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Annexure - II(b)
Details of clinical trial Permissions (Form CT-06)
Year 2020
S.No. File No. Firm Name Name of Product Phase Title of the study Permission No. Date of Issue Summary
1 BIO/CT/19/000032 M/s Cadila HealthcareInactivated Therapeutic Phase II Double-Blind, Randomized, Placebo- CT- 01/2020 20-01-2020 Based on review of
Limited,PlotSurveyNo.Tuberculosis Vaccine. ControlledPhaseIIbClinicalTrialto documentssubmitted
23,25/P,37,40/P,42To(RUTI® Vaccine) Investigate the Efficacy of RUTI® and the
47 Sarkhej-Bavla N.H. TherapeuticVaccinationasadjuvantof recommendations of
No-8A, Opposite Tuberculosis chemotherapy" Protocol IND meeting dated
RamdevMasala,Village no. RUTIP2-2019-01, version 2.0, 18.09.2019 (S. No.
Changodar, Tal. Sanand dated 4 November, 2019. 10) CT permission
Ahmedabad (India) - was granted.
382213
2 BIO/CT/19/000098 M/s Biological ETyphoid Vi Conjugate Phase III A multicentre follow-up study to CT- 02/2020 14-02-2020 Based on review of
Limited,PlotNo1,S.P.Vaccine, IP assess the immunological persistence documentssubmitted
Biotechnology Park, ofanti-ViIgGantibodiesat12,24and and the
PhaseII,KolthurVillage, 36monthspostprimarydoseandto recommendations of
Shameerpet Mandal evaluate the immune response to a Subject Expert
(India) -500078 single booster dose of typhoid Vi Committee (SEC)
conjugatevaccineadministeredat36 meeting dated
monthspostprimarydoseto6months 13.12.2019 CT
to 45-year-old subjects in both permission was
treatmentarmswhoparticipatedinthe granted.
BECT053 study, vide Protocol no.
BECT059/TCV-Pha-III,VersionNo.1
Dated 09-SEP-2019”
3 BIO/CT/19/000104 M/s Sanofi HealthcareDiphtheria, Tetanus, Phase III Phase III, randomized, open-label, CT- 03/2020 24-02-2020 Based on review of
India Private Limited,Pertussis (Whole cell), multicenter study evaluating the documentssubmitted
Sanofi House, C.T.S-Hepatitis B (rDNA), immunogenicityand safetyof Shan6 and the
117B,L&TBUSINESSHaemophilus vaccine administered, concomitantly recommendations of
PARK,SakiViharRoad,influenzaeTypebConjugate with or without Measles-Mumps Subject Expert
PowaiMumbai(India)-and Poliomyelitis Rubella (MMR) vaccine, to healthy Committee (SEC)
400072 (Inactivated) Vaccine toddlersinIndiavideProtocolno.- meeting dated
(Adsorbed) Version 1.0 dated 08 November 2019” 09.01.2020 CT
permission was
granted.
4 BIO/CT/19/000073 M/s Biological EHepatitis B Vaccine (rDNA) Phase IV A multicentre single blind, parallel CT- 04/2020 13-03-2020 Based on review of
Limited,PlotNo1,S.P. randomized phase-IV non-inferiority documentssubmitted
Biotechnology Park, studytoevaluatetheimmunogenicity and the
PhaseII,KolthurVillage, and safety of Biological E’s recommendations of
Shameerpet Mandal monovalent Hepatitis-B (rDNA) Subject Expert
(India) -500078 vaccinewhenadministeredfirstdose Committee (SEC)
toneonateswithin24hoursofbirth meeting dated
followedbyadoseat6and14weeks 21.10.2019 CT
ofageincomparisonwithalicensed permission was
comparator.” vide Protocol no. granted.
BECT058/rHepB-Birth_Dose-
PIV/CTP-02, Version No. 2.0 Final
dated 11.11.19.
