Home India Ministry of Health and Family Welfare Drug Alert for the Month of January 2024...
Date: 2024-02-21 Category: Not Applicable State: Union Government Country: India

Drug Alert for the Month of January 2024

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

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Executive Summary & Key Takeaways

Overview

  • This gazette notification lists drugs, medical devices, vaccines, and cosmetics declared as Not of Standard Quality (NSQ), Spurious, Adulterated, or Misbranded for January 2024.
  • A total of 846 samples were received, and 932 were tested.
  • 886 samples were declared to be of Standard Quality.
  • 46 samples were declared as Not of Standard Quality.
  • 0 samples were declared as Spurious.
  • 0 samples were declared as Misbranded.

Key Changes

  • 46 samples failed quality tests due to reasons such as deviations in pH, weight per ml, assay, dissolution, microbial enumeration, clarity, particulate matter, sterility, identification, average volume, resistance to antibiotic, presence of Salmonella species, description, related substances.
  • The list includes the name of the drug/medical device/cosmetic, batch number, manufacturing and expiry dates, manufacturer, reason for failure, the authority that drew the sample, and the laboratory that conducted the test.
  • Manufacturers include Jpee Drugs, Karnataka Antibiotics & Pharmaceuticals Limited, Hygeia Pharmaceuticals MFG. (P) Ltd., Modern Laboratories, Unimarck Healthcare Ltd., Sun Pharma Laboratories Ltd., Aru Healthcare Pvt. Ltd., Sunvet Healthcare, Regency Healthcare, Aquinnova Pharmaceuticals, Zee Laboratories Limited, Lotus Surgicals Pvt. Ltd., JMS Co. Ltd., Allianz Biosciences Pvt. Ltd., Vilin Bio Med Ltd., DM Pharma Private Limited, Global Formulations, ANG LIFESCIENCES INDIA LTD., Modi Antibiotics, Vivek Pharmachem (India) Ltd., Hetero Labs Limited, Amkay Laboratories Pvt. Ltd., Healers Lab, Magnatek Enterprises, Unicure India Ltd., Sri Ram Healthcare Pvt. Ltd., Biomax Biotechnics (P) Ltd., Apple Formulations Pvt. Ltd., PASCHIM BANGA PHARMACEUTICAL, Forgo Pharmaceuticals, ASPO PHARMACEUTICALS LLP., RACHIL PHARMA, Ridley Life Science Pvt. Ltd..

Impact Analysis

Supply Chain

  • Action Item: Implement measures to track and trace products, ensuring authenticity and quality at every stage of the supply chain.

Manufacturers

  • Action Item: Conduct thorough internal audits, review manufacturing processes, and strengthen quality control measures.

Consumers

  • Action Item: Public awareness campaigns to inform consumers about the affected products and potential risks.

Regulatory Authorities (CDSCO, State Drug Controllers)

  • Action Item: Enhance collaboration between central and state drug control authorities to improve monitoring and enforcement.

Laboratories

  • Action Item: Ensure adherence to established protocols and GLP guidelines.

