Efforts to put in place a strict patenting regime and an abundance of world class scientific manpower makes India a cost-effective R&D centre for global contract research firms
India is being seen as a cost-effective world-class research and development centre by global contract research firms.
As a strong intellectual property rights (IPR) regime gets ready in India by the year 2005, there is a large market developing here for contract research, said Dennis Gillings, chairman and chief executive officer of the North Carolina-based Quintiles Transnational Corporation.
As India conforms with World Trade Organisation (WTO) standards, there are signals in the market that the country is ready for contract research, he said.
Contract research organisations (CROs) such as Quintiles, which has a market capitalisation of $3 billion, provide independent product development for pharmaceutical, biotechnology and other industries.
Quintiles specifically provides full-service contract research, sales and marketing services to the world-wide pharmaceutical, biotechnology and medical devices industries. It also provides healthcare policy consulting and health information management services to the healthcare industry.
In India, research is mostly done either in-house or by individuals, experts say. Facilities for documenting any form of trial are as yet unavailable. The market for contract research in the country at this point is almost non-existent.
On a long-term basis, after the year 2005, the potential for contract research in India is quite high, affirmed J M Khanna, executive vice-president of Ranbaxy Laboratories Ltd.
He added that while his company does most of its research and development work in-house, with negligible outsourcing, he felt that outsourcing would become a trend in the Indian pharmaceutical industry in the times to come.
Quintiles is upbeat on the potential of the Indian market. The company is targeting $10 million worth of business in the next four years. Growth ranging between 50 and 100 per cent in successive years is possible, Gillings said.
However, Khanna warned that contract research would benefit only those Indian companies that are looking at going international. The industry has to reorganise itself for this kind of activity, which is something that I see only five or ten companies doing, he observed.
In June, Quintiles had announced a joint venture with Spectral, a subsidiary of Core Healthcare Ltd, an Ahmedabad-based healthcare company, to offer clinical trial management services in the country.
In India, the company is performing contract research in the fields of CNS (that deals with psychiatry and neurology) and oncology. We hope to move towards cardiology, infectious diseases, especially AIDS, and also endocrinology, he added.
Quintiles clientele in India consists primarily of multinational companies.
Gillings saw an opportunity for the Indian industry in the field of herbal medicine. There is a move towards more natural medication in the Western countries. It would be very timely at this point to provide objective information, about the effect of herbal remedies, he said.
Gillings felt that after 2005, India would conform to the outsourcing trend that has emerged in the pharmaceutical industry. There is a rising need to speed up the process of developing new products, as products have only a limited patent life. We want to be here when this trend emerges in India, he said.
The company takes care of the stage between the development and launching of a drug. We provide the evidence and the information that gives the labelling to the new drug. With that information, regulators can approve the new drug, and doctors would be able to prescribe it, he explained.
Gillings warned that survival for Indian pharmaceutical companies would be difficult if they did not look at the international market. To be global is important as it is very expensive to develop a drug just for the domestic market, he said.
The company is also looking at bringing back non-resident Indians (NRIs) to join its operations in India. Gillings said, while we have employed local talent, we have found that there is a large number of Indians who have studied abroad and are looking for a job opportunity to come back to the country.
The global pharmaceutical and biotechnology industries spent an estimated $35 billion in 1994 on research and development, of which an estimated $22 billion was spent on drug development services of the type offered by the CRO industry.
