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W 48: Regulatory Turnaround Makes India an Increasingly Attractive Location for Clinical Research
Suneela Milind Thatte
Vice President, Global Operations
This poster will describe recent changes in the regulatory environment for clinical trials in India, highlighting recent improvements and lessons learned.
ORAL PRESENTATION SCHEDULED: Session 2B at 1:10- 1:20 PM
Various successful advocacy approaches have been implemented in India, resulting in improved clinical trial regulations due to broader stakeholder involvement, engagement with professional and industry associations, discussions on operational challenges and policy matters, and media education.
Today, India has 17% of the world’s population and 20% of the global disease burden (the highest in the world). In common with other emerging markets, India faces a ‘triple burden’ of communicable disease, non-communicable disease and socio-behavioral illness. Despite this unmet medical need, less than 1.4% of global clinical trials take place in India (source: www.clinicaltrials.gov).
As India emerges from a challenging period in its regulatory environment, the country is poised to become an increasingly attractive location for clinical research. This followed a period of
decline in clinical research activity in 2013 – 2014 in India as a result of negative activism, sensational media reporting and constant scrutiny of the regulators by parliament and the judiciary which led to a slew of new regulations, guidelines and orders. While the intent of these regulations was to ensure patient safety and data integrity, they were issued without appropriate stakeholder consultation or operational guidance
Regulators also spent significant time responding to queries from the court and parliament, impacting their ability to process new drug and clinical trial applications in a timely fashion. The resulting long, unpredictable timelines, coupled with new regulations, resulted in a decline in clinical research in India by commercial organizations, academic institutions and individual investigators. Patients, who were denied an opportunity to participate in clinical trials, were the worst affected stakeholders of clinical research process.
The future for Indian clinical trials looks promising. As a result of consistent advocacy and ongoing dialogue with regulatory and policy makers, there has been a significant change in the regulatory environment.
Lessons learned include the importance of supporting responsible and ethical research through:
• Broader stakeholder involvement
• Advocacy on operational challenges and policy matters
• Actively providing feedback to regulators
• Engaging with industry associations, such as the Organization of Pharmaceutical Producers of India (OPPI), Confederation of Indian Industries (CII) Federation of Indian Chambers of Commerce and Industries (FICCI) and professional associations like Indian Society for Clinical Research (ISCR)
• Active engagement in media education and awareness.
All these elements have had a positive impact, culminating in a promise from India’s Drug Controller General Dr. G.N. Singh that his goal involved “streamlining regulatory procedures without compromising patient safety.” (source: http://www.cdsco.nic.in/writereaddata/DCGI%20Message(1).pdf)
Indian regulators have now adopted a consultative approach, and are committed to creating a more rational and scientific framework for clinical trials in India. Investments are being made to strengthen the regulatory infrastructure, including training of regulatory personnel, leading to shorter timelines for clinical trial approvals. Balanced compensation guidelines are also in place.
The approach of the regulators is more collaborative and open and they have repeatedly assured stakeholders of their commitment to bringing clinical research back on track in India. There are also indications of regulatory capacity building being taken seriously where, there will be an opportunity for industry and academia to partner with the regulators. These ongoing efforts continue to shape the regulatory environment through dialogue and collaboration.