Medical R&D in India

India is a significant contributor to knowledge on health, with research outputs ranging the full spectrum, from epidemiology and clinical care to biotechnology and genomic. A large number of Government Departments like Health, Science & Technology, Atomic Energy, Human Resource Development, Social Welfare etc. support health research. Work is carried out in National Institutes, Autonomous Research Institutes, Universities and other Academic Institutions and by a variety of private organisations, including the Pharmaceutical Industry.

A relatively recent development is the growth in the number, size and financial outlay of "philanthropic" Foundations and International NGOs. In India most of the agencies funding research have plans in general linked to the National 5 year plans.

The contributions of the pharmaceutical industry in making available at affordable cost almost all drugs required by the Indian population, is the direct result of the considerable investment in research on alternate processes, which are cost effective.

Clinical Research
India's journey into global Good Clinical Practice (GCP) quality trials started in last decade, when several multinational pharma companies and contract research organizations (CRO) set up their global clinical trials in India. These early pioneers faced the regulatory and ethics environment, which was unfriendly for quality clinical trials. Besides, there was a dearth of experienced investigators and clinical research professionals. However, with patience and persistence, they brought about a change in the quality of research professionals, brought awareness of GCP compliance and made efforts to improve ethical aspects.

Over the years, India has emerged as an attractive new destination for global pharma companies. As India moves towards a patent regime aligned with international norms, it will increasingly be a favoured country for placing clinical trials.

The developments during the last decade have converted clinical trials from a registration activity to status of an industry. According to CenterWatch, estimated size of Indian clinical trials market in 2002 (industry spending on CRO services and investigator grants) was US $30 to $35 million. About 40-50 ICH, GCP clinical studies were undertaken with about 200-250 GCP trained investigators.
The size of the industry in India is however still very small by global standards. In US, for example, the number of GCP trials is 60,000 and the number of GCP trained investigators is over 40,000. According to CenterWatch 2.8 million US subjects completed initial screening in 1999, of which 5 per cent (140,000) completed the trial. By 2005 an estimated 19.8 million subjects were screened. However, because of global pressures on industry to recruit patients faster and make the trials economical, large numbers of clinical trials are likely to be placed in countries like India. This is expected to explode the Indian clinical trials market over next 5 years.

CenterWatch has predicted that by 2010, the industry will spend around US$ 250 - $300 million on clinical trials in India. McKinsey estimates much higher figure of US$ 1-1.5 billion. The projections for annual growth (2002 to 2010) of Indian clinical trials range from 30-50%.

This rapid acceleration of market will create huge challenges for medical manpower and healthcare infrastructure. For example, a minimum of 50,000-60,000 patients (at conservative estimates of US$ 250-300 million) and 200,000 - 300,000 patients (at the ambitious estimates of US$ 1-1.5 billion), will have to be recruited. Similarly, the country will require 2500-3000 trained investigators at conservative estimates and 10,000-15,000 investigators at ambitious targets. The current efforts at training are fragmented. The training focus of sponsors and CROs is on the investigators involved in their own trials only. The enormous challenge of large number of quality professionals for medical and clinical research, can only be met by cooperative and collaborative efforts between industry, academia and government and international organisations.

Medical/ Health Research organisatios in Public Sector

	Indian Council of Medical research
	Council of Scientific and Industrial Research,
	Department of Biotechnology,
	Department of Science and Technology, etc.
	University Grants Commission
	Councils of Research in the Health Ministry for Ayurvedic and other systems of Medicine.

Government Initiatives

The National Health Research Plan

	A rolling biennial plan, with main focus on the current and emerging issues such as Demographic and Epidemiologic Transition, emerging scientific developments such as Modern Biotechnology (Genomics, Human Genetics, New Drug Development, Stem Cell research), Health system research, Health Economics, Behavioral and social issues, Emerging and re-emerging infections,
	Health Research, in addition to the field of Health, intersectorally encompasses Education, Environment, Ecology, Social and Behavioural Sciences, Population, Agriculture, Trade, Commerce, in addition to the physical, chemical, biological and mathematical sciences.

