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Date: 2024-08-30 Category: Not Applicable State: Union Government Country: India

Details of clinical trial Permissions of Year 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 notification provides details of clinical trial permissions granted in the year 2024. It lists the permissions in Form CT-06, including the name of the firm, product, trial phase, study title, permission number, date of issue, and a brief summary based on document review and Subject Expert Committee (SEC) recommendations.

Key Changes

  • A total of 8 clinical trial permissions (CT-01/2024 to CT-08/2024) were granted between February 16, 2024, and August 19, 2024.
  • M/s Biological E received permission for a Phase II study of their DTwP-rHepB-Hib-IPV hexavalent vaccine (CT-01/2024).
  • M/s Cadila Pharmaceuticals Limited received permission for a Phase I clinical trial of their Varicella Zoster Virus (VZV) vaccine (CT-02/2024).
  • M/s Panacea Biotec Ltd. received permission for a Phase III study of their Dengue Tetravalent Vaccine (CT-03/2024).
  • M/s Bharat Biotech International Ltd. received permission for a Phase III study of their Typhoid Vi Conjugate Vaccine (Typbar TCV®) in adults >65 years (CT-04/2024).
  • M/s Bharat Biotech International Ltd. received permission for a Phase II trial of their Mycobacterium Tuberculosis (Live, Attenuated) vaccine (MTBVAC) (CT-05/2024).
  • M/s Biological E received permission for a Phase IV follow-up study to assess the continued safety of their 14-valent pneumococcal polysaccharide conjugate vaccine (CT-06/2024).
  • M/s Zydus Lifesciences Limited received permission for a Phase I study of their Bivalent Typhoid and Paratyphoid A Conjugate Vaccine (CT-07/2024).
  • M/s GSK Pharma India Private Limited received permission for a Phase 3 study of their Respiratory Syncytial Virus (RSV) vaccine (CT-08/2024) in older adults ≥60 years of age and adults 50-59 years of age at increased risk.

Impact Analysis

Pharmaceutical Companies (M/s Biological E, M/s Cadila Pharmaceuticals, M/s Panacea Biotec, M/s Bharat Biotech, M/s Zydus Lifesciences, M/s GSK Pharma India)

  • Action Items: Ensure adherence to all regulatory guidelines and ethical standards during the clinical trials. Monitor trial progress and report findings to the relevant authorities.

Patients and General Public

  • Action Items: Public awareness campaigns to inform potential participants about the clinical trials and their potential benefits. Ensure transparency and ethical conduct in recruiting and treating trial participants.

Healthcare Providers

  • Action Items: Stay informed about the progress and results of these clinical trials. Prepare for the potential introduction of new vaccines into clinical practice.

Regulatory Authorities

  • Action Items: Continue to monitor the progress of these clinical trials and ensure compliance with regulatory standards. Review trial data and make informed decisions regarding vaccine approval and licensing.

Investors

  • Action Items: Monitor the progress of these clinical trials and assess the potential market value of the vaccines under development.

