Elucidating the Guidelines on Similar Biologics for India


20 reviewers and inspectors from CDSCO will be attending the “Elucidating the Guidelines on Similar Biologics for India” at the Third Training Event of the DBT COE for Biopharmaceutical Technology. The event will be held at IIT Delhi from 12th to 14th December. Eight courses to be taught from World Class faculty.

The Center of Excellence for Biopharmaceutical Technology (CBT) was established at IIT Delhi in 2015 by the Department of Biotechnology, Government of India, in recognition of the importance of Biotechnology for India, particularly that of producing affordable biotech therapeutics.

The vision of CBT is to deliver innovation in biopharmaceutical technology to effectively address the challenges faced by the Indian biotech industry and thereby assist in the “Make in India” initiative by making India the global hub of manufacturing economical, safe and efficacious therapeutics.

CBT aspires to achieve this tall objective by providing a foundation of scientific and technology development to create novel technologies, engage with the biotech industry to translate these into applications, and finally to offer short-term training courses to industry, academia, and regulatory agencies to facilitate creation of an ecosystem that delivers affordable biotech therapeutics to India and to the world.

CBT is bringing forth a world-class training program that brings together leaders from across the world to come together and share the best practices and cutting-edge technologies on a diverse set of topics:

  • Elucidating the Guidelines on Similar Biologics for India
  • Continuous Processing for production of Biopharmaceuticals
  • Process Optimization and Scale-Up with Single-Use Bioreactors
  • Formulation and Stability of Biotherapeutic Product
  • Multivariate Data Analysis for Bioprocessing Data
  • Proteomic Characterization of Biotherapeutics
  • Design of Experiments

Regulatory approval is the desired endpoint of all development and commercialization activities in the biopharmaceutical industry. A critical aspect of similar biologics development is having comprehensive regulatory guidelines. Indian regulatory authorities published the Guidelines on Similar Biologics in 2012 with a revision in 2016. This proposed three-day course aims to strengthen our regulators and the industry on the various aspects of the Guidelines: process and analytical development, preclinical and clinical development, and regulatory and GMP issues that relate to development and manufacturing of biopharmaceutical products. The audience is expected to consist primarily of Indian regulators and other stakeholders that play a key role in the approval process. Limited participants from the Indian biotech industry will also be accommodated.

For more details (about the lectures): http://cbt.iitd.ac.in/assets/cbt_2018_brochure_29102018.pdf 


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