The Central Drugs Standard Control Organisation (CDSCO), Ministry of Health and Family Welfare (MoHFW), India hosted the 19th International Conference of Drug Regulatory Authorities (ICDRA 2024) in collaboration with the World Health Organisation (WHO). This marks the first time India has hosted the ICDRA since its inception in 1980.
- The conference was held from 14th October to 18th October 2024 at Yashobhoomi, India International Convention Centre (IICC) in New Delhi, Delhi.
- Union Minister Jagat Praksah Nadda, MoH&FW inaugurated the 19th ICDRA in New Delhi.
- Theme of 19th ICDRA: “Smart Regulation: Delivering Quality Assured Medical Products for All”.
- The forum has brought together regulatory authorities, policy makers, and health official from over 194 member states of WHO.
Note:
i.The 18th ICDRA was held in Dublin, Ireland from 3rd to 7th September, 2018.
ii.India was supposed to host the 19th ICDRA in 2020 which was postponed due to COVID-19 pandemic.
Iii.WHO had organized the Virtual International Conference of Drug Regulatory Authorities (ICDRA), from 20th – 24th September, 2021
About 19th ICDRA:
i.The 5-day conference was focused on strengthening global regulatory systems through partnerships and collective efforts. Regulatory bodies from different countries discussed challenges and opportunities in harmonizing regulations for medical products, addressing Antimicrobial Resistance (AMR) and advancing traditional medicines.
ii.The first 2 days of the conference were designated as PRE-ICDRA and the remaining 3 days were designated as ICDRA.
- PRE-ICDRA: It was an open session, which saw the participation of delegates from drugs regulatory authorities, governments and inter-government organisations, industries, among others.
- While, ICDRA session was open for only drug regulatory authorities of WHO member states.
iii.The 5-day conference organised a range of insightful sessions where regulatory authorities and industry leaders discussed on key issues affecting global drug and medical device regulation and some of the important sessions were:
- During the session, discussions held around the evolving landscape of regulatory reliance and the World Listed Authorities (WLA) framework.
- The main focus of this session was on the regulation of medical devices, including In Vitro Diagnostics (IVDs).
- Quality of Pharmaceutical Starting Materials.
- Artificial Intelligence in Healthcare.
- Regulatory Preparedness in Response to the COVID-19 Pandemic.
Union Minister JP Nadda Inaugurated 19th ICDRA
On 14th October 2024, Union Minister Jagat Praksah Nadda, MoH&FW inaugurated the 19th ICDRA in New Delhi. While addressing the conference, Union Minister JP Nadda underscored on the shared commitment for enhancing global healthcare standards and safeguarding public health.
Key People: Dr. Rajiv Bahl, Secretary, Department of Health Research and Director General (DG) of Indian Council of Medical Research (ICMR); Rajiv Wadhawan, Advisor (Cost), MoHFW; Dr. Roderico H. Offrin, WHO Representative to India and other senior officials from MoHFW were present at the event.
India’s efforts in Pharmacy sector:
i.Union Minister JP Nadda outlined some of the achievements of CDSCO like: CDSCO has developed robust systems for approving safe and efficacious drugs and medical devices in the country and for export to over 200 countries in the world.
ii.He mentioned that at present 8 drug testing labs are operational while 2 more are in pipeline. Also, 8 mini testing labs are operational at various parts for quick testing and release of drugs and raw material being imported.
iii.He further informed that over 95% regulatory processes currently have been digitized at CDSCO, which has brought transparency and increased trust among stakeholders.
iv.The Government of India (GoI) has made it mandatory to provide Bar code or Quick Response Code (QR Code) on top 300 brands of drug products as well as mandatory to provide QR Code on all API packs, either being imported or manufactured.
Union MoS Anupriya Singh Patel Addressed 19th ICDRA
On 16th October 2024, Union Minister of State (MoS) for MoH&FW Anupriya Singh Patel addressed 19th ICDRA. She was accompanied by Dr. VK. Paul, Member (Health), National Institute for Transforming India (NITI Aayog) at the event.
- While addressing the event, she highlighted the 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 in India at par with global expectation and international practices.
- India approved eight vaccines for pandemic use through a proper regulatory process. The country developed various vaccine types, including mRNA, DNA, and nasal vaccines, which were offered at a fraction of the cost compared to other global vaccines.
- She has outlined significant milestones achieved by India and its regulatory bodies in medical research like: India has been recognized as an affiliate member of International Medical Device Regulators Forum (IMDRF) as well as recognition of Indian Pharmacopoeia by the Pharmacopoeial Discussion Group (PDG).
About Central Drugs Standard Control Organisation (CDSCO):
It is the National Regulatory Authority (NRA) of India. It works under Directorate General of Health Services, MoHFW.
Drug Controller General of India (DCGI)- Dr. Rajeev Singh Raghuvanshi
Headquarters- New Delhi, Delhi
