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Date: 2023-03-15 Category: Not Applicable State: Union Government Country: India

Details of clinical trial Permissions of Year 2022

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

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Executive Summary & Key Takeaways

What it means

  • This gazette notification provides details of clinical trial permissions (Form CT-06) granted in the year 2022.
  • It lists the permissions granted for various vaccines and pharmaceutical products after review of submitted documents and recommendations of the Subject Expert Committee (SEC).

Key Changes

  • A total of 27 clinical trial permissions were granted in 2022.
  • Bharat Biotech received permission for Phase III trials of its Chimpanzee Adenovirus Vectored COVID-19 Vaccine (BBV154) for both primary vaccination and booster doses (CT-01/2022, CT-02/2022).
  • National Institute of Epidemiology was granted permission for a Phase IV trial to study the safety and immunogenicity of a third dose of COVISHIELD/COVAXIN in immunocompromised patients (CT-03/2022).
  • Dr. Reddy’s Laboratories Limited received permission for a Phase III clinical study to evaluate the immunogenicity and safety of a booster dose of Sputnik Light Vector Vaccine against COVID-19 in adult Indian subjects (CT-04/2022).
  • Serum Institute of India Pvt. Ltd. received permission for Phase III trials of its SARS-CoV-2 rS Protein (COVID-19) recombinant Nanoparticle Vaccine [COVOVAX] as a booster dose (CT-05/2022).
  • Joint Force Pharamchem Pvt. Ltd. received permission for Phase III trials of Hepatitis A (Live) Vaccine, Freeze-Dried (CT-06/2022).
  • Biological E received permission for a Phase I clinical study to evaluate the safety, tolerability, reactogenicity and immunogenicity of single intramuscular dose of Biological E’s 24valent pneumococcal polysaccharide conjugate vaccine in 18-45 years-old healthy adults (CT-07/2022).
  • Serum Institute of India Pvt. Ltd. received permission for Phase II/III trials of Inactivated Salk Polio Vaccine (Adsorbed) (CT-08/2022).
  • Gennova Biopharmaceuticals Limited received permission for Phase II/III trials of HGCO19 Lyophilized mRNA Vaccine for Injection (COVID-19) in healthy pediatric subjects of 5 to less than 18 years (CT-09/2022).
  • Pfizer Limited received permission for Phase IV trials of Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) (13-valent) in adults 18 to 49 years of age in India (CT-10/2022).
  • Cadila Healthcare Limited received permission for Phase III trials of Inactivated Influenza Vaccine(Split Virion)I.P.(Tetravalent) in healthy children aged 6 to 35 months (CT-11/2022).
  • VHB Life Sciences Limited received permission for Phase III trials of Varicella Vaccine Live Attenuated IP (CT-12/2022).
  • Post Graduate Institute Of Medical Education And Research, Chandigarh, received permission for Phase IV trials of Whole Virion Inactivated Corona Virus Vaccine (CT-13/2022).
  • Zydus Lifesciences Ltd. received permission for Phase III trials of Novel Coronavirus-2019-nCoV Vaccine (recombinant) (CT-14/2022).
  • Serum Institute of India Pvt. Ltd. (SIIPL) received permission for Phase I trials of Typhoid Conjugate Vaccine (Bivalent) (CT-15/2022).
  • Cadila Healthcare Limited received permission for Phase I trials of Rabies Vaccine, Human I.P. [Purified Inactivated Vero Cell Rabies vaccine – Lyophilized (PVRV)] (CT-16/2022).
  • G.C.Chemie Pharmie Ltd. received permission for Phase III trials of Pneumococcal Polysaccharide Conjugate Vaccine I.P.(PCV13-TT) (Adsorbed) (CT-17/2022).
  • Biological E Limited received permission for Phase III trials of Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) (14 Valent) (CT-18/2022).
  • Indian Immunological Limited received permission for Phase I trials of Live Attenuated Tetravalent Recombinant Dengue Vaccine (CT-19/2022).
  • Syngene International Limited received permission for Phase Ib trials of Adenoviral-Vector Based Vaccine (VXA-CoV2-1.1-S) (Enteric Coated Tablet) (CT-20/2022).
  • Tergene Biotech Private Limited received permission for Phase III trials of Pneumococcal Polysaccharide Conjugate Vaccine (adsorbed), I.P. (15 valent) (CT-21/2022).
  • Gennova Biopharmaceuticals Limited received permission for Phase II trials of Lyophilized mRNA Vaccine for Injection(COVID-19 [Omicron variant - sublineage BA.1]) (CT-22/2022).
  • Serum Institute of India Pvt. Ltd. (SIIPL) received permission for Phase IV trials of Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) I.P. (10- Valent) (CT-23/2022).
  • Panacea Biotec Ltd. received permission for Phase II/ III trials of Diphtheria and Tetanus vaccine (adsorbed) for adults and adolescents I.P. (Td Vaccine) (CT-24/2022).
  • Serum Institute of India Pvt. Ltd. (SIIPL) received permission for Phase III trials of Typhoid Conjugate Vaccine (Bivalent) (CT-25/2022).
  • IQVIA RDS (India) Private Limited received permission for Phase IV trials of Inactivated Influenza Vaccine(Split Virion)I.P.(Quadrivalent) (CT-26/2022).
  • Zydus Lifesciences Ltd. received permission for Phase II trials of Recombinant Hepatitis E Vaccine (Adsorbed) (CT-27/2022).

