Shri Jagat Prakash Nadda, Union Minister of Health and Family Welfare inaugurated the 19th International Conference of Drug Regulatory Authorities (ICDRA), here today. 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 194 WHO member states.

Addressing the occasion, Shri JP Nadda emphasized on the shared commitment for enhancing global healthcare standards and safeguarding public health. He highlighted that during the unprecedented COVID 19 pandemic, India emerged not only as a global leader in health resilience and innovation but also reaffirmed its role as the Pharmacy of the World. “India rapidly expanded its healthcare infrastructure and scaled up vaccine production to meet both domestic and global demands. The successful rollout of the COVID-19 vaccination program, covering over a billion people, is a testament to the robustness of our healthcare system, the dedication of our health workers, and the soundness of our policies”, he said.

The Union Health Minister highlighted that India played a crucial role in ensuring affordable access to essential medicines, vaccines, and medical supplies for nations across the globe. “Guided by the principle of ‘Vasudhaiva Kutumbakam’ – the world is one family, we extended our support to more than 150 countries, providing life-saving drugs and vaccines during the pandemic. This spirit of international solidarity is at the heart of India’s approach to global health. We believe that our progress is inseparable from the progress of the world, and as such, we remain committed to contributing to global health security and sustainability”, he said.

Shri Nadda noted that “the ICDRA platform provides a space to share knowledge, foster partnerships, and develop regulatory frameworks that ensure the safety, efficacy, and quality of medical products worldwide.”

Highlighting the achievements of CDSCO, Shri Nadda said that “it has developed robust systems for approving safe and efficacious drugs and medical devices in the country and for export to more than 200 countries in the world”. Availability of Quality medicine at affordable price is at the core, he said. He also informed that “8 drug testing labs are operational today while 2 more are in pipeline. 8 Mini testing Labs are operational at different ports for quick testing and release of drugs and raw material being imported. In addition, 38 State Drug Regulator’s Testing Labs are operational. Altogether, more than a hundred thousand samples are being tested every year under regulatory surveillance mechanism.”

The Union Minister also stated that “more than 95% regulatory processes currently have been digitized at CDSCO, bringing transparency and increasing trust among stakeholders.” He also stated that, “Considering the importance of medical devices in health care delivery, Medical Device industry in India is also being regulated. Drugs Rules have been amended to make Good Manufacturing Practice Guidelines more comprehensive and at par with the WHO-GMP guidelines.”

It was also pointed out that in order to make drug supply chain robust, it has been made mandatory to provide Bar Code or Quick Response Code (QR Code) on top 300 brands of drug products. Similarly, QR Code is mandatory on all API packs, either being imported or manufactured in India.

The Union Minister concluded his address by underscoring India’s full committed to advancing global health. “We believe in 3 Ss i.e. “Skill, Speed and Scale” and by focusing on these three aspects, we have been able to meet the increasing demand for Pharma products while adhering to global quality standards without any compromise. We are prepared to address pressing challenges, from antimicrobial resistance to ensuring equitable access to life-saving treatments. We are not just participants in this dialogue; we are partners in building a healthier, safer and more resilient world”, he said.

Dr. Tedros Adhanom Ghebreyesus, Director-General of WHO, in his speech, commended India for hosting this crucial global regulatory forum and highlighted the importance of global cooperation in drug regulation, particularly in light of challenges such as antimicrobial resistance, the post-pandemic world, and the safe use of AI in healthcare.

Dr Saima Wazed, Regional Director, WHO Southeast Asia Region stated that “India is the largest provider of generic medicines while the Indian Pharmaceutical Industry is the third largest in the world. She noted that India provides over 50% of the world’s vaccine demands. She emphasized that a strong regulatory system is crucial to achieving universal health coverage and highlighted the need for strengthened regulatory convergence and information sharing between national regulatory authorities.

Smt. Punya Salila Srivastava, Union Health Secretary stated that “the Indian pharmaceutical industry has recently become the 4^th largest export sector of India, exemplifying the level of our integration into the global pharmaceutical supply chain. India is the third largest producer of pharmaceuticals in the world, and has the largest number of US FDA approved plants outside the USA.” She also highlighted that “India supply 50% of the world’s vaccines, most of them going to UN agencies like WHO, UNICEF and the Pan American Health Organization (PAHO) and to organisations like GAVI.

Ms. Malebona Precious Matsoso, Co-Chair, WHO Intergovernmental Negotiation Body, South Africa said that “regulation of medical products is one of the most crucial aspects today. The impact of regulatory decisions is found not only at the national or global level but also in the hospital rooms.” Public health interventions and response can be shortened through efficient regulation and oversight, she said.

Highlighting India as the pharmacy of the world, she said that this tag comes with certain expectations and capacities about India. She concluded her address by emphasising on smart regulation as opposed to under-regulation and over-regulation.

Dr. Rajeev Singh Raghuvanshi, Drugs Controller General of India highlighted India’s achievements in drugs control and medical devices sector, including the approval of India’s first CAR T-cell therapy. “We are continuously upgrading our skills and capacities in our systems and are on a path towards low regulation and high execution”, he said.

As a precursor to the main conference, an exhibition was also held which showcased India's innovation, capabilities, and leadership in the pharmaceutical, medical devices, and clinical research sectors. Key industry players, including pharmaceutical giants, medical device manufacturers, and healthcare innovators, presented their advancements and breakthroughs to an international audience of regulators and stakeholders. This exhibition served as a testament to India’s standing as the “Pharmacy of the World” and its growing influence in global healthcare.

In addition to the main conference sessions, several side meetings will take place, where representatives from various countries will engage in focused discussions on specific regulatory challenges and opportunities. These meetings will facilitate bilateral and multilateral dialogues on strengthening regulatory systems, promoting innovation, and fostering collaboration to address global health needs.

Key Discussions and Regulatory Challenges

The 5-day conference will feature a series of insightful sessions where regulatory authorities and industry leaders will deliberate on key issues affecting global drug and medical device regulation. Some of the prominent sessions include:

• Plenary Session on Smart Regulation: Discussions will revolve around the evolving landscape of regulatory reliance and the World Listed Authorities (WLA) framework. Global regulators will explore how to enhance cooperation to streamline processes across countries.
• Workshops on Medical Devices: A significant focus will be placed on the regulation of medical devices, including IVDs (In Vitro Diagnostics), where experts will discuss trends in global and regional regulatory frameworks.
• Quality of Pharmaceutical Starting Materials: This workshop will shed light on the need for stringent regulations in ensuring the quality and safety of pharmaceutical products from their very inception.
• Artificial Intelligence in Healthcare: Regulators and industry experts will discuss the role of AI in improving regulatory oversight, pharmaco-vigilance, and clinical trials, while also addressing the challenges related to data privacy and implementation.
• Regulatory Preparedness in Response to the COVID-19 Pandemic: This is a plenary session focused on the lessons learned from the COVID-19 pandemic and the need for continued regulatory innovation to prepare for future public health emergencies.

The 19th ICDRA will emphasize strengthening global regulatory systems through partnerships and collective efforts. Regulatory authorities from various nations will discuss challenges and opportunities in harmonizing regulations for medical products, addressing antimicrobial resistance (AMR), and advancing traditional medicines.

Dr Rajiv Bahl, Secretary, Dept. of Health Research and DG ICMR; Shri Rajiv Wadhawan, Advisor (Cost), Health Ministry; Dr Roderico H. Ofrin, WHO Representative to India and senior officials of the Union Health Ministry were present at the event.

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