As the COVID-19 pandemic continued in 2021, the off-patent industry stepped in to provide relief in a variety of ways, whether through securing supplies of essential medicines or helping to manufacture and distribute newly-developed treatments.

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.

The vaccines segment continues to draw the interest of participants beyond those firms with a traditional core presence, with new players largely building partnered capabilities around COVID-19 inoculations. Are these merely opportunistic forays or will the competitive landscape for vaccines stand altered more widely?

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.