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India Regulatory

Focus Area: Global Regulatory

India Regulatory

In 2013, Indian regulators moved towards implementing a series of clinical trial regulations that had far-reaching detrimental effects on the Indian clinical research industry.

New regulations include the provision that sponsors must provide compensation for any clinical trial participant who is injured or who dies while in a trial, regardless of whether participation in the trial directly caused the injury or death. In response to this increased liability, many global sponsors, such as the National Institutes of Health, placed ongoing clinical trials in India on hold.

In 2013 and 2014, the MRCT Center has worked closely with industry stakeholders and government officials to develop alternative reforms that would not only reinvigorate the industry but also ensure the welfare of trial participants. As part of these efforts, 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.

mrct_india_group

Current status: ongoing

Impact:

Development of alternative reforms for Indian clinical trial regulations will enable the India clinical research industry to flourish and create safeguards for 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
  • Technical and privacy aspects of required videotaping of the consent process
  • Compensation and causality requirements

Key Milestones:

  • January 2014 — Output of roundtable included a draft of detailed recommendations embodying the consensus of different stakeholders, including leading academicians, investigators, industry representatives and government officials who met on January 20 and 21, 2014 to discuss the proposals of Prof. Ranjit Roy Chaudhury’s Committee. This document also suggests additional issues that the Ministry of Health and Family Welfare, Government of India, may wish to reconsider when implementing the reforms involving clinical research regulations 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
  • May 2017 — Submitted comments on new draft rules in India

Project Leader: Barbara Bierer