India Strengthens Collaboration with WHO for Global Public Health: MoS Patel

Patel highlighted the government’s ongoing efforts to modernize its regulatory framework in line with international expectations.

India is enhancing its global collaboration with international organizations and regional networks to harmonize regulatory standards in the area of medical devices and diagnostics, said Union Minister of State for Health and Family Welfare, Anupriya Singh Patel.

In a recent event, Patel underscored India's commitment to aligning its regulations with global standards to ensure the safety and efficacy of medical products.

Patel further highlighted the government’s ongoing efforts to modernize its regulatory framework in line with international expectations.

“We have recently published the revised Schedule M, which aligns with WHO's Good Manufacturing Practices (GMP) requirements for medical products, including biologicals and investigational products,” she said.

These updated regulations, coupled with the implementation of e-governance for all regulatory procedures, have strengthened the regulation of medical products in India, improving transparency and efficiency.

New rules for clinical trials and medical devices, such as the New Drugs and Clinical Trial Rules (2019) and the Medical Device Rules (2017), have promoted ethical and scientific research on par with global standards.

The medical device regulations include a risk-based classification system, bringing all devices under regulatory control through a robust registration process and clearly defined regulatory pathways.

Global Collaboration

Patel emphasized India’s growing collaboration with international organizations such as the International Medical Device Regulators Forum (IMDRF), the International Organization for Standardization (ISO), WHO, and regional networks such as the South-East Asia Regulatory Network (SEARN).

These partnerships aim to harmonize regulatory requirements for medical devices and diagnostics, ensuring a consistent approach to safety and quality.

India's recent recognition as an affiliate member of the IMDRF marks a significant step towards global regulatory harmonization.

Patel also highlighted the recognition of the Indian Pharmacopoeia by the Pharmacopoeial Discussion Group (PDG) as another important milestone in aligning India's regulatory standards with international benchmarks.

“We are committed to further strengthening our collaboration with the WHO to contribute to various areas, including promoting good regulatory practices and improving global public health,” Patel said.

Focus on AMR

India is also prioritizing the containment of antimicrobial resistance (AMR), a growing global health challenge.

Patel noted that India is building a comprehensive strategy to manage and control AMR effectively. “We are actively working to ensure the judicious use of antimicrobials and strengthen surveillance and monitoring systems,” she said.

In addition to addressing AMR, India is focusing on incorporating new technologies into its regulatory processes. Patel praised the WHO for promoting the use of advanced technologies like anti-counterfeiting tools, pharmacovigilance systems, and a reduction in animal experimentation.

She also emphasized the importance of collaboration, deliberation, and inclusive decision-making, which bring together all stakeholders for the best possible outcomes in healthcare.

Artificial intelligence (AI) is transforming healthcare, and India is eager to adopt these technologies to improve patient care and accelerate research. Patel expressed the government's enthusiasm for the potential of AI in healthcare.

“AI can assist us in making quicker decisions, enhancing patient care, and speeding up research. By adopting new technologies, we can offer improved services to our people and achieve better health outcomes,” she said.

India's Post-Pandemic Regulatory Achievements

Dr VK Paul, Member (Health) of NITI Aayog, spoke at the ICDRA event, highlighting India's regulatory advancements during the COVID-19 pandemic.

He noted that India licensed eight vaccines through a rigorous regulatory process and developed a range of vaccines, including mRNA, DNA, and nasal vaccines, at a fraction of the cost of other global alternatives.

“The COVID-19 pandemic underscored the importance of a robust regulatory system, and India has risen to the challenge by delivering affordable and effective solutions,” said Dr. Paul.

He added that India’s rich traditional system of medicine, practiced for centuries, should be mainstreamed to improve healthcare outcomes.

Dr Paul emphasized the future of healthcare being driven by technology, pointing to India’s strong talent pool and government initiatives on digital health and medical infrastructure as key drivers of this transformation.

Dr Rajiv Bahl, Secretary of the Department of Health Research and Director General of the Indian Council of Medical Research (ICMR), highlighted the crucial role of regulators in health research.

He cited India's rapid development of indigenous diagnostic tests during the early stages of the pandemic at a fraction of the cost of imported tests.

Within nine months, India also approved a COVID-19 vaccine, showcasing the nation's capability in fast-tracking innovation while adhering to rigorous regulatory standards.

Bahl further informed the audience about the development of three diagnostic tests for MPox, which were approved by CDSCO, highlighting India's commitment to rapid diagnostic development.

Regulatory Innovation

Dr Yukiko Nakatani, Assistant Director-General of the WHO, emphasized the importance of a strong regulatory system, which was highlighted during the pandemic.

She congratulated India for achieving Maturity Level III in vaccine regulation and stressed the need for continued collaboration to strengthen global regulatory frameworks.

Kimberlee Trzeciak, Deputy Commissioner of the US Food and Drug Administration (FDA), also addressed the conference, discussing the opportunities and risks associated with advanced drug manufacturing practices.

She also stressed the need for global regulatory bodies to collaborate closely to ensure compliance with quality standards and adapt to new manufacturing technologies.

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