ICH GUIDELINES AND ITS IMPACT IN INDIA

Mentions the 4 ICH guidelines in brief, its history, objectives, impact on India and latest conference points.

1. ICH Guidelines & its Impact in Bharat UNDER THE SUPERVISION O F DR. AMITAVA ROY DEPARTMENT OF PHARMACEUTICAL TECHNOLOGY UNIVERSITY OF NORTH BENGAL PRESENTED BY: SHOVANGI DEY M.PHARM.,FIRST YEAR DEPARTMENT OF PHARMACEUTICAL TECHNOLOGY UNIVERSITY OF NORTH BENGAL 1

2. ICH International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Formerly known as International Conference for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (2015) ICH’s inception: 1990 Founding Members : FDA(US),MHLW(JAPAN),EC(EU) OBJECTIVE OF ICH (1) T o increase international harmonization of technical requirements to ensure safety, efficacy & high quality of medications are developed & registered in a cost-effective manner. Adopted to: Promote public health. Avoid unnecessary duplication of clinical trials in humans. Minimized use of animals while testing without compromising safety & effectiveness . Registration and supervision of new medicines(4). 2

3. Ich guidelines QUALITY SAFETY EFFICACY MULTIDISCIPLINARY 3

4. QUALITY GUIDELINES Harmonisation achievements in the Quality area include pivotal milestones such as the conduct of stability studies, defining relevant thresholds for impurities testing and a more flexible approach to pharmaceutical quality based on Good Manufacturing Practice (GMP) risk management(1). 4

5. Q1A Stability Testing of New Drug Substances and Products Q1B Stability Testing: Photostability Testing of New Drug Substances and Products Q1C Stability Testing of New Dosage Forms Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products Q1E Evaluation of Stability Data Q1F Stability Data Package for Registration Applications in Climatic Zones III and IV Q1/Q5C EWG Targeted Revisions of the ICH Stability Guideline Series 5

6. 6 PHOTOSTABILITY CHAMBER

7. SAFETY GUIDELINES ICH has produced a comprehensive set of safety Guidelines to uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity. A recent breakthrough has been a non-clinical testing strategy for assessing the QT interval prolongation liability: the single most important cause of drug withdrawals in recent years(1). 7

8. EFFICACY GUIDELINES The work carried out by ICH under the Efficacy heading is concerned with the design, conduct, safety and reporting of clinical trials. It also covers novel types of medicines derived from biotechnological processes and the use of pharmacogenetics/genomics techniques to produce better targeted medicines(1). 8

9. MULTIDISCIPLINARY GUIDELINES Those are the cross-cutting topics which do not fit uniquely into one of the Quality, Safety and Efficacy categories. It includes the ICH medical terminology (MedDRA), the Common Technical Document (CTD) and the development of Electronic Standards for the Transfer of Regulatory Information (ESTRI)(1). 9

10. India(CDSCO) joined the ICH in 2007 along with 6 other countries. increasing international outreach. Cost effective production, import and export. Open trade and help from the steering committee to promote public health. Well emphasized GMP in Indian Pharmaceutical industry. Ich guidelines impact in bhara t 10

11. LATEST ADVANCEMENTS I CH Assembly meeting in June 2023 in Vancouver, Canada, were: The adoption of new ICH guidelines on drug-drug interactions, clinical trial design, and biopharmaceutics classification system-based biowaivers. The progress of ongoing ICH guideline development work on topics such as quality risk management, drug substance impurities, genomic sampling and management, and clinical electronic structured harmonised protocol. The endorsement of new ICH Reflection Papers on patient-focused drug development and regulatory reliance. The approval of new ICH Observers and Members from various regions and organisations. The ICH conference is held twice a year. Next ICH Assembly conference will happen on 31st October-01st November,2023 in Prague, Czech Republic. 11

12. ICH has been a successful organization for over 30 years, delivering on its mission to achieve greater harmonization worldwide to ensure that safe, effective, and high-quality medicines are developed and registered in the most resource-efficient manner. Apart from the many efficacy, quality, safety, and multidisciplinary guidelines that have been issued, its success can be measured by both the increased participation and the growing number of regulatory authorities and other organizations becoming members of ICH or following its activities closely (5) . CONCLUSION 12

13. references ICH Official web site : ICH International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Wikipedia ICH Q9: Quality Risk Management - an update 14 May 2014 https://admin.ich.org/sites/default/files/2020-12/OverviewOfICH_2020_1130.pdf ICH Quality Guidelines: Present Initiatives & ISPE Involvement | Pharmaceutical Engineering https://admin.ich.org/sites/default/files/2023-06/Assembly_Vancouver_June2023.jpg 13

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