Home India Ministry of Health and Family Welfare State Drug Alert for the Month of December 2024...
Date: 2025-01-24 Category: Not Applicable State: Union Government Country: India

State Drug Alert for the Month of December 2024

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

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Executive Summary & Key Takeaways

What it means

  • The gazette is a monthly notification issued by the Central Drugs Standard Control Organization (CDSCO) listing drugs identified as Not of Standard Quality (NSQ) in the market during December 2024.
  • The purpose is to inform stakeholders about NSQ batches found through regulatory surveillance, where drug samples are picked from sales/distribution points and analyzed.

Key Changes

  • The notification lists 84 drugs deemed NSQ, based on tests conducted by various State Drug Testing Laboratories.
  • The listed NSQ drugs come from manufacturers located across India, including Himachal Pradesh, Gujarat, Telangana, Uttarakhand, Tamil Nadu and others.
  • The reasons for being classified as NSQ vary, including failing dissolution tests, assay tests, uniformity of weight tests, identification tests, microbial contamination, presence of spots/discoloration, and not conforming to IP/USP specifications.
  • Some drugs are declared as 'spurious' and 'misbranded' under Section 17B of the Drugs and Cosmetics Act, 1940.
  • Data was received from several states and union territories, while some states did not submit data or did not submit data in the required format.

Impact Analysis

Manufacturers

  • Suggested action: Conduct thorough investigations into the causes of the quality failures and implement corrective and preventive actions (CAPA).

Distributors/Retailers

  • Suggested action: Verify inventory against the NSQ list and coordinate with manufacturers for returns and replacements.

Consumers

  • Suggested action: Check the batch numbers of purchased medicines against the NSQ list and consult a healthcare professional if concerned.

Regulatory Authorities

  • Suggested action: Strengthen regulatory surveillance and enforcement to prevent the manufacture and sale of NSQ drugs. Ensure states submit data in the required format.

Hospitals and Healthcare Providers

  • Suggested action: Implement a robust system for checking drug quality and reporting adverse events.

