This article has been written by Mr. A Raj Singh, a 3rd-year law student of JEMTEC Department of Law, Greater Noida.

ABSTRACT 

This study aims to investigate the relationship between the pharmaceutical business and India’s National IPR Policy in detail. India has struck a balance in developing its intellectual property rights (IPR) rules between promoting innovation and guaranteeing the welfare of the public, especially in vital industries like medicines. With a focus on affordability and large investments in R&D, India is positioned to be a major participant in the pharmaceutical sector. The industry’s sustained expansion is a testament to its dedication to quality, innovation, and solving global health issues. India’s participation in the TRIPS agreement shows that it is dedicated to upholding international norms even in the face of difficult obstacles and disputes. The country’s dynamic strategy was further demonstrated in 2005 when it transitioned to a product patent regime, striking a difficult balance between encouraging innovation and guaranteeing cheap access to important medicines.

KEYWORDS

Pharmaceuticals, National, IPR, India, Innovation, TRIPS

INTRODUCTION 

India’s Intellectual Property Rights (IPR) policy has changed significantly throughout time, influenced by economic growth, international agreements, and domestic demands. International accords such as the Trade-Related Aspects of Intellectual Property Rights (TRIPS) have an impact on the current system. The Patent Act of 1970, its revisions, and continuing changes to find a balance between encouraging innovation and guaranteeing access to necessary products and services are all part of India’s IPR journey. India’s pharmaceutical industry is vital to the country’s economy, significantly boosting both GDP and jobs. Known for its ability to produce generic drugs, India is frequently called the “pharmacy of the world.” In addition to providing for local healthcare requirements, the sector offers reasonably priced medications on a worldwide scale. The pharmaceutical industry has an impact on public health, research, and innovation in addition to economic factors. Diverse country intellectual property laws present opportunities as well as problems for global trade and cooperation. India’s IPR environment has been greatly impacted by the historic Patent Act of 1970, especially in the pharmaceutical industry. Although it promoted the production of generic drugs and made medications more accessible, it also presented difficulties for high-end innovation. 

HISTORICAL CONTEXT OF INDIA’S IPR POLICY 

The development of the IPR policy in India has a progressive stand which is briefly explained hereunder:

1. Prior to Independence:  Prior to gaining independence, India had few laws pertaining to intellectual property, mostly concentrating on patents and trademarks. There were laws governing British colonialism in place, and intellectual property protection was not given much thought.
2. 1950s–1960s: Post–Independence Period: In 1959, the Controller General of Patents, Designs, and Trademarks was founded in India. A number of inventions, notably those involving chemicals and pharmaceuticals, had their patentability limited by the Patents Act of 1970.
3. Patent Act, 1970:  It was passed with the intention of fostering regional innovation, avoiding monopolies, and favouring process patents over product patents. There were rigorous patent limits on pharmaceuticals and agricultural chemicals.
4. 1995’s TRIPS Agreement: India signed the TRIPS agreement, which required the government to harmonise its intellectual property laws with international norms.
5. Modifications between 1999 and 2002: The introduction of EMRs, or exclusive marketing rights: EMRs were implemented to safeguard specific products in order to close the gap between the previous and current patent regimes.
6. 2005 Amendment: In accordance with TRIPS, India made the transition to a product patent system. The pharmaceutical industry was greatly impacted by this reform, which permitted medication product patents.
7. Provisions Governing Mandatory Licencing (2005): These provisions were enacted with the purpose of finding a Balance between Access and Innovation. In order to guarantee affordability and accessibility, the government may now issue licences for the manufacture of patented medications under certain conditions thanks to provisions for compulsory licencing that were added to the Patents Act.
8. 2016 National IPR Policy: This all-encompassing approach sought to foster an atmosphere that protects intellectual property and encourages innovation in a variety of sectors, including medicine. It also stresses the value of using a balanced strategy to promote innovation while preserving public health.
9. Current Development: In order to meet new issues and bring its IPR laws into compliance with global norms, India keeps making amendments to them. As digital technologies have grown, it has become more important to manage copyright and digital piracy issues.

