Over the last few years, the number of clinical trials in India has dropped by 90%. In March 2018, India’s Health Ministry released a comprehensive set of rules for clinical trials that will apply to all new drugs. The rules, covering everything from academic study standards to manufacturing permissions and inspections, are a big step forward. These rules aim to address problems that have held back the sector, such as a lack of standardization in reviewing research applications.
The new regulations clearly define the requirements for academic studies, the role of the central licensing authority, and trial protocols. They state that clinical trials must establish data to verify a new drug’s pharmacodynamics, pharmacokinetics, and adverse effects. The draft rules will be open for 45 days to receive comments from industry and other stakeholders.