New Delhi: Union Minister of State for Health and Family Welfare, Anupriya Singh Patel, underscored India’s commitment to global health and regulatory harmonization during her address at the 19th International Conference of Drug Regulatory Authorities (ICDRA) held in New Delhi today. For the first time, India is hosting this prestigious event, organized by the Central Drugs Standard Control Organization (CDSCO) in collaboration with the World Health Organization (WHO). The conference brings together regulators, policymakers, and health officials from over 200 countries.
In her speech, Patel emphasized the crucial role of ICDRA in fostering partnerships and knowledge sharing to ensure the availability of safe and effective medicines worldwide. “Our efforts in regulation can lead to better health outcomes for people across the globe,” she remarked, stressing the importance of global collaboration in the healthcare sector.
The Union Minister highlighted India’s recent regulatory advancements, including the introduction of new clinical trial and medical device rules that align with global standards. “The New Drugs and Clinical Trial Rules 2019 and Medical Device Rules 2017 have promoted scientific and ethical research at par with international practices,” she stated, adding that these regulations are key to ensuring robust control throughout the product lifecycle.
She further noted India’s recognition as an affiliate member of the International Medical Device Regulators Forum (IMDRF) and the Indian Pharmacopoeia’s acknowledgment by the Pharmacopoeial Discussion Group (PDG). These milestones, she said, signal India’s growing role in harmonizing global regulatory standards.
Patel also highlighted India’s initiatives in e-governance and the recent update of Schedule M, aligned with WHO’s Good Manufacturing Practices. She mentioned the government’s focus on antimicrobial resistance (AMR) containment as a top priority.
Recognizing WHO’s contributions to strengthening regulatory systems worldwide, Patel lauded the organization’s efforts in promoting partnerships and innovative practices like pharmacovigilance systems, anti-counterfeiting technologies, and the reduction of animal experimentation. She reiterated India’s dedication to working closely with WHO, adding, “Hosting ICDRA is a demonstration of our intent and commitment to Global Public Health.”
Dr. VK Paul, Member (Health) of NITI Aayog, also addressed the event, emphasizing the vital role that quality medicines play in improving lives. He noted that this year’s ICDRA is especially significant as the world moves forward from the COVID-19 pandemic. Dr. Paul outlined India’s achievements, including licensing eight vaccines during the pandemic and pioneering cost-effective mRNA and DNA vaccine solutions.
Dr. Rajiv Bahl, Secretary of the Department of Health Research and Director-General of ICMR, highlighted the regulatory response during the pandemic, noting that India developed indigenous COVID-19 tests and vaccines at a fraction of global costs. He also announced that three diagnostic tests for MPox have been developed and approved by CDSCO.
The conference also featured international regulatory leaders, including WHO’s Dr. Yukiko Nakatani and Kimberlee Trzeciak from the US Food and Drug Administration, who both emphasized the need for stronger global regulatory frameworks and collaboration.