Patent Policies and Provisions Relating to Pharmaceuticals in India

Abstract

Indian generic pharma industry has established a ‘pride of place’ as the largest generic manufacturer and supplier of essential and life-saving medicines to UNICEF, WHO, MSF and others. India has the largest number of manufacturing facilities approved by the USFDA and EDRM, etc. While the Patents Act and related IP laws are substantially TRIPS compliant and is reasonably well enforced, there is a need for substantial refinement in other pharma related laws such as Drugs and Cosmetics Act, Biodiversity Act. Need for more uniform and stringent enforcement of quality including upgradation of regulatory agencies is also called for. The Indian Patent Law which provides equitable balance between rights and obligation has also been hailed by all the third world countries and acknowledged, though reluctantly, by developed countries. Such a balanced patent law is essential to provide affordable access to essential medicines to the masses. An analysis of the policies and provisions of (Indian) Patents Act, 1970 and other pharma related laws are provided in this article.