India: A Future Clinical Hub
India: A Future Clinical Trial Hub
Analysis of Indian and Global conditions, susceptible for emerging India as a Clinical Trial Hub
Kaustubh Aparajit, Samveg Sethi, Nitesh Kumar and Sachin Chavare,
Shailesh J Mehta School of Management, IIT Bombay
1. Concept Definition
1.1 Clinical Trails
Clinical Trials are studies performed with human subjects in order to test the performance of a new drug, new approaches to surgery or procedures to improve the diagnosis of disease and quality of life of the patient.
The National Institute of Health (NIH) in USA defines a Clinical Trial as a prospective biomedical or behavioural research study of human subjects that ...view middle of the document...
Trend of Clinical Trial Business and Global Hubs
In 2012 North America reported to have conducted the highest number of Clinical Trials worldwide. In the same year number Clinical Trials conducted in western European countries was greater than that of rest of the world put together.
The whole of the Asian region is one of the most rapidly growing markets for global Clinical Trials. India, China, Taiwan, Korea, and Singapore are leading drug and device development in this region while giving a stiff competition to each other. Emerging markets now contribute to ~36% of global patient enrolment as compared to ~20% in 2001.The main reason for Asia to have immense potential as a Clinical Trial market is its large, diverse patient population with illnesses that are prevalent in most countries. This helps drug companies complete the Clinical Trials on time and saves millions of dollars.
The major players (Contract Research Organizations) and Pharmaceutical companies in the clinical research business include Quintiles, ICON, PPD, Parexel, Kendle, Eli Lilly, Pfizer, Biocon etc. The 20 largest U.S.-based drug makers conduct a third of their phase III Clinical Trials abroad.
Fig 2.1: Number of Clinical Trials conducted in major countries in 2012
3. Regulatory Aspects: Opportunities and Challenges
Clinical Trials are now regulated by the Drugs Controller General of India (DCGI), who is responsible for assuring that all Clinical Trials comply with the requirements of the International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use, as well as Good Clinical Practices. The DCGI approval process categorizes Clinical Trials into two types. If the study protocol has already been approved by a cognizant regulatory authority in one or more developed countries (such as the U.S., Canada, U.K., Switzerland, Germany, Australia, Japan, and South Africa), the study is classified as a Type A trial and can be approved using a fast-track process within two to six weeks after the required documentation has been submitted. All other studies are classified as Type B. For these, the approval process is generally 8 to 12 weeks. The Institutional Review Board (IRB) approval process can be conducted in parallel with the DCGI review and, if import licenses are needed, the applications for these can also proceed in parallel. These provisions facilitate the process of getting study protocols in place and quickly initiating the trials.
India: A Future Clinical Hub
Fiscal and other incentives have been churned out to the clinical research industry over the past few years:
1. No import duty on Clinical Trial supplies
2. Exemption from registration requirements for Clinical Trial supplies
3. Export of Clinical Trial-related human blood specimens allowed based on the earlier practice of seeking DCGI-NOC-Approval from the Director General Foreign Trade being no longer required
4. Exemption from...