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Date: 2015-01-05 Category: Not Applicable State: Union Government Country: India

Drugs Alert for the month of December 2014

Issued by Ministry of Health and Family Welfare · Central Drugs Standard Control Organization

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Executive Summary & Key Takeaways

Key Changes

  • A total of 16 items are listed, including tablets, injections, and vaccines.
  • Reasons for failure include dissolution issues, assay failures, disintegration problems, particulate matter, and not conforming to IP (Indian Pharmacopoeia) standards.
  • Manufacturers of the listed items are located across India, including in the states of Maharashtra, Gujarat, Uttarakhand, Himachal Pradesh, Assam, Delhi.
  • Specific drugs include Cefpodoxime Proxetil, Ibuprofen, Etamsylate, Paracetamol, Flufite, Ceporab-200, Ronak-Plus, Metronidazole Benzoate, Primaquine Phosphate, Ciprofloxacin, Fexofenadine HCl, Flupentixol, Serratiopeptidase, Azithromycin and DPT Vaccine.
  • Batch numbers, manufacturing dates, and expiry dates of the substandard items are provided.

What it means

  • The gazette notification lists drugs, medical devices, and cosmetics declared as Not of Standard Quality, Spurious, Adulterated, or Misbranded for December 2014.
  • The listed items failed quality tests conducted by various CDSCO (Central Drugs Standard Control Organization) and State Drug Control Laboratories.

Impact Analysis

Manufacturers

  • A thorough review of manufacturing processes, quality control procedures, and supplier qualification is warranted.

Consumers/Patients

  • Increased awareness and vigilance are needed to ensure the quality and safety of medicines.

Regulatory Agencies (CDSCO, State Drug Controllers)

  • Enhanced surveillance and testing of pharmaceutical products are crucial to protect public health.

Pharmacies/Distributors

  • Pharmacies and distributors should implement robust systems to verify the authenticity and quality of drugs they procure.

