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
  • CDSCO (Central Drugs Standard Control Organisation) News
  • CDSCO Panel Recommends...

CDSCO Panel Recommends Phase III Trial of Tetanus Vaccine by Indian Immunologicals in Pregnant Women

Written By : Dr. Kamal Kant Kohli Published On 2025-06-04T15:33:23+05:30  |  Updated On 4 Jun 2025 3:33 PM IST
CDSCO Panel Recommends Phase III Trial of Tetanus Vaccine by Indian Immunologicals in Pregnant Women
  • facebook
  • twitter
  • linkedin
  • whatsapp
  • Telegram
  • Email

New Delhi: The Subject Expert Committee (SEC) for Vaccines under the Central Drugs Standard Control Organisation (CDSCO) has recommended the conduct of a Phase III clinical trial for the Tetanus Vaccine (Adsorbed, I.P.) developed by Indian Immunologicals Limited, Hyderabad.

The recommendation came during the SEC meeting held on May 22, 2025, through hybrid mode, where the panel reviewed and re-deliberated the firm’s proposal [File No. BIO/CT/23/000129].

Indian Immunologicals presented crucial data in response to earlier observations made by the SEC during its meeting on February 5, 2024. The submission included:

Developmental and Reproductive Toxicity (DART) study reports conducted in rats and rabbits.

Post-marketing safety data of the marketed vaccine.

Published literature on the vaccine's safety and efficacy.

After detailed examination of the submitted documentation and data, the expert panel gave the go-ahead to conduct the Phase III clinical trial specifically in healthy pregnant women, as per the protocol submitted by the company.

Also Read: Indian Immunologicals, ICMR to develop Zika Vaccine

Indian Immunologicals Limited (IIL) is a leading biotechnology company based in Hyderabad, India, and a subsidiary of the National Dairy Development Board (NDDB). Established in 1982, IIL is known for its significant contributions to human and animal health through the development and production of high-quality vaccines. The company manufactures a wide range of vaccines, including those for rabies, hepatitis, measles, and tetanus, and is recognized for its strong R&D capabilities and affordable healthcare solutions.

indian immunologicalsmaternal healthvaccine developmentphase iii trialsclinical trialscdscosecvaccinetetanus vaccinephase iii trialpregnant womendart studybiologicalsclinical trial approvalhyderabadbiotechnddbvaccine safetyreproductive toxicitycdsco sec meeting
Dr. Kamal Kant Kohli
Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

Show Full Article
Next Story

Editorial

ABYSS Trial Finds Elevated BP, HR & Deleterious CV Outcomes After Beta blocker Withdrawal Post-MI: EuroPCR 2025 Update

ABYSS Trial Finds Elevated BP, HR & Deleterious CV Outcomes After Beta blocker Withdrawal Post-MI:...

Aspirin Use in Male Smokers Aged 40-45 Years with Hypertension: Identifying the Ideal Candidates

Aspirin Use in Male Smokers Aged 40-45 Years with Hypertension: Identifying the Ideal Candidates

National Consensus 2025 on Role of Bisoprolol Across CV Continuum in Women: Top 10 Takeaways

National Consensus 2025 on Role of Bisoprolol Across CV Continuum in Women: Top 10 Takeaways

Relevance of Pioglitazone in Indian T2DM Care Continuum

Relevance of Pioglitazone in Indian T2DM Care Continuum

Azmarda Outperforms Generic Sacubitril/Valsartan in HFrEF Management, says new study

Azmarda Outperforms Generic Sacubitril/Valsartan in HFrEF Management, says new study

View All

Journal Club Today

AI vs. Clinicians: Study Explores the Future of Diagnosing in Healthcare

AI vs. Clinicians: Study Explores the Future of Diagnosing in Healthcare

View All

Health News Today

Health Bulletin 04/June/2025

Health Bulletin 04/June/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