INDIA’S PHARMACEUTICAL SECTOR 

The overview of pharmaceutical sector in India is explained as follows:

1. 1. Historical Context: Since its founding, the Indian pharmaceutical industry has grown significantly, moving from a concentration on generics and formulations to becoming a major player on the international stage. Prior to the TRIPS Agreement, process patents incentivized generic businesses to lower medication production costs, but the lack of product patents permitted local production of patented drugs at a fraction of the original cost. Indian pharmaceutical companies now have fewer strategic alternatives due to the country’s compliance with the TRIPS agreement, which was finalised in 2005 and permits product patents.
   2. Economy-wide Contribution:
      1. GDP Contribution: The pharmaceutical sector plays a significant role in the economy and makes a significant contribution to India’s GDP.
      2. Creation of Employment: It is a significant source of employment, giving both skilled and unskilled workers jobs.
   3. Worldwide Presence:
      1. Manufacturing of Generic Drugs: Because of its expertise in the production of generic drugs, India is frequently referred to as the “pharmacy of the world”. Numerous well-known international pharmaceutical corporations get their generic medications from producers in India.
      2. Export Centre: Exporting medications to numerous nations, this industry has grown to be a major force in the worldwide pharmaceutical industry.

• Development and Research (D&R):

1. 1. Investment in Innovation: Prominent Indian pharmaceutical firms make significant R&D investments, which support innovation in drug discovery and development.
   2. Collaborations & Partnerships: India’s position in pharmaceutical R&D is further improved via partnerships with foreign pharmaceutical corporations and research institutes.
2. Accessibility and Affordability:
   1. Production of Generic Drugs: The focus on the production of generic drugs has been instrumental in lowering the cost of vital medications for both domestic and international consumers.
   2. Medicine Access: Indian pharmaceutical businesses have played a significant role in giving developing nations’ citizens access to life-saving medications.
3. The regulatory landscape:
   1. Strict Regulations: The pharmaceutical industry is governed by laws that guarantee the effectiveness, safety, and calibre of drugs made in India.
   2. Adherence to International Standards: Adherence to international standards has facilitated Indian pharmaceutical enterprises in fulfilling the mandate of various regulatory bodies.
4. Major Players:
   1. Sun Pharmaceutical Industries Ltd.: By market value, Sun Pharmaceutical Industries Ltd. is the top pharmaceutical firm in India. Products for the treatment of neurological, psychiatric, nephrological, gastroenterological, orthopedic, ophthalmologic, and heart problems are among the company’s offerings.
   2. Dr. Reddy’s Laboratories: Renowned for its emphasis on research and development, Dr. Reddy’s has achieved notable progress in both local and global markets.
   3. Cipla: By market value, Cipla Ltd. is yet another top pharmaceutical firm in India. The business also deals with biosimilars and consumer healthcare.

THE PATENT ACT, 1970

The Patent Act of 1970 represented a dramatic change from the patent system of the colonial era, replacing product patents with process patents. The Act sought to prevent the monopolisation of necessary items and promote local innovation by placing a strong emphasis on process patents. By permitting companies to manufacture medications using alternative procedures, the Act significantly contributed to the growth of the generic drug manufacturing industry. The production of generic medications helped to lower the cost of healthcare, increasing the general public’s access to necessary medications.

Section 3(d) of the Act prohibits patents from being granted for just altering already-existing compounds unless there is a notable improvement in efficacy. Numerous reasonably priced generic medications are now readily available due in part to the emphasis on process patents and the lack of product patents. India became known as the “pharmacy of the world,” providing both industrialised and developing nations with affordable medications. The phrase “universal or global patent” does not exist. The applicant is granted border-specific patent protection that is exclusive to the nation in where the application was made. To get patent protection in multiple nations at the same time, the patent holder may submit applications in each of those nations. India’s pharmaceutical industry was greatly influenced by the Patent Act of 1970, however changes made in 2005 forced the country to switch to a product patent system in order to comply with TRIPS.

THE TRIPS AGREEMENT AND INDIA’S ADHERENCE 

The World Trade Organisation (WTO) is responsible for overseeing the international agreement known as Trade-Related Aspects of Intellectual Property Rights (TRIPS). It establishes international norms for the defence and upholding of intellectual property rights, such as trade secrets, copyrights, trademarks, and patents. In 1994, India ratified the TRIPS agreement, demonstrating its determination to bring its national intellectual property laws into compliance with global norms. The agreement sets minimal requirements for member nations to follow when it comes to safeguarding and upholding intellectual property rights.

