The Biosecure Act is back, presenting an excellent opportunity for the Indian pharmaceutical industry. 

The Biosecure Act is back, presenting an excellent opportunity for the Indian pharmaceutical industry. 

In a surprising turn of events, the Biosecure Act has been revived by the US Senate – this time as part of the 2026 National Defense Authorization Act (NDAA). The goal of the act is to limit US biotech partnerships with foreign companies that pose a national security threat, especially companies based in China. Suppose the act passes the US House of Representatives and is signed into law by President Trump. In that case, it will change international biotech partnerships and create new opportunities for the pharmaceutical and biotechnology industry in India.

What is the Biosecure Act? 

Initially introduced in 2024, the Biosecure Act aimed to prevent foreign actors from exploiting sensitive US biotechnology and genomic information. The act would block federal agencies and contractors from using machines or services derived from biotech firms considered “of concern.” Previous drafts mentioned the Chinese companies BGI Group and WuXi AppTec because of potential safety concerns.

The 2025 amendment does not name specific companies. Instead, it allows the US government to maintain a continuously updated list of sanctioned companies that are owned by foreign militaries or are under the influence of foreign adversaries. In other words, the US will support a dynamic list of sanctioned companies with annual updates. This flexible approach allows the US to mitigate risks without stopping research or procurement.

 Important Components of the 2025 Act 

The Act contains several significant changes. Current US contracts for suppliers who may be subject to restrictions will have a five-year transition period. Certain exemptions still apply for pharmaceuticals and public health, and researchers on pharmaceutical and health projects can still apply for temporary waivers. Minor laboratory equipment, such as a PCR machine, will be excluded to allow critical research to continue.

Why Would India Benefit?

The decoupling of US biotech from China provides an opportunity for India’s pharma and biotech sectors. Indian companies with regulatory credentials would be relatively well-positioned to offer alternatives to Chinese suppliers, especially if they have FDA-approved facilities. Companies such as Divi’s Laboratories, Syngene International, Neuland Labs, Jubilant Life Sciences, Piramal Pharma, Cohance Labs, and Laurus Labs could be targeted. In addition, some Indian stocks rose by upwards of 5% after the Senate vote, which investors have interpreted as a positive sign.

The opportunities extend beyond manufacturing. Indian firms may be able to secure high-margin contracts in contract research, biologics development, and supply chain management. India can expand its global biotech footprint by establishing itself as a trusted and compliant service provider.

The Challenges and Path Forward

Despite good opportunities, challenges will need to be addressed. Although the Biotech Biosecurity Act still requires House approval, it will be implemented slowly to give federal agencies time to adjust their procurement policies. Analysts have warned that the legislation may also slow the progress of international collaboration and obstruct international scientific partnerships.

Indian firms will need to be strategic to win contracts that they can comply with, and to also build a reputation of trustworthiness with clients in the US. Indian pharma and biotech firms will ultimately be among the big winners of the reconstructed global biotech supply chain.

The recommissioned Biotech biosecure act is not only an American security policy, but it has the potential to be a game-changer for the India’s pharma and biotech companies- if India can operate strategically and capitalize on the opportunity, it can deepen its grip on high-value US contracts and further establish India’s pharma as a credible, globally competitive biotech zone.

 

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