Key Entities Referenced

M/s. Comed Chemicals Ltd.: Manufacturer of Serratiopeptidase Tablets I.P. (LYSER), Batch No. B142302 M/s. Rescuers Life Sciences Ltd.: Manufacturer of Azithromycin Tablets IP (AMZIT-205), Batch No. HG141153T M/s. Human Biologicals Institute: Manufacturer of DPT Vaccine IP (Abhay-TAG), Batch No. TAG 05A/14 CDSCO: Central Drugs Standard Control Organization, the national regulatory authority for pharmaceuticals and medical devices in India. RDTL: Regional Drugs Testing Laboratory, a laboratory that tests drugs for quality. IP: Indian Pharmacopoeia, the official book of standards for drugs manufactured and/or marketed in India. M/s. Zest Pharma: Manufacturer of Cefaz 200 Tablets, Batch No.: T14136 M/s. Jay Formulations Ltd.: Manufacturer of Ibuprofen Tablets IP 400mg, Batch No.: IG-61 M/s. Mercury Laboratories Ltd.: Manufacturer of K-stat I.V./IM (Etamsylate Injection), Batch No.: 14301110 M/s Hindustan Laboratories: Manufacturer of Paracetamol Tablets, Batch No. APC3022AL and Primaquine Phosphate Tablets IP 2.5mg, Batch No. TPR3001AL M/s Ridley Lifescience Pvt. Ltd.: Manufacturer of Flufite Tablets, Batch No. RT-130657 M/s Regent Ajanta Biotech: Manufacturer of Ceporab-200 Tablets, Batch No. A-2673 M/s Scott-Edil Pharmacia Ltd.: Manufacturer of Ronak-Plus Tablets, Batch No. S273050 M/s Viva Pharma Pvt. Ltd.: Manufacturer of Metronidazole Benzoate Oral Suspensions, Batch No. MS/1405 M/s. Technical Labs & Pharma Pvt. Ltd.: Manufacturer of Ciprofloxacin Tablets IP 250mg, Batch No. TT-140114 and Ibuprofen Tablets I.P. 400 mg, Batch No. TT-450413 M/s. Healers Labs: Manufacturer of Fexofenadine HCl Tablets IP 120mg, Batch No. FXD-502 M/s. Zee Laboratories: Manufacturer of Flupentixol Tablets (Entix), Batch No. ZT-1945
Official Source Record View Original Source →
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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 December, 2014 Sl. Name of Batch No./Date of Reason for failure with Drawn By From No. Drugs/medical Manufacture/Date of Report No. device/cosmetics Expiry/Manufactured By (in Form-13)& Date 1 Cefaz 200 Tablets B. No.: T14136 Dissolution CDSCO, Sub CDL, (Cefpodoxime Mfg dt: 04/2014, 32-13/2014-SS/ Zone, Kolkata Exp dt: 03/2016 DCA(B)-29/1815 Bangalore Proxetil Tablets IP Mfd by: M/s. Zest Pharma, 275, Dt. 09.12.2014 200mg) Sector F, Sanwer Road, Indore 452015 2 Ibuprofen Tablets B. No.: IG-61 Dissolution CDSCO, Zonal CDL, IP 400mg Mfg dt: 11/2012, 32-11/2014-SS/ Office, Kolkata Exp dt: 10/2015 DCA(A)-42/1820 Ahmedabad Mfd by: M/s. Jay Formulations Dt. 09.12.2014 Ltd., Unit No. 1301 & U-1, GIDC Kerala, Bavla, Dist- Ahmedabad 382220, Gujarat 3 K-stat I.V./IM B. No.: 14301110 Description & Particulate CDSCO, Zonal CDL, (Etamsylate Mfg dt: 05/2014, Matter Office, Kolkata Exp dt: 04/2017 32-11/2014-SS/ Ahmedabad Injection) Mfd by: M/s. Mercury DCA(A)-55/1821 Laboratories Ltd., Industrial Dt. 09.12.2014 Estate, Gorwa, Distt. Vadodara - 390016 4 Paracetamol B. No. APC3022AL, Dissolution Drugs Control RDTL, Tablets D/Mfg. 05/2013, Report No. 09938/2014- Department, Guwahati D/Exp. 04/2016, 15 Assam Mfg. By. Dated M/s Hindustan Laboratories, 01-12-2014 Plot No. 5, 6, 7, Survey No. 38/2, Aliyali, Palghar (W), Dist.-Thane, Maharashtra. 