This article has been written by Ms. Aarshiya Punera, a IInd year student at Law Centre-II, Faculty of Law, University of Delhi.
ABSTRACT
The fields of medicine and health have been India’s strengths since time immemorial. Be it providing aid to pandemic-stricken countries under “Vaccine Maitri” or collaborating in R&D with an international stakeholder, India has always ferociously pursued developments in the medical field.
Post-independence, India grew self-sufficient in generic drugs and low-cost effective vaccines. After compliance with the TRIPS Agreement, the focus shifted to extensive R&D, Collaborations, and alliances with global pharma giants. This article talks about the global phenomenon in pharmaceuticals and India’s participation in them. The effect of TRIPS compliance on the domestic industry is noted in brief. India’s effort for a TRIPS Waiver during the pandemic is also noted. Lastly, the commitment of the Indian government to fight illegal rackets operating worldwide and collaboration with INTERPOL is also discussed.
Keywords: TRIPS Agreement, Patents, TRIPS compliance, Essential medicines, Illegal drugs, R&D.
INDIAN PHARMACEUTICAL INDUSTRY AT PRESENT
India, at present, is the ‘pharmacy heaven’ of the world. The annual report (2022-2023) of the Pharmaceuticals Department of the Government of India cites that India globally is the third-largest producer of pharmaceuticals by volume. We are the leading exporters of low-cost generic drugs and vaccines that are effective and meet the required standards.1
The domestic pharma industry has entered the global value chain (GVC), emerging as a global leader undertaking substantial R&D in the field. The industry meets 60% of the global demand for vaccines. According to a report by a leading pharma company, PwC, India is the largest contributor of DPT (Diphtheria, Pertussis, and Tuberculosis), BCG, and measles vaccines to WHO.2
The Indian pharmaceutical industry is expanding more than ever. The turnover for the year 2021-2022 was Rs. 3,44,125 crores [USD 42.34 Bn] (1). The government has increased the budget allocation and investments for the sector. Pharma companies are engaged in extensive R&D and collaborations with global companies. Many Indian pharma companies are doing CRAMS (contract-based research and manufacturing services) business for global pharmaceutical companies. It involves outsourcing and collaboration with foreign-based pharmaceutical giants.
Recently, in September 2023, the Union government launched the National Policy on Research and Development and Innovation in Pharma-MedTech Sector. The objective of the scheme is to promote research and innovation in the pharmaceutical and medical technology sectors. Through this scheme, the government aims to develop a pro-research infrastructure and encourage research in new drug discovery and innovative medical devices.3
INDIAN PHARMACEUTICAL INDUSTRY PRE-TRIPS (1970s – 1995)
The Indian Pharmaceutical industry bloomed and was self-sufficient by the 1980s, thanks to the weak patent protection by the indigenous Patent law. The Patent Act of 1970 provided only for process patents for pharmaceuticals and did not protect the final pharmaceutical product. It also reduced the duration of protection of the process from 14 years to 7 years from the date of filing a patent application, after which the processes fell into the public domain and could be used by anyone without any danger of infringement.
The patented processes could not be used without the consent of the rightful owner. People would, however, reverse engineer the drug through an alternate means. The industry was thus thriving in an anti-patent environment that encouraged the production of generic and non-branded medicines.
Besides, the Drug Policy of 1978, was drafted with the prime objective of making India self-sufficient in pharmaceutical drugs and boosting the availability of drugs at a reasonable price. It aimed at improving the technological competence of the Indian pharma companies to promote R&D.
In the same year, the World Health Organization (WHO) adopted the Alma-Ata Declaration on Primary Healthcare which had a provision stating it to be the responsibility of the government to provide “essential drugs” at all Primary Health care units.
Together, these circumstances called for an increased demand for affordable and effective drugs, which India was producing by then. The 1990s saw the opening of the Indian market to foreign trade. India thus started importing its low-cost generic drugs abroad.
INDIA’S PARTICIPATION IN GLOBAL INITIATIVES:
COMPLIANCE WITH TRIPS AGREEMENT (AMENDMENTS IN PATENT ACT, 1970)
A watershed moment in the Indian pharmaceutical scene came when India, being a member of the World Trade Organization (WTO), complied with the TRIPS Agreement of 1995 and amended its Patent law thrice.
The Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS) is a multilateral agreement administered by the WTO that aims to achieve a global minimum standard for protecting Intellectual Properties (IP). Each member state of the WTO has to provide the standard minimum protection to the IP of the rightsholder. It further provides for effective enforcement of IP rights and dispute prevention and settlements.
