US FDA Participates in Indian Medical Product Safety Forum

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by Genna Liu
Rituximab, which is used to treat certain types of autoimmune diseases and cancer, is sold under the name MabTabs by Indian pharmaceutical Intas. [Image: intaspharma]

The US Food & Drug Administration’s India Office participated in a meeting in February that focused on promoting medical product safety. Titled “Towards Excellence in Quality,” the Indian Pharmaceutical Alliance Second Forum brought together various stakeholders in the Indian medical manufacturing sector, who discussed ways to achieve high quality production. Responsible for inspecting Indian medical and food products exported to the United States, the FDA’s India Office is well-positioned to aid in supporting product safety in India.

Stronger quality control in India can make medical care more affordable in the United States. India currently supplies over 20% of the US generic drug market. Improved manufacturing conditions will enable more generic drugs to pass FDA regulations and become available on the US market. Generic drugs, which make up 88% of all drugs dispensed, can cost 80% less than brand name equivalents, thus lessening the financial burden for US patients. In 2010, purchasing generic instead of name brand drugs saved consumers $158 billion.

The FDA meeting represents one of many collaborations between the United States and India in the medical field. The US-India Business Council worked with Indian officials to incentivize investment in medical technology centers and ensure patient access and affordability to healthcare. Duke University currently partners with Medanta, a group of multi-specialty medical institutes in India, in an early phase clinical research facility near Delhi. The Stanford India Biodesign team, a project established by Stanford University and the Indian government, is looking to create high quality and cost-efficient medical devices.  

In addition to India, the United States partners with several other Asian countries for medical research and innovation. In 2015, a Japanese and American scientist team consisting of Satoshi Ōmura and William Campbell earned the Nobel Prize in medicine for discovering a therapy against parasitic infections. Johns Hopkins University School of Medicine maintains ties with medical institutions in India, China, Singapore, and Japan. Pfizer Inc., a US pharmaceutical company, invested $350 million in a Chinese biotechnology center to advance treatments for patients worldwide.

Genna Liu is a research intern at the East-West Center in Washington and a government and economics student at Dartmouth College.