India’s Patents Act of 1970 reduced patentability, particularly in the pharmaceutical industry, hence the country experienced difficulties in keeping its TRIPS responsibilities in balance. In order to ensure access, India responded to this by including provisions for compulsory licencing in the modified Patents Act of 2005, which permits the production of patented medications under certain conditions. There have been debates about the idea of “evergreening,” which extends patent protection with small changes. India has come under fire for its use of forced licencing, with some claiming it may discourage innovation and international investment. Global trade ties have occasionally been tense due to India’s rigid interpretation of TRIPS, especially when it comes to pharmaceutical industries and nations advocating for more robust intellectual property protection.

GLOBAL ASPECT

 The various consequences for global trade and collaboration can be explained as follows:

1. Collaboration and Technology Transfer: Due to varying degrees of protection and expectations, collaboration between India and these nations may provide difficulties. Partnerships may result in the sharing of cutting-edge innovations, but the conditions of these partnerships may be impacted by worries about intellectual property protection.
2. Dynamics of the Pharmaceutical Industry: Variations in intellectual property laws have an effect on the accessibility and cost of medications worldwide, particularly in the pharmaceutical industry. The degree of intellectual property protection and the regulations in each nation may have an impact on collaborations in the pharmaceutical manufacturing industry.
3. Trade relations and market access: Trade Agreements: Variations in intellectual property rights can be a topic of discussion in trade agreements, impacting trade relations and market access. Countries with disparate intellectual property rules may have trouble harmonizing laws, which could affect how simple it is to do business in those countries. The United States and India maintain their active engagement on a number of venues, including the U.S.-India IP Dialogue, as well as through regular bilateral contacts on particular intellectual property problems.  Furthermore, the United States upholds constructive collaboration with Indian law enforcement, customs, and judiciary authorities, together with industry leaders, to deliberate on strategies for fortifying India’s crucial enforcement infrastructure.
4. Innovation Environment: incentives: As research and development incentives guaranteed exclusivity and protection, nations with robust intellectual property laws may draw in greater funding for R&D. Open innovation models may be promoted by nations with more lenient IP laws, which would promote cooperation and knowledge exchange.

CONCLUSION 

India’s progressive policy towards intellectual property over the years is demonstrated by the transition from a process patent regime to a product patent regime and the adoption of rules such as compulsory licencing. These achievements demonstrate a persistent endeavour to balance national requirements with international norms while fostering an atmosphere that is supportive of innovation. India’s pharmaceutical industry has grown to become a worldwide powerhouse. Important actors support global healthcare accessibility in addition to the economy. Particularly in vital industries like healthcare, the nation has attempted to strike a careful balance between defending intellectual property rights and guaranteeing access to reasonably priced medications. The disputes and difficulties draw attention to the continuous discussions and changes required to balance national and international commitments in the field of intellectual property. Fostering a cooperative and just global environment requires striking a balance between defending intellectual property rights and advancing global innovation and access to necessities. In order to guarantee that intellectual property regulations promote global collaboration and economic advancement rather than obstruct it, policymakers must effectively negotiate these distinctions.

REFERENCES 

1. The article “Intellectual property protection in India and implications for health innovation: emerging perspectives” originally written by Basant R, Srinivasan S and published on the dove press website. The link for the same is herein:

https://www.dovepress.com/intellectual-property-protection-in-india-and-implications-for-health–peer-reviewed-fulltext-article-IEH 

1. The article “Top 10 Pharma Companies in India by Market Capitalization” originally published on global data website. The link for the same is herein:

https://www.globaldata.com/companies/top-companies-by-sector/healthcare/india-companies-by-market-cap/

1. The article “Intellectual property rights and Indian pharmaceutical industry: Present scenario” originally written by  Ajay Prakash, Phulen Sarma, Subodh Kumar, and Bikash Medhi and published on the national center for biotechnology information website. The link for the same is herein:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6044128/ 

1. The article “India – Protecting Intellectual Property” originally published on the international trade administration website. The link for the same is herein:

https://www.trade.gov/country-commercial-guides/india-protecting-intellectual-property