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First fully indigenously developed Pneumococcal Polysaccharide Conjugate Vaccine approved by DCGI

First fully indigenously developed Pneumococcal Polysaccharide Conjugate Vaccine approved by DCGI

The first fully indigenously developed Pneumococcal Polysaccharide Conjugate Vaccine has received the approval of the Drug Controller General of India (DCGI). The vaccination is done to immunize infants actively against invasive diseases and pneumonia that are caused by “Streptococcus pneumonia”.

Key Points:

  • The Pneumococcal Polysaccharide Conjugate Vaccine is administered in an intramuscular manner.
  • The development of the vaccine has taken place in the Serum Institute of India, Pune.
  • The approval for conducting the Phase-I, Phase-II and Phase-III clinical trials of Pneumococcal Polysaccharide Conjugate Vaccine in India was obtained by Serum Institute from DCGI, which have been concluded.
  • The company has also carried out the trials in the Gambia, a country of West Africa following which the application for approval and permission for the manufacture of the vaccine was requested.
  • The vaccine is the first indigenously developed vaccine, whereas earlier it was imported from foreign countries since all the manufacturing companies were located outside India.

Note:

  • DCGI is a department functioning under the Central Drugs Standard Control Organization and holds the prime responsibility of approving licences of specified categories of drugs.
  • DCGI functions under the Ministry of Health and Family Welfare and sets standards for manufacturing, sales, distribution and import of drugs in India.

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