The Indian pharmaceutical market is valued at approximately $20 billion and U.S. imports of Indian drugs comprise about $5 billion per year. However, the U.S. and India face two key issues barring even stronger cooperation in the drug sector. First, some Western drug companies – such as Gilead and Novartis – have been denied patents for their drugs in India. Second, the U.S. Food and Drug Administration (FDA) has been penalizing Indian pharmaceutical manufacturers for violations of intellectual property rights, tampering with manufacturing data, and not paying their required annual fees.
In January 2015, U.S. President Barack Obama met with Indian Prime Minister Narendra Modi. The two leaders discussed a variety of issues — including healthcare, trade policy and intellectual property rights. A statement released at the end of the visit outlined key areas to the U.S.-India relationship. The document noted that the two countries will form a High Level Working Group on Intellectual Property, develop a Healthcare Dialogue and engage in strengthened regulatory cooperation for pharmaceuticals. India has also recently developed a revised draft intellectual property rights policy.