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Steps Taken for setting up of cGMP facility for yellow fever drugs by the government of India

To ensure that Indian vaccine manufacturers have global quality standards, the government is exploring the feasibility of establishing WHO approved Current Good Manufacturing Practice (cGMP) facility for yellow fever drugs which will help in supplying yellow fever vaccine to African and Latin American countries as well.

The first government facility for cGMP compliance for DPT and TT vaccines has been established at the Central Research Institute (CRI) in Kasauli in Himachal Pradesh. TT vaccine has been commercialized from this facility for universal immunization programme use and production of DPT bulk has been initiated. Recent advancements in regulatory requirement and introduction of cGMP concept in vaccine manufacturing led to the need for creation of cGMP compliant infrastructure and processes.

As it is essential for vaccine manufacturers to have global quality standards, CRI is exploring the feasibility of establishing WHO prequalified cGMP compliant manufacturing facility for yellow fever vaccine. This will enable the institute to supply yellow fever vaccine to African and Latin American countries. The Health Minister said as part of its expansion plans, CRI is in process of acquiring 128 bighas of land from the Himachal Pradesh government for creation of cGMP compliant facility for manufacturing of therapeutic anti-serums.

CRI plans to create state of the art, fully dedicated cGMP compliant laboratory for research on vaccine development and various other public health related issues. The institute plans to undertake research on newer vaccine candidates for existing and emerging diseases and to manufacture more efficacious and safer vaccines as also to contribute to the prevention of spread of novel antigenic variants.



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