“ICDRA is crucial in sharing knowledge, building partnerships, and working in harmonisation to ensure safe and effective medicines for everyone. How well are we doing in regulation - our efforts can lead to better health outcomes for people all over the world.” This was stated by Smt. Anupriya Singh Patel, Union Minister of State for Health and Family Welfare during her address at the 19th International Conference of Drug Regulatory Authorities (ICDRA), here today. Dr VK Paul, Member (Health), NITI Aayog was also present.

The event which is being hosted for the first time in India, from 14^th – 18^th October by the Central Drugs Standard Control Organization (CDSCO), Ministry of Health and Family Welfare, in collaboration with the World Health Organization (WHO) brought together regulatory authorities, policymakers, and health officials from over 200 countries.

Addressing the session, Smt. Patel emphasized on the new rules and regulatory procedures introduced in India. She said, “new regulations published in the areas of clinical trial as New Drugs and Clinical Trial rules 2019 and Medical Device Rules 2017 have promoted scientific and ethical research at par with global expectation and international practices. The medical device rules include risk-based classification, bringing all devices under regulation through registration and framing regulatory pathway.” She further stated that “there is robust pre-approval and post approval regulatory procedures of all medical devices, diagnostics managing product lifecycle indicating robust control.  We are collaborating globally with international organizations such as IMDRF, ISO, WHO and regional network like SEARN to harmonise regulatory requirements in the area of medical devices and diagnostics.”

The Union Minister noted that India has been recently recognised as an affiliate member of IMDRF. “Recognition of Indian Pharmacopoeia by the Pharmacopoeial Discussion Group (PDG) is another milestone marking the harmonisation and recognition of regulatory standards”, she added.

Smt. Patel highlighted that the recently published revised Schedule M, aligned with WHO requirements of good manufacturing practices for various products including biologicals, investigational products, further establish the harmonisation goal. “This coupled with e-governance for all regulatory procedures have established good regulatory practices in the regulation of medical products in India”. She also informed that “AMR containment is another priority area in which India is building its strategy for effective management and control.”

Lauding WHO’s efforts in upgrading the regulatory systems of different countries, Smt. Patel stated that “the way WHO promotes partnership, reliance, experiential learning, pharmacovigilance systems, anticounterfeiting technologies and monitoring systems and reduction in use of animal experimentation need a word of appreciation. What is more important is the model of collaboration, deliberation and inclusive decision making which bring all the stakeholders together for best outcome.” On this note, Smt. Patel also underscored India’s commitment to work closely with WHO in contributing to many of these areas. “We have wealth of knowledge and appreciation for inclusive processes. Hosting ICDRA is a demonstration of our intent and commitment towards Global Public Health”, she said.

On the Government’s commitment to Healthcare, the Union Minister said that “the focus is on building a strong healthcare system that meets the needs of our population. Programs like Ayushman Bharat ensure that over 500 million people have access to quality healthcare. This shows our commitment to making healthcare a right for everyone, not just a privilege.”

She also highlighted the Union Government’s enthusiasm about how Artificial Intelligence (AI) is changing the face of 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 results”, she said.

The Union Minister concluded her address by urging everyone to work together for a healthier future. “The ICDRA is not just a conference; it is a chance for us to collaborate, innovate, and support one another in our shared mission for better health for all”, she stated.

Speaking on the occasion, Dr VK Paul said that “quality medicines improve the quality of life, human productivity as well as the way of life.” He said that this year’s ICDRA is crucial for its commitment to strengthen regulatory environment worldwide, especially coming after the Covid-19 pandemic.

Dr Paul highlighted the efforts being taken on healthcare sector by the present government such as the launch of the world’s largest health assurance scheme and a massive effort being taken in digital health. He said the future of healthcare in India and the world will be driven by technology and noted that India with its rich talent pool, strong government initiatives on digital health and medical infrastructure can be a driver of this change.

Dr Paul informed that India licenced 8 vaccines for use during the pandemic through a proper regulatory process. He noted that India developed different variants of vaccines including mRNA, DNA, nasal vaccines etc which were available for a fraction of the cost of other vaccines that were available in the world.

He also pointed out India’s heritage of a rich traditional system of medicines being practiced for hundreds of years. He underscored the importance of mainstreaming such traditional medicinal practices which can aid in improving the healthcare of people.

Dr Rajiv Bahl, Secretary, Dept of Health Research and DG, ICMR highlighted the crucial role of regulators in health research. He said, “In the first three months of the pandemic, India developed indigenous tests at one-fortieth of the cost. Similarly, within nine months of the pandemic, India approved a Covid-19 vaccine.” He informed that three diagnostic tests have also been developed for MPox which were approved by CDSCO.

Dr Yukiko Nakatini, Assistant Director-General, WHO noted that ICDRA 2024 is the first ICDRA after the Covid-19 pandemic. She noted that one urgent need highlighted by the pandemic was the need for a strong regulatory system. Dr Yukiko also congratulated India for its achievement of retaining Maturity level III for vaccine regulation.”

Ms. Kimberlee Trzeciak, Deputy Commissioner, US Food and Drug Administration, USA highlighted the opportunities and risks brought about by the introduction of advanced drug manufacturing practices as opposed to the traditional methods. She also emphasized on the need to ensure compliance with quality and underscored the importance of collaboration between drug regulatory bodies across the world.

Dr Rogerio Gasper, Director, Regulation and Prequalification Dept., WHO; Dr Rajiv Bahl, Secretary, Dept. of Health Research and DG ICMR; Dr. Rajeev Singh Raghuvanshi, Drugs Controller General of India; Shri Rajiv Wadhawan, Advisor (Cost), Health Ministry; Dr Roderico H. Ofrin, WHO Representative to India; Mr. Hiiti Sillo, Unit Head, Regulation and Safety, WHO Dept of Regulation and Prequalification and senior officials of the Union Health Ministry were present at the event.

***

MV/AKS

HFW/ MoS ICDRA Plenary /16^th October 2024/1