Impact Analysis

Government and Regulatory Bodies

  • Action Item: Continue to ensure the safety and ethical conduct of clinical trials.

Pharmaceutical Companies

  • Action Item: Monitor the progress of clinical trials and adapt strategies as needed.

Healthcare Providers

  • Action Item: Educate patients about the benefits and risks of participating in clinical trials.

Patients

  • Action Item: Consult with healthcare providers to make informed decisions about treatment options.

General Public

  • Action Item: Consult with healthcare providers about appropriate preventive measures and treatments.

Key Entities Referenced

M/s Bharat Biotech International Limited: Pharmaceutical company that received permission for Phase III trials of its Chimpanzee Adenovirus Vectored COVID-19 Vaccine (BBV154). M/s National Institute Of Epidemiology: Research institute that received permission for a Phase IV trial to study the safety and immunogenicity of a third dose of COVISHIELD/COVAXIN in immunocompromised patients. M/s Dr Reddy’s Laboratories Limited: Pharmaceutical company that received permission for a Phase III clinical study to evaluate the immunogenicity and safety of a booster dose of Sputnik Light Vector Vaccine against COVID-19. M/s Serum Institute Of India Pvt. Ltd.: Pharmaceutical company that received permission for Phase III trials of its SARS-CoV-2 rS Protein (COVID-19) recombinant Nanoparticle Vaccine [COVOVAX] and other vaccines. M/s Joint Force Pharamchem Pvt. Ltd.: Pharmaceutical company that received permission for Phase III trials of Hepatitis A (Live) Vaccine, Freeze-Dried. M/s Biological E Limited: Pharmaceutical company that received permission for a Phase I clinical study to evaluate the safety, tolerability, reactogenicity and immunogenicity of single intramuscular dose of Biological E’s 24valent pneumococcal polysaccharide conjugate vaccine. M/s Gennova Biopharmaceuticals Limited: Pharmaceutical company that received permission for Phase II/III trials of HGCO19 Lyophilized mRNA Vaccine for Injection (COVID-19). M/s Pfizer Limited: Pharmaceutical company that received permission for Phase IV trials of Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) (13-valent). M/s Cadila Healthcare Limited: Pharmaceutical company that received permission for Phase III trials of Inactivated Influenza Vaccine(Split Virion)I.P.(Tetravalent) and Phase I trials of Rabies Vaccine, Human I.P. [Purified Inactivated Vero Cell Rabies vaccine – Lyophilized (PVRV)]. M/s VHB Life Sciences Limited: Pharmaceutical company that received permission for Phase III trials of Varicella Vaccine Live Attenuated IP. M/s Post Graduate Institute Of Medical Education And Research, Chandigarh: Research institute that received permission for Phase IV trials of Whole Virion Inactivated Corona Virus Vaccine. M/s Zydus Lifesciences Ltd.: Pharmaceutical company that received permission for Phase III trials of Novel Coronavirus-2019-nCoV Vaccine (recombinant) and Phase II trials of Recombinant Hepatitis E Vaccine (Adsorbed). M/sG.C.ChemiePharmie Ltd.: Pharmaceutical company that received permission for Phase III trials of Pneumococcal Polysaccharide Conjugate Vaccine I.P.