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Date: 2024-01-03 Category: Not Applicable State: Union Government Country: India

Details of clinical trial Permissions of Year 2023

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 2023 and early 2024 (up to January 1st) based on the review of documents and recommendations of the Subject Expert Committee (SEC).
  • The permissions are listed in Form CT-06.

Key Changes

  • A total of 17 clinical trial permissions were granted between January 12, 2023, and January 1, 2024.
  • The clinical trials cover a range of vaccines and therapeutic areas, including pneumococcal conjugate vaccine, rabies, DTwP-HepB-IPV-Hib, Japanese Encephalitis, Varicella, Poliomyelitis, SARS-CoV-2, Typhoid, and Dengue.
  • Various phases of clinical trials (Phase I to Phase IV) have been approved.
  • Several companies, including Pfizer, Cadila Pharmaceuticals, Biological E, TechInvention Lifecare, Reliance Life Sciences, Serum Institute of India, IQVIA RDS, Zydus Lifesciences, NOVO MEDI SCIENCES, and Bharat Biotech International are conducting these trials.
  • The trials are being conducted on diverse populations, including adults, children, and infants.
  • CT-01/2023 was issued to Pfizer for their 20-valent Pneumococcal Conjugate Vaccine on 12-01-2023.
  • CT-02/2023 was issued to Cadila Pharmaceuticals for their Recombinant Rabies G Protein Vaccine on 03-02-2023.
  • CT-03/2023 was issued to Biological E for their DTwP-HepB-IPV-Hib Vaccine (Liquid Hexavalent Vaccine) on 27-04-2023.
  • CT-04/2023 was issued to Biological E for their Japanese Encephalitis Vaccine Inactivated (Adsorbed, Human) on 23-05-2023.
  • CT-05/2023 was issued to TechInvention Lifecare for their Varicella Vaccine, Live Attenuated on 28-06-2023.
  • CT-06/2023 was issued to Biological E for their Inactivated Poliomyelitis Vaccine (Adsorbed) on 19-07-2023.
  • CT-07/2023 was issued to Reliance Life Sciences for their Protein Subunit Vaccine against SARS CoV 2 Virus on 27-07-2023.
  • CT-08/2023 was issued to Biological E for their Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) (14-Valent) on 21-08-2023.
  • CT-09/2023 was issued to Serum Institute of India Pvt. Ltd. for their Quadrivalent Human Papillomavirus (Serotypes 6,11,16&18) Vaccine on 24-08-2023.
  • CT-10/2023 was issued to IQVIA RDS (India) Private Limited for their Dengue Tetravalent Vaccine (Live, Attenuated) on 19-09-2023.
  • CT-11/2023 was issued to TechInvention Lifecare Pvt. Ltd. for their Combined tetanus toxoid, reduced diphtheria toxoid, reduced recombinant pertussis vaccine. (Tdapgen) on 03-11-2023.
  • CT-12/2023 was issued to Zydus Lifesciences Limited for their Typhoid Vi Conjugate Vaccine I.P. on 23-11-2023.
  • CT-13/2023 was issued to NOVO MEDI SCIENCES PRIVATE LIMITED for their Varicella Vaccine (Live, Attenuated) on 21-12-2023.
  • CT-14/2023 was issued to Serum Institute of India Pvt. Ltd. for their Dengue Tetravalent Vaccine (Live, Attenuated) on 21-12-2023.
  • CT-15/2023 was issued to Serum Institute of India Pvt. Ltd. for their Yellow Fever Vaccine (Live) I.P. on 27-12-2023.
  • CT-16/2023 was issued to Bharat Biotech International Limited for their Mycobacterium Tuberculosis (Live, Attenuated) Vaccine on 01-01-2024.
  • CT-17/2023 was issued to Biological E Limited for their SARS-CoV-2 (Covid-19) Vaccine (Variant XBB.1.5) on 01-01-2024.

Impact Analysis

Pharmaceutical Companies

  • Action Item: Ensure adherence to all protocol requirements and reporting obligations as specified in the clinical trial permissions.

Healthcare Providers

  • Action Item: Stay updated on the progress and outcomes of these clinical trials to inform future treatment decisions.

Patients/General Public

  • Action Item: Participate in clinical trials if eligible and interested, contributing to medical advancements.

