Bio-entrepreneurs' bugbear: Regulatory rigmarole.

ABSTRACT

Indian biotech startup sector - a rapidly growing business segment focused on the development of innovative products has the potential to make significant contributions to the country's economy. Indian bio-entrepreneurs' optimistic expectation of rapidly moving product development from bench to bedside faces tremendous challenges of the complex Indian regulatory system, which is shaped by a diversity of regulatory authorities, rules, guidelines, and processes. This brief review discusses specific regulatory issues faced by bio-entrepreneurs investing in a variety of innovative products - new drugs, vaccines, medical devices, cell, and gene therapy and suggests approaches which can ease Indian entrepreneur's endeavors.