Context:
Recently, the Union Minister of Health and Family Welfare inaugurated the 19th International Conference of Drug Regulatory Authorities (ICDRA).
19th International Conference of Drug Regulatory Authorities (ICDRA)
- The event is being hosted for the first time in India, from 14th – 18th October 2024.
- The theme of the 19th ICDRA: Smart Regulation: Delivering Quality Assured Medical Products for All”.
- Host: The Central Drugs Standard Control Organization (CDSCO), Ministry of Health and Family Welfare, in collaboration with the World Health Organization (WHO).
It is a 5-day conference, wherein the first 2 days are designated as Pre-ICDRA and the remaining 3 days are designated as ICDRA.
- Pre-ICDRA is an open session, wherein delegates from the different national and international organizations will participate.
- Whereas, ICDRA is a regulators-only session open for Drug Regulatory Authorities of WHO Member States.
Other Key Discussion of the Conference
- Plenary Session on Smart Regulation: discussions will revolve around the World Listed Authorities (WLA) framework.
- Workshops on Medical Devices including IVDs (In Vitro Diagnostics).
- Quality of Pharmaceutical Starting Materials: the workshop will shed light on the need for stringent regulations in ensuring the quality and safety of pharmaceutical products
- Role of AI: Regulators and industry experts also discussed the role of AI in improving regulatory oversight, pharmaco-vigilance, and clinical trials.
About the International Conference of Drug Regulatory Authorities (ICDRA)
- ICDRA was founded in 1980, it brought together regulatory authorities from WHO Member States to strengthen collaboration and develop international consensus on regulatory priorities.
- The conferences have been held since 1980 with the aim of promoting exchange of information and collaborative approaches to issues of common concern.
- 18th International Conference of Drug Regulatory Authorities (ICDRA) hosted by the Health Products Regulatory Authority (HPRA) of Ireland and the World Health Organization (WHO) Dublin, Ireland.
Objective of ICDRA
- To enhance global healthcare standards and safeguard public health.
- Identify priorities for action in the regulation of medicines, vaccines, biomedicines, and herbals.
India’s Pharmaceutical Industry
- India is the largest provider of generic medicines globally and over 60% of global vaccine production.
- The Indian Pharmaceutical Industry ranks 3rd globally in pharmaceutical production by volume.
- India also has the highest number of US-Food and Drug Administration (FDA) compliant Pharma plants outside of the USA and is home to more than 3,000 pharma companies.
- Recently, India’s pharmaceutical and meditech exports became the 4th largest export sector of India.
- India is the third largest producer of pharmaceuticals in the world, and has the largest number of US Food and Drug Administration (FDA) approved plants outside the USA.