Clinical research industry is growing exponentially in the past few years. It has opened large number of career opportunities to medical, pharma and all interdisciplinary fields. Global clinical trials market is worth of over USD 45 billion and India has good potential to tap the clinical research pie. India is one of the favored destinations for clinical research by MNC's. The Indian Pharma market is about $8 billion today and overall Indian Pharma market is growing at 8-10%. Indian Pharmaceutical industry has immense opportunities in contract research activities, clinical research, New drug delivery system, drug discovery, outsourcing for IT needs, Custom synthesis, manufacturing etc.
Clinical Research: Global Scenario
The global pharmaceutical market is estimated at USD 427 billion and Research & Development cost is estimated at USD 60-65 billion annually. Clinical trials involve almost 70 % of time and money of new drug development. Cost of conducting clinical trials for new drug is approximately between USD 200-250 million.
Clinical research industry has grown around the world at an unparallel rate in the past few years. It has opened up new vistas of employment for a large number of people. The clinical trials market worldwide is worth over USD 45 billion and the industry has employed an estimated 2,10,000 people in the US and over 70,000 people in the UK and they form one third of the total R&D staff. These large numbers can be attributed to the fact that this industry offers lucrative employment opportunities.
Clinical trials: An Indian Perspective
India is fast emerging as a favored destination for clinical trials in new products by multinational pharmaceutical companies. Two major reasons for its popularity are:
. Easy access and availability of a large, diverse and therapy-naïve population with vast gene pool
. And lower cost of technical services resulting into lowest per patient trial cost.
It is well documented that the average costs of doing Phase I/II/III drug trials in US are $20/50/100 million respectively whereas in India they are 50-60% of the same and could be up to 75% faster (Table I).
India also has the advantage of having a large pool of highly:
. Trained doctors,
. Nurses, and technical personnel;
. World-class medical hospitals;
. Strong information technology infrastructure;
. A favorable IPR environment after signing the WTO and
. Use of English as the primary business and
. Medical language making it an attractive option for health care companies for clinical trials. (Figure 1)
Major Players In Clinical Research
India has numerous clinical research players with a global standard infrastructure and manpower. The number of players in the clinical research industry in India has risen to over hundred from less than eight, three years ago.(Figure 2)
India as a hub for clinical research:
1. McKinsey estimates that European and US pharmaceutical companies will spend US$1.5 billion per year on clinical trials in India by 2010.
2. Currently, there are more than 20 well-established clinical trial organizations in India with a well-developed skill set to comply with the standards such as ICH-GCP guidelines.
3. In January 2005, the government of India enacted a new rule that allows foreign pharmaceutical companies and other interested parties to conduct trials of new drugs in India at the same time that trials of the same phase are being conducted in other countries. This new rule supersedes a directive of India's Drugs and Cosmetics Rules that required a "phase lag" between India and the rest of the world.
4. Ranbaxy, Quintiles, Sun Pharma, Cadila, Nicholas Piramal, Lupin and many others have set up world-class clinical research centers in India to bring the drug from mind to market.
5. CDSCO in 2005 with the help of World Bank have started Pharmacovigilance system in India and is having six peripheral centers across the country.
6. Apart from Phase I-IV clinical trials, Indian companies also have large commercial opportunities in pre-clinical & "Proof of concept studies".
7. At present there are more than 100 CRO's operating in the country.
8. In India, public research institutes provide good infrastructure for conducting clinical trials. There are super specialty hospitals with state-of-the art facilities; more that 220 medical schools, 180 dental schools, seven lakh hospital beds, and over 40 research institutes of repute. Currently, about 80 government and privately owned Indian hospitals are engaged in global and local clinical trials with 14,000 hospitals, five lakh doctors, seven lakh beds, 162 medical colleges and 17,000 medical graduates per year.
Clinical Research in India: The challenges
The challenges, which India faces for expansion of its clinical research market, are:
1. Non-availability of sufficient number of hospital sites and trained personnel meeting ICH-GCP norms.
2. Equipments at hospitals/ sites for conducting trials not always on par with trial sites in western countries.
3. Bureaucratic hurdles for regulatory approvals for global clinical trials. Approval time in India for phase I studies which is restricted to Indian molecules is around 90 days whereas the same in western countries is about 30 days.
4. Lack of data protection for the data generated in these trials.
5. Concerns over ethical issues in patient recruitment and conduct of trial.
6. Lack of sufficient infrastructure for central laboratory services.
As of today the key issues of CRO market are consistent high quality, credibility, reliability, offering a range of services, broad and focused therapeutic expertise, timeliness, GLOCAL approach (Global Reach Local Expertise) and expertise in developing NDDS packages.
To meet the challenges and address the key issues India will have to devise policies and insure implementation in legislative, IPR structure and regulatory issues. India also needs to help develop CROs with adequate capacity and competency in carrying out Clinical Research activities in compliance with ICH/GCP guidelines.
Need for Clinical Research Institutes in India
India is emerging "As hub for global clinical research" According to Mckinsey report -the global clinical trial outsourcing opportunity in India is estimated to be around Rs 5,000 crores by 2010, and there will be requirement of approximately 50,000 Clinical research professionals.Today there are more than 2,50,000 positions vacant worldwide. And salaries vary from a minimum of $ 40,000 per annum for a Clinical Research Co-ordinator to almost $10,000 per annum for a business development manager. What this means is that Clinical Research is definitely the next big career. And now is the time to make it a vocation.
Institute of clinical research (India) addresses the need for qualified and trained clinical Research professionals by offering various programs in clinical research at its center of excellence campuses at Delhi, Mumbai and Bangalore.
ICRI is India's first and only Clinical Research institute dedicated to Promoting Ethical Research and high-quality Clinical Research education in India.The courses offered by ICRI are in collaboration with Cranfield University, UK. ICRI is the only institute in India offering courses at multiple campuses throughout the country, thus giving the courses a national character.
Courses offered:
. Post graduate diploma in clinical research
. Two years masters programme in Clinical Research (M.Sc) · One year post graduate diploma in clinical research
. PhD in clinical research
Conclusions
As the drug development is a high-risk investment global pharmaceutical companies under pressure from stakeholders are trying to find ways for cost containment and increase the productivity. India with its intellectual powerhouse, patient population, world-class scientific and technical skills and discipline is an attractive destination for global players for cost and time containment. This is the reason why MNCs are outsourcing clinical research and trials to India. With Government initiatives in full swing a favorable environment is being created not only for the conduct of outsourced clinical research but also for the growth of local pharmaceutical industry at a rapid pace. With full efforts being made on the part of Government and cooperation from Indian CRO industry to meet the challenges in this field, India is set to become the "Global hub of Clinical Research."
The author is Dean, Institute of Clinical Research (India)