Key Entities Referenced

M/s Biological E: A pharmaceutical company involved in the development of vaccines, including a hexavalent vaccine and a pneumococcal polysaccharide conjugate vaccine. M/s Cadila Pharmaceuticals Limited: A pharmaceutical company involved in the development of a Varicella Zoster Virus (VZV) vaccine. M/s Panacea Biotec Ltd.: A pharmaceutical company involved in the development of a Dengue Tetravalent Vaccine. M/s Bharat Biotech International Ltd.: A pharmaceutical company involved in the development of a Typhoid Vi Conjugate Vaccine and a Mycobacterium Tuberculosis vaccine. M/s Zydus Lifesciences Limited: A pharmaceutical company involved in the development of a Bivalent Typhoid and Paratyphoid A Conjugate Vaccine. M/s GSK Pharma India Private Limited: A pharmaceutical company involved in the development of a Respiratory Syncytial Virus (RSV) vaccine. Subject Expert Committee (SEC): A committee that reviews clinical trial applications and provides recommendations to the regulatory authority. Form CT-06: The form used to detail clinical trial permissions.
Official Source Record View Original Source →
See Full Document Text
Annexure - II(b) Details of clinical trial Permissions (Form CT-06) Year 2024 S.No. File No. Firm Name Name of Product Phase Title of the study Permission No. Date of Issue Summary 1 BIO/CT/23/000127 M/s Biological E -Diphtheria, Tetanus,Phase II “A prospective randomised CT- 01/2024 16-02-2024 Based on review of documents Shameerpet, Plot No 1,Pertussis (Whole active controlled Phase-II safety submitted and the Phase II, Kolthur VillageCell), Hepatitis B andimmunogenicitystudywith recommendations of Subject Shameerpet, Medchal-(rDNA), Inactivated 3-doses of Biological E’s ExpertCommittee(SEC) meeting Malkajgiri District,Poliomyelitis and Liquid Hexavalent Vaccine dated14.12.2023CTpermission Telangana-500078, India Haemophilus (DTwP-rHepB-Hib-IPV)in6-8 was granted. influenzae Type b weeks old infants” [Protocol Conjugate Vaccine no. BECT084/LHV-P-II/CTP- (Adsorbed) 01, Version no. 1.0 dated 15.09.2023] 2 BIO/CT/23/000027 M/sCadilaPharmaceuticalsVaricellaZosterVirusPhase I A randomized, open label CT- 02/2024 21-02-2024 Based on review of documents Limited, 1389, Trasad(VZV) Vaccine clinical trial to evaluate the submitted and the Road,Dholka,Ahmedabad, safetyand immunogenicityof recommendations of Subject Gujarat (India) - 382225 varicella-zoster virus (VZV) ExpertCommittee(SEC) meeting vaccine in healthy subjects dated 14.09.23 CT permission [Protocol No.: CRSC23001, was granted. Version no.: 02 dated 16.06.2023]. 3 BIO/CT/21/000117 M/sPanaceaBiotecLtd.,A-Dengue TetravalentPhase III “A Phase III, Multicenter, CT- 03/2024 28-02-2024 Based on review of documents 27,B-1Extension,MohanVaccine, Live Randomized, Double-Blind, submitted and the Cooperative IndustrialAttenuated Placebo Controlled Study to recommendations of Subject Estate,MathuraRoadNew(Recombinant, Evaluate the Efficacy, ExpertCommittee(SEC) meeting Delhi (India) - 110044 Lyophilized) ImmunogenicityandSafetyof dated24.01.2023CTpermission Single dose of Dengue was granted. Tetravalent Vaccine, Live Attenuated (Recombinant, Lyophilized) – “DengiAll” of Panacea Biotec Limited in Healthy Indian Adults.” [Protocol no. PAN-ICMR- DengiAll-001,Versionno.4.0 dated 24 Nov. 2022] 4 BIO/CT/23/000112 M/s Bharat BiotechTyphoidViConjugatePhase III “APhaseIIIOpen-labelStudy CT- 04/2024 19-03-2024 Based on review of documents International Ltd., Sy. No.Vaccine(Typhoid(Vi toEvaluatetheImmunogenicity submitted and the 230,231 & 235, GenomeCapsular andSafetyofTyphoidTetanus recommendations of Subject Valley, Turkapally,Polysaccharide) - Toxoid Conjugate Vaccine; ExpertCommittee(SEC) meeting Shameerpet Mandal,Tetanus Toxoid Typbar TCV® in Adults dated31.10.2023CTpermission Medchal - MalkagiriConjugate Vaccine) (>65Years)” [Protocol no. was granted. District,Telangana(India)- BBIL/TCV-III/2023, Version 500078 no. 02 dated 03.11.2023. 5 BIO/CT/24/000042 M/s Bharat BiotechMycobacterium Phase II A Phase II CT- 05/2024 25-06-2024 Based on review of documents International Ltd., Sy. No.Tuberculosis (Live, Randomized, Double-blind submitted and the 230,231 & 235, GenomeAttenuated) Vaccine TrialtoAccesstheSafetyand recommendations of Subject Valley, Turkapally, Immunogenicity of MTBVAC ExpertCommittee(SEC) meeting Shameerpet Mandal, (BBV169),withBCGvaccine dated30.04.2024CTpermission Medchal - Malkagiri as a comparator in Healthy was granted. District,Telangana(India)- adolescent and adult 500078 populations [Protocol no. BBIL/MTBVAC-II/2024, Version no. 2.0 dated 30.04.2024]. 6 BIO/CT/24/000027 M/s Biological E -Pneumococcal Phase IV APhase-IVmulticentrefollow- CT - 06/2024 23-07-2024 Based on review of documents Shameerpet, Plot No 1,Polysaccharide up study to assess the continued submitted and the Phase II, Kolthur VillageConjugate Vaccine safety of Biologica E's 14- recommendations of Subject Shameerpet, Medchal-(Adsorbed) (14 valent pneumococcal ExpertCommittee(SEC) meeting Malkajgiri District,Valent) polysaccharide conjugate dated30.04.2024CTpermission Telangana-500078, India vaccine in subjects, who was granted. received3-dose(3+0)primary PCV vaccination as part of BECT051 and BECT061 studies " [Protocol no. BECT087/PCV-Phase- IV_SF/CTP-01, Version no. 1.0 dated 16.01.2024].7 BIO/CT/24/000013 M/s Zydus LifesciencesBivalent TyphoidandPhase I An open-label, single- CT- 07/2024 31-07-2024 Based on review of documents Limited, Plot Survey No.Paratyphoid A treatment,single-period,single submitted and the 23, 25/P, 37, 40/P, 42 toConjugate Vaccine dose,clinicalphase1studyto recommendations of Subject 47,49&50,Sarkhej-Bavla assessthesafetyandtolerability ExpertCommittee(SEC) meeting N. H. No. 8A, Opp. of Bivalent Typhoid and dated27.03.2024CTpermission Ramdev Masala, Village: Paratyphoid A Conjugate was granted. Changodar, Tal.: Sanand, Vaccine(BTPT)ofM/sZydus Dist.: Ahmedabad – Lifesciences Ltd., India in 382213, State: Gujarat, healthy,adulthumansubjects” (India) vide[ProtocolNo.:BTPT1001 Version No. 02 Dated 16th May 2024] 8 BIO/CT/23/000155 M/s GSK Pharma IndiaRespiratory SyncytialPhase III A Phase 3, randomized, CT- 08/2024 19-08-2024 Based on review of documents PrivateLimited,01,BatteryVirus (RSV) vaccine placebo-controlled, observer submitted and the House Bhulabhai Desai(recombinant, blindstudyinIndiatoevaluate recommendations of Subject Road Mumbai (India) -adjuvanted) immune response, ExpertCommittee(SEC) meeting 400026 reactogenicityand safetyofa dated31.05.2024CTpermission single intramuscular dose of was granted. RSVPreF3 OA investigational vaccine when administered to olderadults≥60yearsofage andadults50-59yearsofageat increased risk of respiratory syncytialviruslowerrespiratory tractdiseasevideprotocolno.: 221265 protocol amendment 01 Dated 19-Apr-2024 Format No. QMS-GNL-019/F02(b)-00

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