Key Entities Referenced

CDSCO: Central Drugs Standard Control Organization, the national regulatory body for pharmaceuticals and medical devices in India. State Drugs Licensing Authorities: State-level regulatory bodies responsible for licensing and monitoring pharmaceutical manufacturers and distributors within their respective states. Drugs and Cosmetics Act, 1940: The primary legislation governing the import, manufacture, distribution, and sale of drugs and cosmetics in India. IP: Indian Pharmacopoeia, the official book of standards for drugs manufactured and marketed in India. USP: United States Pharmacopeia, a pharmacopeia for the United States. BP: British Pharmacopoeia, the official collection of standards for UK medicinal products and pharmaceutical substances DCC Guidelines on Not Of Standard Quality (NSQ) Drugs Approved in 1993 (Annexure A): Guidelines approved by the Drugs Consultative Committee (DCC) regarding the handling of Not of Standard Quality (NSQ) drugs.
Official Source Record View Original Source →
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NOT OF STANDARD QUALITY ALERT FOR THE MONTH OF DECEMBER– 2024 As part of the continuous regulatory surveillance, drug samples are picked from sales/distribution point, analyzed and list of Not of Standard Quality (NSQ) drugs are displayed on CDSCO portal on monthly basis. The purpose of displaying the NSQ list is to make stakeholders aware about the NSQ batches identified in the market. B. State Laboratories S.No Product/Drug Batch No. Manufact Expiry Manufactured By NSQ Result Reported by State Name uring Date Laboratory Date 1. Divalproex 2406031 06/2024 05/2026 Biodeal Uniformity of DTL Srinagar (J&K) Extended Pharmaceuticals Ltd Weights & MDTL Kathua Release Tablets Vill Saini (J&K) IP MajraNalagarhRopar (JKMSCL Road , Nalagarh - Hospital Supply 174101 , Distt. Solan not for sale) (H.P) India 2. Divalproex 2407185 07/2024 06/2026 Biodeal Uniformity of DTL Srinagar (J&K) Extended Pharmaceuticals Ltd Weights Release Tablets Vill Saini IP MajraNalagarhRopar (JKMSCL Road , Nalagarh - Hospital Supply 174101 , Distt. Solan not for sale) (H.P) India 3. Cefpodoxime CT3096 09/2023 08/2025 Bharat Parenterals Assay of CFDL Jammu (J&K) Tablets IP 200 Ltd Survey No. 144-A, Cefpodoxime mg (Jan Jarod-SamlayaRoad Aushadhi) ,Vill. Haripura , Tal. Savil Dist. Vadodara - 391520 Gujarat India 4. DEXTROMETH AST- Aug-23 Jul-25 M/s.AASSK On visual inspection Puducherry ORPHAN 23303 Pharmaceuticals Pvt. dark spots are HYDROBROMI Ltd. Plot No.9, S.no found on tablet DE 243/2, surface.CappingandPHENYLEPHRI Dr.AmbedhkarStreet, lamination defects NE Kozhumanivakkam, are found. Some HYDROCHLOR Mangadu, Chennai- t a b le t s were brittle IDE & 600 122 on opening from the CHLORPHENIR strip - NSQ AMINE MALEATE TABLETS (Expal) 5. BETAHISTINE CT242502 May-24 Apr-26 M/s CMG BIOTECH On the received Puducherry DIHYDROCHL 84B PVT. LTS (Unit-II), sample presence of ORIDE Plot No. 58, PhaseIII, spots were TABLETS IP Industrial Area, observed which (CGHEST-8) Sansarpur Terrace, should not be Tehsil Jaswan, present As per DCC Distt.Kangra, HP- Guidelines on Not 176501 Of Standard Quality (NSQ) Drugs Approved in 1993 (Annexure A) Tablets vide serial No.(i) Presence of Spot/discolouration 6. METFORMIN 4O30069 Feb-24 Jan-27 M/s.Cipla Ltd., Ropar Does not comply Puducherry HYDROCHLOR Road, Nalagarh, Dist. with respect to the IDE TABLETS Solan (H.P)-174 101 Assay as per IP IP (OKAMET- specification 500) 7. PANTOPRAZO WAM2401 May-24 Apr-26 M/s Admed Pharma Does not comply Puducherry LE GASTRO- 1 Pvt Ltd., Plot No 87, with respect to the RESISTANT HPSIDC, Industrial Disintegration test TABLETS IP Area, Badddi, as per IP 40mg DisttSolan HP- 173 specification (Pentowok) 205 8. ZINC TH241106 Aug-24 Jul-26 M/s Orchid On the received Puducherry SULPHATE MedlifePvt. ltd., sample chipping DISPERSIBLE (WHO GMP & GLP and rough surface TABLETS IP certified company) d e f e cts were20mg (CARE Vill.Kaundi,P.O observed, which ZINC) Thane, s h o u l d not be Khasra No. 646/513, present As per DCC Tehsil Baddi, Dist. Guidelines on Not Solan (H.P)- Of Standard Quality 173 205. (NSQ) Drugs Approved in 1993 (Annexure A) Tablets vide serial No.