India’s biosimilar regulations

· TGI - Regulatory

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




Leave a Reply

Fill in your details below or click an icon to log in: Logo

You are commenting using your account. Log Out /  Change )

Google+ photo

You are commenting using your Google+ account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )


Connecting to %s

%d bloggers like this: