India Pharma Outlook Team | Friday, 06 June 2025
 (1).png "CDSCO Clears Phase III Trial of Tetanus Vaccine in Pregnant Women")
The major boost for maternal immunization in New Delhi, the Subject Expert Committee (SEC) on Vaccines of the Central Drugs Standard Control Organisation (CDSCO) has approved conducting the Phase III clinical trial of Indian Immunologicals Limited's (IIL) Tetanus Vaccine (Adsorbed, I.P.) among healthy pregnant women.
The proposal was tabled at the May 22, 2025, SEC meeting in a hybrid format. The committee re-raised the Hyderabad-based company (File No BIO/CT/23/000129) proposal, which was already tabled in February 2024.
To address the observation of the committee earlier, Indian Immunologicals submitted extensive details, including Developmental and Reproductive Toxicity (DART) rat and rabbit studies, post-marketing safety outcomes of the vaccine currently licensed. Peer-reviewed published literature testifying to the vaccine's safety and efficacy profile.
After reviewing closely documents submitted closely, the SEC accorded the subsequent stage of clinical evaluation to allow IIL to continue its Phase III trial among pregnant women as per the proposed protocol.
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Indian Immunologicals Limited, the pioneering biotech company based in Hyderabad, owned by the National Dairy Development Board (NDDB), has been a trendsetter in low-cost healthcare. Its efforts, since its establishment in 1982, have been spearheaded in vaccine research both for human and veterinary drugs, and it has a glittering portfolio that encompasses rabies, hepatitis, measles, and tetanus vaccines. The company is also stated to have a sound R&D infrastructure and dedication to public health innovation.
The move is a significant milestone towards providing safe and effective immunization products for pregnant women in India, again emphasizing preventive healthcare and the maternal health impetus of the country.
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