2021 Saw India Enable Accelerated Regulatory Pathways – Can It Become The Norm?
India saw a raft of vaccine and drug approvals in 2021, backed by pandemic-related accelerated regulatory processes, and outlined its intent to step up biopharma innovation in the country. Pharma wants some of the regulatory flexibility to stay, though experts are seeking increased transparency in the overall approach.
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While an mRNA vaccine is still missing, 2021 saw Indian companies strike alliances, battle legal action and gain funding while the regulator played a crucial enabling role in the run up to the approval of eight COVID-19 vaccines from zero in 2020.
Merck and Lilly tackle some early challenges before striking voluntary licensing deals for COVID-19 therapies with Indian firms. Data around the use of these drugs in low- and middle-income countries could also potentially make them ‘more acceptable’ elsewhere, experts say.
Evotec's CEO and Takeda’s president of R&D provide insights around how India could shape its efforts to accelerate biopharma innovation. Backing the right technologies, fostering a culture to "stop losses" early on for projects that don't work and learning from China’s overhaul of its healthcare system were among the key takeaways.