5 BIO/CT/19/000079 M/s Bharat BiotechZika Virus Vaccine Phase IIa A Phase 2a Double(cid:2)Blind, Placebo- CT- 05/2020 16-03-2020 Based on review of
International Limited,(Adsorbed) ControlledRandomizedClinicaltrialto documentssubmitted
Genome Valley, Evaluate Immunogenicity and Safety of and the
Shameerpet (India) - A Zika Virus Vaccine (BBV121) in recommendations of
500078 Dengue Sero-Negative and Dengue Subject Expert
Sero(cid:2)Positive Healthy Adults” vide Committee (SEC)
Protocol Number: meeting dated
BBIL/ZIKV/IIa/2019 Version and 10.10.2019 CT
date: 1.0 dated 13 August 2019. permission was
granted.6 BIO/CT/20/000038 M/s Serum Institute ofVPM1002 (rBCG) Vaccine Phase III Amulticentre,phaseIII,double-blind, CT-06/2020 12-04-2020 Based on review of
India Pvt. Ltd. (SIIPL), randomized,placebocontrolledstudy documentssubmitted
212/2, Off Soli toevaluatetheefficacyofrecombinant and the
Poonawalla Road, BCGVPM1002inreducinginfection recommendations of
Hadapsar,Pune-411028, incidence and disease severity of SARS- IND meeting dated
India COV-2/COVID(cid:2)19 among high-risk 08.04.2020 CT
subjects” vide protocol number:SII- permission was
rBCG/COVID-19/IN-01, version 3.0 granted.
dated 11.04.2020
7 BIO/CT/20/000039 M/s CadilaMycobacterium w (Heat Phase III Aclinicaltrialtoevaluatethesafety CT- 07/2020 15-04-2020 Based on review of
Pharmaceuticals Killed) and efficacy of Mw in critically ill documentssubmitted
Limited,1389, Dholka, patients suffering from COVID 19 and the
Ahmedabad-382225 infection” vide protocol number: recommendations of
Gujarat, India CRSC20004 version-02, dated 10th Subject Expert
April 2020 Committee (SEC)
meeting dated
08.04.2020 CT
permission was
granted.
8 BIO/CT/20/000041 M/s CadilaMycobacterium w (Heat Phase III A Randomized, Double-blind, Two CT- 08/2020 22-04-2020 Based on review of
Pharmaceuticals Killed) arm,PlaceboControlledClinicalTrial documentssubmitted
Limited,1389, Dholka, toEvaluatetheEfficacyandSafetyof and the
Ahmedabad-382225 Mycobacterium w in preventing recommendations of
Gujarat, India COVID-19insubjectsatriskofgetting Subject Expert
infected with COVID-19” vide Committee (SEC)
Protocol Number: CRSC20005 meeting dated
Version-02, dated 15th April 2020 19.04.2020 CT
withtheconditionthatserologyshall permission was
beconductedinitiallyandattheendof granted.
one of the study period
9 BIO/CT/20/000042 M/s CadilaMycobacterium w (Heat Phase III A Randomized, Double-blind, Two CT- 09/2020 22-04-2020 Based on review of
Pharmaceuticals Killed) arm, controlled clinical trial to documentssubmitted
Limited,1389, Dholka, compare the Efficacy and Safety of and the
Ahmedabad-382225 Mycobacteriumw(Mw)administered recommendations of
Gujarat, India along with standard of care versus Subject Expert
Placebo administered along with Committee (SEC)
standardofcare,inadult,COVID19 meeting dated
positive patients hospitalized but not 19.4.2020 CT
critically ill” vide Protocol Number: permission was
CRSC20006 Version-02, dated 15th granted.
April 2020
10 BIO/CT/20/000049 M/s Haffkine InstituteBacillus Calmette-Guerin Phase II protocol no. 1.0 titled “Phase 2 Clinical CT- 10/2020 01-05-2020 Based on review of
ForTraining,Research&Vaccine I.P. (Freeze Dried) Trial for the Evaluation of BCG as documentssubmitted
Testing ,Acharya Donde potential therapy for COVID-19” and the
Marg Parel Mumbai subjecttothefollowingconditions:1. recommendations of
(India) - 400012 Thestudyshouldbecarriedoutonlyin Subject Expert
moderate patients. Accordingly the Committee (SEC)
objective criteria for classifying meeting dated
moderatepatientsshouldbedefined.2. 28.04.2020 CT
The primaryobjective should bethe permission was
time for resolution of COVID-19 granted.
infection only. All other objectives
should be secondary objectives.
Progressionfrommoderatetosevere
disease should also be a secondary
objective11 BIO/CT/20/000009 M/s Serum Institute ofYellow Fever Vaccine Phase I AnOpen-Label, Randomized, Active CT- 11/2020 04-06-2020 Based on review of
India Pvt. Ltd., 212/2,(Live) I.P. Controlled,PhaseIClinicalStudyto documentssubmitted
Off. Soli Poonawalla AssesstheSafetyandTolerabilityof and the
Road, Hadapsar Pune SIIYellowFeverVaccine inhealthy recommendations of
(India) - 411028 adults” vide Protocol Number: Subject Expert
YWF:01,Version:2.0Finaldated15 Committee (SEC)
May 2020 meeting dated
12.05.2020 CT
permission was
granted.
