The conference will highlight the fundamental opportunities and challenges faced by all in conducting Clinical Research in India, through solution driven sessions presented by experts from the industry and academia with practical global experience. Fostering free discussion, the programme will concentrate on the real-world issues and look to develop a consensus on how India should move forward practically to ensure accurate, auditable and above all ethical pre and post marketing Clinical Research data.
Current Clinical Research Scenerio In India
As the demand for reducing drug development costs and achieving higher patient recruitment rate increases globally, India is being projected to become a dominant clinical trial location. By 2011, it is expected that India will conduct more than 15% of the total number of global clinical trials. Several factors are responsible for this predicted growth which includes India’s large, genetically diverse, treatment – native patient population (over one billion), thereby greatly facilitating patient recruitment and significantly reducing the cost of conducting clinical research (60% less than in the West), have all turned up as the major contributing factors. The emergence of common Western diseases in the Indian population is another factor as is the high rate of English proficiency among clinical investigators.
Despite the presence of many leading biopharmaceutical companies in India, however, there are several challenges that Global companies continue to face. These include language and cultural barriers, socioeconomic factors and the effects of genetic diversity on drug testing. In addition to it, because of the continued surge of clinical trial activity in the country and the lack of professionals adequately trained in ICH-GCP practices, issues regarding ethical practices have raised concern. Finally, despite an improved regulatory environment, sponsors must overcome hurdles in the regulatory approval process. The recent regulatory initiatives like Registry of Clinical Trials, Review of Ethical Committees, Registration of CRO’s, transparency in the regulatory system & pharmacovigilance activity and FDA’s presence in India are the clear indicators of India turning up as an emerging destination for clinical trials.