Research Institutions

  • Action Item: Strengthen research capabilities and infrastructure to support clinical trial activities.

Government and Regulatory Bodies

  • Action Item: Continue to streamline the regulatory process for clinical trials while maintaining high standards of safety and efficacy.

Key Entities Referenced

M/s Pfizer Limited: Pharmaceutical company conducting a Phase III clinical trial for a 20-valent Pneumococcal Conjugate Vaccine. M/s Cadila Pharmaceuticals Limited: Pharmaceutical company conducting a Phase III clinical trial for a Recombinant Rabies G Protein Vaccine. M/s Biological E: Pharmaceutical company conducting clinical trials for DTwP-HepB-IPV-Hib Vaccine, Japanese Encephalitis Vaccine, Inactivated Poliomyelitis Vaccine, Pneumococcal Polysaccharide Conjugate Vaccine and SARS-CoV-2 Vaccine. M/s TechInvention Lifecare Pvt. Ltd.: Pharmaceutical company conducting clinical trials for Varicella Vaccine and Combined tetanus toxoid, reduced diphtheria toxoid, reduced recombinant pertussis vaccine. M/s Reliance Life Sciences: Pharmaceutical company conducting a Phase II clinical trial for a Protein Subunit Vaccine against SARS-CoV-2 Virus. M/s Serum Institute of India Pvt. Ltd.: Pharmaceutical company conducting clinical trials for Quadrivalent Human Papillomavirus Vaccine, Dengue Tetravalent Vaccine and Yellow Fever Vaccine. M/s IQVIA RDS (India) Private Limited: Company conducting a Phase III clinical trial for a Dengue Tetravalent Vaccine. M/s Zydus Lifesciences Limited: Pharmaceutical company conducting a Phase IV clinical trial for a Typhoid Vi Conjugate Vaccine. M/s NOVO MEDI SCIENCES PRIVATE LIMITED: Company conducting a Phase III clinical trial for a Varicella Vaccine. M/s Bharat Biotech International Limited: Pharmaceutical company conducting a Phase I clinical trial for a Tuberculosis Vaccine. Subject Expert Committee (SEC): Committee responsible for reviewing documents and providing recommendations for clinical trial permissions. Form CT-06: Form used to detail clinical trial permissions.
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Annexure - II(b) Details of clinical trial Permissions (Form CT-06) Year 2023 S.No. File No. Firm Name Name of Product Phase Title of the study Permission No. Date of Issue Summary 1 BIO/CT/22/000051 M/s Pfizer Limited, The20-valent Phase III Aphase3,single-arm,multicentertrialto CT- 01/2023 12-01-2023 Basedonreviewofdocumentssubmittedandtherecommendationsof Capital1802/1901PlotNo.Pneumococcal describethesafetyandimmunogenicityofa Subject Expert Committee (SEC) meeting dated 21.11.2022 CT C-70 G Block Bandra-Conjugate (20vPnC) 20-valentpneumococcalconjugatevaccine permission was granted. KurlaComplexBandra(E)Vaccine inpneumococcalvaccine–naïveadults≥18 Mumbai City (India) - yearsofage inIndia"vide Protocolno.: 400051 B7471010,FinalprotocolAmendment-1, 22-DEC-2022. 2 BIO/CT/22/000088 M/s CadilaRecombinantRabiesGPhase III Arandomized,openlabel,assessorblind, CT-02 /2023 03-02-2023 Basedonreviewofdocumentssubmittedandtherecommendationsof Pharmaceuticals Limited,Protein Vaccine parallel, Active controlled, multicentric, Subject Expert Committee (SEC) meeting dated 24.01.2023 CT 1389-Trasad Road Dholka bridging clinical trial to evaluate the permission was granted. Dholka (India) – 387810 immunogenicityand safetyof three dose THRABISvaccine(RecombinantRabiesG Protein Vaccine), administered as a simulated post exposure immunization in healthy children ” [Protocol No. CRSC22001, Version 04, Dated - 20/12/2022]. 