National Health Research System (NHRS), managed by National Health Research Management Forum (NHRMF), is being developed with the following objectives:

	To generate and communicate knowledge that helps to form the national health plan and guides its implementation, and thus contributes, directly or indirectly, to equitable health development in the country;
	To adapt and apply knowledge generated elsewhere to national health development; and
	To contribute to the global knowledge base on issues relevant to the country

The Private Sector in Health Research

The private sector, comprising of pharmaceutical industry, biotechnology and biomedical technology oriented industries, private educational institutions, hospitals and nursing homes, research foundations and institutions, private practitioners, is now a major stake holder in Health care research and delivery. Details of some of these organisations are given below:

	Wellquest, the clinical trials division of the Nicholas Piramal Group, is conducting 40 product tests in five cities.
	Ranbaxy, India's largest pharmaceutical company has two ongoing collaborative research programs.
	Hyderabad based Divi's Laboratories does customized research for Merck, Abbott Laboratories, Glaxo and other firms.
	Matrix Laboratories, a bulk drug manufacturer, has diversified into outsourced research, achieving a 500% growth, and annual revenue of $10 million.
	Biocon, which has tied up with Pfizer, AstraZeneca, and Bristol,Myers Squibb, has 300 scientists on its rolls, a significant rise from just 25 in 2000.

Besides the pharma companies testing the waters of research by in-sourcing, there are the pure CROs, which mostly provide outsourced services for data management. The main among these are Bangalore based Quintiles, Chennai based Biomines Research Solutions, Bangalore based Pharmanet’s (now SFBC International) and Mumbai based Asian Clinical Trial, ClinInvent and DnO. Bangalore based Synchron offers complete clinical data management services for data processing, analysis and management.

Besides the private sector, there are also several charitable health service providers as well.

International Linkages

In the current global scenario international collaborative efforts are recognized as one of the factors in successful research because of the complementarity of technology transfer, capacity building and access to diseased populations. The linkages with traditional international developmental partners and WHO and other UN Agencies are being further developed and strengthened. In addition, there are a large number of potential partners to be engaged in R&D activities in line with the priorities of the National Health Research Plan.

Biotechnology and IPR Regime
Implementation of the TRIPS Agreement provisions on Biotechnology will have a significant impact on biotechnology related IPR regime in developing countries, especially for the pharmaceutical and public health care sectors. Patent regime covers the following aspects

	Patent protection of life forms: scope is still being negotiated while scientific research is going ahead:
	Any new material or process in any field of science can be patented if it meets the novelty, progressivity, and usefulness criteria.
	Medical treatment and diagnostic techniques for humans and animals can be exempt from patentable subject material.
	Microorganisms and microbiological processes is subject to patents, but animals, plants and non-microbiological patents can be exempt. New plant varieties should be patented either by patents, special laws or by combination

Opportunities

	Technology transfer: Some of the areas aredrugs & pharmaceuticals research, genetics research, general medical research, and toxicology research
	Capacity building: India will need 10,000 - 15,000 investigators and 6000 to 9000 trained professionals like monitors, medical advisors, project managers and auditors in the next 5 years. Dutch companies can offer facilities in Holland and/or India for training this substantial manpower.
	Trials: The introduction of Ethical Guidelines for Biomedical Research in Human Beings and Indian GCP guidelines has provided an assurance of the quality of trials in India. The next major step has been revision of Schedule Y. When the revised Schedule Y comes into force, it will enhance acceptability as per global standards. Dutch companies can outsource their trials to India, which offers a cost effective alternative for conducting trials on animals and humans for pharmaceutical formulations.
	Ethical guidelines: Help India in harmonising Ethical Guidelines for Biomedical Research on Human Subjects and Animals with International Guidelines and facilitate training in ethical research
	IPR:Provide legal and technological expert to Indian companies to overcome any problems arising of the IPR regime

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