New Drugs, Medical Devices and Global Standards: India’s Regulatory Advancements

The World Health Organization (WHO) has played a pivotal role in promoting global regulatory excellence.

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Standards
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Last Updated on November 3, 2024 by The Health Master

Regulatory

India has made significant strides in strengthening its healthcare regulatory framework, aligning itself with international standards and promoting scientific and ethical research.

Key advancements, such as the New Drugs and Clinical Trial Rules of 2019 and the Medical Device Rules of 2017, have brought all medical devices under regulation through a risk-based classification system.

These measures have not only enhanced India’s reputation in the global healthcare landscape but also facilitated the development of innovative medical solutions.

A Global Perspective on Healthcare Regulation

The 19th International Conference of Drug Regulatory Authorities (ICDRA) provided a platform for India to showcase its regulatory achievements and foster collaboration with global health organizations.

Anupriya Patel, Minister of State for Health and Family Welfare, highlighted India’s commitment to harmonizing its regulatory standards with international practices, emphasizing the country’s collaboration with organizations like IMDRF, ISO, WHO, and SEARN.

WHO’s Role in Upgrading Global Regulatory Systems

The World Health Organization (WHO) has played a pivotal role in promoting global regulatory excellence.

Patel lauded WHO’s efforts in fostering partnership, reliance, experiential learning, and pharmacovigilance systems.

Additionally, WHO’s push towards adopting anti-counterfeiting technologies and reducing animal experimentation in research aligns with India’s commitment to ethical and sustainable healthcare practices.

India’s Commitment to Healthcare for All

The Indian government has demonstrated its unwavering commitment to providing accessible and affordable healthcare to its citizens.

Ayushman Bharat, the world’s largest health assurance scheme, has extended quality healthcare coverage to over 500 million people.

This initiative underscores India’s vision of making healthcare a fundamental right for all, not just a privilege.

The Future of Healthcare: Technology-Driven Transformation

Dr. V.K. Paul, Member (Health) of NITI Aayog, emphasized the transformative role of technology in the future of healthcare.

India’s rich talent pool and strong government initiatives position the country to lead this digital revolution.

The country’s successful pandemic response, characterized by the rapid development and licensing of multiple vaccines, further demonstrates its capacity for innovation and resilience.

The Role of Regulators in Health Research

Dr. Rajiv Bahl, Secretary of the Department of Health Research and DG of ICMR, highlighted the crucial role of regulators in supporting health research.

India’s ability to develop indigenous tests at a fraction of the global cost during the pandemic underscores the country’s research capabilities and regulatory efficiency.

The recent approval of three diagnostic tests for MPox by CDSCO further exemplifies India’s commitment to addressing emerging health challenges.

Addressing the Challenges of Advanced Drug Manufacturing

Kimberlee Trzeciak, Deputy Commissioner of the US Food and Drug Administration, emphasized the need for international collaboration to ensure compliance with quality standards in the context of advanced drug manufacturing technologies.

As these technologies continue to evolve, regulatory bodies worldwide must work together to mitigate potential risks and harness the benefits of innovation.

In conclusion, India’s regulatory framework has emerged as a global leader, driving innovation, promoting ethical research, and ensuring accessible healthcare for its citizens.

The country’s commitment to international collaboration, technological advancements, and traditional medicinal systems positions it as a key player in shaping the future of healthcare.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.

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