The impact of intellectual property rights in particular patent relating to public health has posed numerous challenges faced by developing countries who are members of World Trade Organisation (WTO). This paper examines the impact of TRIPS Agreement (Trade Related Intellectual Property Rights) in relation to developing countries in general with specification made to India. Significant changes brought about by the TRIPS flexibilities in particular usage of compulsory licensing and Bolar provision have to a certain extent benefited the developing countries in the field of public health during national emergency. The TRIPS flexibilities by way of amendment have helped countries that (do not possess manufacturing capacities) to import medicines. Some developing countries even utilised TRIPS flexibilities in an aggressive manner to enforce their right to have access to medicines from other countries for the benefit of their citizens. Further, TRIPs flexibilities have helped developing countries to manufacture generic products to make it affordable to the people. This paper specifically examines the impact of the TRIPS Agreement on Indian generic pharmaceutical industry and the legal challenges faced by Indian pharmaceutical industry after the implementation of product patent regime effective from 1 January 2005. The Patent Amendment Act 2005(India) will be looked into especially on the controversy in respect of Section 3(d) of the Patent Amendment Act 2005(India) on the requirement of patentability. The new Section 92A of the Patent Amendment Act 2005(India) on the grounds to invoke compulsory licensing will be analysed to see whether Indian government has applied restrictive or broad approach, as compulsory licensing is certainly an important legal
Off label prescription occurs when a drug is prescribed for an indication, a route of administration, or a patient group that I snot included in the approved product in relation to the Federal Drug Administration (FDA). Off label prescription has been a major challenge for patients as most of time they are not aware of the indication they are prescribed for. For instance, the drug Methotrexate to treat cancer is being prescribed as off label to treat psoriasis. The adverse drug reactions incurring from a cancer drug can cause severe reactions, in which the burden being passed to a patient suffering from auto immune disease and skin disorder such as psoriasis. The legality aspects are certainly importance to enhance the role of the doctors which prescribing the off label prescription to the patients. The lack of awareness by the practitioners while practicing off label prescription for the sake of insufficient medication or lack of medication for certain diseases does not give a room to practice off label prescription. The purpose of this paper is to further define and discuss the status of off-label use of medications in children as the medication of children is lacking compared to adults. The legality of off label prescription has not been addressed and mainly left at the discretion of medical practitioners to apply off label prescription. The legality aspect of off label prescription can be addressed with improvise interpretations under Section 14(4) (d) of the Patents Act 1983.
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