Key Entities Referenced

CDSCO: Central Drugs Standard Control Organisation, the national regulatory body for pharmaceuticals and medical devices in India. State Drug Controllers: State-level regulatory authorities responsible for licensing, monitoring, and enforcement of drug regulations within their respective states. Drugs and Cosmetics Act, 1940 and Rules, 1945: The primary legislation governing the quality, safety, and efficacy of drugs, cosmetics, and medical devices in India. GLP: Good Laboratory Practices
Official Source Record View Original Source →
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List of Drugs, Medical Devices, Vaccine and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded for the Month of January– 2024 Total no. of samples received - 846 Total number of samples tested - 932 Total number of samples declared as of Standard Quality - 886 Total number of samples declared as Not of Standard Quality - 46 Total number of samples declared as Spurious - 0 Total number of samples declared as Misbranded - 0 S.No Name of Batch No. Date of Date of Manufactured By Reason for Drawn By From (Name Drugs/medical Manufacture Expiry failure (From of device/cosmetics state/CDSCO Laboratory) Zone) 1 Chlorhexidine Central Gluconate Jpee Drugs, Plot No. - 53, pH, weight per ml CDSCO, East Drugs Solution 4% w/v JDO-1027 05/2023 04/2025 Sector 6-A, SIDCUL, and Assay Zone, Kolkata Laboratory, Surgical Haridwar (Uttarakhand). Kolkata Scrubbing 2 Karnataka Antibiotics & Pharmaceuticals Limited Arka The Business Central Centre, Plot No. 37, Site Glimepiride Dissolution of CDSCO, East Drugs GLI10923 05/2023 04/2025 No. 34/4, NTTF Main Tablets I.P. 1 mg Glimepiride Zone, Kolkata Laboratory, Road, Peenya Industrial Kolkata Area, 2nd Phase, Bengaluru - 560 058, India. 3 Hygeia Pharmaceuticals Levosalbutamol, Assay/content of Central MFG. (P) Ltd. 608, Dwarir Guaiphenesin & Levosalbutamol & CDSCO, East Drugs DPD030 01/12/2023 30/11/2026 Road Dhamaitala Ambroxol Ambroxol Zone, Kolkata Laboratory, Dakshin Jagaddal, Pin- (Duvent- PD) Hydrochloride Kolkata 700151 Page 1 of 84 Assay of Modern Laboratories, 45- Amoxycillin and Amoxycillin, Central 47, Sector D-2, Industrial Potassium Clavulanic Acid & CDSCO, East Drugs APCT2305 02/2023 01/2025 Area, Sanwer Road, Clavulanate Dissolution of Zone, Kolkata Laboratory, Indore (M.P.) 452015, Tablets IP 375 mg Amoxycillin, Kolkata India Clavulanic Acid 5 Unimarck Healthcare CDSCO, East Mesalazine Central Ltd., Plot No. 24, 25 & 37, Zone, Kolkata Prolonged-release Drugs UGT23128 01/2023 12/2024 Sector 6A, SIDCUL, Dissolution Tablets IP 1200 Laboratory, Haridwar- 249403 mg Kolkata (Uttarakhand). 6 CDSCO, East Central Jpee Drugs, Plot No. - 53, Vitamin A Oral Microbial Zone, Kolkata Drugs JDL-2921 06/2023 11/2024 Sector 6-A, SIDCUL, Solution 100 ml Enumeration Laboratory, Haridwar (Uttarakhand). Kolkata 7 Levosalbutamol, Hygeia Pharmaceuticals CDSCO, East Central Ambroxol & MFG. (P) Ltd. 608, Dwarir Zone, Kolkata Assay/content of Drugs Guaiphenesin BXE064 01/12/2023 30/11/2026 Road Dhamaitala 'Levosalbutamol' Laboratory, Syrup (Bromex - Dakshin Jagaddal, Pin- Kolkata LS Expectorant) 700151 8 Pure & Cure Healthcare CDSCO, East Trypsin, Pvt. Ltd., Plot No. 26A, Zone, Kolkata Central Bromelain & 27-30, Sector- 8A, IIE, Drugs PF8CC12 08/2023 07/2025 Assay of 'Trypsin' Rutoside SIDCUL, Ranipur, Distt. Laboratory, Trihydrate Tablets Haridwar - 249403, Kolkata Uttarakhand. 