DGCI gives nod for Pneumococcal Polysaccharide Conjugate Vaccine
New Delhi/UNI: The Drug Controller General of India (DCGI) has given its nod to the first fully indigenously-developed Pneumococcal Polysaccharide Conjugate Vaccine for pneumonia,developed by M/s Serum Institute of India Pvt Ltd, Pune.
The vaccine is used for active immunisation against invasive disease and pneumonia caused by "Streptococcus pneumonia" in infants and is administered in a intramuscular manner, an official release here said.
Serum Institute first obtained the DCGI's approval to conduct Phase I, Phase II and Phase III clinical trials of the vaccine in India which have since concluded. The company has also conducted these clinical trials in Gambia.
Thereafter, the company applied for approval and permission to manufacture this vaccine. 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 authorisation to the vaccine.
On July 14, M/s Serum Institute of India Pvt Ltd was granted permission to manufacture domestically developed first Pneumococcal Polysaccharide Conjugate 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.