5 Flufite Tablets B. No. RT-130657, Disintegration and Assay Drugs Control RDTL, D/Mfg. 06/ 2013, Report No. 09937/2014- Department, Guwahati D/Exp. 05/2015, 15 Arunachal Mfg. By. Dated Pradesh M/s Ridley Lifescience Pvt. Ltd., 01-12-2014 D-1651, DSIDC Industrial Complex, Narel-110040, Delhi. 6 Ceporab-200 B. No. A-2673, Dissolution and Assay Drugs Control RDTL, Tablets D/Mfg. 07/ 2013, Report No. 10000/2014- Department, Guwahati D/Exp. 06/ 2015, 15 Arunachal Mfg. By. Dated Pradesh M/s Regent Ajanta Biotech, 15-12-2014 86-87, Vill-Makhiyali Dundi, Peerpura Road, Roorkee, Uttarakhand, 247667. 7 Ronak-Plus B. No. S273050, Assay Drugs Control RDTL, Tablets D/Mfg. 05/ 2013, Report No. 10030/2014- Department, Guwahati D/Exp. 04/ 2016, 15 Assam Mfg. By. Dated M/s Scott-Edil Pharmacia Ltd., 22-12-2014 56, EPIP Phase-I, Jharmajri- 173205. 8 Metronidazole B. No. MS/1405, Assay Drugs Control RDTL, Benzoate Oral D/Mfg. 06/ 2014, Report No. 10052/2014- Department, Guwahati D/Exp. 05/2016, 15 Assam Suspensions Mfg. By. Dated M/s Viva Pharma Pvt. Ltd., 23-12-2014 Jorhat-785005, Assam9 Primaquine B. No. TPR3001AL, Does not conform to IP CDSCO, West CDTL, Phosphate Tablets D/Mfg. 01/2013 standard with respect to Zone Mumbai D/Exp. 12/2014, the test for Assay. IP 2.5mg Mfg. By. M/s Hindustan Laboratories, Plot No. 5,6 ,7, Survey No. 38/2, Aliyali Palghar (W), Dist-Thane (M.S.) 10 Ciprofloxacin B. No. TT-140114 Dissolution and Assay of CDSCO North RDTL, Tablets IP 250mg D/Mfg.01/ 2014 Ciprofloxacin Zone Chandigarh D/Exp. 12/2015, Hydrochloride Calculated (CIPROTEC-250) Mfg. By. M/s. Technical Labs & as Ciprofloxacin Pharma Pvt. Ltd., Plot No. 100, Report No. Sector-7, I.I.E., Haridwar, LSD/RDTL/0393/14-15 Uttarakhand. Dated:-09-12-2014 11 Ibuprofen Tablets B.No. TT-450413 Assay of Ibuprofen CDSCO North RDTL, I.P. 400 mg D/Mfg-04/ 2013 Report No. Zone Chandigarh D/Exp. 03/2015 RDTL/0394/14-15 Mfg. By. M/s. Technical Labs & Dated:-15-12-2014 Pharma Pvt. Ltd., Plot No. 100, Sector-7, I.I.E., Haridwar, Uttarakhand. 12 Fexofenadine HCl B.No. FXD-502 Dissolution CDSCO, Sub- RDTL, Tablets IP 120mg D/Mfg-11/2013 Report No. Zone, Chandigarh (FIXD 120) D/Exp. 10/2015 LSD/RDTL/0042/14-15 Chandigarh Mfg. By. M/s. Healers Labs, Unit Dated:-30-12-2014 II, Plot No. 33, HPSIDC, Ext. Baddi 13 Flupentixol Tablets B.No. ZT-1945 Assay of Flupentixol CDSCO, Sub- RDTL, (Entix) D/Mfg-08/2013 Hydrochloride Zone, Chandigarh D/Exp. 07/2015 Report No. Chandigarh Mfg. By. M/s. Zee Laboratories, LSD/RDTL/0081/14-15 47, Industrial Area, Paonta Sahib, Dated:-19-12-2014 Distt. Sirmour, H.P. 14 Serratiopeptidase B.No. B142302 Assay of Serratiopeptidase CDSCO, Sub- RDTL, Tablets I.P. D/Mfg-06/2014 Report No. Zone, Chandigarh (LYSER) D/Exp. 05/2016 LSD/RDTL/0112/14-15 Chandigarh Mfg. By. M/s. Comed Chemicals Dated:-30-12-2014 Ltd., Village-Dassomajra, P.O. Bhud, Baddi, Tehsil-Naiagarh, Solan (H.P.) 15 Azithromycin B.No. HG141153T Assay of Azithromycin CDSCO, Sub- RDTL, Tablets IP D/Mfg-11/ 2014 Calculated as Zone, Chandigarh (AMZIT-205) D/Exp. 10/2016 Azithromycin Chandigarh Mfg. By. M/s. Rescuers Life Report No. Sciences Ltd., 131-132, EPIP, LSD/RDTL/0405/14-15 Phase-1, Jharmajri, Baddi, Distt. Dated :-30-12-2014 Solan (H.P.)-173205 16 DPT Vaccine IP B. No. TAG 05A/14 Not to be of Standard FDA , Jalgaon CDL, (Abhay-TAG) Mfg Dt. 01/2014 Quality (Maharashtra) Kasauli Exp. 12/2015 Report No. Mfg by. M/s. Human Biologicals CDL/2014/7110 Institute, Hyderabad Dated:-29-10-2014

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