9 Sun Pharma Laboratories Central Levetiracetam Ltd., Plot No. 107-108, CDSCO (North Drugs Tablets IP (Levipil SIE1003A 04/2023 03/2025 Namli Block, P.O. Dissolution Zone), Laboratory, 500) Ranipool, Sikkim - 737 Ghaziabad Kolkata 135 10 Livocitra Aru Healthcare Pvt. Ltd., Central CDSCO (North (Levocetirizine K-12, Industrial Area, Drugs AHT-23503 10/2023 09/2025 Dissolution Zone), Hydrochloride Begrajpur, Muzaffarnagar Laboratory, Ghaziabad Tablets I.P.) - 251 003 Kolkata Page 2 of 811 Drugs Control Sunvet Healthcare, Central Clindamycin Administration, Village Shambhuwala, Description & Drugs Injection I.P. SAI-16589 11/2022 10/2024 Narasaraopet, Paonta Road, Distt. Particulate Matter Laboratory, (Clindacin-300) Andhra Sirmour (H.P.) 173001 Kolkata Pradesh 12 Drugs Control Sunvet Healthcare, Central Amikacin Sulphate Administration, Village Shambhuwala, Description & Drugs Injection I.P. SVI-6964 11/2022 10/2024 Narasaraopet, Paonta Road, Distt. Particulate Matter Laboratory, (Amicin-100) Andhra Sirmour (H.P.) 173001 Kolkata Pradesh 13 Regency Healthcare, Drugs Central Fungal Diastase & 4KM Stone Kashipur Inspector, O/o Assay of Fungal Drugs Pepsin Syrup 23RL0230 07/2023 12/2024 Road, Danpur Rudrapur, CMO Bilaspur, Diastase Laboratory, (NVZYME) Distt. U.S. Nagar, Himachal Kolkata Uttarakhand Pradesh 14 Aquinnova Drugs Cyproheptadine Central Pharmaceuticals Plot No. Inspector, O/o HCl & Tricholine Assay of Drugs AQC2339A 03/2023 02/2025 85, Ind. Area, Lodhimajra, CMO Bilaspur, Citrate Syrup Tricholine Citrate Laboratory, Baddi, Distt. Solan - Himachal (Cypermed Syrup) Kolkata 174101 (H.P.) Pradesh 15 Moxifloxacin & Drugs Zee Laboratories Limited, Central Prednisolone Assay of Inspector, Behind 47, Industrial Drugs Acetate Eye 1223-51 02/2023 01/2025 Prednisolone Paonta Sahib, Area, Paonta Sahib - Laboratory, Drops (MOXIZEE- Acetate Himachal 173025. Kolkata P Eye Drops) Pradesh 16 Clarity of Drugs Central Ceftriaxone Jpee Drugs, Plot No. - 53, Solution, Inspector, Drugs Injection I.P. JDI-3074 01/2023 12/2024 Sector 6-A, SIDCUL, Particulate matter Cuttack, Laboratory, (DOXONE 1000) Haridwar (Uttarakhand). & Sterility Odisha Kolkata 17 Absorbable Suture Lotus Surgicals Pvt. Ltd., (Synthetic) USP Khasra No. 1051/1 & 2, Central Monolus Twin Industrial Estate, CDSCO, South Drugs Monofilament Poly N190096AF 05/2019 04/2024 Diameter Selaqui, Dist. Dehradun, Zone, Chennai Laboratory, (Glycolide-Co- Pin 248197 Kolkata Caprolactone) (Uttarakhand), India. Poliglecaprone-25 Page 3 of 818 JMS Co. Ltd., 12-17 Central Surgical Tape Kako-Machi, Naka-Ku, CDSCO, West Drugs (JMS Medi-Tape 2022006 04/2022 03/2025 Length Hiroshima 730-82452, Zone, Mumbai Laboratory, 300) Japan Kolkata 19 JMS Co. Ltd., 12-17 Central Surgical Tape Kako-Machi, Naka-Ku, CDSCO, West Drugs (JMS Medi-Tape 2022003 02/2022 01/2025 Length Hiroshima 730-8652, Zone, Mumbai Laboratory, 310) Japan Kolkata 20 JMS Co. Ltd., 12-17 Central Surgical Tape Kako-Machi, Naka-Ku, CDSCO, West Drugs (JMS Medi-Tape 2022004 03/2022 02/2025 Length Hiroshima 730-8652, Zone, Mumbai Laboratory, 320) Japan Kolkata 21 JMS Co. Ltd., 12-17 Central