India is the largest global provider of clinical R&D, manufacturing generic drugs, antibiotics, and active pharmaceutical ingredients. The FDA’s footprint in India is larger than that in the US.Peter Marks, the Director of the FDA’s Center for Biologics Evaluation and Research (CBER), is currently collaborating with Indian regulatory authorities to simplify the manufacturing and licensing of biologics from India. The cost of cell biologics manufacturing in the US is very high, which presents a significant burden. India is referred to as the “pharmacy of the world,” and streamlining the production of cellular biologics—similar to how synthetic chemicals and antibiotics are already manufactured and exported from India—has the potential to reduce overhead costs. This reduction may also facilitate easier adaptation by US insurance companies. We are proud to be involved in the evolution of these regulations, ensuring patient safety in this area of medicine.