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Vigyaan Lecture 3

Central Drugs Standard Control Organisation (CDSCO) is the national regulatory authority of India responsible for approving new drugs and clinical trials. It is also responsible for laying down standards for drugs, overseeing quality of imported drugs, and coordinating activities of state drug control organisations for granting licenses of blood products, vaccines, and sera. Biotechnology Industry Research Assistance Council (BIRAC) is a not-for-profit public sector organization set up by the Department of Biotechnology to strengthen the biotech industry through strategic research, addressing national product needs. The National Biopharma Mission aims to accelerate biopharmaceutical development through industry-academia collaboration, including developing vaccine and biosimilar leads and upgrading shared infrastructure facilities.

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56 views12 pages

Vigyaan Lecture 3

Central Drugs Standard Control Organisation (CDSCO) is the national regulatory authority of India responsible for approving new drugs and clinical trials. It is also responsible for laying down standards for drugs, overseeing quality of imported drugs, and coordinating activities of state drug control organisations for granting licenses of blood products, vaccines, and sera. Biotechnology Industry Research Assistance Council (BIRAC) is a not-for-profit public sector organization set up by the Department of Biotechnology to strengthen the biotech industry through strategic research, addressing national product needs. The National Biopharma Mission aims to accelerate biopharmaceutical development through industry-academia collaboration, including developing vaccine and biosimilar leads and upgrading shared infrastructure facilities.

Uploaded by

varshayadav231020
Copyright
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We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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CDSCO: Central Drugs standard Control

Organisation
National India.
Regulatory, Authority of
-

Responsible for: approval of New drugs


approval of clinical trials
.

down standards for drugs


laying
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·
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quality of imported drugs
&2 in
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act coordination of activities of State Drug
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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.

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