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Bharath Biotech Gets CDSCO Panel Nod To Manufacture Cholera Vaccine, Inactivated, Oral for 1 year age and above
New Delhi: Noting the outcome of inspections of clinical trial sites conducted by the Central Drug Standard Control Organisation (CDSCO), the Subject Expert Committee (SEC) functional under the CDSCO has granted approval to the vaccine makers Bharat Biotech for manufacturing Cholera vaccine (Inactivated, Oral) for the age group of 1 year and above.This came after the vaccine maker Bharat...
New Delhi: Noting the outcome of inspections of clinical trial sites conducted by the Central Drug Standard Control Organisation (CDSCO), the Subject Expert Committee (SEC) functional under the CDSCO has granted approval to the vaccine makers Bharat Biotech for manufacturing Cholera vaccine (Inactivated, Oral) for the age group of 1 year and above.
This came after the vaccine maker Bharat Biotech presented the Phase-III clinical trial report, including immunogenicity and safety results as per the approved protocol for granting manufacturing permission for the Cholera vaccine (Inactivated, Oral).
In light of the recommendation of the SEC Vaccine meeting dated 18.07.2023, inspections of clinical trial sites were conducted by CDSCO. The committee noted the outcome of the inspections.
Cholera is an acute diarrhoeal infection caused by ingestion of food or water contaminated with the bacterium Vibrio cholerae. Cholera remains a global threat to public health and an indicator of inequity and lack of social development.
Cholera is an extremely virulent disease transmitted through the ingestion of contaminated food or water. Cholera can cause severe acute watery diarrhea and the severe forms of the disease can kill within hours if left untreated.
At the recent SEC meeting for Vaccine held on 27th March 2024, the expert panel reviewed the Phase III clinical trial report including immunogenicity and safety results of the Cholera vaccine (Inactivated, Oral) presented by Bharat Biotech.
After detailed deliberation, the committee recommended the grant of manufacturing permission for the Cholera vaccine (Inactivated, Oral) for the age group of 1 year and above.
Also Read: CDSCO Panel Approves J&J's Protocol Amendment Proposal For Amivantamab, Lazertinib combination
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Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.
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: editorial@medicaldialogues.in. Contact no. 011-43720751