“CLINICAL TRIALS IN INDIA”

Abstract

The larger context of clinical trials in India is poverty and the absence of affordable healthcare. For more than a decade, government policy has been to reduce public support for healthcare services, and these services are under-resourced. Health economists have pointed out that only 15 per cent of the Rs 1,500 billion spent in the health sector in India comes from the government. Clinical trials (also called medical research studies) are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people. If the drug successfully passes through Phases I, II, and III, it will usually be approved by the national regulatory authority for use in the general population. Phase IV are 'post-approval' studies. The level of concern about the impact of the CTD on clinical research activities is intense and widespread overall stakeholder groups. Opinions and quantitative survey results draw a picture of increased bureaucracy and costs, reduction of important research without creating benefits for patients. However, concrete, comprehensive figures about the clinical trial activities are only available from competent authorities. Figures on the CTD’s impact on organisation, staffing, costs and processes of the different stakeholders are missing.These trials violated the the Indian Council of Medical Research’s Ethical guidelines for biomedical research on human subjects and the World Medical Association Declaration of Helsinki: Ethical principles for medical research involving human subjects. The trial designs do not seem to have violated regulations for the conduct of clinical research in India. The existing regulatory apparatus therefore permits unethical trials of no benefit to Indians. Clearly, trials are being conducted in India that could not be conducted in developed countries, taking advantage of people’s lack of access to affordable, good quality care.

The benefits of research do not reach the community as drugs found effective following these trials may not be affordable to the community in which they were tested. Such practices are in violation of the Declaration of Helsinki as well as the general principles laid down in the Indian Council of Medical Research’s ethical guidelines for biomedical research.The infrastructure for regulation, ethics review and monitoring is insufficient. The government’s priority seems to be ensuring that clinical research in India produces good quality data according to Good Clinical Practice standards. Ethical guidelines – including its own ethical guidelines – seem to be of secondary importance. The ethical concerns raised by these clinical trials; the weak regulatory apparatus to protect trial participants, government policy to encourage international clinical trials without taking active steps to put in place a system to protect participants from harm; people’s desperation for affordable health care – all this will only worsen the harm being done to trial participants in India.tum since the dis