12 BIO/CT/20/000001 M/s Cadila HealthcareDiphtheria and TetanusPhase II/IIIAprospective,randomized,two-arm, CT- 12/2020 10-06-2020 Based on review of
Limited,plot surveyno.Vaccine (Adsorbed) for parallel,single-blind,active-controlled, documentssubmitted
23,25/P,37,40/P,42ToAdults and Adolescents I.P. multicentre, noninferiority clinical and the
47 Sarkhej-Bavla N.H. studytoevaluatetheimmunogenicity recommendations of
No-8A, Opposite andsafetyofDiphtheriaandTetanus Subject Expert
RamdevMasala,Village vaccine (adsorbed) for adults and Committee (SEC)
Changodar, Tal. Sanand adolescents I.P. of M/s Cadila meeting dated
Ahmedabad (India) - Healthcare Limited compared to 12.05.2020 CT
382213 Diphtheria and Tetanus vaccine permission was
(adsorbed)foradultsandadolescents granted.
I.P. ofM/sBiologicalE. Limited in
healthysubjects"videprotocolno.19-
07, version 1.0 dated 20/05/2020
13 BIO/CT/20/000004 M/s IndianMeasles and RubellaPhase II/IIIA Phase II/III, Multicentric, CT- 13/2020 12-06-2020 Based on review of
Immunological Limited,Vaccine (Live), I.P. Randomized, Single Blind Study to documentssubmitted
Rakshapuram, Compare the Immunogenicity and and the
Gachibowli post SafetyofMeaslesandRubellaVaccine recommendations of
Hyderabad Rangareddi (Live) of HBI with MR-VAC® Subject Expert
Hyderabad-500032, India VaccineinHealthySubjects”Protocol Committee (SEC)
no. HBI/MR/II/III/2019/001.02.00, meeting dated
Version-02, Dated: 14 May 2020. 21.02.2020 CT
permission was
granted.
14 BIO/CT/20/000077 M/s Bharat BiotechWhole Virion Inactivated Phase I/II Multicenter Study to Evaluate the CT- 14/2020 29-06-2020 Based on review of
International Limited,Corona Virus Vaccine, Safety,Reactogenicity,Tolerabilityand documentssubmitted
Genome Valley,[BBV152] Immunogenicityof the Whole-Virion and the
Shameerpet (India) - Inactivated SARS-CoV-2 Vaccine recommendations of
500078 (BBV152)inHealthyVolunteers”vide Subject Expert
Protocol No: BBIL/BBV152-A/2020 Committee (SEC)
Version No: 2.0 Date: 26-06-2020 meeting dated
after approval of Ethics committee. 25.06.2020 CT
permission was
granted.
15 BIO/CT/201000085 Mis Cadila HealthcareNovel Corona Virus-2019- Phase I/II Aprospective, randomized,adaptive, CT-15/2020 02-07-2020 Based on review of
Limited,plot surveyno.nCov vaccine PhaseIIIIclinicaltrialtoevaluatethe documentssubmitted
23,25/P,37,40/P,42To safetyand immunogenicity of Novel and the
47 Sarkhej-Bavla N.H. Corona Virus 2019-nCoV Vaccine recommendations of
No-8A, Opposite Candidate of MIs Cadila Healthcare Subject Expert
RamdevMasala,Village Limitedbyintradermalrouteinhealthy Committee (SEC)
Changodar, Tal. Sanand subjects" meeting dated
Ahmedabad (India) - 01.07.2020 CT
382213 permission was
granted.
16 BIO/CT/20/000044 M/s Cadila HealthcareTyphoid Vi Conjugate Phase-IV A prospective, randomized, parallel, CT- 16/2020 10-07-2020 Based on review of
Limited,plot surveyno.Vaccine I.P. three-arm, open-label, multicenter, documentssubmitted
23,25/P,37,40/P,42To phaseIVclinicaltrialtoevaluatethe and the
47 Sarkhej-Bavla N.H. immunological non-interference of recommendations of
No-8A, Opposite Typhoid Vi conjugate vaccine with Subject Expert
RamdevMasala,Village Measles and Rubella vaccine Committee (SEC)
Changodar, Tal. Sanand administered to healthyinfants"vide meeting dated
Ahmedabad (India) - protocolno.20-03,version00dated 06.07.2020 CT
382213 17/03/2020. permission was
granted.17 BIO/CT/20/000024 M/s Cadila HealthcareTyphoid Vi Conjugate Phase IV A prospective, randomized, parallel, CT- 17/2020 28-07-2020 Based on review of
Limited,plot surveyno.Vaccine I.P. multicentre,phaseIVclinicaltrialto documentssubmitted
23,25/P,37,40/P,42To evaluatetheLottoLotconsistencyof and the
47 Sarkhej-Bavla N.H. ZyVacTCVofM/sCadilaHealthcare recommendations of
No-8A, Opposite Ltd. Vide protocol No.: 20-02, Subject Expert
RamdevMasala,Village Version: 01 dated: 26-06-2020 Committee (SEC)
Changodar, Tal. Sanand meeting dated
Ahmedabad (India) - 01.06.2020 CT
382213 permission was
granted.
