“The needle has moved,” declares Anil Matai, Director General of the Organization of Pharmaceutical Producers of India (OPPI), in a recent podcast interview with Scrip. The statement refers to the substantial changes in India’s intellectual property rights (IPR) regime, which witnessed some critical amendments in the past year. As the representative body for foreign pharmaceutical companies in India, OPPI plays a crucial role in shaping the country’s IPR and regulatory environment, which continues to evolve as the industry adapts to both domestic and global pressures.
Matai’s remarks signal that India’s pharmaceutical sector is undergoing a transformation, particularly in areas such as patent regulations, data protection, and the ongoing debates surrounding Section 3(d) of the Indian Patent Act.
Key Amendments and the State of Play
India’s intellectual property landscape has been in flux, with several key amendments to the patent law being introduced last year.
However, one of the most controversial aspects of India’s patent system remains Section 3(d) of the Indian Patents Act. Section 3(d) prevents the patenting of new forms of known substances unless they result in significantly enhanced efficacy.
The ruling emphasized the need for innovation beyond mere incremental changes, a stance that was seen as a win for public health over the interests of global pharmaceutical companies. However, for foreign firms like those represented by OPPI, Section 3(d) remains a longstanding sticking point. Matai pointed out that while India’s patent system has evolved, challenges such as these continue to make it difficult for global innovators to protect their products in the country.
Data Protection: A Global Imperative
Another critical issue discussed by Matai is the need for Regulatory Data Protection (RDP), which he describes as a “no-brainer.” RDP refers to the protection of clinical trial data submitted to regulatory authorities in the drug approval process, ensuring that competitors cannot rely on this data to gain approval for their own versions of a drug without conducting their own trials. Matai cites China’s rapid advancement in the biologics space as an example, noting that China has already made significant strides in protecting RDP and attracting global pharmaceutical investment.
China’s National Medical Products Administration (NMPA) recently introduced guidelines that outline specific periods of data exclusivity for different categories of drugs. These guidelines are part of the broader regulatory framework that has seen China move ahead of India in the biologics sector.
The issue of data exclusivity (DE) has been contentious in India for years. Under the TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement, India, like other member states, is required to protect undisclosed data necessary for regulatory approval of new chemical entities. However, India has not yet provided for data exclusivity in its laws. While the generics industry and public health advocates argue that this is a matter of confidentiality and not exclusivity, foreign firms see data exclusivity as crucial for fostering innovation and protecting intellectual property.
Matai emphasized that India’s reluctance to adopt data exclusivity is a hindrance to attracting foreign investment in the pharmaceutical sector. “Without adequate data protection, global pharmaceutical companies may look elsewhere for growth opportunities,” he warned, citing how China has leveraged RDP to become a hub for life sciences research and development.
US-India Trade Relations and the Road Ahead
The issue of intellectual property rights is not only a domestic matter but also an international one, particularly in the context of India’s trade relationships. India remains on the Priority Watch List in the United States Trade Representative’s (USTR) Special 301 Report, which highlights countries that are seen as not providing adequate protection for intellectual property rights. India shares this distinction with China, reflecting ongoing concerns about patent protection, data exclusivity, and the safeguarding of undisclosed data.
The U.S. has long pushed for stronger IP protection in India, with senior figures such as Eli Lilly’s CEO, David Ricks, calling for the country to rethink its stance on IPR and become a leader in life sciences. According to Ricks and other pharmaceutical leaders, India’s regulatory framework must evolve to align with global standards to attract the level of investment needed for the country to become a competitive player in the pharmaceutical industry.
Both India and the U.S. are now working toward the first tranche of a multi-sector Bilateral Trade Agreement (BTA), which is expected to be finalized by the fall of 2025. It remains to be seen whether intellectual property issues, including those surrounding patent eligibility and data exclusivity, will be part of the negotiations. If they are, the outcome could have a profound impact on the future of the pharmaceutical industry in India.
The Path Forward
India’s evolving IPR landscape presents both challenges and opportunities. While the changes in the regulatory environment signal progress, much remains to be done to balance the needs of public health with those of global pharmaceutical companies. As foreign firms continue to call for stronger IP protections, India faces the delicate task of crafting a system that promotes innovation without undermining access to affordable medicines.
Anil Matai’s comments reflect the tensions at play in this balancing act. As India moves toward a more integrated role in the global pharmaceutical market, the next few years will be pivotal in shaping the future of the country’s intellectual property and regulatory framework. Whether India can find the right balance between fostering innovation, attracting investment, and maintaining access to essential medicines will be key to its future as a global leader in the life sciences sector.
In the meantime, the global pharmaceutical community will be watching closely, as India’s regulatory evolution continues to unfold.