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If India’s biopharmaceutical players are to compete effectively on the global scale and capture 10% of the global biosimilars market by 2020, India’s private sector will have to invest a considerable amount of capital in building the necessary manufacturing capacity and skills base. At the same time, the Government of India (GOI<\/span>) will also need to provide the necessary enabling environment. India’s biopharma sector consists primarily of vaccines, monoclonal antibodies, recombinant proteins and diagnostics, and the guidelines for biosimilars are already in place. All India needs to take market share is entrepreneurship.<\/p>\n The GOI’s Department of Pharmaceuticals, in partnership with the biotechnology industry body ABLE<\/span><\/a> and PricewaterhouseCoopers<\/a> have taken up the task of addressing this opportunity and provided recommendations into the following six sections: R&D; manufacturing and commercialization; human capital; the regulatory framework; innovation; and intellectual property.<\/p>\n 1 Research and Development<\/b><\/p>\n \u2022\tBuild protein characterization laboratories and GLP<\/span>-certified animal study facilities<\/p>\n \u2022\tCreate a national animal breeding facility<\/p>\n \u2022\tExpand viral testing facilities<\/p>\n \u2022\tProvide financial assistance for ensuring compliance with global standards<\/p>\n \u2022\tPromote the development of pre-clinical service providers<\/p>\n \u2022\tProvide practical support for clinical trials<\/p>\n \u2022\tSimplify the procedures for importing and exporting biologics<\/p>\n 2 Manufacturing and Commercialization<\/b><\/p>\n \u2022\tCreate a single-window system for approvals and clearances<\/p>\n \u2022\tIntroduce flexible pollution controls<\/p>\n \u2022\tInvest in better transport links and cold-chain facilities<\/p>\n \u2022\tProvide fiscal incentives<\/p>\n 3 Human Capital<\/b><\/p>\n \u2022\tExpand India’s capability in toxicity studies<\/p>\n \u2022\tFoster a trilateral relationship between industry, academia and government<\/p>\n \u2022\tImprove and expand the workforce development pipeline<\/p>\n \u2022\tEstablish exchange programmes, “finishing schools” and scholarships<\/p>\n \u2022\tIncrease public awareness about career opportunities in the industry<\/p>\n \u2022\tProvide more training for existing employees<\/p>\n 4 The Regulatory Framework<\/b><\/p>\n \u2022\tSimplify the procedure for approving biologics<\/p>\n \u2022\tCreate an independent inspection facility<\/p>\n \u2022\tModify the regulations on process validation<\/p>\n 5 Innovation<\/b><\/p>\n \u2022\tProvide seed funding for innovation<\/p>\n \u2022\tConstruct biotechnology clusters<\/p>\n \u2022\tPromote translational research<\/p>\n 6 Intellectual Property<\/b><\/p>\n \u2022\tProtect innovation<\/p>\n \u2022\tApprove the bill liberalizing the commercialization of intellectual property generated in state-funded institutions<\/p>\n In the next few blog posts, I will be discussing these six sections of India’s Vision 2020: BioPharma Strategy.<\/p>\n Viren Konde<\/a><\/p>\n","protected":false},"excerpt":{"rendered":" If India’s biopharmaceutical players are to compete effectively on the global scale and capture 10% of the global biosimilars market by 2020, India’s private sector will have to invest a considerable amount of capital in building the necessary manufacturing capacity and skills base. At the same time, the Government of India (GOI) will also need to provide the necessary enabling environment. India’s biopharma sector consists primarily of vaccines, monoclonal antibodies, recombinant proteins and diagnostics, and the guidelines for biosimilars are already in place. All India needs to take market share is entrepreneurship. The GOI’s Department of Pharmaceuticals, in partnership with … Read more<\/a> Continue reading