18 BIO/CT/20/000095 M/s Serum Institute ofChAdOx1nCoV-19CoronaPhase II/IIIA Phase II/III, Observer-blind, CT- 18/2020 03-08-2020 Based on review of
India Pvt. Ltd., 212/2,Virus Vaccine randomized, Controlled study to documentssubmitted
Off. Soli Poonawalla(Recombinant) determine the safety and and the
Road, Hadapsar Pune immunogenicity of COVISHIELD recommendations of
(India) - 411028 (Covid-19Vaccine)inhealthyIndians Subject Expert
adults "Videprotocolno.ICMR/SII- Committee (SEC)
COVISHIELDVersionNo.2.0,Dated: meeting dated
29 July 2020 31.07.2020 CT
permission was
granted.
19 BIO/CT/20/000019 M/s Cadila HealthcareTyphoid Vi Conjugate Phase IV Aprospective,randomized,two-arm, CT- 19/2020 11-08-2020 Based on review of
Limited,plot surveyno.Vaccine I.P. parallel,single-blind,active-controlled, documentssubmitted
23,25/P,37,40/P,42To multicentre, noninferiority, phase IV and the
47 Sarkhej-Bavla N.H. clinicaltrialtoevaluatethelong-term recommendations of
No-8A, Opposite immunogenicityandsafetyofZyVac Subject Expert
RamdevMasala,Village TCVofM/sCadilaHealthcareLimited Committee (SEC)
Changodar, Tal. Sanand compared to Typbar TCV of M/s meeting dated
Ahmedabad (India) - BharatBiotechInternationalLimitedin 01.06.2020 CT
382213 healthysubjects"videprotocolno.20- permission was
01, version 01 dated 26/06/2020 granted.
20 BIO/CT/20/000078 M/s Bharat BiotechWhole Virion Inactivated Phase II An Adaptive, Seamless Phase I, CT- 20/2020 20-08-2020 Based on review of
International Limited,Corona Virus Vaccine, FollowedbyaPhaseII,Randomized, documentssubmitted
Genome Valley,[BBV152D] Multicenter Study to Evaluate the and the
Shameerpet (India) - Safety, Reactogenicity, and recommendations of
500078 ImmunogenicityoftheWholeVirion Subject Expert
Inactivated SARS-CoV-2 Virus Committee (SEC)
Vaccine, BBV152D Administered meeting dated
Intradermally in Healthy Volunteers” 13.08.2020 CT
vide Protocol No: permission was
BBIL/BBV152D(cid:2)B/2020 VersionNo: granted.
2.0 Date: 27-07-2020
21 BIO/CT/20/000150 M/s Biological ESARS-CoV-2Equine Phase I A phase I, open label, parallel, CT- 21/2020 16-10-2020 Based on review of
Limited,PlotNo1,S.P.Antiserum Immunoglobulin randomised trial to assess the safety documentssubmitted
Biotechnology Park,(Purified F(ab’)2 fragment) andefficacyofSARS-CoV-2Equine and the
PhaseII,KolthurVillage, Antiserum Immunoglobulin (Purified recommendations of
Shameerpet Mandal F(ab')2fragment) in hospitalised Subject Expert
(India) -500078 COVID-19 patients with moderate Committee (SEC)
disease in addition to standard of meeting dated
care.” vide Protocol no. 05.10.2020 CT
BECT063/Equine.CoV.Ab- permission was
Phase(cid:2)I/CTP-01, Version No. 1.1 granted.
dated 07.10.2020.