(PCV13-TT) (Adsorbed). M/s Indian Immunological Limited: Pharmaceutical company that received permission for Phase I trials of Live Attenuated Tetravalent Recombinant Dengue Vaccine. M/s Syngene International Limited: Pharmaceutical company that received permission for Phase Ib trials of Adenoviral-Vector Based Vaccine (VXA-CoV2-1.1-S) (Enteric Coated Tablet). M/s Tergene Biotech Private Limited: Pharmaceutical company that received permission for Phase III trials of Pneumococcal Polysaccharide Conjugate Vaccine (adsorbed), I.P. (15 valent). M/s IQVIA RDS (India) Private Limited: Pharmaceutical company that received permission for Phase IV trials of Inactivated Influenza Vaccine(Split Virion)I.P.(Quadrivalent). Subject Expert Committee (SEC): Committee responsible for reviewing documents and providing recommendations for clinical trial permissions. COVAXIN: COVID-19 vaccine developed by Bharat Biotech. COVISHIELD: COVID-19 vaccine. Sputnik Light: COVID-19 vaccine developed by Russia's Gamaleya Research Institute. COVOVAX: COVID-19 vaccine developed by Serum Institute of India. GEMCOVAC-19: COVID-19 vaccine developed by Gennova Biopharmaceuticals Limited. PNEUMOSIL: Pneumococcal Conjugate Vaccine (10-Valent) developed by Serum Institute of India Pvt. Ltd. (SIIPL).
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Annexure - II(b) Details of clinical trial Permissions (Form CT-06) Year 2022 S.No. File No. Firm Name Name of Product Phase Title of the study Permission No. Date of Issue Summary 1 BIO/CT/22/000007 M/s Bharat BiotechChimpanzee Adenovirus Phase III APhaseIIIrandomizedopenlabelmulti-centerstudyto CT- 01/2022 27-01-2022 Basedonreviewofdocumentssubmittedand International Limited,Vectored COVID-19 compare immunogenicityand safetyof BBV154 with the recommendations of Subject Expert Genome Valley,Vaccine (BBV154) COVAXIN®,andtoassessLottoLotConsistencyof Committee(SEC) meetingdated04.01.2022 Shameerpet (India) - BBV154 in Healthy Volunteers” vide Protocol No: CT permission was granted. 500078 BBIL/BBV154-III/2022VersionNo:1.0; Date:05-01- 2022. 2 BIO/CT/21/000163 M/s Bharat BiotechChimpanzee Adenovirus Phase III “Phase 3, Randomized, Multi-Centric, Open-labeled CT- 02/2022 27-01-2022 Basedonreviewofdocumentssubmittedand International Limited,Vectored COVID-19 StudytoEvaluateImmunogenicityandSafetyofBBV154 the recommendations of Subject Expert Genome Valley,Vaccine (BBV154) BoosterDoseinParticipantsPreviouslyVaccinatedwith Committee(SEC) meetingdated04.01.2022 Shameerpet (India) - theCOVID-19VaccinesapprovedunderNewDrugs& CT permission was granted. 500078 Clinical Trials Rules, 2019” vide Protocol No: BBIL/Booster/2021 Version No: 2.0; Dated 05-01-2022. 3 BIO/CT/22/000003 M/s National Institute OfWhole Virion Inactivated Phase IV Safety and immunogenicity of the third dose of CT- 03/2022 08-03-2022 Basedonreviewofdocumentssubmittedand Epidemiology, IndianCorona Virus Vaccine COVISHIELD/COVAXIN vaccine using homologous the recommendations of Subject Expert Council Of Medical and heterologous regimen in immunocompromised Committee(SEC) meetingdated31.01.2022 Research,R127,2ndMain patients:Single-blind,Randomized,noninferiority”vide CT permission was granted. Road,TamilNaduHousing Protocol No: NIE/IHEC/202112-0 Board(TNHB)Ayapakkam, Chennai-600077, Chennai (India) – 600077 4 BIO/CT/21/000156 M/s Dr Reddy’sA vector vaccine for the Phase III A Phase III, Randomized, Open Label, Multicentre CT- 04/2022 22-03-2022 