3 BIO/CT/22/000107 M/s Biological E -DTwP-HepB-IPV-Hib Phase I “AProspectiveRandomisedPhase-Istudy CT- 03/2023 27-04-2023 Basedonreviewofdocumentssubmittedandtherecommendationsof Shameerpet, Plot No 1,Vaccine (Liquid to evaluate the Safety, Reactogenicity & Subject Expert Committee (SEC) meeting dated 24.01.2023 CT S.P.Biotechnology Park,Hexavalent Vaccine) Immunogenicityofsingleboosterdoseof permission was granted. Phase II Kolthur Village BiologicalE’sLiquidHexavalentVaccine ShameerpetMandal(India)- (DTwP-rHepB-Hib-IPV) in 16-24 months 500078 old healthy toddlers” [Protocol no. BECT078/LHV-PI/CTP-02,Versionno.:2.0 dated 28.12.2022] 4 BIO/CT/22/000092 M/s Biological E -Japanese EncephalitisPhase III A Phase III, open label, prospective, CT- 04/2023 23-05-2023 Basedonreviewofdocumentssubmittedandtherecommendationsof Shameerpet, Plot No 1,Vaccine Inactivated multicenter, label expansion study to Subject Expert Committee (SEC) meeting dated 26.04.2022 CT S.P.Biotechnology Park,(Adsorbed, Human) evaluate safety and immunogenicity of permission was granted. Phase II Kolthur Village Inactivated Japanese Encephalitis Vaccine ShameerpetMandal(India)- (JEEV™)in49-70yearsoldadultsandin 500078 thehealthy9-12monthsoldinfantseither alone or when co-administered with a licensedMMRvaccineat9monthsofage” [Protocolno.BECT071/JEV-PIII_LE/CTP- 01, Version no.:2.0 dated 27.12.2022].5 BIO/CT/22/000084 M/sTechInventionLifecareVaricellaVaccine,LivePhase III A prospective, randomized, single blind, CT-05/2023 28-06-2023 Basedonreviewofdocumentssubmittedandtherecommendationsof Pvt. Ltd., # 1004, TheAttenuated parallel,activecontrolled,multicentre,non Subject Expert Committee (SEC) meeting dated 06.09.2022 CT SummitBusinessBay,Off. InferiorityPhaseIIIstudytoevaluatethe permission was granted. WEH Metro Station, immunogenicity and safety of Live Andheri Kurla Road, Attenuated Varicella Vaccine of Sinovac Andheri E, Mumbai – Biotech Ltd, China compared to 400093 VARIPED® Vaccine (Varicella Vaccine Live I.P by MSD Pharmaceuticals Pvt., Ltd.,India)inhealthypaediatricsubjectsin India” [Protocol No. CRN_3110/2021, Version 1.0, dated 27-10-2021]. 6 BIO/CT/22/000101 M/s Biological E -Inactivated Phase II A prospective CT- 06/2023 19-07-2023 Basedonreviewofdocumentssubmittedandtherecommendationsof Shameerpet, Plot No 1, S.P.Poliomyelitis Vaccine multicentre open label randomized active Subject Expert Committee (SEC) meeting dated 21.12.2022 CT BiotechnologyPark, Phase(Adsorbed) controlled Phase-II study to evaluate safety, permission was granted. II, Kolthur Village tolerability and immunogenicity of ShameerpetMandal(India)- inactivated poliomyelitis vaccine 500078 (Adsorbed) of Biological E Limitedin6-8weeksoldinfants”[Protocol no. BECT077/IPV-S19-Phase-II/CTP-01, Version no.:1.1 Final, dated 26-Dec-2022]. 