Clinical Trials in Developing Countries: Issues and Concerns

-- Subhash Chandra Singh

In recent years, the increasingly global nature of health research, and in particular the conduct of clinical trials in the developing countries involving human subjects, has highlighted a number of ethical issues. Some of these issues have begun to take the center stage because of the concern that research conducted by scientists from more prosperous countries in poorer countries that are more heavily burdened by diseases may, at times, be seen as imposing ethically inappropriate burdens on the host countries and on those who participate in research trials. Less stringent ethical review, lower risk of litigation, less requirements for informed consent, and the availability of ‘treatment-naive’ patients who are much less likely to have been previously exposed to drugs or trials make research in the developing world more attractive for pharmaceutical industries. India accounts for some 15% of worldwide clinical drug studies where costs are low and regulations less strict than in the US and Europe. This marks a titanic shift of drug trials in this country. This paper critically examines the complexity of modern-day trials in which a host of regulatory and ethical issues are involved.

© 2011 IUP. All Rights Reserved.

The Structure and Elements of an Inland Wetlands and Water Bodies Act for West Bengal

-- Susmita Sen

Wetlands as natural resource systems generate conflicting interests which pose challenge to the paradigm of conservation. In such areas of conflict law becomes an important tool for protection, wise use and conservation of wetlands. It is now understood that wetlands should be managed and conserved irrespective of their size and ownership. Their functional attributes are generally ill-conceived, and therefore, only a selected few are identified for protection and conservation. The ecosystem value of wetlands in general is yet to be established decisively enough for bringing them under the purview of legal restraints. The present paper proposes the structure and basic elements of an Inland Wetlands and Water Bodies Act based on the multiple values and characteristics of wetlands. The elements proposed are expected to provide a foundation for developing legal provisions for prohibitive and restrictive actions in wetlands as well as for wise use of all freshwater inland wetlands of West Bengal in general, and a few important ones in particular.

© 2011 IUP. All Rights Reserved.

Constitutional Perspective of Right to Health in India: An Analysis

-- Dnyaneshwar Chouri

Generally, the context in which an individual lives is of great importance to health and quality of life. Health is the level of functional or metabolic efficiency of a living being. It is the general condition of a person’s mind, body and spirit, usually meaning to be free from illness, injury or pain. Law is an important pubic health tool that plays a critical role in protecting the health of general public. Right health is central to all human rights and denial of health right would mean denial of all human rights. The framers of the constitution incorporated right to health in the Directive Principles of State policy (DPSP) which enjoins the state to provide comprehensive, creative, preventive, promotional and rehabilitative health services and proper nutrition to all the people of India. Ultimately, it is the effort of the Indian judiciary who treat health as a right to life which is fundamental to all human beings under Article 21 of the constitution. Therefore, entitlement to heathcare must be ensured by developing specific statutes, programs and services. In this article, an attempt has been made to analyze the constitutional provisions to protect the right health and to evaluate the creative response of judiciary in making the right health as a fundamental right.

© 2011 IUP All Rights Reserved.

The India-EU FTA: Depriving the Common Indian of Lifesaving Drugs?

-- J Bishen and Kartikeya S

The India-European Union (EU) Free Trade Agreement (FTA) is still in the pipeline, and most aspects of the agreement are still not in the public domain. The agreement, likely to be concluded sometime this year, is highly controversial as it aims to include a data exclusivity law which could delay the market entry of various generic drugs. This in turn could lead to a number of lifesaving drugs becoming inaccessible and unaffordable to Indians as well as citizens of various third world nations to which India exports. Though the Indian Government has recently clarified that it will not compromise the interests of the common man, it will be interesting to see if the EU can arm-twist India into strengthening its Intellectual Property Rights (IPR) regime. While the EU’s stand may seem unjustified to most Indians, this article endeavors to throw light on the arguments of both sides.

© 2011 IUP. All Rights Reserved.