Basedonreviewofdocumentssubmittedand Laboratories Limited,prevention of the Clinical Study in Parallel Assignment to Evaluate the recommendations of Subject Expert IPDO, Survey no 54,coronavirus infection ImmunogenicityandSafetyofaBoosterDoseofSputnik Committee(SEC) meetingdated04.03.2022 Bachupally Vilage LightVectorVaccineagainstCOVID-19inAdultIndian CT permission was granted. Qutubullapur Mandal Subjects” [Protocol No: DRL-SLB-007]. (India)- 500090 5 BIO/CT/22/000018 M/s Serum Institute OfSARS-CoV-2 rS Protein Phase III Aphase3,observer(cid:2)blind, randomized,controlledstudy CT- 05/2022 22-03-2022 Basedonreviewofdocumentssubmittedand IndiaPvt.Ltd.,S.No.105-(COVID-19) recombinant toevaluatethesafetyandimmunogenicityofabooster the recommendations of Subject Expert 110, Manjari Bk. ManjarispikeproteinNanoparticle doseofCOVOVAXinIndianadultswhohavereceived Committee(SEC) meetingdated04.03.2022 Bk. Pune (India) - 412307 Vaccine [COVOVAX] primary vaccination against COVID19”[Protocolno.: CT permission was granted. COVOVAX-Booster6 BIO/CT/21/000048 M/s Joint ForceHepatitis A (Live) Phase III Prospective, Multicentre, Randomized, Double-Blind, CT- 06/2022 25-03-2022 Basedonreviewofdocumentssubmittedand Pharamchem Pvt. Ltd.,,Vaccine, Freeze-Dried Parallel-Group, Phase III Study Comparing the recommendations of Subject Expert 504, Part B,Samarth Immunogenicity,Safety,andTolerabilityofSingleDose Committee(SEC) meetingdated02.07.2021 Commercial of Hepatitis A (Live) Vaccine, Freeze-dried versus CT permission was granted. Premisesco.So.Ltd 5th BiovacTM-A(Freeze-driedLiveAttenuatedHepatitisA Floor,Survey Vaccine)inHealthyIndianChildren”[ProtocolNumber: No.27/E,Hissa JFP/HAV/CT-01/21, Version no. 1.1, Dated 25.08.2021] No.1(PT),CTS No.337/1,Mumbai city Govandi (India) - 400088 7 BIO/CT/21/000135 M/s Biological E -Pneumococcal Phase I A prospective open label non-comparative Phase-I CT- 07/2022 25-03-2022 Basedonreviewofdocumentssubmittedand Shameerpet, Plot No 1,Polysaccharide Conjugate clinicalstudytoevaluatesafety,tolerability,reactogenicity the recommendations of Subject Expert S.P.Biotechnology Park,Vaccine (Adsorbed) (24 and immunogenicity of single intramuscular dose of Committee(SEC) meetingdated21.09.2021 Phase II Kolthur VillageValent) Biological E’s 24valent pneumococcal polysaccharide CT permission was granted. ShameerpetMandal(India) conjugate vaccine in 18-45 years-old healthy adults” - 500078 [Protocol no. BECT075/PCV-Phase-I/CTP-01, Version no.:1.0 Final dated 01.09.2021]. 8 BIO/CT/21/000057 M/s Serum Institute OfInactivated Salk Polio Phase II/III "APhaseII/III,Multicenter,DoubleBlind,Randomized, CT-08/2022 28-03-2022 Basedonreviewofdocumentssubmittedand IndiaPvt.Ltd.,212/2,Off.Vaccine (Adsorbed) Active Controlled Study to evaluate Safety and the recommendations of Subject Expert Soli Poonawalla Road Immunogenicityof SII Inactivated Salk Polio Vaccine Committee(SEC) meetingdated02.07.2021 Hadapsar Pune (India) - (Adsorbed)incomparisonwithSiiLicensedInactivated CT permission was granted. 411028 PoliovirusVaccine(IPV)”[Protocolno.:IPV:01,Version no.: 2.0, Final dated 03-Sept-2021]. 