Medical Dialogues
  • Dermatology
Login Register
This site is intended for healthcare professionals only
Login Register
  • MD Brand Connect
  • Vaccine Hub
  • MDTV
    • Breaking News
    • Medical News Today
    • Health News Today
    • Latest
    • Journal Club
    • Medico Legal Update
    • Latest Webinars
    • MD Shorts
    • Health Dialogues
  • Fact Check
  • Health Dialogues
Medical Dialogues
  • Medical News & Guidelines
      • Anesthesiology
      • Cardiology and CTVS
      • Critical Care
      • Dentistry
      • Dermatology
      • Diabetes and Endocrinology
      • ENT
      • Gastroenterology
      • Medicine
      • Nephrology
      • Neurology
      • Obstretics-Gynaecology
      • Oncology
      • Ophthalmology
      • Orthopaedics
      • Pediatrics-Neonatology
      • Psychiatry
      • Pulmonology
      • Radiology
      • Surgery
      • Urology
      • Laboratory Medicine
      • Diet
      • Nursing
      • Paramedical
      • Physiotherapy
  • Health news
      • Doctor News
      • Government Policies
      • Hospital & Diagnostics
      • International Health News
      • Medical Organization News
      • Medico Legal News
      • NBE News
      • NMC News
  • Fact Check
      • Bone Health Fact Check
      • Brain Health Fact Check
      • Cancer Related Fact Check
      • Child Care Fact Check
      • Dental and oral health fact check
      • Diabetes and metabolic health fact check
      • Diet and Nutrition Fact Check
      • Eye and ENT Care Fact Check
      • Fitness fact check
      • Gut health fact check
      • Heart health fact check
      • Kidney health fact check
      • Medical education fact check
      • Men's health fact check
      • Respiratory fact check
      • Skin and hair care fact check
      • Vaccine and Immunization fact check
      • Women's health fact check
  • AYUSH
    • Ayurveda
    • Homeopathy
    • Siddha
    • Unani
    • Yoga
  • State News
      • Andaman and Nicobar Islands
      • Andhra Pradesh
      • Arunachal Pradesh
      • Assam
      • Bihar
      • Chandigarh
      • Chattisgarh
      • Dadra and Nagar Haveli
      • Daman and Diu
      • Delhi
      • Goa
      • Gujarat
      • Haryana
      • Himachal Pradesh
      • Jammu & Kashmir
      • Jharkhand
      • Karnataka
      • Kerala
      • Ladakh
      • Lakshadweep
      • Madhya Pradesh
      • Maharashtra
      • Manipur
      • Meghalaya
      • Mizoram
      • Nagaland
      • Odisha
      • Puducherry
      • Punjab
      • Rajasthan
      • Sikkim
      • Tamil Nadu
      • Telangana
      • Tripura
      • Uttar Pradesh
      • Uttrakhand
      • West Bengal
  • Medical Education
      • Ayush Education News
      • Dentistry Education News
      • Medical Admission News
      • Medical Colleges News
      • Medical Courses News
      • Medical Universities News
      • Nursing education News
      • Paramedical Education News
      • Study Abroad
  • Industry
      • Health Investment News
      • Health Startup News
      • Medical Devices News
      • Pharma News
      • Pharmacy Education News
      • Industry Perspective
  • MDTV
      • Health Dialogues MDTV
      • Health News today MDTV
      • Latest Videos MDTV
      • Latest Webinars MDTV
      • MD shorts MDTV
      • Medical News Today MDTV
      • Medico Legal Update MDTV
      • Top Videos MDTV
      • Health Perspectives MDTV
      • Journal Club MDTV
      • Medical Dialogues Show
This site is intended for healthcare professionals only
LoginRegister
Medical Dialogues
LoginRegister
  • Home
  • Medical news & Guidelines
    • Anesthesiology
    • Cardiology and CTVS
    • Critical Care
    • Dentistry
    • Dermatology
    • Diabetes and Endocrinology
    • ENT
    • Gastroenterology
    • Medicine
    • Nephrology
    • Neurology
    • Obstretics-Gynaecology
    • Oncology
    • Ophthalmology
    • Orthopaedics
    • Pediatrics-Neonatology
    • Psychiatry
    • Pulmonology
    • Radiology
    • Surgery
    • Urology
    • Laboratory Medicine
    • Diet
    • Nursing
    • Paramedical
    • Physiotherapy
  • Health news
    • Doctor News
    • Government Policies
    • Hospital & Diagnostics
    • International Health News
    • Medical Organization News
    • Medico Legal News
    • NBE News
    • NMC News
  • Fact Check
    • Bone Health Fact Check
    • Brain Health Fact Check
    • Cancer Related Fact Check
    • Child Care Fact Check
    • Dental and oral health fact check
    • Diabetes and metabolic health fact check
    • Diet and Nutrition Fact Check
    • Eye and ENT Care Fact Check
    • Fitness fact check
    • Gut health fact check
    • Heart health fact check
    • Kidney health fact check
    • Medical education fact check
    • Men's health fact check
    • Respiratory fact check
    • Skin and hair care fact check
    • Vaccine and Immunization fact check
    • Women's health fact check
  • AYUSH
    • Ayurveda
      • Ayurveda Giuidelines
      • Ayurveda News
    • Homeopathy
      • Homeopathy Guidelines
      • Homeopathy News
    • Siddha
      • Siddha Guidelines
      • Siddha News
    • Unani
      • Unani Guidelines
      • Unani News
    • Yoga
      • Yoga Guidelines
      • Yoga News
  • State News
    • Andaman and Nicobar Islands
    • Andhra Pradesh
    • Arunachal Pradesh
    • Assam
    • Bihar
    • Chandigarh
    • Chattisgarh
    • Dadra and Nagar Haveli
    • Daman and Diu
    • Delhi
    • Goa
    • Gujarat
    • Haryana
    • Himachal Pradesh
    • Jammu & Kashmir
    • Jharkhand
    • Karnataka
    • Kerala
    • Ladakh
    • Lakshadweep
    • Madhya Pradesh
    • Maharashtra
    • Manipur
    • Meghalaya
    • Mizoram
    • Nagaland
    • Odisha
    • Puducherry
    • Punjab
    • Rajasthan
    • Sikkim
    • Tamil Nadu
    • Telangana
    • Tripura
    • Uttar Pradesh
    • Uttrakhand
    • West Bengal
  • Medical Education
    • Ayush Education News
    • Dentistry Education News
    • Medical Admission News
    • Medical Colleges News
    • Medical Courses News
    • Medical Universities News
    • Nursing education News
    • Paramedical Education News
    • Study Abroad
  • Industry
    • Health Investment News
    • Health Startup News
    • Medical Devices News
    • Pharma News
      • CDSCO (Central Drugs Standard Control Organisation) News
    • Pharmacy Education News
    • Industry Perspective
  • Home
  • News
  • Industry
  • Pharma News
  • Bharat Biotech: CDSCO...

