CDSCO: Central Drugs standard Control

Organisation
National India.
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Responsible for: approval of New drugs

approval of clinical trials
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 BIRAC

Biotechnology Industry Research Assistance Council

(BIRAC) is a not-for-profit Section 8, Schedule B,
Public Sector Enterprise, set up by Department of
Biotechnology (DBT), Government of India as an
Interface Agency to strengthen and empower the
emerging Biotech enterprise to undertake strategic
research and innovation, addressing nationally relevant
product development needs.
-
The National Biopharma Mission (NBM) is an industry-
Academia Collaborative Mission for accelerating
biopharmaceutical development in the country.

BIRA)
Under this Mission the Government has launched Innovate in
India (i3) programme to create an enabling ecosystem to
promote entrepreneurship and indigenous manufacturing in
the sector.
 It has a focus on following four verticals:

O
3 Development of product leads for Vaccines , Biosimilars
and Medical Devices that are relevant to the public health
need by focussing on managed partnerships.

I Upgradation of shared infrastructure facilities and

establishing them as centres of product discovery/discovery
validations and manufacturing.

e
Developing human capital by providing specific training.

i Developing technology transfer offices to help enhance

industry academia inter-linkages.
 =
Biologics are complex drugs that are made from living
organisms or their products, such as proteins, antibodies, or
nucleic acids. They are used to treat a variety of diseases,
including cancer, autoimmune disorders, and inflammatory
conditions.

Biosimilars are similar versions of biologics that have been

approved by regulatory agencies based on their similarity to the
original biologic. Biosimilars are not identical to the original
biologic, but they have been shown to have similar efficacy and
safety profiles.