There are many different regulatory guidelines that healthcare professionals must follow when conducting clinical research. Two of the most common guidelines are ICH-GCP and Indian GCP. While these two guidelines share some similarities, there are also some key differences. In this blog post, we will explore the differences between ICH-GCP and Indian GCP. We will also discuss the benefits of following each guideline.
What is ICH-GCP?
ICH-GCP is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials. ICH-GCP harmonizes these key elements across trials conducted in different countries to ensure that high standards are met throughout the research process.
ICH-GCP is important in ensuring the safety and well-being of clinical trial participants, as well as the validity and reliability of trial data. ICH-GCP standards are continuously evolving in response to advances in medical research and technology, and new guidance is regularly issued. Compliance with ICH-GCP standards is therefore essential for all organizations involved in clinical research.
What is Indian GCP?
- Indian GCP is a private, not-for-profit organization that aims to improve the quality of clinical research conducted in India. The organization was established in 2009 by a group of Indian and international experts in the field of clinical research.
- Indian GCP is dedicated to promoting ethical and scientific standards in Indian clinical trials and to fostering collaborations between Indian and international researchers.
- Indian GCP is also committed to providing education and training opportunities for Indian researchers. In addition, the Indian GCP provides a forum for the exchange of ideas and information among members of the Indian clinical research community. Currently, the Indian GCP has over 500 members from across India.
Difference between ICH-GCP and Indian GCP
ICH-GCP and Indian GCP both are guidelines that are related to clinical research. ICH-GCP is an international guideline that was formulated by experts from different regulatory authorities and the pharma industry.
- ICH-GCP stands for International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use – Good Clinical Practice.
- On the other hand, the Indian GCP is the guideline that was formulated by the Central Drugs Standard Control Organization (CDSCO) which is the national regulatory authority of India.
- ICH-GCP is more comprehensive as compared to Indian GCP. ICH-GCP covers all aspects of clinical research right from sponsor responsibilities to monitor responsibilities whereas Indian GCP focuses more on investigator site selection, protocol, informed consent forms, etc.
ICH-GCP is applicable to all clinical trials conducted across the globe whereas Indian GCP is applicable only to clinical trials conducted in India. Hence ICH-GCP is a more preferred guideline in the conduct of clinical research studies.
Conclusion
The ICH-GCP is an international ethical and scientific quality standard for the conduct of clinical trials on human subjects. It has been adopted by countries all over the world, including India. However, there are some key differences between ICH-GCP and Indian GCP. The most notable difference is that under ICH-GCP, independent ethics committees must review and approve all clinical trial protocols, while in India this responsibility falls on the Drugs Controller General of India (DCGI). In addition, sponsors conducting trials in India are required to register with the DCGI, whereas this is not a requirement under ICH-GCP. Finally, there are certain sections of ICH-GCP that are not applicable in India.