Surgical Tape Kako-Machi, Naka-Ku, CDSCO, West Drugs (JMS Medi-Tape 2022004 03/2022 02/2025 Length Hiroshima 730-8652, Zone, Mumbai Laboratory, 330) Japan Kolkata 22 Identification, Bacillus Clausii Allianz Biosciences Pvt. Average Volume, Drug & Food Central Spores Ltd., 55/1, 2 & 3, Resistance to Control Drugs Suspension (LB AVA23I1 05/2023 04/2025 Whirlpool Road, antibiotic, Organisation, Laboratory, LAC Oral Thiruvandar Koil, Presence of Jammu & Kolkata Suspension) Puducherry - 605102 Salmonella Kashmir species & Assay 23 Metformin HCl Prolonged- Vilin Bio Med Ltd., Unit-II, Assay & Central Release & Khasra No. 85, Uniformity of CDSCO, Drugs Glimepiride T-230761 07/2023 06/2025 Madhopur, Hazarathpur, Content of Rishikesh Laboratory, Tablets IP Roorkee-247667, Glimepiride Kolkata (Glimycare-M3 Uttarakhand. Forte) 24 Tranexamic Acid DM Pharma Private & Mefenamic Acid Limited, Village Bhud, CDSCO, CDTL, DMT1127 01-Aug-2023 01-Jul-2025 Assay Tablets NH-21A, Baddi, District Hyderabad Hyderabad (Trancycle-MF) Solan (H.P.) Page 4 of 825 Ambroxol Global Formulations, Plot Hydrochloride I.P. No.7, P & T Colony, CDSCO, CDTL, GF296 Dec-2023 Nov-2025 Weight per ml Syrup Medipally, Medchal Dist., Hyderabad Hyderabad (AMBROS) Hyderabad-500098, T.S 26 Ambroxol HCl, Global Formulations, Plot Levosalbutomol No.7, P & T Colony, 30-Nov- CDSCO, CDTL, Sulphate GF.292 01-Dec-2023 Medipally, Medchal- Weight per ml 2025 Hyderabad Hyderabad Guaiphenesin Malkajgiri Dist., - Syrup (Brotex-LS) 5000098, 27 Terbutaline Sulphate, Global Formulations, Plot Ambroxol No.7, P & T Colony, Weight per ml & CDSCO, CDTL, Hydrochloride, GF-279 Nov-2023 Oct-2025 Medipally, Medchal- Assay Hyderabad Hyderabad Guaiphenesin & Malkajgiri Dist., Menthol Syrup Hyderabad-500098, (Scoril) 28 ANG LIFESCIENCES Description as the INDIA LTD., Village Folic Acid Tablets tablets are brittle CDSCO, West- CDTL- T112005 May-22 Apr-24 Malkumajra, Nalagarh IP 5 mg & shows mottled Zone, Mumbai Mumbai Road, Distt. Solan- appearance 173205 (H.P.) 29 Modi Antibiotics., Plot No, Bisacodyl Tablets 28, G.I.D.C. Estate, Related CDSCO, West- CDTL- I.P. 5 mg 230754 Jul-23 Jun-26 Odhav, Ahmedabad - Substances Zone, Mumbai Mumbai (Laxagen) 382415, (Guj). 30 Vivek Pharmachem Metronidazole (India) Ltd., EPIP, Bari CDSCO, West- CDTL- MZTJ23002 Jun-23 May-25 Description Tablets IP 400 mg Brahmana, Jammu- 181 Zone, Mumbai Mumbai 133 Page 5 of 831 Hetero Labs Limited (Unit-I), Kalyanpur Pantosec (Village), Chakkan Road, Dissolution in CDSCO, West- CDTL- (Pantoprazole PNS230422 Apr-23 Mar-25 Baddi (Tehsil), Solan Buffer stage Zone, Mumbai Mumbai Tablets IP 40mg) (Distt.), Himachal Pradesh - 173 205., India 32 Terbutaline, Bromhexine, Amkay Laboratories Pvt. Assay of CDSCO (North RDTL, Guaiphenesin and LKM-38 Sep-2022 Aug-2024 Ltd., Preet Vihar, Bromhexine Zone), Chandigarh Menthol Syrup Nauchandi, Meerut. Hydrochloride Ghaziabad (Terbo-Q Syrup) 33 Healers Lab, Unit II, Plot Identification and CDSCO (North Levocetirizine No.33, H.P.S.I.D.C., Assay of RDTL, LVU-515 Jun-2023 May-2025 Zone), Tablets IP Extn., Baddi, Distt. Solan Levocetirizine Chandigarh Ghaziabad (HP) Hydrochloride 34 Identification and O/o State Glimepiride, Magnatek Enterprises, Assay of Drugs Pioglitazone and Plot No. 74 C (II) HPSIDC Pioglitazone