(V) and (VII) respectively 9. CEFIXIME AND T925 Sep-23 Aug-25 M/s. Swiss Biotech On the received Puducherry LACTIC ACID Parentrals., Kewat sample presence of BACILLUS No. 1138,VPO - spots/discoloration TABLETS (CFI- Kachhwa, Karnal- observed which 200) 132001 (Haryana) should not be present As per DCC Guidelines on Not Of Standard Quality (NSQ) Drugs Approved in 1993 (Annexure A) Tablets vide serial No.(i) Presence of Spot/discoloration 10. METFORMIN G0374057 Jun-24 May-27 M/s.Franco-Indian Does not comply Puducherry TABLETS IP Pharmaceuticals Pvt with respect to the 500 mg Ltd, 20, DR. E. Moses Assay as per IP (GLYCIPHAGE) Road, Mumbai-400 specification 011 11. Ceaxil -500 BT-227375 01/2024. 12/2025. Dr Edwin Medilabs White coloured, State Lab, Tablets, Pvt Ltd Plot No.B-29, elongated, biconvex Drugs Control Cefuroxime Industrial Area, Focal tablets with score Laboratory, Axetil Tablets IP Point, Chanalon, on one side, and Telangana. Kurali, SAS Nagar- plain on other side, 140103(Pb) PUNJAB 10 out of 50 tablets have brown- coloured spots onthe entire surface. Hence, the tablets failed the test for Description of tablets. 12. Jakclav-625 BPT-3002 02/2024. 01/2026. Geenac Pharma Plot The sample Does State Lab, Tablets, No: 582, Raipur, not meet the Drugs Control Amoxicillin and Bhagwanpur, Specifications wrt. Laboratory, Potassium Roorkee, Identification test - Telangana. Clavulanate Uttarakhand-247667. Negative, Assay- Nil Tablets UTTARAKHAND A s p e r I P u / s . 1 7 B . o f D r u g s a n d Mrkt By: Cosmetics Act WellnowHelathcare, 1940. the Sample Kanal Industrial deemed to be Estate, Road No. 6, SPURIOUS and Borivali East, Misbranded. Mumbai-400066. 13. Jikcef-LB BPT-3005 02/2024. 01/2026. GeenacPharma Plot S t a t e L a b , Tablets, No: 582, Raipur, The sample does Drugs Control Cefixime and Bhagwanpur, not meets the Laboratory, Lactic Acid Roorkee, Specifications with Telangana. Bacillus Tablets Uttarakhand-247667. respect to UTTARAKHAND I d e n t i f i c a t io n t e s t - N i l . A s s a y - N i l Mrkt By: As per STP u/s. WellnowHelathcare, 17B of Drugs and Kanal Industrial Cosmetics Act Estate, Road No. 6, 1940. The Sample BorivaliEast, Mumbai- deemed to be 400066. SPURIOUS. 14. Jikcf-AZ BPT-3001 02/2024. 01/2026. Geenac Pharma Plot S t a t e L a b , Tablets, No: 582, Raipur, The sample does Drugs Control Cefixime and Bhagwanpur, not meets the Laboratory, Azitromycin Roorkee, Specifications with Telangana. Tablets Uttarakhand-247667. respect to UTTARAKHAND I d e n t i f i c a t io n t e s t - N i l . A s s a y - N i lMrkt By: As per STP u/s. WellnowHelath care, 17B of Drugs and Kanal Industrial Cosmetics Act Estate, Road No. 6, 1940. The Sample Borivali East, deemed to be Mumbai-400066. SPURIOUS. 15. Vithrocin AZ/L/01/40 08/2024. 07/2026. Vital Therapeutics & As sample failed State Lab, Suspension, 09 Formulations Pvt.Ltd . with respect to test Drugs Control Azithromycin Plot No. 47b/2, in pH as per IP Laboratory, Oral Phase-1, IDA, further product is Telangana. Suspension Cherlapally, Medchal- MISBRANDED Malkajgiri District - 500051, Telangana, INDIA. Telangana 16. Pantacea 40 PNTC3007 11/2023. 10/2025. Windlas Biotech S ta t e L a b , Tablets and Limited Plant-2, The sample Does Drugs Control Pantoprazole Khasra No. 141 to not complies in Laboratory, Gastro 143 & 145, respect of Telangana. Resistant MohabewalaIndl.area, Dissolution Test as Tablets IP 40mg Dehradun – 248110 per IP. (U.K.) UTTARAKHAND Mrkt By: Panacea Life Sciences Limited, DCM Building, OffceNo.5, Seventh floor, 16 Barakhamba Road, Connauught place, New Delhi- 110001. 17. Pantoprazole P01824 08/2024. 