The Scope and Issues of Trade Related Aspects of Intellectual Property Rights (TRIPS) in Indian Pharmaceutical Industry

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ACKNOWLEDGEMENT

I would like to take this chance for thanking my research facilitator, friends & family for support they provided & their belief in me as well as guidance they provided without which I would have never been able to do this research.

DECLARATION

I, (Your name), would like to declare that all contents included in this thesis/dissertation stand for my individual work without any aid, & this thesis/dissertation has not been submitted for any examination at academic as well as professional level previously. It is also representing my very own views & not essentially which are associated with university.

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TABLE OF CONTENTS

ACKNOWLEDGEMENTii

DECLARATIONiii

CHAPTER 01: INTRODUCTION1

Background1

Aims and Objectives2

Research Questions3

The Pharmaceutical Market in India3

The Indian Regulatory Framework5

Research Methodology6

Research Strategy7

Sources and Methods of Data collection8

Sampling Method9

Reflective Diary10

CHAPTER 02: INDIAN PHARMACEUTICAL INDUSTRY - PRE AND POST TRIPS13

History of Past Legislation (Till 1995)13

A Basic Goal of the Policy Makers14

Legislation Amendments after Signing TRIPs20

Article 1.122

Article 39.323

Other Legislations and Impact over Industry23

Amendments in Indian Patents Act under the TRIPS Regime25

Summary26

BIBLIOGRAPHY28

CHAPTER 01: INTRODUCTION

Background

One of the trade-related intellectual property rights (TRIPS) is an issue that became prominent at the beginning of the Uruguay Round of General Agreement on Tariffs and Trade (GATT) negotiations in late 1980. Violations and inadequate protection of intellectual property rights were seen as non-tariff barriers (NTBs) to trade. These were some of the concerns of member countries of commerce, which needed to be addressed. Thus, intellectual property rights are essentially a legal question came to the table in the original GATT. India became signatory to TRIPS in the Uruguay Round, which concluded in December 1994 only after a strong opposition to the inclusion of intellectual property rights in the forum of GATT. WTO (World Trade Organization) membership involves a commitment to comply with all rules governing the international body, including the protection of internationally agreed standards of intellectual property rights, the acceptance of a mechanism for consultation and resolution dispute and subject to retaliation in WTO-sanctioned rape.

With respect to patent law, the signing of the TRIPS Agreement has had a particular impact on the functioning and future prospects of the pharmaceutical industry in India. It was the pharmaceutical industry had engaged in intense lobbying against the inclusion of TRIPS in the forum and later the WTO GATT. There is a huge contrast between rules and standards advocated in the TRIPS and Patents Act of India, 1970. In January 1995, India has until 2005 to fully comply with international standards of intellectual property protection established in the agreement. In the meantime, India is obliged to meet certain basic requirements. 1995-2005, so you can get to being a crucial transition period for the pharmaceutical industry in India.

Compositions of the company in several therapeutic sectors, along with the structures of production companies will change. In the background are the national structures, legal and administrative procedures for collecting fees, anti dumping and countervailing duties, the application of products and safety regulations, other laws and regulations, and ...