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Date: 2019-07-08 Category: Not Applicable State: Union Government Country: India

Drug Alert list for month of June 2019

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

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Executive Summary & Key Takeaways

Gazette Overview

  • This gazette notification lists drugs, medical devices, and cosmetics declared as Not of Standard Quality, Spurious, Adulterated, or Misbranded for June 2019.
  • A total of 843 samples were tested.
  • 817 samples were declared to be of Standard Quality.
  • 26 samples were declared as Not of Standard Quality, Spurious, or Misbranded.

Key Changes

  • The notification identifies 25 specific drugs, medical devices, or cosmetics along with their batch numbers, manufacturing and expiry dates, manufacturer details, reason for failure, and the testing laboratory.
  • Reasons for failure include issues with dissolution, particulate contamination, pH, salicylic acid content, assay, identification, uniformity of weight, and description.
  • The listed products failed quality tests conducted by various CDSCO zones and RDTLs across India.
  • Manufacturers span multiple states including Himachal Pradesh, Madhya Pradesh, Meghalaya, Goa, Uttarakhand, Jammu & Kashmir, Bihar, West Bengal, Tamil Nadu and Sikkim.

Impact Analysis

Impact on Manufacturers

  • Action Item: Review manufacturing processes and quality control procedures to identify and address the root causes of the quality failures. Implement corrective and preventive actions (CAPA) to prevent recurrence.

Impact on Consumers

  • Erosion of trust in the pharmaceutical industry and regulatory oversight.

Impact on Government

  • Action Item: Enhance surveillance and monitoring of pharmaceutical manufacturing facilities. Increase investment in testing infrastructure and personnel. Strengthen legal frameworks to deter the production and sale of substandard drugs.

Impact on Supply Chain

  • Action Item: Implement robust traceability systems to track the movement of pharmaceutical products throughout the supply chain. Conduct regular audits of suppliers to ensure compliance with quality standards.

