Kushank Sindhu and Abhishek K. Singh here throw light on the ignorance of the government on the data screening process through this article.
Abstract
The central point of conflict between innovator and generic pharmaceutical companies is how generic companies circumvent drug authorization procedures for manufacturing products already invented by innovator companies. Governments rely on the post-screening data submitted by innovators to check the similarity of the generic’s product with the innovator’s product. Generics are able to reduce costs because of low trial and testing costs. This helps them market cheap and similar medicines but according to the innovators, there must be intellectual property protection given on the data that they have already submitted given its newness and expensive generation. Governments should not rely on them at least for a few years. The TRIPS Agreement is ambiguous on this issue leading to different interpretations. India interprets against such protection on the misplaced belief that imposing it would finally lead to delay and increase in medicine costs. This paper brings out the fallacy in the above line of thought by interpreting the TRIPS in a manner which clearly indicates towards a regime of data exclusivity as a
means of intellectual property protection. Analysis of data from countries shows the benefits of such interpretation encouraging critical research and development of cheaper and more effective medicines. It allows for foreign investment and collaboration opportunities. India’s position on data exclusivity is incorrect and dangerous making the country lose out on crucial benefits. Concerns such as high prices of medicines can be remedied utilizing the provisions already there in Indian law. This plan of action will protect intellectual property towards better public healthcare conditions.