9 BIO/CT/22/000004 M/s GennovaHGCO19 Lyophilized Phase II/III "AProspective,Multicentre,Randomized,PhaseIIstudy CT- 09/2022 29-03-2022 Basedonreviewofdocumentssubmittedand Biopharmaceuticals mRNA Vaccine for seamlesslyfollowedbyaPhaseIIIstudytoevaluatethe the recommendations of Subject Expert Limited ,T-184 EmcureInjection (COVID-19) Safety,TolerabilityandImmunogenicityofthecandidate Committee(SEC) meetingdated31.01.2022 HouseBhosariMIDCPune GEMCOVAC-19 (COVID-19 vaccine) in healthy CT permission was granted. Maharashtra (India) - pediatricsubjectsof5tolessthan18years”videprotocol 411026 no.GBL/GEMCOVAC-19/2022/01Version3.0Dated10 Feb 2022. 10 BIO/CT/21/000159 M/s Pfizer Limited, ThePneumococcal Phase IV APhase4,open-label,single-arm,multicenterstudyto CT- 10/2022 07-04-2022 Basedonreviewofdocumentssubmittedand Capital 1802/1901, PlotPolysaccharide Conjugate describethesafetyof13-valentPneumococcalConjugate the recommendations of Subject Expert No.C-70GBlockBandra-Vaccine (Adsorbed) (13- vaccineinadults18to49yearsofageinIndia[Protocol Committee(SEC) meetingdated03.03.2022 KurlaComplexBandra(E)valent) no: B1851214 Version No. Final Date 15-OCT-2021]. CT permission was granted. Mumbai City (India) - 40005111 BIO/CT/21/000169 M/s Cadila HealthcareInactivated Influenza Phase III “A prospective, randomized, two arm, parallel, active CT-11 /2022 21-04-2022 Basedonreviewofdocumentssubmittedand Limited, Plot Survey No.Vaccine(SplitVirion)I.P. controlled, multicentre, phase III clinical study to the recommendations of Subject Expert 23,25/P,37,40/P,42To(Tetravalent) compare the immunogenicityand safetyofInactivated Committee(SEC) meetingdated03.03.2022 47Sarkhej-BavlaN.H.No- Influenzavaccine(splitvirion)I.P.(Tetravalent)0.5mlof CT permission was granted. 8A, Opposite Ramdev M/sCadilaHealthcareLimitedwithFluarix-TetraofM/s Masala,VillageChangodar, GlaxoSmithKline Pharmaceuticals Limited in healthy Tal. Sanand Ahmedabad children aged 6 to 35 months” [Protocol No. 21-13, (India) - 382213 Version no. 00, Dated 07-DEC-2021] 12 BIO/CT/21/000147 M/s VHB Life SciencesVaricella Vaccine Live Phase III “APhase-III,Randomized,OpenLabel,ParallelGroup, CT- 12/2022 05-05-2022 Basedonreviewofdocumentssubmittedand Limited, 50-Attenuated IP ActiveControlled,Multicentre,Non(cid:2)Inferiority Clinical the recommendations of Subject Expert AB,Government(Erstwhile Studyto Evaluate the Immunogenicityand SafetyOf Committee(SEC) meetingdated21.02.2022 Kandivali Co-operative) Varivax® [Varicella vaccine (Live Attenuated, CT permission was granted. IndustrialEstate,Charkop, Lyophilized I.P.) of VHB Life Sciences Limited] Kandivali West, Mumbai- ComparedtoaMarketedVaricellaVaccineinHealthy 400 067, Maharashtra, Paediatric Subjectsaged between1 to12 years”vide India Protocol No: BCR-VHB-001 Version No. 2.0 dated 28.02.2022. 13 BIO/CT/21/000150 M/sPostGraduateInstituteWhole Virion Inactivated Phase IV “Safety, tolerability and immunogenicity after CT- 13/2022 24-05-2022 Basedonreviewofdocumentssubmittedand OfMedicalEducationAndCorona Virus Vaccine administration of Covid-19 vaccine in homologous the recommendations of Subject Expert Research, Chandigarh, prime/boostschedule[Covishield:Covishield;Covaxin: Committee(SEC) meetingdated11.04.2022 Room Number 4043, Covaxin] as compared with heterologous prime/boost CT permission was granted. Research Block B, [Covishield: Covaxin; Covaxin: Covishield] schedule PGIMER, Chandigarh- among adults in North India: An observer blind non 160012Chandigarh(India)- inferiority