07/2026. Spansules S ta t e L a b , Sodium formulation India Pvt The sample Does Drugs Control Tabletes IP Ltd Sy. No. 172, not comply in Laboratory, 40mg Plot.No.154/A4 IDA respect of Telangana. Bollaram (V), Dissolution Test as Jinnaram (M), per IP. Sangareddy (D), HyderabadTelangana 18. Metoprolol URDT0654 03/23 02/25 Unicure India Ltd., It fails the test Drugs Testing Succinate Plot No. 46(B)/49B ‘Assay’ as per IP Laboratory Prolonged Village Raipur, standards Thiruvananthapuram Release Tablets Bhagwanpur [Amendment List - IP ,RoorkeeDist, 05 to IP 2022] Haridwar, Uttarakhand 19. Metoprolol URDT0653 03/23 02/25 Unicure India Ltd., It fails the test Drugs Testing Succinate Plot No. 46(B)/49B ‘Assay’ as per IP Laboratory Prolonged Village Raipur, standards Thiruvananthapuram Release Tablets Bhagwanpur [Amendment List - IP ,RoorkeeDist, 05 to IP 2022] Haridwar, Uttarakhand 20. Metoprolol URDT0652 03/23 02/25 Unicure India Ltd., It fails the test Drugs Testing Succinate Plot No. 46(B)/49B ‘Assay’ as per IP Laboratory Prolonged Village Raipur, standards Thiruvananthapuram Release Tablets Bhagwanpur [Amendment List - IP ,RoorkeeDist, 05 to IP 2022] Haridwar, Uttarakhand 21. Losartan HLOA09 11/23 10/25 Hindusthan It fails the test Drugs Testing Potassium Antibiotics Ltd, At 11, ‘Dissolution’ as per Laboratory Tablets IP 50 W.E.A, Faridabad - IP as specified in Thiruvananthapuram mg 121 001, Haryana the Laboratory Protocol 22. Amoxymoon VT 241704 10/24 03/26 VADSP It fails the tests Drugs Testing CV-625 Pharmaceuticals, Plot ‘Assay’ and Laboratory [Amoxycillin and No.124, EPIP, ‘Dissolution’ for Thiruvananthapuram Potassium Indl.Area, Phase-1, Clavulanic Acid as Clavulanate Jharmajri, Baddi (H.P) per IP, as specified Tablets IP] 174 103 in the Laboratory Protocol . 23. Balarishtam 107 09/24 10 Yrs. Alappat Pharma, It fails the test Total Drugs Testing Form Kollam-691503 Solids and Specific Laboratory packing Gravity as per API Thiruvananthapuram 24. Metformin D2164/24- Kerala Medical It fails the test Drugs TestingHydrochloride 25 Services Corporation microbial Laboratory Sustained Ltd, Thycaud P.O, contamination in Thiruvananthapuram Release Tab IP Thiruvananthapuram- Non-sterile products 500 mg 14 and Descriptive part for tablets as per IP 25. Paracetamol D2370/24- Kerala Medical It fails the test Drugs Testing Tab IP 500 mg. 25 Services Corporation ‘Dissolution’ as per Laboratory Ltd, Thycaud P.O, IP Thiruvananthapuram Thiruvananthapuram- 14 26. CIPRODAC 500 A N24014 Jan-24 Dec-26 Cadila The Sample does State Drugs Testing (Ciprofloxacin Pharmaceuticals not conform to Laboratory, Agartala, Tablets IP Limited, 1389, Dholka standard in respect Tripura. 500mg) – 382225, Dist: of the test Ahmedabad, At: A-1, "Dissolution" Ratan Industrial Area, performed Harsuliya, Jaipur. C/o. M/S. Anon Pharmaceutical, Jaipur. Mfg. Lic. No.: RAJ/JPR/2718. 27. Metoheal XL 25 T24D800A D/M: D/E: M/s. Bajaj Test for Dissolution” Karnataka (Metoprolol Apr/2024 Mar/2026 Formulation, Khasra & content of Succinate No.161, Village- Metoprolol Extended LakeshwaryBhagwan Succinate in the release Tablets pur, RoorkeeDistt: Assay U.S.P) Haridwar (UK) 28. Panik-D Tablets KPT24K08 D/M:02/2 D/E:01/202 M/s. Kaizen test for Karnataka (Pantoprazole A 024 6 Pharmaceuticals, Vill. Disintegration Sodium Katha, Baddi-173205 &Domperidone Distt. Solan (H.P) Tablets) 29. Fercobate-XT 240603 D/M: D/E: M/s. Folic Acid in the Karnataka Suspension Jun/2024 Nov/2025 ShinestarPharma, Assay and (Ferrous Begapali Road, Misbranded Ascorbate& SIPOCT-1, Hosur- Folic acid 635126 (T.N) Suspension)30. CefpodoximePr KCT- D/M:03/2 D/E:02/202 M/s. Knox Life Test for Uniformity Karnataka oxetil 403002 024 6 Sciences, Vill. of Dispersion Dispersible Gullarwala, Sai Road, Tablets (Qupod- Baddi, Distt. Solan 200 Tablets) (H.P) 31. Calcium MWT2311 D/M: D/E: M/s. MedworPharma, Test for Dissolution Karnataka Carbonate & 80 Jan/2024 Dec/2025 140 EPIP, Phase-II, for Calcium, Assay Vitamin D3 Thana, Baddi 173205 for Vitamin D3” and Tablets with respect to (Calcovit D3 “Description Tablets) 32. Ranitidine AV3082 D/M: D/E: M/s. Alpa Test for Sterility Karnataka Hydrochloride 02/2023 01/2025 Laboratories Ltd., Injection I.P 33/2 A.B. Road, Pigdamber-453 446, Indore (M.P) 33. Cipex-500 MUTAD23 D/M: D/E: M/s. Maxtar Bio- Test for Dissolution Karnataka (Ciprofloxacin 01 Jun/2023 May/2026 Genics, K.No.705, only Tabets I.P) Nalagarh Road, MalkuMajra, Baddi- 173205 (H.P) 