Bharat Biotech: CDSCO panel rejects Phase 3 trial of Covaxin, asks to submit safety data from previous trial

Ruchika SharmaWritten by Ruchika Sharma Published On 2020-10-12T17:11:30+05:30  |  Updated On 12 Oct 2020 5:14 PM IST
Bharat Biotech: CDSCO panel rejects Phase 3 trial of Covaxin, asks to submit safety data from previous trial
  • facebook
  • twitter
  • linkedin
  • whatsapp
  • Telegram
  • Email

"Bharat Biotech should submit safety and immunogenicity data from the phase II trial for consideration, " CDSCO Committee said.

New Delhi: The expert panel at Central Drugs Standard Control Organisation (CDSCO) has asked drug maker Bharat Biotech to submit safety and immunogenicity data from the ongoing phase II trial in order to conduct a phase III clinical trial of the indigenous COVID-19 vaccine, Covaxin.

According to the Subject Expert Committee (SEC) meeting, the firm presented the phase III clinical trial protocol along with interim data of phase I and II clinical trials on October 2.
"The committee noted the interim data of phase I and II clinical trials. After detailed deliberation, the committee opined that the design of the phase III study is in principle satisfactory except for clarification on the definition of asymptomatic, etc," SEC noted on 114th meeting on October 5, reports ANI.
"However, the study should be initiated with an appropriate dose identified from phase II safety and immunogenicity data. Accordingly, the firm should submit safety and immunogenicity data from the phase II trial for consideration," it said.
In July, the Drug Controller General of India had granted permission to pharma company Bharat Biotech to conduct phase I and II clinical trials to develop an indigenous vaccine for COVID-19.
In this regard, Bharat Biotech has partnered with the Indian Council of Medical Research (ICMR) to develop a fully indigenous vaccine for COVID-19 using the virus strain isolated at ICMR's National Institute of Virology, Pune.
The Medical Dialogues team had earlier reported that the indigenous and the inactivated vaccine was developed at Bharat Biotechs BSL-3 (Bio-Safety Level 3) high containment facility located in the Genome Valley. The Drug Controller General of India CDSCO (The Central Drugs Standard Control Organisation), Ministry of Health & Family Welfare had granted permission to initiate Phase I & II Human clinical trials after the company submitted results generated from pre-clinical studies, demonstrating safety and immune response. Human clinical trials are scheduled to start across India in July 2020

Also Read: FIRST: Bharat Biotech Covid-19 Vaccine COVAXIN Gets DCGI Nod For Human Trials,

bharat biotechbharat biotech newscovaxincdscoclinical trialcoronaviruscovid-19
Source : with agency inputs
Ruchika Sharma
Ruchika Sharma

    Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

    Show Full Article
    Next Story

    Editorial

    Dapagliflozin Shines in Post-TAVI Patients:DAPA-TAVI Trial Findings

    Dapagliflozin Shines in Post-TAVI Patients:DAPA-TAVI Trial Findings

    Identifying Candidates for Aspirin in Primary Prevention: Men Aged 40-50 with Hypertension, Dyslipidemia, and Familial ASCVD Risk

    Identifying Candidates for Aspirin in Primary Prevention: Men Aged 40-50 with Hypertension,...

    Featured image representing thinking

    Is Pharma Marketing Going Through "Thinking Recession"?

    Beyond BMI: Why Pioglitazone Deserves a Place in Managing Thin-Fat Type 2 Diabetes in India

    Beyond BMI: Why Pioglitazone Deserves a Place in Managing 'Thin-Fat' Type 2 Diabetes in India

    How to Improve Adherence in Hypertensive Patients? Bridging the Gap with CONNECT Tool

    How to Improve Adherence in Hypertensive Patients? Bridging the Gap with CONNECT Tool

    View All

    Journal Club Today

    Early Bedtimes May Boost Physical Activity: Study Finds

    Early Bedtimes May Boost Physical Activity: Study Finds

    View All

    Health News Today

    Health Bulletin 2/July/ 2025

    Health Bulletin 2/July/ 2025

    View All
    © 2022 All Rights Reserved.
    Powered By: Hocalwire
    X
    We use cookies for analytics, advertising and to improve our site. You agree to our use of cookies by continuing to use our site. To know more, see our Cookie Policy and Cookie Settings.Ok