Key Entities Referenced

CDSCO: Central Drugs Standard Control Organization, the national regulatory body for pharmaceuticals and medical devices in India. RDTL: Regional Drugs Testing Laboratory, responsible for testing drug samples for quality and compliance. CDTL: Central Drugs Testing Laboratory Drugs and Cosmetics Act, 1940: The primary legislation governing the regulation of drugs, medical devices, and cosmetics in India. (Implied) State Drug Control Departments: State-level regulatory agencies responsible for enforcing the Drugs and Cosmetics Act within their respective states.
Official Source Record View Original Source →
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List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, for the Month of June 2019 Total number of samples tested 843 Total number of samples declared as of Standard Quality 817 Total number of samples declared as Not of Standard Quality /Spurious /Misbranded (under Form-13, Form-34 and Form- MD-32) 26 S. Name of Batch No./Date of Reason for Drawn By From N. Drugs/Medical Manufacture/Date of failure device/cosmetics Expiry/Manufactured By. 1. TELMISARTAN B. No.:78TML18002, Test for CDSCO, CDTL, TABLETS IP 40 MG Mfg dt: 11/2018, Dissolution South Zone, Chennai (TELMIRAL 40) Exp dt: 06/2020, Chennai. Mfd by: M/s. Crescent Therapeutics Limited Khasra No. 587/588, Beside Jharmajri, Village: Kunjhal, Baddi, Tehsil: Nalagarh, Dist. Solan(H.P) 173205. 2. Compound Sodium B. No.: R-1/18/145, BET Drug Control RDTL, Lactate Injections Mfg dt: 07/2018, Department, Guwahati Exp dt: 06/2020, I.P. Meghalaya Mfd by: M/s. Sanctus Drugs & Pharmaceutical Pvt. Ltd, Plot No. 251, Sector-1, Pithampur, Dist. Dhar (M.P.). 3. Compound Sodium B. No.: R-1/18/140, BET Drug Control RDTL, Lactate Injections Mfg dt: 07/2018, Department, Guwahati Exp dt: 06/2020, I.P. Meghalaya Mfd by: M/s. Sanctus Drugs & Pharmaceutical Pvt. Ltd, Plot No. 251, Sector-1, Pithampur, Dist. Dhar, Madhya Pardesh. 4. Amoxycillin And B. No.: SBPT- 4321, Test for Drug Control RDTL, Potassium Mfg dt: 02/2018, Dissolution Department, Guwahati Exp dt: 07/2019, Clavulanate Tablets Mizoram Mfd by: M/s. Saitech I.P. (Clavage-1000) Medicare Pvt. Ltd. Trilokpur Road, Kala Amb (H.P.)- 173030. 5. Pantoprazole For B. No.: 318-7, Particulate Drug Control RDTL, Injection (Panzel) Mfg dt: 01/2018, Contamination Department, Guwahati Exp dt: 06/2019, Assam Mfd by: M/s. Zee Laboratories, 47, Industrial Areas, Paonta Sahib- 173025.6. Finzest (Terbinafine B. No.: FZ0417, pH CDSCO, Sub CDTL, Hydrochloride Mfg dt: 11/2017, Zone/Port Mumbai Exp dt: 10/2019, Cream 1% w/w) Office, Goa Mfd by: M/s. Medizest Pharmaceuticals Pvt. Ltd., Plot No. L-40, Verna Industrial Estate, Verna, Goa-403722. 7. LEVOCETIRIZINE B. No.: SHT8957, Test of CDSCO, RDTL, HYDROCHLORIDE Mfg dt: 09/2018, Dissolution North Zone, Chandigarh Exp dt: 08/2021, TABLETS IP 5 MG Ghaziabad Mfd by: M/s. SYNCOM Health care Limited,D- 42,IIE SIDCUL, Selaqui, (Dehradun) 248197 Uttarakhand. 8. ASPIRIN GASTRO- B. No.: HAGT18004, Test for Salicylic CDSCO, RDTL, RESISTANT Mfg dt: 09/2018, Acid and assay North Zone, Chandigarh Exp dt: 08/2020, TABLETS IP of Aspirin Ghaziabad Mfd by: M/s. RAVIAN LIFE SCIENCE PVT.LTD Plot No 34 Sector -8 A IIE SIDCUL Haridwar-249403, Uttarakhand India. 9. Cefixime Tablets IP B. No.: R-132, Identification & Office of RDTL, (MICRA-200 Mfg dt: 02/2018, Assay Drugs Chandigarh Exp dt: 01/2020, Tablets) Inspector, Mfd by: M/s. Escape Sirmour (H.P) Lifesciences Pvt. Ltd. Chudiala Station Road, Village Khelpur Bhagwanpur, Roorkee, UK. 10. Ciprofloxacin Tablets B. No.: R-124, Identification, Office of RDTL, IP (P-CIP 500 Mfg dt: 02/2018, Uniformity of Drugs Chandigarh Exp dt: 01/2020, TABLETS ) weight & Assay Inspector, Mfd by: M/s. Pansun, Sirmour (H.P) Pharmaceuticals,Plot No. 183, Sector 6A, IIE,Sidhgual, Haridwar (U.K). 