BRICS clinical research framework can position member nations as global innovation hubs: ISCR

The ongoing efforts for collaboration among the Medical Products Regulatory Authorities of BRICS member countries to consolidate the best regulatory practices followed by each of them can be a defining step towards a more aligned, quality-led and innovation-focused clinical research ecosystem across BRICS nations, says Dr. Seema Pai, President, Indian Society for Clinical Research (ISCR).

In an email response to Fortune India, she said a shared BRICS good clinical, laboratory, and manufacturing practices (GxP) framework can collectively position BRICS countries as globally relevant innovation hubs, with mutual capability-building as a shared strategic goal. It can result in greater consistency in quality systems, operational processes, investigator capability, data governance and responsible use of AI, she said.

“For India, this agenda builds on a strong foundation: a maturing regulatory environment, internationally experienced investigators, expanding site capabilities and a proven track record of contributing high-quality data to global clinical development programmes and regulatory submissions. India is not entering this conversation from the margins; it is well positioned to help shape it," Dr. Pai said.

The New Delhi Declaration of the BRICS country heads during its 18th annual Summit hosted by India had encouraged stronger collaboration among the national drug regulatory agencies of BRICS nations by extending the scope of the existing Memorandum of Understanding on cooperation in the field of medical products regulation to the Regulatory Authorities of all BRICS Member countries.

It had also reiterated the importance of strengthening collaborative regulatory approaches to ensure the continued availability and accessibility of quality, safe, and efficacious medical products. The New Delhi Declaration had also lauded the collective efforts of BRICS Regulatory Authorities in developing the BRICS GxP White Paper, consolidating best practices of regulatory experience and technical approaches.

Dr. Pai said India’s readiness to be part of such a collaborative effort should be viewed with confidence and ambition. “Many Indian sites already operate to global sponsor expectations and have demonstrated the ability to deliver complex, multi-country studies with robust quality, ethics oversight and data integrity. At the same time, a harmonised BRICS GxP framework would accelerate the next phase of ecosystem strengthening by encouraging broader standardisation across all site tiers, deeper investment in specialised early-phase infrastructure, dedicated Phase-I units, advanced pharmacokinetic capabilities and consistently benchmarked quality systems," she explained.

“Given India’s scientific talent, patient diversity, digital capability and policy momentum towards global alignment, Indian sites are not only capable of meeting a common BRICS GxP standard but can become an important reference point for scalable, high-quality and inclusive clinical research across emerging markets," she added.

According to her, a BRICS GxP framework can and should move the needle on globally benchmarked quality systems. “From ISCR’s perspective, a shared BRICS GxP framework offers an important opportunity to recognise the quality maturity that already exists across BRICS countries, including India, and to reinforce confidence in the ethical, scientific and operational standards with which these countries have been contributing to global clinical development for many years," she said.

For India, the 2019 New Drugs and Clinical Trials Rules have been an important inflection point, providing greater regulatory clarity, predictability and confidence for global clinical development in the country. National initiatives such as Biopharma SHAKTI, together with the broader Viksit Bharat 2047 vision, are also sending a strong policy signal that India is serious about becoming a global hub for innovation, life sciences research and patient-centred drug development.

“India’s position within a BRICS GxP framework should therefore be affirmatory and forward-looking: India is prepared to contribute high-quality evidence, shape harmonised standards, expand inclusive access to research and help define a more balanced, globally credible clinical research ecosystem for the future," Dr. Pai said.