DCGI approves India’s first indigenous pneumonia vaccine by Serum Institute

New Delhi: Drug Controller General of India (DCGI) has given approval to the first fully indigenously developed Pneumococcal Polysaccharide Conjugate Vaccine on 14th July, 2020. This vaccine has been developed by Pune based Serum Institute of India.

Serum Institute had earlier btained the approval to conduct Phase I, Phase II and Phase III clinical trials of Pneumococcal Polysaccharide Conjugate Vaccine in India. The trials have since been concluded within the country besides in another country, Gambia.

The clinical trial data submitted by the company has been reviewed by the Office of Drug Controller General of India with the help of Special Expert Committee (SEC) for vaccines.  Finally, the Committee recommended for grant of permission of market authorization to the said vaccine.

This is the first indigenously developed vaccine in the field of pneumonia. 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.

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.