11. Amoxycillin and B. No.: R-20219, Identification & Office of RDTL, Potassium Mfg dt: 12/2018, Assay Drugs Chandigarh Exp dt: 11/2020, Clavulanate Tablets Inspector, Mfd by: M/s. AnA IP 625 mg Sirmour (H.P) Pharmaceuticals Plot (ANAXIM-CV 625 No.183, Sector 6A, IIE, TABLETS) Sidhgual Haridwar (U.K). 12. Cefixime Tablets IP B. No.: R-129, Identification & O f fice of RDTL, (GECEFF-200 Mfg dt: 02/2018, Assay Drugs Chandigarh Exp dt: 01/2020, Tablets) Inspector, Mfd by: M/s. GEFEX Sirmour (H.P) PHARMA Pvt. Ltd. IGC, Phase-I, Samba- 184121(J&K).13. Neomycin Sulphate, B. No.: GLEP-181020, Identification CDSCO, RDTL, Polymixin-B Mfg dt: 10/2018, North Zone, Chandigarh Exp dt: 09/2020, Sulphate and Ghaziabad Mfd by: M/s. Grampus Bacitracin Zinc Laboratories Vill. Johron, Powder Industrial Area,Kala Amb, Distt. Sirmour (H.P). 14. Neomycin Sulphate, B. No.: GLEP-181006, Identification CDSCO, RDTL, Polymixin-B Mfg dt: 10/2018, North Zone, Chandigarh Exp dt: 09/2020, Sulphate and Ghaziabad Mfd by: M/s. Grampus Bacitracin Zinc Laboratories Vill. Johron, Powder Industrial Area,Kala Amb, Distt. Sirmour (H.P). 15. Cefixime and B. No.: R-110, Identification, & Office of RDTL, Ofloxacin Tablets Mfg dt: 02/2018, Assay Drugs Chandigarh Exp dt: 01/2020, (P-XIME-O Inspector, Mfd by: M/s. Pansun TABLETS ) Sirmour (H.P) Pharmaceuticals, Plot No. 22&23, Station Road,Bala Industrial Area, Sikkim. 16. Ciprofloxacin HCl B. No.: R-21719, Identification, & Office of RDTL, Tablets IP (PENCIP- Mfg dt: 12/2018, Assay Drugs Chandigarh Exp dt: 11/2020, 500 TABLETS) Inspector, Mfd by: M/s. Pansun, Sirmour (H.P) Pharmaceuticals,Plot No. 183, Sector 6A, IIE, Sidhgual, Haridwar (U.K). 17. Glimepiride Tablets B. No.: GPDT18005, Test for Drugs Control RDTL, IP 3mg Mfg dt: 10/2018, Dissolution Department, Chandigarh Exp dt: 09/2020, Delhi Mfd by: M/s. RAVIAN LIFESCIENCE PVT. LTD., Plot No. 34, Sector- 8A, IIE, SIDCUL, Haridwar-249403, (Uttarakhand). 18. Lignocaine and B. No.: V-7079, Test for Assay Drugs Control RDTL, Adrenaline Injection Mfg dt: 11/2017, Officer, Chandigarh Exp dt: 10/2019, IP Jhajjar Mfd by: M/s. ALPA LABORATORIES LTD, 33/2, A.B.Road, Pigdamber-453446, Indore (M.P.). 19. PRE AND B. No.: UPPC-1801 Identification & CDSCO, RDTL, PROBIOTIC Mfg dt: 08/2018, Assay North Zone, Chandigarh Exp dt: 01/2020, CAPSULES-DS Ghaziabad Mfd by: M/s. Heal (India) Laboratories Pvt. Ltd.,No. 197/1,Periyapalayam Road, Manjankaranai- 601102,Tamilnadu.20. METRONIDAZOLE B. No.: MNSG18-255, Test for CDSCO, RDTL, BENZOATE ORAL Mfg dt: 11/2018, Metronidazole North Zone, Chandigarh Exp dt: 10/2020, SUSPENSION Ghaziabad Mfd by: M/s. ORNATE LABS PVT. LTD. Bela Industrial Estate, Muzaffarpur-842005, Bihar 21. Drotaverine B. No.: DTB-003, Description & CDSCO, CDL, Hydrochloride Mfg dt: 10/2017, Particulate Hyderabad Kolkata Exp dt: 09/2019, Zone Injection Matter Mfd by: M/s. Radico Remedies, 123, Mandhala, Barotiwala, Distt. Solan (H.P.) 174103. 22. Ofloxacin Tablets B. No.: BT8291, Uniformity of CDSCO, CDL, I.P. 400 mg Mfg dt: 10/2018 weight North Zone, Kolkata Exp dt: 09/2020, Ghaziabad Mfd by: M/s. Omega Biotech Ltd., 7th Mile Stone, Dehradun Road, Roorkee-247667, Uttarakhand. 23. Alprazolam Tablets B. No.: TAZP-002, Test for CDSCO, CDL, I.P. Mfg dt: 11/2018, Dissolution North Zone, Kolkata Exp dt: 10/2020, Ghaziabad Mfd by: M/s. Medipol Pharmaceuticals India Pvt. Ltd., 1199/3, Bhud, Baddi, Distt. Solan, H.P., India. 24. M-BETASONE B. No.: OPT7531, Assay & Related CDSCO, CDL, (Betamethasone Mfg dt: 01/2018, substances Ahmedabad Kolkata Exp dt: 06/2020, Tablets I.P. 0.5 mg) Zone. Mfd by: M/s. Omega Pharma, Khasra No. 482, Village Saliyar, Roorkee, Dist. Haridwar, Uttarakhand 25. Domperidone B. No.: DMP-18, Assay & CDSCO, CDL, Tablets I.P. 10 mg Mfg dt: 02/2017, Dissolution East Zone, Kolkata Exp dt: 01/2020, Kolkata Mfd by: M/s. Bewell Labs Pvt. Ltd., Rabindranagar, P.O. Laskarpur, Dist. 24 Parganas (S) West Bengal 700 153.

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