India is fast emerging as one of the most strategic locations for global pharmaceutical companies to persuade their drug research and development. Since clinical research, the most crucial part of the drug development, is gaining paramount importance in the era of evidence based medicines, the research oriented pharmaceutical companies around the world want to adopt the most effective and economic methods into this process. These strategic approaches, especially in the global clinical research, are driven by the ongoing technology developments in this area and the identification of most potential locations.
The selection of strategic locations for clinical research in case of global trials is very important as it is based on the long term planning of the company as far as the marketing potential of the drug is concerned. However, the drug registration requirements, the language, patient pool, availability of reliable investigators and institutions, easy and fast recruitment possibilities and the regulatory framework in each of these markets are the prime considerations of the companies while choosing various locations worldwide for global clinical research.
The drug research companies targeting promising molecules perhaps the blockbusters to be introduced to the world market cannot miss out thus any country, which offers all these key factors. With a varied patient population, skilled human resource and a pool of GCP trained investigators and the cost leadership, India is currently considered to be a classic example of this ideal concept. This English speaking country, which helps to overcome the critical language barrier for global companies, promises yet another value addition to the economies of a global clinical research as far as the communication and the documentation are concerned.
Though the current clinical research (CR) spending in India is estimated to be around $100 million, which is miniscule compared to the worldwide spend of $25 billion, the industry experts predicts that the CR spend in the country would double by 2008 even if there is no significant support coming from the regulatory front. This natural increase in the CR spend is estimated on the basis of the pharmaceutical market growth in the country anticipated by the local as well as global drug companies.
However, with a set of policy measures suggested by the industry and the expected improvements in the regulatory framework, the size of clinical research business in India is likely to touch the magic figure of $1 billion within the same period.
As Dr S Mukherjee, medical director, Pfizer Limited, says if the regulatory framework in the country is further tightened to ensure adequate protection to the data and also to the patent, the multi-national companies would surely look forward to shifting sizable amount of research to India.
The faster volunteer recruitment, diverse and large patient pool, less expenses are definitely the biggest merits a multinational pharmaceutical company would expect from the country when they take such an economic decision for persuading global trials, he adds. "The government now seems very supportive to local as well as foreign companies aspiring the big league in the pharmaceutical research. But, certainly the authorities are yet to get familiar with the technical aspects of it to come out with clear policy initiatives to open the floodgates," Mukherjee said.
Though the country has relatively low commercial potential at present, the industry experts are of the view that that if the government along with its current initiative to introduce a well defined regulatory framework for conducting clinical research, proposes some sort of incentives for the global pharma companies for imports, it will help attracting new product introductions into the country. This drive, which would certainly boost the MNCs' interest in the market, will certainly prompt them to undertake more drug development works in the country, opines industry experts.
The country would ultimately gain through such incentives, says Dr Mukherjee. As the market expands, the companies will assign more projects here, which will result in more foreign currency flow towards CR spending in the country. With the government incentives and other regulatory supports, 10 per cent of the worldwide patient enrollment in CR is expected to be achieved in India by 2008 with a compounded annual growth at the rate of 75 per cent. Apart from this, an additional employment of 16,000 is also expected with the CR volume growth within the period, he hopes.
India can not only reduce the cost of research, but also contribute enormously to the increasing multi centric global trials, says Dr N K Ganguly, director general, ICMR. "India's multifarious ethnic conditions would offer a vast pool of generic material for clinical drug research," he said. This is one of the factors prompted international clinical research organizations (CROs) to set up shops in India. India's outstanding IT skills also offer them online data generation and management, which is a major component of the drug research programmes using the standard operating procedures (SOPs) as per the international protocols, Ganguly added.
According to a senior professional in the Indian drug industry, the country could emerge as the top 10 destinations of the world for innovation in pharma in the next 10 to 15 years.
"Even a country like China, which is more populous than India, is not as abundant in ethnic varieties as India," he adds. The multinational CROs that already have presence in India include Simbec Research- UK, RCC, Quintiles, Covance-Siro and the Indian majors like Speciality Ranbaxy, Reliance, Well quest, Clinigene, Lotus, Strand Genomics are at present handling both local and global trials for Indian and multinational innovator drug companies.
The future projections in the country's clinical research potential seems quiet realistic considering the number of ongoing trials undertaken by the multinational companies and the local pharma majors are handsomely high. The world's largest pharma research company Pfizer alone has presently 20 clinical research projects in India, of which ten are international trials and another 10 are targeting Indian market.
Normally, the pharma companies are interested to conduct the trials in a country where they have a sizable market. However, expecting that Indian pharma market would grow significantly according to its population, the companies would now prefer this location as part of their long-term strategy. For international trials, Indian's unique advantage is the language. Since English is a common language here, the documents need not to be translated into local languages, which is a difficult problem in China, Japan and various European countries.
Dr Arun Bhatt, president, ClinInvent Research Pvt Ltd., an emerging CRO major in India, adds that the current trials in the country are essentially a mixture of local phase III and IV and also bio-equivalence. At present in India there are about 50 GCP trials going on and the country has about 200-250 GCP trained investigators now. Though the total spending on these trials are pegged at $ 30 million, which is likely to grow to $ 300 million by 2010.
Apart from the natural advantages of the country in the area of clinical research like proficiency in English and availability of patients, the recent developments in infrastructure, information technology, improved healthcare segment could really help creating a boom in the area. However, the recent changes in regulatory frame work for clinical trials e.g. acceptance of concurrent phase II-III trials, adoption of GCP guidelines, ethics committee functioning and the provisions for patient protection are the significant mile stones in the policy front towards the growth of this unconventional business sector here, he asserts.
But still the country needs further improvements in certain very important areas to keep the CR practices on par with international standards. The major factors needing such improvements are the epidemiological database, basic infrastructure and regulatory supports. The country currently lacks availability of readymade epidemiological databases on patient populations, CR specific infrastructure in certain institutions. Similarly, the GCP training and culture can be further improved to make it globally competitive, Dr Bhatt feels.
Another key area, which needs urgent attention of the government is the functioning of ethical committees. Currently many ethics committees do not have composition and functioning in line with GCP. The uncertainty of obtaining clinical trial permission in a reasonable time and lack of regulatory inspection of clinical trials also needs to be changed for better. Though the overlapping role of regulatory authority and other government agencies - ICMR, GEAC, DGFT etc, creates confusion at present, the government's current moves are expected to bring more clarity. Lack of clinical trial registry from regulatory office and accredited central labs, availability of special service providers like special couriers, contract clinical trials management suppliers, public awareness about need for clinical trials and current provisions for patient protection and adequate media support in creating a favourable opinion about drug development and clinical trials also forms hurdles for the progress.
Still, if the country manages to ward off the concerns of global companies like uncertainty about intellectual property, data exclusivity and confidentiality, protection of illiterate and poor patients and quality of clinical trials, India could be a compelling new region for conducting global clinical trials considering the sizable and growing pharmaceutical market, highly attractive professionals and patient population, he opines.