7 BIO/CT/23/000008 M/sRelianceLifeSciences,RLS Protein SubunitPhase II “Prospective, multi-center, randomized, CT- 07/2023 27-07-2023 Basedonreviewofdocumentssubmittedandtherecommendationsof Center, R-282, TTC AreaVaccineagainstSARS openlabel,activecontrol,phase2clinical Subject Expert Committee (SEC) meeting dated 28.06.2023 CT ofMIDC, Thane -BelapurCoV 2 Virus study to evaluate immunogenicity, safety permission was granted. Road, Rabale, Navi and tolerability of single heterologous Mumbai (India) – 400 701 booster dose of RelCoVax® (Protein SubunitVaccineofRelianceLifeSciences against SARS-CoV-2 Virus) with Corbevax® (Protein Subunit Vaccine of Biological E Ltd. against SARS-CoV-2 Virus) vide Protocol no.: RLS/VAC/2023/01, Version 3.0, Dated: 30- Jun-2023 8 BIO/CT/23/000065 M/s Biological E -Pneumococcal Phase IV A prospective multicentre Phase-IV study to CT- 08/2023 21-08-2023 Basedonreviewofdocumentssubmittedandtherecommendationsof Shameerpet, Plot No 1,Polysaccharide evaluate the safetyofBiological E’s14- Subject Expert Committee (SEC) meeting dated 27.06.2023 CT S.P.Biotechnology Park,Conjugate Vaccine valent pneumococcal polysaccharide permission was granted. Phase II Kolthur Village(Adsorbed) (14 conjugatevaccinewhenadministeredin6- ShameerpetMandal(India)-Valent) 10-14weeksdosingscheduleto6-8weeks 500078 oldhealthyIndianinfantsvideprotocolno: BECT081/PCV-Phase-IV/CTP-01, Version no: 1 dated 14.03.2023.9 BIO/CT/23/000055 M/s. Serum Institute ofQuadrivalent HumanPhase IV APhase-IV,single(cid:2)arm, multicentricstudy CT- 09/2023 24-08-2023 Basedonreviewofdocumentssubmittedandtherecommendationsof IndiaPvt.Ltd.,212/2,Off.Papillomavirus to assess the safety of SIIPLs qHPV Subject Expert Committee (SEC) meeting dated 27.06.2023 CT Soli Poonawalla Road(Serotypes6,11,16& vaccine(CERVAVAC) when administered permission was granted. Hadapsar, Pune (India) -18) Vaccine inatwo-dosescheduletogirlsandboys 4110288 aged 9-14 years and in a three(cid:2)dose scheduletowomenandmenaged15-26 years [Protocol No. SII-qHPV/IN-04 Version 2.0, dated12-Jul-2023] 10 BIO/CT/22/000121 M/s IQVIA RDS (India)Dengue TetravalentPhase III A Randomized, Double(cid:2)Blind, Placebo- CT- 10/2023 19-09-2023 Basedonreviewofdocumentssubmittedandtherecommendationsof Private Limited,OmegaVaccine (Live, Controlled,Phase3TrialtoInvestigatethe Subject Expert Committee (SEC) meeting dated 16.05.2023 CT Embassy Tech Square,Attenuated) Safetyand Immunogenicityof a Dengue permission was granted. Marathahalli- Sarjapur, Tetravalent Vaccine (Live, Attenuated) Outer Ring Road (TDV) Administered Subcutaneously to Kadubeesanahalli HealthySubjectsAged 4 to 60 Yearsin Bangalore (India)- 560103 India”[Protocolno.:DEN-302,Versionno. 2.0, Dated 15-JUN-2023]. 11 BIO/CT/22/000154 M/sTechInventionLifecareCombined tetanusPhase III aMulticentre,Randomized,Observer-blind, CT- 11/2023 03-11-2023 Basedonreviewofdocumentssubmittedandtherecommendationsof Pvt. Ltd., # 1004, Thetoxoid, reduced Non-inferiority,PhaseIIIStudytoEvaluate Subject Expert Committee (SEC) meeting dated 24.01.2023 CT SummitBusinessBay,Off.diphtheria toxoid, the Immunogenicity and Safety of permission was granted. WEH Metro Station,reduced recombinant BoostagenRED (combined tetanustoxoid, Andheri Kurla Road,pertussis vaccine. reduced diphtheria toxoid, reduced Andheri E, Mumbai –(Tdapgen) recombinantpertussisvaccine)byBioNet- 400093 Asia compared to ADACEL vaccine by SanofiPasteurLimitedinHealthySubjects Aged 4-65 years Protocol Number: CRNI/CTP/009VersionNumber:1.0dated 17-11-2022. 