Updated on 21 September 2016
Ms Suneela Thatte, president, ISCR
Singapore: Factors such as technically competent workforce, large genetically diverse population, easy patient availability make India one of the most preferred destination for clinical trials. However the booming clinical trial industry was hit in the past few years due to the uncertain regulatory environment in the country and as a result many foreign companies withdrew their clinical trials from India Fluctuations in regulations over the past few years have reduced the number of clinical trials run on the subcontinent but now governing bodies are looking at new ways to attract trials and prepare a robust regulatory framework for the billion dollar clinical trial industry in India.
In a bid to create a conducive environment that fosters research and new drug development in India, the government has amended some critical clauses and framed new guidelines in line with the global regulations. The latest changes have cheered the industry. Speaking to BioSpectrum Asia Magazine, Ms 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.
In an interaction with Ms Suneela Thatte:
Q.India's clinical trials industry has been through a trying phase for the past few years. In your opinion what could be the major reasons.
A. The last few years were extremely challenging for all stakeholders involved in clinical research in India. Various external factors - hasty regulatory reforms, judicial and social activism and some sensational/misleading media reporting- posed a challenge to the conduct of clinical research in the country.
The judicial proceeding of the Supreme Court PIL and social activism resulted in knee-jerk regulatory reforms that had patient wellbeing as an objective but were hastily thought through without any stakeholder consultation and implementation guidance. The hardest hitting was perhaps Rule 122 DAB of the Drugs and Cosmetics Act (released in January, 2013) which introduced new compensation guidelines that made it untenable for clinical research to be done in the country. Slow approval timelines and other unexpected guidelines that were also introduced in 2013-2014 made the Indian regulatory climate uncertain and unpredictable and acted as another major deterrent for sponsors of clinical research.