India’s pharmaceutical industry is seeking greater government support to safeguard its formulations segment following concerns raised in the USTR Special 301 Report. However, industry leaders acknowledge that the likelihood of legal complications remains negligible, as Indian companies are compliant with the norms of the World Trade Organization.
According to the latest Special 301 Report, India is among six countries on the list due to continuing concerns regarding the protection and enforcement of intellectual property rights, especially in the pharmaceutical sector.
“India manufactures the most affordable generic medicines. But now the pharma lobby in the US is trying to restrict imports. Indian manufacturers could face increased competition in the formulations segment,” said RS Goswami, founder and CEO of Hind Pharma.
However, exporters said the report may not trigger immediate regulatory action, though it could create competitive pressures — especially for smaller Indian drugmakers that rely heavily on exports of low-cost generics.
Goswami added that just as India has introduced incentives for active pharmaceutical ingredients (APIs), similar policy support may be required to protect formulation businesses. “There is also a need to simplify ease of doing business for the pharma sector,” he said.
Industry stakeholders emphasised that India’s intellectual property framework is compliant with the TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement, limiting the scope for any legal fallout.
“The US itself provides significant patent protections domestically, so it would be incorrect to suggest that India’s approach is somehow wrong. As far as the USTR Special 301 Report is concerned, it is an ongoing process and largely reflects differing viewpoints under the TRIPS Agreement framework. There won’t be any material legal implications or a significant impact on India’s pharmaceutical exports,” said Jatish N Sheth, director at Srushti Pharma.
However, concerns remain for smaller firms, which often operate on thin margins. Some fear that heightened scrutiny or non-tariff barriers could affect market access in the US.
According to industry leaders, Indian companies are highly competitive in developing cost-effective pharmaceutical products, helping sustain the global pharmaceutical supply chain.
Ramesh Juneja, chairman of Mankind Pharma, said Indian exporters operate within global rules.
“There is no infringement by Indian pharma exporters. In 2005, India fully complied with the WTO’s TRIPS Agreement by amending its Patent Act to introduce product patents. A majority of pharma exports are WTO-compliant,” he said, adding that India plays a critical role in supplying affordable essential drugs, including cancer medicines.