1.1 KEY PROVISIONS UNDER TRIPS AGREEMENT:
- The TRIPS Agreement seeks to protect any invention, product, or process [Article 27(1)]. The patent is valid for 20 years from the first date of filing the patent application (Article 33). The requirements for patentability are that the invention should be novel, non-obvious to a person skilled in the art, and capable of industrial application.
- Articles 27(2) and 27(3) highlight certain exceptions to patentability that include inventions against public morality, harmful to humans and animals, therapeutic, diagnostic, and surgical methods of treatment, etc.
- The applicant is bound to make a clear, descriptive, and detailed disclosure of his invention so that a person skilled in the art can understand it. (Article 29)
- Article 28 confers the Patent owner (either product patent or process patent) the exclusive right to deal with his invention. Any person making, using, or selling the owner’s invention without his consent is said to infringe his right.
- Rights under the TRIPS are subject to certain limitations and are not absolute. A “3-Step Test” is formulated to assess if allowing the use of a patent to persons other than the owner “unreasonably conflicts with a normal exploitation of the patent.”
1.2 CHANGES IN INDIAN PATENT ACT 1970 TO ENSURE COMPLIANCE WITH TRIPS:
Indian Patent law, as previously mentioned, was amended thrice in 1999, 2002, and finally in 2005 to align with the TRIPS Agreement. The key amendments are discussed below:
- The definition of “invention” under section 2(1)(j) was amended to include the word “product” making both new processes and products that are novel and capable of industrial application patentable.
- Compulsory patent was granted to microorganisms under section 3(j)
- The term of Patent protection was increased from the previously existing 7 years to 20 years from the date of filing the patent application.
- An exception was inserted allowing pharmaceutical companies to make, use, and sell patented inventions for further research and developmental activities. This is the “research exception” inserted by article 107 A.
- Another exception in the Patent Act of 1970 empowered the Patent Controller to grant compulsory licenses for manufacturing patented products in emergencies like a national emergency, non-availability of drugs to the public at a reasonable rate, etc. (Section 84).
The 3rd Amendment Act of 2005 added Section 92 that allowed manufacturing and export of patented drugs to low-income countries that are incapable of drug production to help them deal with public health crises.
- To discourage “evergreening” by pharma companies, Section 3(d) was modified. The mere discovery of a “new form” of a known substance that did not enhance the efficiency of the product was made non-patentable. A patent application of pharma company Novartis AG for the anti-cancer drug Glivec was rejected. The SC held that the said drug was merely a modification of the already existing drug and hence rejected the Patent.4
1.3 INDIAN PHARMACEUTICAL INDUSTRY POST TRIPS:
In the pre-TRIPS era, Indian Pharmaceutical companies were heavily engaged in developing alternate processes to manufacture branded drugs as there was an absence of a product patent. Once compliance with TRIPS was sought companies shifted their R&D investments towards new formulations and new products.
There was a rise in collaborations with global pharma giants. As the expiry date of world-known branded drugs was approaching, pharma giants cut their manufacturing costs and started outsourcing the majority of their labor, ingredients, and technology. This was supplemented by India’s improved R&D investments and capabilities.
With sanctions on product patents, many Indian companies readily jumped into CRAMS (Contract-based research and manufacturing services) business with global pharmaceutical companies.
Pre-TRIPS, India was a leading exporter of generic drugs. Post-TRIPS India also started manufacturing patented drugs. Advanced technological capabilities and collaborations with foreign companies and CRAMS business helped India enter the Global Value chain (GVC). Earlier, it was present in the GVC as a supplier of API (Active Pharma Ingredients) that were processed into a final product abroad.
WHO’S ALMA-ATA DECLARATION ON “ESSENTIAL DRUGS” 1978
In 1978, during an international conference on Primary Health Care, WHO adopted the Alma-Ata Declaration. This declaration made Primary healthcare a responsibility of the government. The member states committed to include primary healthcare in their national policy.
Medicines being an indispensable part of health care, the concept of “Essential Medicines” was promulgated. These medicines are affordable, effective, and available 24/7 to the community. In India, many state governments have rolled out lists of essential medicines. Tamil Nadu was the first state to do so. The lists get updated regularly.
The Central Government has launched various schemes to provide subsidized medicines to people in the lower strata. One such successful scheme is the Pradhan Mantri Jan Ausadhi Yojana (PMJAY). The objective of the scheme is to provide quality medicines to all sections of society, especially the deprived ones, and to create awareness about generic medicines.
According to the official record at 9182 Pradhan Mantri Bhartiya Janaushadhi Kendras (PMBJKs) are functional across the country at present. These kendras provide approximately 50% cheaper medicines. In some cases, the medicines are available at prices that are 80% to 90% of the market price of branded medicines.