Controller, H.Q. RDTL, Metformin (PR) MPT-22149 Sep-2022 Aug-2024 Ind. Area Baddi, Distt. Hydrochloride Baddi, Distt. Chandigarh Tablets (GLEM- Solan (HP) 173205 calculated as Solan, HP- GMP2 Tablets) Pioglitazone 173205 35 Unicure India Ltd., C-21, Calcium and 22 & 23, Sector-3, Noida- Inspector of RDTL, Vitamin D3 UDT10704 Mar-2023 Aug-2024 Description 201301, Distt. Gautam Drugs, Assam Guwahati Tablets I.P Budh Nagar (U. P.) 36 Sri Ram Healthcare Pvt. Pantoprazole Ltd., Plot No. 81-C/2, Inspector of RDTL, Gastro-Resistant PFT23007MB May-2023 Apr-2025 EPIP Phase - I, Jharmajri, Dissolution Drugs, Assam Guwahati Tablets I.P. (P40) Baddi, Distt. - Solan, (H.P.) - 174 103. Page 6 of 837 Pantoprazole Biomax Biotechnics (P) Dissolution of Sodium (EC) & Ltd., 261, HSIIDC, Pantoprazole in Inspector of RDTL, Domperidone BBC22550 May-2022 Apr-2024 Industrial Estate, Alipur, acid stage & Drugs, Assam Guwahati (SR) Capsules IP Barwala134118 Description (Panzon-DSR) (Haryana) 38 Apple Formulations Pvt. GLIMEPIRIDE Ltd,, Plot No.208, Inspector of RDTL, TABLETS I.P. 1 GLT-2301 Jan-2023 Dec-2024 Dissolution Kishanpur, Roorkee- Drugs, Assam Guwahati mg. 247667 (U.K) 39 PASCHIM BANGA COMPOUND PHARMACEUTICAL, Sterility SODIUM NH-31, TIN MILE HAT, Particulate Inspector of RDTL, LACTATE 03B3911 Jun-2023 May-2026 SONAPUR HAT, P.S.- Contamination Drugs, Assam Guwahati INJECTION I.P. CHOPRA, DIST : UTTAR and Description (RL) DINAJPUR, PIN - 733214 (W.B.) 40 Montelukast Sodium & Forgo Pharmaceuticals., Inspector of Levocetirizine 27, DIC IND AREA, Assay/Content of RDTL, FPT-2067 Oct-2022 Sep-2024 Drugs, Hydrochloride Barotiwala, Teh: Baddi, Montelukast Guwahati Jharkhand Tablets IP. Distt. Solan (HP) 174103 (Folcet- MT) 41 Montelukast ASPO Sodium & PHARMACEUTICALS Dissolution Levocetirizine LLP., Plot No. 10, (Montelukast & Inspector of RDTL, Dihydrochloride AT22-0667A Sep-2022 Aug-2024 HIMUDA Industrial Area, Levocetirizine Drugs, Bihar Guwahati Tablets Phase-IV, Bhatoli Kalan, Dihydrochloride) IP..(Pevicet M Baddi Distt. Solan (H.P.) TABLETS) 173205 42 Unicure India Ltd,, C-21, Ondansetron 22 & 23, Sector-3, Noida- Inspector of RDTL, SMT1006 Nov-2022 Oct-2024 Dissolution Tablets IP 4 mg 201 301, Distt. Gautam Drugs, Bihar Guwahati Budh Nagar (U.P.). Page 7 of 843 Levocetirizine RACHIL PHARMA, 18- Dihydrochloride & Dissolution Inspector of 19, Phase-1, Ind. Area, RDTL, Montelukast RT22464 Jul-2022 Jun-2024 (Levocetirizine Drugs, Sansarpur Terrace, Distt : Guwahati Tablets (Tesact- Dihydrochloride ) Jharkhand Kangra (H.P.) -176501. M Tablets) 44 Ridley Life Science Pvt. Cefixime Oral Inspector of Ltd.,, D-1651, DSIDC, RDTL, Suspension IP RD230004 Jan-2023 Dec-2024 Assay of Cefixime Drugs, Indl. Complex, Narela, Guwahati 50mg/5ml Meghalaya Delhi- 110040 45 Ridley Life Science Pvt. Cefixime Oral Inspector of Ltd.,, D-1651, DSIDC, RDTL, Suspension IP RD230003 Jan-2023 Dec-2024 Assay of Cefixime Drugs, Indl. Complex, Narela, Guwahati 50mg/5ml Meghalaya Delhi- 110040 46 ANG Lifesciences India Diclofenac Ltd., Village Malkumajra, Particulate matter Inspector of RDTL, Sodium Injection I213108 Jul-2023 Jun-2025 Nalagarh Road, Baddi, and Description Drugs, Assam Guwahati IP Distt. Solan173205 (H.P.) Page 8 of 8

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