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.

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.

Evidence that the new variant dulls drugs and vaccines’ efficacy creates uncertainty for 2022, but new products are in the wings.