34. Terbicharge 250 NT-4303 D/M: D/E: M/s. Neptune Life Test for Dissolution Karnataka mg 06/2023 05/2025 Sciences Pvt. Ltd., only (TerbinafineHyd 100-B, EPIP, Phase- rochloride II, Thana, Baddi- Tablets IP) 173205 (H.P) 35. Levocetirizin 2405097 D/M: D/E: M/s. Aban Test for Dissolution Karnataka Hydrochloride May/2024 Apr/2026 Pharmaceuticals, Plot of Levocetirizine &Montelukast No. 1018, Kerala, Hydrochloride and Sodium Tablets G.I.D.C., Bavla, Dist. Montelukast IP (Montefirst- Ahmedabad-382220 LC) 36. Paracetamol PCT24135 D/M: D/E: M/s. Test for Dissolution Karnataka Tablets IP 650 06/2024 05/2026 VivekPharmachem mg (India) Ltd., NH-8, Chimanpura, Amer, Jaipur-303102 37. Aluminium, C21A1330 D/M: D/E: M/s. Concept Description only KarnatakaMagnesium 03 06/2023 05/2026 Pharmaceuticals Ltd., &Simethicone A-28/3, MIDC, Oral Chikalthana, Suspension I.P Aurangabad-431006 38. ITRACHARGE NC-0805 D/M: D/E: M/s. Neptune Life Dissolution Test Karnataka 200 06/2023 05/2025 Sciences Pvt. Ltd., only (Itraconazole 100-B, EPIP, Phase- Capsules BP) II, Thana, Baddi- 173205 (H.P) 39. Ondansetron A24AM130 04/2024 03/2026 Skymap sample does not King Institute of Injection IP-2ml Pharamceuticals Pvt. conform to Preventive Medicine Ltd, B-2 Dev Bhoomi requirement for & Research, Guindy, Industrial Estate, assay and related Chennai-32 Puhana Iqbalpur substances Road, Roorkee - 247 667 40. Cipladine CH040103 03/2024 02/2026 HSN International, At Sample does not Drugs Testing Multipurpose Plot No.54-55, Sector conform to USP Laboratory, Chennai - Antiseptic Skin 6A, I.I.E, Sidcul, specification for 6 Ointment Haridwar, povidone-Iodine Uttarakhand,249403. Ointment with respect to content of available Iodine in povidone Iodine. 41. Povidone- VG24025 04/2024 03/2026 Microwin Labs PVt Sample does not Drugs Testing Iodine Ointment Ltd, Plot No.363, conform to USP Laboratory, Madurai - USP Industrial Focal Point, Spcification for 19. Phase-9, Mohali- povidine-IODINE 160062. Ointment with respect to the content of Avaible Iodine in povidone Iodine. 42. Atorvastatin HTN414D 04/2024 03/2026 Himalaya Meditek Sample does not Drugs Testing Calcium Tablets Pvt. Ltd, Plot No. 35 & conform to IP Laboratory, Chennai - IP 10mg 36, Pharmacity, Specification for 6 Selaqui, Industrial Atorvastatin Area, Dehradun - 248 Calcium Tablets197 with respect to Dissolution 43. Atorvastatin HTN405D 04/2024 03/2026 Himalaya Meditek Sample does not Drugs Testing Calcium Tablets Pvt. Ltd, Plot No. 35 & conform to IP Laboratory, Chennai - IP 10mg 36, Pharmacity, Specification for 6 Selaqui, Industrial Atorvastatin Area, Dehradun - 248 Calcium Tablets 197 with respect to Dissolution 44. Ciprofloxacin HTN1126L 11/2023 10/2025 Himalaya Meditek Sample does not Drugs Testing Hydrochloride Pvt. Ltd, Plot No. 35 & conform to IP Laboratory, Chennai - Tablets IP 36, Pharmacity, specification for 6 500mg Selaqui, Industrial ciprofloxacin tablets Area, Dehradun - 248 with respect to 197 Dissolution 45. Amlod-At DT240289 02/2024 01/2026 Daeiou Sample does not Drugs Testing Pharmaceutical (P) conform to IP Laboratory, Chennai - Ltd, R.S.No.158, Specification for 6 Puducherry - Amlodipine and Villupuram Main Atenolol Tablets Road, Villianur, with respect to Puducherry, 605110. Dissolution for Amlodipine and to the Content of Amlodipine in Amlodipine in Amlidipine Besylate. 46. Glimepiride PGG24- 06/2024 05/2026 Pondchy Sample does not Drugs Testing Tablets IP 1mg 002 Pharmaceuticals, conform to IP Laboratory, Chennai - R.S.No.218/4, 218/5, specification for 6 Odiaampet, Manaveli Glimepiride Tablets Road, Villianur with respect to Commune, Dissolution. Puducherry, 605110. 47. Snikuf 4 RZAB01 05/2023 04/2025 Akums Drugs & Sample does not Drugs Testing Pharmaceuticals Ltd, conform to label Laboratory, Chennai - 22, Sector-6A, I.I.E, claim with respect 6 Sidcul. Ranipur, to the content ofHaridwar-249403, Terbutaline Uttrakhand. Sulphate. 48. Trubery LS Z-23388 09/2023 08/2025 CSD Lifesciences, Sample does not Drugs Testing Village Malkumajra, conform to Label Laboratory, Chennai - Morepen Road, with respect to the 6 Baddi, Distt, Solan, content of (H.P). 