Clinical Trials: An Overview of Global Standards and Indian Scenario

Abstract:

Clinical trials are essential for the development of new drugs, formulations, drug delivery systems, dosage regimen, surgical and diagnostic techniques, devices and therapies. The adaptation of standard guidelines everywhere increases the credibility of data and makes it acceptable to regulatory authorities across the world. The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) provides a unified standard for the European Union, Japan, the United States, as well as for Australia, Canada, the Nordic countries and the World Health Organization. ICH-Efficacy guidelines are relating to clinical studies in human subject. In India, the Ministry of Health along with DCGI and ICMR has come out with Good Clinical Practices (GCP-India) guidelines as ethical and scientific quality standard for the design and conduct of trials involving human subjects. India has emerged as a global hub for carrying out clinical trials and attracts the sponsors due to i) highly diverse human gene pool and strong availability of study subjects across major therapeutic segments, ii) quality data at a competitive cost, iii) high level of ICH-GCP and USFDA standard compliance, iv) favorable regulatory climate and development speed. However, a gap analysis needs to be done to scale up all the resources for clinical trials. A number of issues are bogging down the clinical trial industry in India. The challenge lies in integrating physician, regulatory authorities and pharmaceutical organizations to optimize the risk-benefit profile and to minimize the abuse/misuse of the study subjects. The study of drugs in humans needs to be logical, with sound scientific basis in both conception and execution.

Key words: Clinical research, ICH guidelines, ICH-Good Clinical Practices (ICH-GCP), Good Clinical Practices- India (GCP-India).