India’s biosimilar regulations

· TGI - Regulatory
Authors

India‘s biosimilar regulations

Killugudi Jayaraman

Nature Biotechnology 30, 815 (2012); doi:10.1038/nbt0912-815b

Published online 10 September 2012

New guidelines for “similar biologics” launched August 15 will help address local patient access to expensive drugs while serving to attract international manufacturers to India. The Department of Biotechnology and Central Drugs Standard Control Organisation developed the regulatory framework with input from industry and academia. Under the new guidelines, manufacturers…

source: nature

 

 

 

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