173205. Levosalbutamol in Levosalbutamol sulphate. 49. Sucrazum-O ALL-899 08/2023 07/2025 Access Life Science, Sample does not Drugs Testing Suspension Khasra No.551/3, conform to Label Laboratory, Chennai - Village Taksal, claim with respect 6 Parwanoo, Distt, to the content of Solan (HP), 173220. Oxetacaine. 50. Rosuvastatin, MC240184 02/2024 01/2026 Mascot Health Series Sample does not Drugs Testing Aspirin & Pvt Ltd., Plot No. 79, conform to Label Laboratory, Chennai - Clopidogrel 80 Sec-6A, IIE, claim with respect 6 Capsules Sidcul, Haridwar- 249 to the content of (20mg/75mg/75 403 Aspirin and to mg) Schedule V of Drugs and Cosmetics Act, with respect to free Salicylic Acid. 51. Metoclopramide 24DQC64 03/2024 02/2026 SVP Life Sciences, sample does not King Institute of HCL Injection C/10-1, Sara conform to the Preventive Medicine I.P-2ml Industrial Estate, requirement for & Research, Guindy, Selaqui, Dehradun Assay of Chennai-32 Metoclopramide 52. Metoclopramide HLI405D 04/2024 03/2026 Himalaya Meditek sample does not King Institute of HCL Injection Pvt. Ltd, Plot No. 35 & conform to the Preventive Medicine I.P-2ml 36, Pharmacity, requirement for & Research, Guindy, Selaqui, Industrial Assay of Chennai-32 Area, Dehradun - 248 Metoclopramide 197 53. Amitriptyline TA24159 04/2024 03/2026 Saintlife Sample does not Drugs Testing Tablets IP 25mg Pharmaceuticals Ltd, conform to IP Laboratory, Chennai - 323, Central Hope specification for 6Town, Industrial Area, tablets with respect Selaqui, Dehradun - to Definition. 248 011, Uttarakhand, India 54. Megapure-TZ IU 23L-162 09/2023 08/2025 Prispag Pharma, Sample does not Drugs Testing suspension Roomi, Jagraon - conform to label Laboratory, Chennai - 142030. claim with respect 6 to the content of Ciprofloxacin in Ciprofloxacin Hydrochloride and Tinidazole. 55. Octenidine PPKAC84 05/2023 04/2026 Pure & Cure Sample does not Drugs Testing Dihydrochlordie Healthcare Pvt Ltd, (A conform to label Laboratory, Madurai - Gel Subsidiary of Akums claim with respect 19. Drugs & to the content of Pharmaceuticals Ltd,) Octenidine Plot No.26A,27-30, Dihydrochloride. Sector - 8A,IIE, Sidcul, Haridwar- 249403. Uttarakhand. 56. Dexamethasone TA24036 01/2024 12/2025 Saintlife Sample does not Drugs Testing Tablets IP Pharmaceuticals Ltd, conform to IP Laboratory, Chennai - 0.5mg 323, Central Hope Specification for 6 Town, Industrial Area, Dexamethasone Selaqui, Dehradun - Tablets with respect 248 011, to the content of Uttarakhand, India Dexamethasone. 57. Dexamethasone TA24035 01/2024 12/2025 Saintlife Sample does not Drugs Testing Tablets IP Pharmaceuticals Ltd, conform to IP Laboratory, Chennai - 0.5mg 323, Central Hope Specification for 6 Town, Industrial Area, Dexamethasone Selaqui, Dehradun - Tablets with respect 248 011, to the content of Uttarakhand, India Dexamthasone. 58. Peedon P2409 05/2024 04/2026 Sharing formulations Sample does not Drugs Testing Pvt Ltd, Plot conform to label Laboratory, Chennai - No.41,G.I.D.C, claim with respect 6Waghodia, Vadodara. to the content of 391760. Available Iodine in Povidone-Iodine. 59. Esilac Soluion ZBL-1154 12/2023 11/2025 Zoic Biotech Pvt Ltd, Sample does not Drugs Testing Plot No.C-15, Focal conform to USP Laboratory, Chennai - Point, Ind. Area, Specification for 6 Chanalon, Mohali, Lactulose Solution (Punjab), 140103. with respect to the Content of Lactulose in Lactulose Concentrate. 60. Amoxycillin PGA24- 03/2024 02/2026 Pondchy Sample does not Drugs Testing Dispersible 002 Pharmaceuticals, conform to IP Laboratory, Chennai - Tablets IP 125 R.S.No.218/4, 218/5, Specification for 6 mg Odiaampet, Manaveli Dispersible Tablets Road, Villianur with respect to Commune, uniformity of Puducherry, 605110. Dispersion and Disintegration 61. Orsiclop-A75 NTT24103 03/2024 02/2026 Nanoceut Sample does not Drugs Testing 6 Therapeutics Pvt Ltd, conform to IP Laboratory, Chennai - R.S.No. 104/19A, specification for 6 E.V.R.Street, Clopidogrel and Sedarapet, Aspirin Tablets with Puducherry, 605111 respect to Dissolution ( Clopidogrel and