The regulatory environment has already transformed from “resistive to conducive” with the introduction of COVID-19 vaccines with further regulatory reforms likely to expedite the development of gene therapy products in the pipeline. With more than 100 biosimilars approved in India, compared to less than half in Europe, or one-third in the US, can India position itself as a global contender in new gene therapy development?


Unlike the capital-intensive and heavily infrastructure-dependent biotech manufacturing, oligonucleotide manufacturing may be relatively easier to manufacture and scale-up. The cell-based genetic engineering and viral vector-carried gene transfer therapies will be much more sophisticated but are already being worked upon by a few companies in India.