randomized Control Trial” [Protocol no.: 160012 ICMR/PGIMER(cid:2)Covishield/Covaxin, Version 3.0] 14 BIO/CT/22/000056 M/s Zydus LifesciencesNovelCoronavirus-2019- Phase III “A prospective, randomized, open label, active CT- 14/2022 03-06-2022 Basedonreviewofdocumentssubmittedand Ltd. (Formerly CadilanCoV Vaccine controlled,multicenter,phaseIIIclinicalstudytoevaluate the recommendations of Subject Expert HealthcareLimited),Zydus(recombinant) theimmunogenicityandsafetyofsingleboosterdoseof Committee(SEC) meetingdated25.05.2022 Corporate Park, Scheme ZyCoV-D ofM/sZydusLifesciencesLimited inadult CT permission was granted. No. 63, Survey No. 536, subjectsalreadyvaccinatedwith2dosesofCovaxinor Nr. Vaishnodevi Circle, Covishield” vide Protocol No. Project No.: 22-04, S.G. Highway, Ahmedabad, Version 01 dated 30.05.2022 Gujarat (India) - 382481 15 BIO/CT/22/000019 M/s Serum Institute ofTyphoid Conjugate Phase I "ADouble-Blind,Randomized,ActiveControlledPhaseI CT-15/2022 17-06-2022 Basedonreviewofdocumentssubmittedand India Pvt. Ltd. (SIIPL),Vaccine (Bivalent) ClinicalStudytoassesstheSafetyandTolerabilityofSII the recommendations of Subject Expert 212/2,OffSoliPoonawalla Typhoid Conjugate Vaccine (Bivalent) in Healthy Committee(SEC) meetingdated26.04.2022 Road, Hadapsar, Pune - Adults.”ProtocolNumber:TCV:01Versionanddate: CT permission was granted. 411028, India. 1.0 dated 08 February 202216 BIO/CT/22/000037 M/s Cadila HealthcareRabies Vaccine, Human Phase I An open-label, single-treatment, single-period, single CT- 16/2022 27-06-2022 Basedonreviewofdocumentssubmittedand Limited, Plot Survey No.I.P. [Purified Inactivated dose, clinical Phase 1 studyto assess the safetyand the recommendations of Subject Expert 23,25/P,37,40/P,42ToVeroCellRabiesvaccine tolerability of Rabies Vaccine, Human I.P. Purified Committee(SEC) meetingdated26.04.2022 47Sarkhej-BavlaN.H.No-– Lyophilized (PVRV)] Inactivated Vero Cell Rabies Vaccine-Lyophilized CT permission was granted. 8A, Opposite Ramdev (PVRV) of M/s. Zydus Lifesciences Ltd. (Formerly Masala,VillageChangodar, CadilaHealthcareLtd.),IndiainHealthy,AdultHuman Tal. Sanand Ahmedabad Subjects.”[ProtocolNo.PVRV1001,VersionNumber: (India) - 382213 01, Dated: 21.03.2022]. 17 BIO/CT/22/000006 M/sG.C.ChemiePharmiePneumococcal Phase III “ARandomized,Double(cid:2)Blind, Multi-Center,PhaseIII CT- 17/2022 01-07-2022 Basedonreviewofdocumentssubmittedand Ltd., 5C Laxmi IndustrialPolysaccharide Conjugate StudytoassessandComparetheImmunogenicityand the recommendations of Subject Expert Estate New Link RoadVaccineI.P.(PCV13-TT) Safety of the 13-Valent Pneumococcal Polysaccharide Committee(SEC) meetingdated21.02.2022 AndheriMumbai(India)–(Adsorbed) ConjugateVaccine(PCV13-TT)withPrevenar13®of and 15.06.2022 CT permission was granted. 400053 Pfizer Inc. in healthy infants in India” [Protocol no.: CRN_India/0106/2021,Versionnumber:2.0,Dated01- 03-2022]] 18 BIO/CT/20/000072 M/sBiologicalE Limited,Pneumococcal Phase III A single blind randomised active-controlled Phase-III CT- 18/2022 08-09-2022 Basedonreviewofdocumentssubmittedand Plot No 1, S.P.Polysaccharide Conjugate studytoevaluateimmunogenicity,safety,tolerabilityofa the recommendations of Subject Expert BiotechnologyPark,PhaseVaccine (Adsorbed) (14 candidate 14-valent Pneumococcal Polysaccharide Committee(SEC) meetingdated29.08.2022 