The Union Minister of Health and Family Welfare, Shri JP Nadda, inaugurated the 19th International Conference of Drug Regulatory Authorities (ICDRA) today, marking the first time that this prestigious event is being held in India. Hosted by the Central Drugs Standard Control Organization (CDSCO) in partnership with the World Health Organization (WHO), the five-day event from 14th to 18th October aims to foster international collaboration among regulatory bodies, policymakers, and healthcare professionals from 194 WHO member states.

India’s Global Leadership in Healthcare Highlighted

In his address, Shri JP Nadda underlined India’s critical role during the COVID-19 pandemic, stating, “India emerged not only as a global leader in health resilience and innovation but also reaffirmed its role as the Pharmacy of the World.” He emphasized India’s ability to scale vaccine production and healthcare infrastructure, meeting global needs while covering over a billion people domestically through its vaccination drive. Nadda reiterated India’s dedication to affordable healthcare and global solidarity through the principle of Vasudhaiva Kutumbakam—“The world is one family”—providing life-saving medicines to over 150 countries during the pandemic.

Nadda remarked, “Our progress is inseparable from the progress of the world. Through the ICDRA platform, we aim to develop regulatory frameworks that ensure the safety, efficacy, and quality of medical products worldwide.”

CDSCO’s Milestones in Digitalization and Regulation

Nadda highlighted CDSCO’s robust regulatory framework, emphasizing its 95% digitized processes, which have increased transparency and trust among stakeholders. He added, “CDSCO ensures the availability of affordable and quality medicines, with drug testing labs and mini labs operational across ports to facilitate quick drug testing and release.” The government has also mandated QR codes on all APIs and top 300 drug brands to strengthen the supply chain.

He further stated, “With India regulating both pharmaceuticals and medical devices, we are aligning our manufacturing practices with WHO-GMP standards, ensuring global compliance.” Nadda concluded by stressing the importance of skill, speed, and scale in meeting global demand for pharmaceuticals.

WHO Commends India’s Regulatory Leadership

Dr. Tedros Adhanom Ghebreyesus, Director-General of WHO, lauded India’s efforts in hosting the conference and emphasized the need for global cooperation in drug regulation to tackle challenges like antimicrobial resistance, post-pandemic health management, and the ethical use of AI in healthcare.

Dr. Saima Wazed, Regional Director of WHO Southeast Asia, emphasized India’s prominence in the pharmaceutical sector: “India provides over 50% of the world’s vaccines and is home to the largest number of US FDA-approved plants outside the USA.” She called for regulatory convergence to achieve universal health coverage.

Global Partnerships and Regulatory Challenges

During the opening session, Ms. Malebona Precious Matsoso, Co-Chair of WHO’s Intergovernmental Negotiation Body, underscored the importance of smart regulation: “India’s position as the Pharmacy of the World comes with expectations to balance under-regulation and over-regulation.”

The event also featured Dr. Rajeev Singh Raghuvanshi, Drugs Controller General of India, who highlighted advancements in CAR T-cell therapy and emphasized that India’s regulatory systems are being enhanced for “high execution with low regulation.”

Key Sessions and Discussions at ICDRA 2024

The ICDRA will host several workshops, panels, and bilateral meetings, addressing global healthcare priorities:

• Smart Regulation and the WLA Framework: Exploring regulatory reliance and cooperation among countries.
• Workshops on Medical Devices and IVDs: Addressing global trends in the regulation of medical devices.
• Artificial Intelligence in Healthcare: Focusing on AI’s role in clinical trials, regulatory oversight, and data privacy.
• Quality of Pharmaceutical Starting Materials: Emphasizing the importance of stringent quality standards for safer pharmaceuticals.
• Post-COVID Regulatory Preparedness: Sharing insights and innovations to prepare for future pandemics.

Exhibition Showcasing India’s Pharmaceutical Innovation

A special exhibition accompanying the event highlighted India’s advancements in pharmaceuticals, medical devices, and clinical research. Major industry players showcased their latest innovations, emphasizing India’s capabilities and leadership in global healthcare.

Dr. Rajiv Bahl, Secretary, Department of Health Research, noted that India’s pharmaceutical industry has become the 4th largest export sector, further solidifying the country’s integration into the global supply chain. Union Health Secretary Smt. Punya Salila Srivastava added, “India supplies 50% of the world’s vaccines, with most going to organizations like WHO, UNICEF, and GAVI.”

Also Read: NPPA Revises Ceiling Prices of Eight Key Drugs to Balance Availability and Affordability in Public Health Programs

Strengthening Global Regulatory Systems

The conference’s bilateral and multilateral meetings will facilitate collaborations on regulatory challenges, including harmonizing regulations, managing AMR, and promoting traditional medicines.

The ICDRA 2024 marks a significant milestone in India’s journey as a global healthcare leader, reinforcing its commitment to safety, innovation, and equitable access in healthcare. The discussions over the next five days will undoubtedly shape future regulatory frameworks and strengthen international partnerships for global health.

This conference not only reflects India’s growing influence in global health governance but also emphasizes the country’s dedication to creating a safer, healthier, and more resilient world. Stay tuned for daily updates from ICDRA 2024 as industry leaders, regulators, and health officials work together to transform healthcare standards.

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