On 15, July 2020 The Ministry of Health and Family Welfare(MoHFW) informed that, the Drug Controller General of India(DCGI) has given approval to India’s first fully indigenously developed vaccine against pneumonia, Pneumococcal Polysaccharide Conjugate Vaccine. The vaccine has been developed by M/s. Serum Institute of India Pvt. Ltd, Pune.
- DCGI has also granted permission to manufacture the vaccine domestically.
About Pneumococcal Polysaccharide Conjugate Vaccine
i.The Pneumococcal Polysaccharide Conjugate Vaccine is used for active immunization against invasive disease and pneumonia caused by ‘Streptococcus pneumonia’ in infants.
ii.It is administered in an intramuscular manner(intramuscular injection is a technique used to deliver a medication deep into the muscles).
Key Info regarding the trials and approval
i.DCGI gave approval to Serum Institute to conduct Phase I, Phase II and Phase III clinical trials of the Vaccine in India.
ii.Apart from India they have also conducted these clinical trials in Gambia
iii.The application for approval and permission to manufacture this vaccine along with the clinical trial data was reviewed by DCGI with the help of the Special Expert Committee(SEC) for vaccines.
The Central Drugs Standard Control Organisation(CDSCO) under the Directorate General of Health Services,Ministry of Health & Family Welfare ,Government of India is the National Regulatory Authority (NRA) of India.
As per the Drugs & Cosmetics Act,1940 CDSCO is responsible for approval of Drugs, Conduct of Clinical Trials among others.
DCGI– V. G. Somani
Union Minister– Harsh Vardhan
Minister of State– Ashwini Kumar Choubey