FTAs are welcome but don’t let them undermine pharma industry and drug access

The Indian pharma industry has come a long way to being one of the largest and most advanced pharma industries in the world.

By Archana Jatkar

Equitable access to safe, effective, and affordable medicines remains a crucial public health challenge. According to the WHO, nearly two billion people worldwide—many in low- and middle-income countries and even some in developed economies still lack access to essential medicines.

This global inequity raises a critical question: How can countries foster pharmaceutical innovation without making life-saving medicines inaccessible?

The Indian experience with IP

India’s experience offers a compelling answer and in 2025, the country will mark 20 years since it institutionalized that approach. When India amended its patent law in 2005 to align with the WTO’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement, it did more than fulfil international obligations. It established a patient-first model that balances innovation with access, a model that continues to shape global thinking.

From being almost non-existent in the 1970s, the Indian pharma industry has come a long way to being one of the largest and most advanced pharma industries in the world. This success stems from entrepreneurial drive supported by policies like the Patent Act, 1970.

A major shift came in 1995 when India joined the WTO and committed to aligning its IP laws with TRIPS, including product patents for pharmaceuticals. For a country with a strong generics base, this was a significant transition. However, India struck a careful balance—encouraging innovation while safeguarding public health. The pharmaceutical industry adapted quickly to this new global IP framework.

Enacting a law to encourage research while preventing ‘evergreening’ patents

The amended Patents Act in 2005 aligned with minimum standards set by TRIPS Agreement and using TRIPS flexibilities included crucial safeguards: patentability criteria that would prevent “evergreening,” pre-grant opposition to ensure the genuineness and quality of patent and to weed out frivolous patent applications, if any, and provisions for compulsory licensing in the public interest.

Over the past two decades, India’s patent framework has become a global example of balancing innovation with access to medicines. For instance- the pre-grant opposition mechanism, used to prevent the grant of patents on salts, polymorphs, formulations, and other derivatives that do not meet patentability criteria set by Indian Patent Act This ensures weak applications are rejected during examination itself.

It has enabled timely launch of generics

As a result, Indian companies have been able to launch generic versions of drugs immediately after the primary patent expires, ensuring timely access to affordable medicines. Without this safeguard, patients would have faced delays and higher costs.

Notable examples include Dapagliflozin (in combination with other antidiabetic agents) and Trastuzumab (subcutaneous formulation), both of which became available in India promptly after the original product patents expired.

Over the last two decades, India has demonstrated that a balanced intellectual property (IP) framework can drive innovation while safeguarding access to medicines. In 2005, only three pharmaceutical product patents were granted in India; by 2008, this number rose to 1,369. Today, India is among the world’s fastest-growing IP jurisdictions, with a 15.7% increase in patent filings in 2023, ranking sixth globally. Pharmaceuticals and Medtech now account for around 15% of filings, reflecting the sector’s growing innovation capacity.

TRIPS-plus push through FTAs

However, this balance is under increasing strain. Several countries are pushing for TRIPS-plus provisions in trade agreements—extending patent terms, introducing data exclusivity, and patent linkage all which risk delaying generic entry. Additionally, some innovators are using both patent and regulatory frameworks to extend monopolies through tactics like patent thickets and product hopping. Such practices threaten to increase medicine prices and limit access, particularly for India and many countries dependent on Indian generics.

India has resisted these pressures, recognizing the risks to domestic and global health security. Protecting this calibrated IP framework is critical for sustaining affordable access to medicines.

Meanwhile, India’s pharmaceutical industry has expanded from $3 billion in 1999 to $58 billion in 2024 cementing its role as the “Pharmacy of the World.” Net foreign exchange earnings surged from $1.1 billion to $19.5 billion.

The COVID-19 pandemic further underscored India’s importance, as it supplied medicines to over 150 countries. Globally, even developed regions like the EU and US are rethinking their pharmaceutical IP policies to curb abuse and ensure access. In the US, legislative efforts like the Affordable Prescriptions for Patients Act and the Drug Competition Enhancement Act aim to curb practices such as patent thickets and product hopping. Notably, in 2021, then Acting FDA Commissioner Janet Woodcock raised concerns over patent thickets with the USPTO about how such practices delay generic and biosimilar competition.

With over $250 billion worth of global drug patents expiring between 2022 and 2030, Indian companies have a major opportunity in biosimilars, complex generics, and innovative therapies.

In last two decades, the country’s IP model continues to serve as a global benchmark for balancing innovation with public health. India’s philosophy remains rooted in a simple principle: innovation and access are not competing goals; they are complementary imperatives. Good health policy isn’t about choosing between science and society; it’s about designing systems where both can thrive, and India’s IP framework proves it’s possible.

(Archana Jatkar, Associate Secretary General, Indian Pharmaceutical Alliance.)

 Views are personal and do not represent the stand of this publication.