India’s First Pneumonia Vaccine Gets DCGI Approval
The Union Health Ministry said that the country’s first fully developed vaccine against pneumonia has received approval from the Drug Controller General of India (DCGI).
With the help of the Special Expert Committee (SEC) for vaccines, the drug regulator reviewed the phase I, II and III clinical trial data submitted by the Pune-based firm Serum Institute of India and then granted market approval for the pneumococcal polysaccharide conjugate vaccine.
The vaccine is administered intramuscularly.
The ministry said that the vaccine would be used for active immunisation against pneumonia and an aggressive disease caused by ‘Streptococcus pneumoniae’ among infants.
The Serum Institute of India first received DCGI approval to conduct Phase I, II, and III clinical trials of the vaccine in India. These tests have since been conducted within the country. The company also conducted clinical trials in The Gambia.
Subsequently, the company applied for approval and permission to manufacture the vaccine.
The Special Expert Committee (SEC) recommended allowing the said vaccine to the market authority. The Ministry stated that on July 14, the Serum Institute of India Private Limited was permitted to manufacture the first domestically developed pneumococcal polysaccharide conjugate vaccine.
“This is the first indigenously developed vaccine in the field of pneumonia,” it said.
Earlier, the demand for vaccine by licensed importers in the country was largely met as the manufacturers were all vaccine companies outside India.
