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India Regulatory

Focus Area: Global Regulatory Engagement

India Regulatory

In 2013, Indian regulators moved towards implementing a series of clinical trial regulations that had significant impact on the Indian clinical research industry. The new regulations included a provision that required sponsors to provide compensation for any clinical trial participant who is injured or who dies while participating in a trial, regardless of whether participation in the trial directly caused the injury or death. In response to this increased liability, many global non-profit, academic, and industry sponsors placed ongoing clinical trials in India on hold.

Since 2013, the MRCT Center has worked closely with government officials, industry stakeholders, investigators, and others to develop alternative reforms that would not only reinvigorate the industry but also ensure the welfare of trial participants. As part of these efforts in January 2014, the MRCT Center convened a two-day roundtable discussion in Delhi between leading academicians, investigators, industry representatives, and government officials. The roundtable culminated with the MRCT Center meeting privately with the Indian Secretary of Health and Family Welfare to detail consensus opinions reached by the roundtable. Since that time, the MRCT Center has visited India repeatedly to work with regulators and others to promote and sustain impactful change.

mrct_india_group

Current status: Ongoing

Impact: Development of workable revisions to Indian clinical trial regulations that will enable the India clinical research ecosystem to flourish while maintaining the highest standards of protections for clinical trial participants.

Objectives:

Work closely with Indian leaders to determine tractable solutions to regulatory reform issues including:

  • Accreditation of sites and ethics committees; certification of investigators
  • Highest standards for execution of the informed consent process
  • Compensation and causality requirements
  • Dynamic process improvements to enable efficient and effective clinical trial performance
  • Predictable and reasonable timelines for regulatory review, response, and/or approval

Key Milestones:

  • January 2014: Output of January 20 and 21, 2014, Roundtable included a draft of detailed recommendations embodying the consensus of different stakeholders, including leading academicians, investigators, industry representatives, and government officials. This document also suggested additional issues that the Ministry of Health and Family Welfare, Government of India, may wish to reconsider when implementing clinical research regulatory reform in India.
  • November/December 2014: Publications in Financial Express, Business Line, and Bloomberg BNA related to clinical trial regulations in India and proposed amendments to Drugs and Cosmetics Act.
  • October 2015: Meetings with regulators and thought leaders in Delhi, India
  • March 2016: Meetings with regulators, investigators, representatives of industry, academia, non-profit organizations and patient advocacy groups in Delhi and Mumbai, India
  • March 2017: Additional meetings with representatives in India
  • May 2017: Submitted comments on draft rules in India
  • March 2018: Submitted comments on updated draft rules in India
  • June 2018: Meetings with regulators, investigators, and industry in Delhi and Mumbai, India

Project Leaders: Barbara Bierer, Mark Barnes