s. IDPL (TN) Ltd. failed due to Description issues. The batch number is 1BCT14, manufactured in April 2014 and expiring in March 2016.
  • One batch of Promethazine Hydrochloride Tablets 10 mg manufactured by M/s. Modi Lifecare Indl Ltd. failed due to Assay issues. The batch number is 150123, manufactured in January 2015 and expiring in December 2017.
  • One batch of Beplex Plus (Vitamin B-Complex Injection) manufactured by M/s. Anglo-French Drugs & Industries Ltd. failed due to issues with Description, Extractable Volume & Particulate Matter. The batch number is 08421Y, manufactured in August 2014 and expiring in January 2016.

Impact Analysis

Suggested Action Items

  • Legal action against the manufacturers for violating drug regulations, if warranted.

Impact on Manufacturers

  • Potential for suspension or cancellation of manufacturing licenses if repeated quality failures occur.

Impact on Consumers

  • Need for increased awareness among consumers about checking drug quality and reporting adverse events.

Impact on CDSCO

  • Potential for review of manufacturing licenses and GMP compliance of the listed manufacturers.

Key Entities Referenced

Central Drugs Laboratory (CDL), Kolkata: A government laboratory responsible for testing and analyzing drugs, medical devices, and cosmetics to ensure their quality and safety. CDSCO: Central Drugs Standard Control Organization, the national regulatory authority for pharmaceuticals and medical devices in India. Drugs Inspector: Official responsible for inspecting drug manufacturing facilities, pharmacies, and other establishments to ensure compliance with drug regulations. M/s. Maxchem Pharmaceuticals Pvt. Ltd.: Manufacturer of Bromax Syrup (Bromhexine Hydrochloride Syrup). M/s. Neclo Chemicals Works: Manufacturer of Oxytocin Injection B.P. (Vet). M/s. Deepin Pharmaceuticals Pvt. Ltd.: Manufacturer of Chloropheniramine Maleate Tablets IP 4 mg. M/s. Azine Healthcare Pvt. Ltd.: Manufacturer of Chloropheniramine Maleate Tablets IP 4 mg. M/s. IDPL (TN) Ltd.: Manufacturer of Vitamin B-complex Tablets NFI. M/s. Modi Lifecare Indl Ltd.: Manufacturer of Promethazine Hydrochloride Tablets 10 mg. M/s. Anglo-French Drugs & Industries Ltd.: Manufacturer of Beplex Plus (Vitamin B-Complex Injection).
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Annexure List of Drugs, Medical Devices and Cosmetics declared as not of standard quality/spurious/adulterated/misbranded Name of the Laboratory: Central Drugs Laboratory, Kolkata For the Month of: NOVEMBER 2015 Sl. Name of the B. No, D/M, D/E, Reasons for Failure Drawn by No. drug/medical Name of the Mfg. & Address with report in Form- device/cosmetic 13/34 No. & Date 1. Bromax Syrup B. No.: MS-14117, Description & Assay G. Narendrakumar, (Bromhexine Mfg dt: 10/2014 32-8/2015-SS/ Drugs Inspector, Hydrochloride Syrup) Exp dt: 09/2016 DCA(E)-89/1138 CDSCO, East Zone, Mfd by: M/s. Maxchem Pharmaceuticals Pvt. Dt. 09.11.2015 Kolkata Ltd., Plot No. 22, Sector-3, I.I.E, Sidcul, Rudrapur- 263153 (U.K). 2. Bromax Syrup B. No.: MS-14121, Description & Assay G. Narendrakumar, (Bromhexine Mfg dt: 10/2014 32-8/2015-SS/ Drugs Inspector, Hydrochloride Syrup) Exp dt: 09/2016 DCA(E)-90/1175 CDSCO, East Zone, Mfd by: M/s. Maxchem Pharmaceuticals Pvt. Dt. 12.11.2015 Kolkata Ltd., Plot No. 22, Sector-3, I.I.E, Sidcul, Rudrapur- 263153 (U.K). 3. Oxytocin Injection B.P. B. No.: 07, Description, Dharmendra Pandey, (Vet) Mfg dt: 03/2015 Particulate Matter, pH Drugs Inspector, Exp dt: 02/2017 & Assay CDSCO, East Zone, Mfd by: M/s. Neclo Chemicals Works, Rang 32-8/2015-SS/ Kolkata Bahadur Road, Gaya. DCA(E)-92/1114 Dt. 02.11.2015 4. Chloropheniramine B. No.: 1464 Uniformity of Content Neerai Katiyar, Maleate Tablets IP 4 Mfg dt: 08/2014 32-11/2015-SS/ Drugs Inspector, mg Exp dt: 07/2016 DCA(A)-28/1129 CDSCO, Ahmedabad Mfd by: M/s. Deepin Pharmaceuticals Pvt. Ltd., Dt. 06.11.2015 Vill. Dharwara, Post: Kalaria-453 001, Tehsil – Depalpur, Madhya Pradesh 5. Chloropheniramine B. No.: AH-2217 Uniformity of Content Kailash Chand Maleate Tablets IP 4 Mfg dt: 12/2014 & Assay Meena, Drugs mg Exp dt: 11/2016 32-11/2015-SS/ Inspector, CDSCO, Mfd by: M/s. Azine Healthcare Pvt. Ltd., Plot DCA(A)-81/1137 Ahmedabad No. 401, GIDC Kerala, Bavla, Ahmedabad, Dt. 09.11.2015 Gujrat. 6. Vitamin B-complex B. No.: 1BCT14, Description Kailash Chand Tablets NFI Mfg dt: 04/2014 32-11/2015-SS/ Meena, Drugs Exp dt: 03/2016 DCA(A)-99/1120 Inspector, CDSCO, Mfd by: M/s. IDPL (TN) Ltd., 9A, Dt. 03.11.2015 Ahmedabad Nandambakkam, Chennai 600089 7. Promethazine B. No.: 150123, Assay Milind P Patil, Drugs Hydrochloride Tablets Mfg dt: 01/2015 32-11/2015-SS/ Inspector, CDSCO, 10 mg Exp dt: 12/2017 DCA(A)-220/1131 Ahmedabad Mfd by: M/s. Modi Lifecare Indl Ltd., 27, Dt. 06.11.2015 GIDC., Opp. Creata Cold Storage, Odhav, Ahmedabad 382415 8. Beplex Plus (Vitamin B. No.: 08421Y, Description, Shyam Narayan B-Complex Injection) Mfg dt: 08/2014 Extractable Volume Singh, Exp dt: 01/2016 & Particulate Matter Drugs Inspector, Mfd by: M/s. Anglo-French Drugs & Industries 32-12/2015-SS/ CDSCO, SubZone Ltd., At Sy. No. 296/7/6, IDA, Bollaram, Medak DCA(H)-13/1199 Hyderabad Distt. - 502325, Andhra Pradesh Dt. 14.11.2015 Director I/c, Central Drugs Laboratory Kolkata - 700 016

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