12 BIO/CT/23/000011 M/s Zydus LifesciencesTyphoid ViConjugatePhase IV A prospective,randomized, parallel,two- CT- 12/2023 23-11-2023 Basedonreviewofdocumentssubmittedandtherecommendationsof Limited,ZydusCorporateVaccine I.P. arm, open-label, multicenter, phase IV Subject Expert Committee (SEC) meeting dated 18.07.2023 CT Park, Scheme No. 63 clinicaltrialtoevaluatetheimmunological permission was granted. Survey No. 536, Khoraj non-interference ofTyphoid Viconjugate (Gandhinagar), Nr. vaccine with Yellow fever vaccine Vaishnodevi Circle, S.G. administered to healthy subjects”. [Study Highway Ahmedabad ProjectNo.23-01,VersionNo.02,Dated (India) - 382481 14/08/2023]13 BIO/CT/23/000048 M/s NOVO MEDIVaricella VaccinePhase III A Prospective, Randomized, Observer CT- 13/2023 21-12-2023 Basedonreviewofdocumentssubmittedandtherecommendationsof SCIENCES PRIVATE(Live, Attenuated) Blind, Parallel, Active Controlled, Subject Expert Committee (SEC) meeting dated 16.05.2023 CT LIMITED, Royal Status Multicentre,Non-InferiorityPhaseIIIStudy permission was granted. Building,PanditWamanrao toevaluatetheImmunogenicityandSafety SadolikarMarg,Lokmanya of Live Attenuated Varicella Vaccine of Tilak Colony, Dadar, NovoMediSciencesPvt.Ltd.comparedto Mumbai, Maharashtra- a marketed Varicella Vaccine in Healthy 400014 (India) Subjects” [Protocol no. CRNI/CTP/013, Version no.:1.0 dated 20.03.2023]. 14 BIO/CT/23/000007 M/s Serum Institute of India Dengue TetravalentPhase I/II A Seamless Phase 1/2, double blind, CT- 14/2023 21-12-2023 Basedonreviewofdocumentssubmittedandtherecommendationsof Pvt.Ltd.,212/2, Off.SoliVaccine (Live, randomized, placebo-controlled study to Subject Expert Committee (SEC) meeting dated 18.07.2023 CT Poonawalla Road.,Attenuated) evaluatethesafetyandimmunogenicityof permission was granted. Hadapsar, Pune, DengusiilinIndianadultsandchildren≥2 Maharashtra (India) – yearsofage”[ProtocolNo.Dengusiil-02 411028 Version No. 2.0 Dated 24.05.2023] 15 BIO/CT/22/000153 M/s Serum Institute of India YellowFeverVaccinePhase II/III APhaseII/III,Multicenter,DoubleBlind, CT- 15/2023 27-12-2023 Basedonreviewofdocumentssubmittedandtherecommendationsof Pvt.Ltd.,212/2, Off.Soli(Live) I.P. Randomized Study of SII Yellow Fever Subject Expert Committee (SEC) meeting dated 14.12.2023 CT Poonawalla Road., Vaccine to Compare Safety and permission was granted. Hadapsar, Pune, Immunogenicity with STAMARIL® in Maharashtra (India) – Adults(ProtocolNo.:YWF:04,Version: 411028 03 dated 17 Oct. 2023)”. 16 BIO/CT/23/000032 M/s Bharat BiotechMycobacterium Phase I AnOpenLabelledPhaseIClinicalTrialto CT- 16/2023 01-01-2024 Basedonreviewofdocumentssubmittedandtherecommendationsof International Limited,Tuberculosis (Live, Assess the Safety, Reactogenicity, Subject Expert Committee (SEC) meeting dated 31.10.2023 CT Genome Valley,Attenuated) Vaccine Tolerability and Immunogenicity of a permission was granted. Shameerpet (India) - Tuberculosis Vaccine BBV169 500078 (MTBVAC), in Healthy Indian Adults”; (Protocol no. BBIL/BBV169-I/2023 Version-4.0; Date: 31-Oct-2023.17 BIO/CT/23/000118 M/s Biological E Limited,SARS-CoV-2 (Covid-Phase III “A Prospective, single-blind randomized CT- 17/2023 01-01-2024 Basedonreviewofdocumentssubmittedandtherecommendationsof Plot No 1, Biotech Park,19) Vaccine (Variant phase-IIIcomparativestudytoevaluate Subject Expert Committee (SEC) meeting dated 07.12.2023 CT Phase II Kolthur Village,XBB.1.5) immunogenicity and safety of Biological E’s permission was granted. Shameerpet, Medchal- XBB.1.5-RBDsubunitCOVID-19vaccine Malkajgiri District: in5-80yearsoldindividuals(ProtocolNo. Telangana -500078 BECT083/XBB-COVID-19-PHASE- III/CTP-01, Ver. 1.1, Dated 20.12.2023). Format No. QMS-GNL-019/F02(b)-00

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