Aspirin), Free Salicylic Acid (Related substance for Aspirin) and to the content of ASpirin 62. Iron Sucrose PGY23118 08/2023 07/2025 Affy Parenterals, Vill. Sample does not King Institute of Injection USP- Gullerwala, P.O. conform to Preventive Medicine 5ML Baddi, Distt. Solan - requirement for & Research, 173 205 (H.P) assay for iron. Guindy, Chennai-3263. Justkof-LS UF267408 01/2024 12/2025 Ultra Drugs sample does not Drugs Testing 2F Formultations Pvt Ltd, conform to Label Laboratory, Madurai - Plot No.338/278, Vill. claim with respect 19. Manakpur, to the content of Lodhimajra, Tehsil- Ambroxol Baddi, Distt. Solan Hydrochloride. (HP)-173205. 64. Gabacure Gel HUAA46 06/2024 11/2025 Akums Druges & Sample does not Drugs Testing Pharmaceuticals Ltd. conform to Label Laboratory, Madurai - 47,48,Sector-6A, claim with respect 19. I.I.E., SIDCUL,, to the content of Haridwar-249 403, Gobapentin. Uttarakhand. 65. Dexamethasone FDDTI-004 02/2024 01/2026 Laborate Sample does not King Institute of Injection IP-2ml Pharmaceuticals India conform to Preventive Medicine Ltd, 51 Indl. Area, requirement for & Research, Paonta Sahib (HP). Assay. Guindy, Chennai-32 66. Ondansetron 320D2401 04/2024 03/2026 SSM Formulations Sample does not Drugs Testing Tablets IP 4 mg Private Limited, conform to IP Laboratory, Chennai - Survey No. 11/1, Specification for 6 Mouza Ashti (Rith), Ondansetron Hinganghar (M.H), Tablets with respect 442301 to Dissolution. 67. O Mak-200 VMWT240 06/2024 03/2026 Vertex Pharma Sample does not Drugs Testing 7 Chemicals, Plot conform to IP Laboratory, Madurai - No.60-A,61-A, Specification of 19. PIPDIC Electronic Ofloxacin Tablets Park, Tirubhuvanai, with respect to the Puducheryy-605107. content of Ofloxacin. 68. Retrazith-250 WT3927F 03/2024 02/2026 Saphnix Life Sample does not Drugs Testing Sciences, Village- conform to IP Laboratory, Chennai - Barotiwala, Paonta specification for 6 Sahib,Distt, Siramour, Azithromycin Himachal Pradesh- Tablets with respect 173025 to Dissolution and to the Content of AnhydrousAzithromycin Dihydrate. 69. Surgi Spirit SS-084032 08/2024 07/2026 Transflex, Hawahar Sample does not Drugs Testing Nagar, Ranipur conform IP Laboratory, Chennai - (C.G),492001. Specifciation for 6 Surgical Spirit with respect to weight per ml. 70. Brokuf-DM CBL- 02/2024 01/2026 C.B.Healthcare, Sample does not Drugs Testing 0024/24 Village Messa Tibba, conform to Label Laboratory, Chennai - Tehsil Nalagarh, Distt, claim with respect 6 Solan (H.P),174101. to the content of phenylephrine Hydrochloride. 71. Tamcof-Ls AGL23022 03/2024 02/2026 Asterisk Healthcare, Sample does not Drugs Testing Syrup 1C V.P.O Bathri, Thesil conform to Label Laboratory, Chennai - Haroli, Distt. Una claim with respect 6 (H.P),174301. to the content of Ambroxol Hydrochloride 72. Cadcof-Lx DLS2378 06/2024 05/2026 Dhwanilife Care Pvt Sample does not Drugs Testing Syrup Ltd, Plot No.C-20/2, conform to Label Laboratory, Chennai - (C-39) & C-20/3, (C- Claim with respect 6 40), Arvind Mega to the content of Parek, Village- Levosalbutamol in Chachravadi Vasna, Levosalbutamol Ahmedabad, Gujarat- Sulphate, Ambroxol 382213. Hydrochloride and Guaiphenesin. 73. Co-Trimoxazole MT404 01/2024 12/2026 Maxwell Lifescience Sample does not Drugs Testing Tablets IP Pvt Ltd, T-53 & T-81, conform to IP Laboratory, Chennai - 480mg M.I.D.C, Tarapur, Specification for Co- 6 Boisar, Dist, Palghar, Trimoxazole Tablets 401506. with respect to Dissolution for Sulphamethoxazole 74. Cipladine CHO40018 01/2024 12/2025 HSN International, At Sample does not Drugs Testing point No.54-55, conform to USP Laboratory, Madurai -Sector 6A, I.IE, Sidcul Specification for 19. Haridwar, Povidone- Iodine (Uttarakhand), Ointment with 249403 respect to the content of Avaible Iodine in Povidone Iodine, 75. Cipladine CHO40020 01/2024 12/2025 HSN International, At Sample does not Drugs Testing Ointment point No.54-55, conform to USP Laboratory, Madurai - Sector 6A, I.IE, Sidcul Specification for 19. Haridwar, Povidone-Iodine (Uttarakhand), Ointment with 249403 respect to the content of Avaible Iodine in Povidone Iodine. 