II, Kolthur Village,Valent) conjugatevaccineadministeredto6-8weeksoldIndian CT permission was granted. ShameerpetMandal(India) Infantsat6weeks,14weeksand9monthsofage(2+1 -500078 alternative dosing schedule)” vide Protocol No.: BECT056/PCV-Phase-III/CTP-01VersionNo.:1.0Final dated 14.05.20 19 BIO/CT/20/000180 M/s Indian ImmunologicalLive Attenuated Phase I “AphaseIsingleblindrandomizedplacebocontrolled CT- 19/2022 12-09-2022 Basedonreviewofdocumentssubmittedand Limited, Rakshapuram,Tetravalent Recombinant studytoevaluatethesafetyandimmunogenicityoflive the recommendations of Subject Expert GachibowlipostHyderabadDengue Vaccine attenuated tetravalent recombinant Dengue Vaccine of Committee(SEC) meetingdated29.08.2022 Rangareddi Hyderabad- HBIinhealthyadultsof18to50yearsofage.”Protocol CT permission was granted. 500032, India Number: HBI/Deng/I/2020/003.01.02 Version, 1.0, Amendment 02, Dated: 21 June 2022 20 BIO/CT/21/000148 M/s Syngene InternationalAdenoviral-Vector Based Phase Ib A Phase 1b Open(cid:2)Label, Randomized, Dose-Ranging CT- 20/2022 12-09-2022 Basedonreviewofdocumentssubmittedand Limited, ClinicalVaccine(VXA-CoV2-1.1- TrialtoDeterminetheSafetyandImmunogenicityofan the recommendations of Subject Expert Development Tower-1S) (Enteric Coated Tablet) Adenoviral-Vector Based Vaccine (VXA-CoV2-1.1-S) Committee(SEC) meetingdated07.09.2022 Semicon Park, Electronic Expressing a SARS-CoV-2 S Protein and dsRNA CT permission was granted. City,Phase-II,HosurRoad AdjuvantAdministeredOrallytoHealthyHumanAdult Bangalore (India)-560100 Volunteers.”[Protocolno.:VXA-COV2-102,Versionno. 2.00, Dated 25-FEB-2022]21 BIO/CT/22/000034 M/s Tergene BiotechPneumococcal Phase III A Phase 3, Observer blind, Randomized, Active- CT- 21/2022 15-09-2022 Basedonreviewofdocumentssubmittedand PrivateLimited,Suite121Polysaccharide Conjugate Controlled Trial Evaluating the Immunologic Non- the recommendations of Subject Expert & 122, Building 450,Vaccine (adsorbed), I.P. inferiority, Safety and Tolerability of a 15-valent Committee(SEC) meetingdated15.06.2022 GenomeValley,Turkapally(15 valent) Pneumococcal Conjugate Vaccine Compared to a 13- CT permission was granted. (V), Shamirpet (M), RR valent Pneumococcal Conjugate Vaccine in Healthy Dist, HYDERABAD InfantsGiveninaReducedDosingSchedulewithRoutine (India) - 500078 Pediatric Vaccinations” vide Protocol no.: CBCC/2021/029, Version no.:2.0, Dated 30.06.2022. 22 BIO/CT/22/000015 M/s GennovaLyophilized mRNA Phase II A Prospective, Multi(cid:2)centre, Open-labelled, CT- 22/2022 03-10-2022 Basedonreviewofdocumentssubmittedand Biopharmaceuticals Vaccine for Randomized, Phase IIstudyseamlesslyfollowed bya the recommendations of Subject Expert Limited,T-184 EmcureInjection(COVID-19 PhaseIIIstudytoevaluatetheSafety,Tolerabilityand Committee(SEC) meetingdated07.09.2022 House, Bhosari,)[Omicron variant - Immunogenicityof GEMCOVAC-OM as a booster in CT permission was granted. M.I.D.C,Pune Maharashtrasublineage BA.1] Subjects 18 years of age and older” vide protocol (India) - 411026 no.GBL/GEMCOVAC-OM/2022/02 23 BIO/CT/22/000063 M/s Serum Institute ofPneumococcal Phase IV A Phase 4, Cross-Sectional Study to Evaluate the CT-23/2022 20-10-2022 Basedonreviewofdocumentssubmittedand India Pvt. Ltd. (SIIPL),Polysaccharide Conjugate Pneumococcal Nasopharyngeal Carriage in Healthy the recommendations of Subject Expert 212/2,OffSoliPoonawallaVaccine (Adsorbed) I.P. Toddlers Following Vaccination with 10-Valent Committee(SEC) meetingdated11.10.2022 Road, Hadapsar, Pune -(10- Valent) Pneumococcal Conjugate Vaccine (PNEUMOSIL®) as CT permission was granted. 