New Delhi: Bharat Biotech has told the Drugs Controller General of India (DCGI) that it proposes to develop India’s first indigenous tuberculosis vaccine.
The Hyderabad-based pharma company has submitted the proposal to initiate the phase 1 and 2 clinical trials in India, a global TB hotspot.
A DCGI expert panel has sought more details about the safety data and treatment plan for subjects.
Also, details have been sought on whether trial cohorts include household contacts, recovered patients, and people who may have the TB bacteria but not full-blown TB.
The Indian Council of Medical Research is also working to develop a TB vaccine.
India is home to more than 2 million TB patients and the Union health ministry is running several programs to eliminate TB by 2025.
The country currently uses BCG preventative shots, which are administered to babies.
However, BCG shots are not thought to be very effective— even vaccinated people can contract the disease.
The DCGI panel also asked the firm to chalk out a treatment plan for any subject who may develop TB in the one-year follow-up period.
Queries were sent to the health ministry and the Bharat Biotech spokesperson did not elicit a reply.
Reported TB cases in 2019 stood at close to 2.4 mn in 2019.
In 2022, the number increased significantly to more than 2.4 mn.
Recently, union health minister Mansukh Mandaviya stressed the urgent need for a TB vaccine and said that it important to fast-track its development and expand manufacturing capacities.
