19th International Conference of Drug Regulatory Authorities kickstarts in New Delhi

The five-day conference will feature a series of insightful sessions where regulatory authorities

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, till October 18 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.

Key discussions and regulatory challenges

The five-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.

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.

Malebona Precious Matsoso, Co-Chair, WHO Intergovernmental Negotiation Body, South Africa said, "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."

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.

Punya Salila Srivastava, Union Health Secretary stated, "The Indian pharmaceutical industry has recently become the 4th 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 US.”

Dr Saima Wazed, Regional Director, WHO Southeast Asia Region stated, "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."

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.

Highlighting the achievements of CDSCO, Nadda said, "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, " Eight drug testing labs are operational today while two more are in pipeline. Eight 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.”

PIB