3. INDIA NEGOTIATES FOR A TRIPS WAIVER
The coronavirus pandemic disrupted the global healthcare infrastructure. Most of the nations faced shortages of vaccines and other therapeutic medicines. Most hit by the pandemic were the low-income countries and the least developed nations.
The mRNA COVID-19 vaccines were manufactured in the West. These effective vaccines were in high demand which led to their hoarding by the developed countries. The least developed countries (LDCs) and low-economic countries were left to look out for themselves. It is then the developing countries, particularly India and South Africa, proposed to temporarily waive off the patent on the process and the technology used in making these vaccines. This waiver aimed to prevent, contain and treat COVID-19.
With multiple rounds of negotiation at the WTO and most member states recognizing the urgent need for a global response to scale up efficient, safe, and affordable vaccine production, the TRIPS waiver was allowed. The waiver was to be in force for three years from 25 May 2021.
Manufacturers in developing countries could then produce mRNA vaccines without requiring permission from the patent owner. Many countries including India, started exporting these vaccines to other countries in need.
- INTERPOL’S FIGHT AGAINST TRANSNATIONAL PHARMACEUTICAL CRIME
Transnational pharmaceutical crime is a big health concern gripping the world in recent times. With easy accessibility and increasing penetration of the internet, people worldwide are vulnerable to online rackets selling compromised, sub-standard, counterfeit, and cheap drugs. This phenomenon has been substantially on the rise since the COVID-19 pandemic.
INTERPOL’s Illicit Goods and Global Health Programme (IGGH) aims to achieve global cooperation among the national drug monitoring agencies worldwide to identify such rackets and launch awareness programs about pharmaceutical crimes and their harmful effects.
It runs a global program, Project Pangea, to collect data about such online sites, counter the illegal sale of counterfeit drugs, and increase global awareness about the crime.
The latest Edition of Project Pangea (Pangea XVI) concluded in October 2023. The agency came down heavily on the illicit drug businesses in 89 countries, including India.6 It arrested 72 persons globally and closed 1300 illegal websites.
Further, in June 2023, the Union Minister for Health, speaking at the 8th edition of the Global Pharmaceutical Quality Summit, highlighted the intolerance of the Indian government towards compromised drugs and assured strict implementation of policies against such malpractices.7
- INDIA’S G-20 PRESIDENCY: THE DELHI DECLARATION, 2023
As India led the G-20 Summit in September 2023, it remained committed to promoting the Sustainable Development Goals (SDGs) on Global Health. The G-20 New Delhi Leaders’ Declaration concluded with the world leaders committed to “strengthening the global health structure”. 8
To ensure the same, they agreed to boost the availability of safe, standard, and effective drugs, vaccines, and diagnostics medical equipment worldwide, especially in the least-developed countries (LDCs) and Middle-income countries.
To facilitate and reach a common consensus against the global crisis plagued by the Russia-Ukraine War and depleting global healthcare was a ray of hope in the global healthcare sector.
REFERENCES
- This report was originally written by and published by the Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers. The link for the same is herein:
- This report was originally written and published by PwC. The link for the same is herein:
Global pharma looks to India: Prospects for growth
- This article was originally written and published on the Press Information Bureau Website. The link for the same is herein:
- Case Law: Novartis AG Vs UOI, 2013, 6 SCC 1
- This article was originally written and published on the Press Information Bureau Website. The link for the same is herein:
https://www.pib.gov.in/PressReleseDetail.aspx?PRID=1904884
- This article was originally written and published on the INTERPOL Website. The link for the same is herein:
Global illicit medicines targeted by INTERPOL operation
- This article was originally written and published on the Press Information Bureau Website. The link for the same is herein:
- This article was originally written and published by the G20 Team. The link for the same is herein:
G20 New Delhi Leaders’ Declaration
- This article was originally written by Gopakumar G Nair published in Journal of Intellectual Property Rights, Volume 13. The link for the same is herein:
Impact of TRIPS on Indian Pharmaceutical Industry
22
- This article was originally written by Atsuko Kamiike and published in the Journals for Interdisciplinary Economics 32(1) 95–113, 2020. The link for the same is herein:
The TRIPS Agreement and the Pharmaceutical Industry in India
- This article was originally written and published on the INTERPOL Website. The link for the same is herein:
Pharmaceutical crime operations
- This article was originally written and published on TRIPS Website. The link for the same is herein:
- This article was originally written by Guru Prasad Mohanta, Himanshu Shekhar Pradhan and Sitanshu Sekhar Kar published in Indian Journal of Community Medicine. The link for the same is herein:
Concept of Essential Medicines and Rational Use in Public Health – PMC
- This article was originally written by Susan B Rifkin published on BMJ Journals Website. The link for the same is herein:
- This article was originally written and published on the World Trade Organization Website. The link for the same is herein: