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