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Outsourced Pharma

Is Your Intellectual Property Safe With Indian CROs And CDMOs?

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Outsourced Pharma

Is Your Intellectual Property Safe With Indian CROs And CDMOs?

With Congress considering the Biosecure Act, which would limit dealings with companies headquartered in China, many life sciences players are looking at alternatives to WuXi, BGI, and other Chinese entities for new deals. This is another case where a China Plus One approach leads many startups as well as Big Pharmas to consider India as a possible alternative. India has 1 million professionals working in biotech and companies distributed across many parts of the country. India also provided COVID-19 vaccines to far more people than Pfizer and Moderna did. But is India a safe country in which to do business?

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Let’s take a deep dive.

India boasts a heritage of ancient sciences like Ayurveda, Siddha, and Unani, with knowledge codified and documented over centuries. Its government vigorously opposes attempts to patent products it believes are based on this existing wisdom.

Modern science validated the medical and health benefits of ancient Indian ingredients like turmeric and ginger. Cultural sensitivity is crucial in engaging with Indian counterparts, who may feel their traditional knowledge is mocked by the West, hindering trust-building efforts.

Western concerns arose regarding intellectual property rights (IPR) starting in 1970, when India modified its Patents Act, favoring process improvements and essentially invalidating product patents for drugs, leading to a domestic pharmaceutical boom. Success by these Indian companies in the U.S. market followed the Hatch-Waxman Act of 1984, which encourages the production of generic medications.

India became a founding member of the World Trade Organization (years before China was admitted) and this meant changing its IPR laws. India’s compliance with Trade-Related Aspects of Intellectual Property Rights (TRIPs) in 2005 marked a shift, necessitating adaptation to a stricter intellectual property framework. Balancing India’s rich heritage with evolving global standards requires mutual respect and understanding.

Last updated: May 13th, 2026

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Amritt Inc. is a management advisory service facilitating trade between the world and India. Amritt was founded in 2003 and since then it has provided guidance to western companies in entering new markets, global strategy execution, finding and managing supplier partners, and establishing overseas offices. Our primary focus is in helping American, Canadian and European executives to attain success in India.

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