Target 140+ part 2 Lecture 16

CDSCO: Central Drugs standard Control Organisation

 National Regulatory, Authority of India.
 Responsible for:
 Approval of New drugs .
 Approval of clinical trials ·
 Laying down standards for drugs under ·
 Control over quality of imported in country ·
 Coordination of activities of State Drug ~ control organizations for granting
 License of blood products , fluids , vaccines , sera
Under drugs and cosmetics act

Cervical cancer:
 2nd most prevalent in India (1st is breast cancer)
 Caused by human papillomavirus (HPV)

HPV vaccine:CERVAVAC
 Developed by BIRAC and SII (serum institute of India )
 Given to all girls between 9 to 14 years

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

National Biopharma Mission (NBM)

 Is an industryAcademia Collaborative Mission for accelerating biopharmaceutical
development in the country (implented by BIRAC)
 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:
1. Development of product leads for Vaccines , Biosimilars and Medical Devices that are
relevant to the public health need by focussing on managed partnerships.
2. Upgradation of shared infrastructure facilities and establishing them as centres of
product discovery/discovery validations and manufacturing.
3. Developing human capital by providing specific training.
4. 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