411028, India. Part of Universal Immunization Program in India As Compared To Non-vaccinated Toddlers” Protocol Number:PCV-10-005ProtocolVersion1.1 Dated:25 Aug 2022 24 BIO/CT/22/000022 M/sPanaceaBiotecLtd.,B-Diphtheria and Tetanus Phase II/ III A randomized, single blind, multicenter, Phase II/ III CT- 24/2022 26-10-2022 Basedonreviewofdocumentssubmittedand 1Extn/G-3,MCIEMathuravaccine (adsorbed) for studyto assess and compare the immunogenicityand the recommendations of Subject Expert Road New Delhi NewadultsandadolescentsI.P. safetyofDiphtheriaandTetanus(Td)vaccine(adsorbed) Committee(SEC) meetingdated15.06.2022 Delhi (India) - 110044 (Td Vaccine) ofPanaceaBiotecLtd.withBETd®ofM/s.BiologicalE CT permission was granted. LtdinHealthyAdults&Adolescents.”ProtocolNumber: PBL/21/01/Td Version Number: 03 Dated: 04-10-22 25 BIO/CT/21/000046 M/s Serum Institute ofTyphoid Conjugate Phase III AnOpenlabel, Randomized, Active-controlled,Multi- CT-25/2022 21-11-2022 Basedonreviewofdocumentssubmittedand India Pvt. Ltd. (SIIPL),Vaccine (Bivalent) centricPhase-IIIStudyinIndianInfantstoAssessthe the recommendations of Subject Expert 212/2,OffSoliPoonawalla Immunogenicity and Safety of SIIPL HEXAVALENT Committee(SEC) meetingdated02.07.2021 Road, Hadapsar, Pune - (DTwP-HepB-IPV-Hib) Vaccine Containing Reduced CT permission was granted. 411028, India. DoseIPVinComparisonwithSIIPLPentavacSD(DTwP- HepB(cid:2)Hib) +Poliovac(IPV)Vaccines,Administeredas Separate Injections” Protocol No. SII(cid:2)wHEXA/IN-03, Protocol Version 1.0 Dated 08 Jan 2021.26 BIO/CT/22/000085 M/s IQVIA RDS (India)Inactivated Influenza Phase IV Asingle-arm,open(cid:2)label, multi-centre,PhaseIVtrialto CT- 26/2022 29-11-2022 Basedonreviewofdocumentssubmittedand Private Limited, OmegaVaccine(SplitVirion)I.P. evaluatethereactogenicity,safety,andimmunogenicityof the recommendations of Subject Expert Embassy TechSquare,(Quadrivalent) Quadrivalentseasonalinfluenzavaccine(FluarixTetra)in Committee(SEC) meetingdated21.11.2022 Marathahalli-Sarjapur, participantsaged65yearsandolderinIndia”[Protocol CT permission was granted. Outer Ring Road no.: 218702, Version number: 1.0, Dated 22-JUN-2022] Kadubeesanahalli Bangalore (India)- 560103 27 BIO/CT/22/000070 M/s Zydus LifesciencesRecombinant Hepatitis E Phase II Aprospective,randomized,two-arm,parallel,placebo- CT- 27/2022 29-11-2022 Basedonreviewofdocumentssubmittedand Ltd. (Formerly CadilaVaccine (Adsorbed) controlled,multicentre,superiority,phaseIIclinicaltrial the recommendations of Subject Expert HealthcareLimited),Zydus to evaluate the immunogenicity and safety of Committee(SEC) meetingdated21.11.2022 Corporate Park, Scheme Recombinant Hepatitis E Vaccine (Adsorbed) of M/s. CT permission was granted. No. 63, Survey No. 536, Zydus Lifesciences Limited in healthy subjects” vide Nr. Vaishnodevi Circle, Protocol No. Project No.: 22-06, Version 01 dated S.G. Highway, Ahmedabad, 07.10.2022 Gujarat (India) - 382481 Format No. QMS-GNL-019/F02(b)-00

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