With the aim of creating a conducive environment that fosters research and new drug development in India, the government has amended some critical clauses and framed new guidelines that are aligned to global regulations.
In an interview with BioSpectrum Asia Magazine, Suneela Thatte, president, Indian Society for Clinical Research said that India now has a very robust regulatory environment which is focused on quality, and where patient safety and confidentiality is not compromised.
“The compensation guidelines for clinical research are now more balanced and rational, and formulae have been introduced by the regulators for calculating the financial compensation based on a no-fault principle. This not only provides ease of implementation and consistency but also helps the sponsor of the trial to understand the maximum possible liability and plan appropriately while protecting the patient well being,” she said.
Restrictions on the number of clinical trials an investigator could do at a given point in time, and the minimum number of beds a clinical trial site needed to have, have been removed.Thatte added, “We hope the new regulatory environment will encourage more innovative and path-breaking R&D in our local biopharma companies as also in many of our well established teaching and academic institutions.