76. Atovaris-F DEMT- 04/2024 03/2026 Dr.Edwin Medilabs Sample does not Drugs Testing 240124B Pvt Ltd, Plot No.B-29, conform to IP Laboratory, Madurai - Industrial Area, Focal Specification with 19. Point, Chanalon, respect to Kurali, SAS Nagar- Uniformity of 140103(pb). Weight. 77. Capiwash FL-050B 08/2023 07/2025 Forgo Sample does not Drugs Testing Mouthwah Pharmaceuticals, 27, conform to IP Laboratory, Madurai - Dic Ind Area, Specification for 19. Barotiwala, the Baddi, Chlorhexidine Distt, Solan (H.P)- Mouthwash IP with 174103 respect to the content of Chlorhexidine Gluconate in Chlorhexidine Gluconate Solution. 78. Povidone- VG23017 11/2023 10/2025 Microwin Labs PVt Sample does not Drugs Testing Iodine Ointment Ltd, Plot No.363, conform to USP Laboratory, Madurai - USP Industrial Focal Point, Specification for 19. Phase-9, Mohali- Povidone - Iodine 160062. Ointment withrespect to the content of Avaible Iodine in Povidone Iodine. 79. Flucent Pour-on PB-105/12 12/2023 11/2025 Indo Gulf Sample does not Drugs Testing Solution Pharmaceuticals, 5.4 conform to Label Laboratory, Madurai - K.M, Meerut Road, claim with respect 19. Muzaffarnagar (U.P) to Identification and Content of Flumethrin. 80. Betamethasone B06 05/2024 04/2026 Syndicate Pharma, Sample does not Drugs Testing Valerate 185/B, 185/B-1, 187/A conform to IP Laboratory, Madurai - Ointment IP & 188, sector -F, specification for 19. 01% w/w Sanwer Road, Indore- Betamethasone 452015. Valerate Ointment with respect to the content of Betamethasone in Betamethasone Valerate. 81. Clobium TYOL-047 07/2024 06/2026 Tanmed Pharma (I) Sample does not Drugs Testing Suspension. Pvt Ltd, No.1/429, conform to BP Laboratory, Chennai- Clobazam Oral Multi Industrial Nagar, specification for 6 Suspension BP Gerugambakkam, Clobazam Oral 5mg Chennai-600128 Suspension with respect to Dissolution and to the content of Clobazam 82. Chlorpheniramin IAL77/23 12/2023 11/2025 Anra Sample does not King Institute of e Maleate Pharamaceuticals Pvt conform to the Preventive Medicine Injection Ltd, Madurai-Melur requirement for & Research, Road, Vellaripati, Assay for Guindy, Chennai-32 Madurai-625122 Chlorpheniramine 83. Chro-B Gold DCBGT- 09/2024 02/2026 Kniss Laboratories Sample does not Drugs Testing 2402 (P) Ltd, Plot No. 9, conform to label Laboratory, Chennai - Multe Industrial claim with respect 6 Estate, to the content ofGerugambakkam, Cholecalciferol Chennai - 600 128 84. Atorvastatin A283 04/2024 03/2026 Rikenbik Pharma, Sample does not Drugs Testing Tablets IP 10mg 113, SIDCO Industrial conform to IP Laboratory, Chennai - Estate, Ambattur, Specification for 6 Chennai-600098. Atorvastatin Calcium Tablets with respect to Dissolution. Not of Standard Quality (NSQ) drugs: The drugs that fail to meet the quality standards or specifications are known as Not of Standard Quality (NSQ) drugs. (Further, the term ‘standards of quality’ is defined under the Section 16 (1) (a) of Drugs & Cosmetics Act, 1940, that the ‘standards of quality’ mean that the drug complies with the standards set out in the Second Schedule of the said Act.) NOTE: 1. NSQ data was received as per Format & in EXCEL SHEET from State Drugs Licensing Authorities of Jammu Kashmir, Tamil Nadu, Himachal Pradesh, Puducherry, Telangana, Thiruvananthapuram (Kerala), Tripura, Ladakh, Karnataka. Further NSQ data was received from West Bengal, Goa as NIL. However, data was not received as per format in Excel Sheet from Assam (PDF Format),Rajasthan (PDF Format), Jharkhand (PDF Format),Mizoram (PDF Format), for the Month of December, 2024 as per DCG(I) Circular dated 09.02.2024. 2. State Drugs Licensing Authorities of Andhra Pradesh, Arunachal Pradesh, Bihar, Chhattisgarh, Gujarat, Haryana, Manipur, Meghalaya, Nagaland, Odisha, Punjab, Sikkim, Delhi, Uttarakhand, Andaman & Nicobar, Dadar and Nagar Haveli; Daman and Diu, Lakshadweep have not submitted any data in respect of the Not of Standard Quality (NSQ) Alert for the Month of December, 2024 as per DCG(I) Circular dated 09.02.2024.

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