First indigenous pneumonia vaccine gets DCGI approval in India

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New Delhi (NVI): The Drug Controller General of India (DCGI) has given its approval to the first fully indigenously developed Pneumococcal Polysaccharide Conjugate Vaccine for pneumonia.

The vaccine has been developed by Serum Institute of India, Pune.

This vaccine is used for active immunization against invasive disease and pneumonia caused by “Streptococcus pneumonia” in infants.  The vaccine is administered in an intramuscular manner.

Serum Institute first obtained the approval of DCGI to conduct Phase I, Phase II, and Phase III clinical trials of Pneumococcal Polysaccharide Conjugate Vaccine. These trials have since been concluded within the country. Serum Institute has also conducted clinical trials in Gambia.

DCGI looked at the evidence from human trials to allow marketing of the vaccine in the country.

A Health Ministry statement said the application along with the clinical trial data has been reviewed by the Office of Drug Controller General of India with the help of Special Expert Committee (SEC) for vaccines.

“The Committee recommended for grant of permission of market authorization to the said vaccine. On July 14, Serum Institute of India, Pune, has been granted permission to manufacture domestically developed first Pneumococcal Polysaccharide Conjugate Vaccine. This is the first indigenously developed vaccine in the field of pneumonia,” Ministry said.

Earlier the demand of such vaccine was substantially met by licensed importers in the country since the manufacturers were all vaccine companies based outside India.