22 BIO/CT/20/000162 M/s Dr Reddy’sGam-COVID-Vac Phase II/IIIRandomized, Double-blind, Placebo- CT- 22/2020 23-10-2020 Based on review of
Laboratories Limited,Combined Vector Vaccine Controlled, Parallel-group, multi- documentssubmitted
IPDO, Survey no 54for SARS-CoV-2 infection CentrephaseII/IIadaptiveclinicatrial and the
Bachupally Vilage(Component I & toassessthesafetyandimmunogenicity recommendations of
Qutubullapur MandalComponent II) of Gam-Covid-vac combined vector Subject Expert
(India) - 500090 vaccine for SARA-Cov-2 infection Committee (SEC)
indiahealthysubjects"ProtocolNo.: meeting dated
RDI-GCV-001Versionno:3.0,Dated: 16.10.2020 CT
19-10-2020 permission was
granted.23 BIO/CT/20/000159 M/s Bharat BiotechWhole Virion Inactivated Phase III An Event-Driven, Phase -3, CT- 23/2020 23-10-2020 Based on review of
International Limited,Corona Virus Vaccine, Randomized, double-blind, placebo- documentssubmitted
Genome Valley,[BBV152D] controlled, multicentre study to and the
Shameerpet (India) - Evaluate the Efficacy, Safety, recommendations of
500078 Immunogenicity and lot-to-lot Subject Expert
consistancyofBBV152,WholeVirion Committee (SEC)
Inactivated Corona Virus Vaccine in meeting dated
adult≥18yearsofage"videprotocol 20.10.2020 CT
no.: BBIL/BBV152-C/2020 Version permission was
no.: 3.0, dated: 20-10-2020 granted.
24 BIO/CT/20/000154 M/s CadilaMycobacterium w (Heat Phase III Aclinicaltrialtoevaluatethesafety CT- 24/2020 27-10-2020 Based on review of
Pharmaceuticals Killed) and efficacy of Mw in critically ill documentssubmitted
Limited,1389, Dholka, patients suffering from COVID 19 and the
Ahmedabad-382225 infection.” vide Protocol Number: recommendations of
Gujarat, India CRSC20004 Version-04, dated Subject Expert
07.10.2020. Committee (SEC)
meeting dated
05.10.2020 CT
permission was
granted.
25 BIO/CT/20/000158 M/s Biological ECovid-19 Vaccine Phase I/II A prospective open label randome CT- 25/2020 29-10-2020 Based on review of
Limited,PlotNo1,S.P.containingReceptorBinding phase-Iseamlesslyfollowedbyphase- documentssubmitted
Biotechnology Park,Domain of SARS-CoV-2 II study to asses the safety, and the
PhaseII,KolthurVillage,(RBD antigen of SARS- reactogenicityandimmunogenicityof recommendations of
Shameerpet MandalCoV-2 (Covid-19)) Biologica'EsNovelCovid-19vaccine Subject Expert
(India) -500078 containigReceptorBindingDomainof Committee (SEC)
SARS-CoV-2 for protection against meeting dated
Covid-19 disease when administered 26.10.2020 CT
intramuscularlyinatwodoseschedule permission was
(0, 28D) to healthyvolunteers.'vide granted.
protocol no.: BECT062/Covid-19-
Phase-I&II/CTP-01 Version no.: 1.1
dated: 07-10-2020
26 BIO/CT/20/000131 s M/s IndianChikungunya vaccine Phase I A Phase IRandomized Single Blind CT- 26/2020 04-11-2020 Based on review of
Immunological Limited,(Inactivated) PlaceboControlledStudytoEvaluate documentssubmitted
Rakshapuram, the Safety and Immunogenicity of and the
Gachibowli post ChikungunyaVaccine(Inactivated)of recommendations of
Hyderabad Rangareddi HBI when administered by two Subject Expert
Hyderabad-500032, India differentdosageschedulestoHealthy Committee (SEC)
Subjectsof19to49Yearsofage.” meeting dated
vide Protocol no. 30.09.2020 CT
HBI/CG/I/2020/001.02.00; Version: permission was
02 dated: 14 October 2020. granted.
27 BIO/CT/20/000194 M/s Cadila HealthcareNovel Corona virus-2019- Phase III AphaseIII,randomized,multi-centre, CT- 27/2020 04-12-2021 Based on review of
Ltd.,PlotSurveyNo.23,nCoV Vaccine doubleblind,placebocontrolled,study documentssubmitted
25/P,37,40/P,42to47, to evaluate efficacy, safety and and the
Opp. Ramdev Masala, immunogenicity of Novel Corona recommendations of
Sarkhej-Bavla,N.H.No. Virus-2019-nCovvaccinecandidateof Subject Expert
8A, Village - M/s Cadila Healthcare Limited Committee (SEC)
Changodar,Taluka - meeting dated
Sanand, Dist. 02.01.2021 CT
Ahmedabad - 382 213 permission was
granted.
Format No. QMS-GNL-019/F02(b)-00