It is felt that India is in a transition period. The country has already witnessed its transformation into an information technology (IT) super power. Now it is in the process to become a primary hub for pharmaceutical and biotech research and manufacturing. Clinical research, clinical trial data management and statistical analysis are the few other areas, which have grown rapidly in the country with a host of players entering into the sector. The Indian ingenuity and innovativeness is clearly visible with the phenomenal increase in the amount of clinical research work being conducted in the country. In addition to IT and BT (biotechnology) skills, we are adding value to credible data generation and the recruitment and prompt retention of patients in multicentric trials.

India is considered as a highly promising outsourcing IT and clinical research hub, largely due to its rich talent pool, technological innovation, creditable quality, operational flexibility, cost effectiveness and speedy marketing activities. All these factors give the country an edge over its competitors. As a result, over 80 per cent of the US companies view India as their first choice for clinical research and IT outsourcing. The country's vast talent pool has attracted the top companies around the world and they are in a race to work or partner with the Indian companies.

Presently, India is one of the most vibrant locations in the globe for outsourcing clinical trail activities. As an emerging destination for outsourcing activities, India has certain advantages, including:
■ A well-diversified industrial base in prime industries as well as large stable economy coupled with a balanced GDP composition
■ A strong industry based knowledge sectors like:
■ IT
■ Biotechnology
■ Pharmaceuticals
■ Strength in statistics, data management skills and Medical writing
■ Western trained physicians with ICH GCP awareness
■ Delivery of committed numbers with least queries
■ Quality and quantity of manpower. The country has over 3 million scientific and technical manpower and about 0.8 million postgraduates in science. Expertise is abundant in genomics, bio informatics, DNA, clinical studies, genetically modified materials, stem cell biology, molecular probes, genetic based vaccines, molecular taxonomy, etc.
■ Strong knowledge driven industries and cutting edge research
■ Indian pharmaceutical industry is expected to grow from $ 6 billion in 2001 to $ 25 billion by 2010. The investment in Indian biotech sector is expected to increase five fold to $10 billion from $2 billion during the decade, thereby increasing the kind of services as well as improving quality of work.
■ Lower cost environment. Clinical research can be conducted in India at a lower cost, compared to research done anywhere else. It leads to lower cost in drug development as well as viable costs on time.
■ The wide spectrum of disease in India gives Indian CROs a better range to research and develop better drugs.

However there are a few disadvantages in the Indian CRO. They are:
■ The Indian CRO is better known as a partner for co-development rather than in 'discovery' of its own leads. This partnering for co-development and adding value by innovation could be turned to an advantage.
■ Indian CROs lack the expertise and resources to bring a drug through US or European regulatory processes. Forced by the new patent regime, some of the Indian companies are looking at investigational new drugs. In view of lack of experience with early phase development, some work is being outsourced to the west.
■ While lower cost may help increase the share of Indian CROs in low-end services, they are viable costs and add value to the customer. High-end value added services like study design, protocol preparation and report writing are being offered by a select few CROs.
■ Industry is extremely capital intensive. Though the market is opening and a lot of funding is available, acquiring funds for capital is still a major challenge for Indian CROs. However VCs are prepared to fund innovative CROs who can take up the CT services
■ While data generation of Indian CROs is widely accepted worldwide, the amount of errors is still high in data management. This too is changing as India has gone a long way in clinical research and data generated is comparable to any western site. Errors are few and with virtual real-time data generation and correction most of the data is accepted both by US FDA and EU authorities.

The Indian market is not yet matured for high-end services. However, to make the CRO industry in India grow, CROs in the country must position itself to make sure that the country capitalises on the advantages it has to offer. At the same time, stricter implementation of patent laws, better regulatory clearances and international level work should be in place. The potential for this industry to be the next 'IT wave' is huge and it is only a matter of time.

(The author is chief operating officer, Manipal AcuNova Pvt. Ltd, Bangalore)