Seven Indian Brands Behind 1 in 7 US FDA Rejections of Food, Drug, and Cosmetic Shipments

Seven Indian manufacturers—Haldiram, Sun Pharma, Nestlé, Cipla, Patanjali, Hindustan Unilever, and Himalaya Wellness—account for 14% of US FDA refusals of India-origin food, drug, and cosmetic shipments since October 2020. Haldiram led food rejections due to alleged unsanitary conditions, while Nestlé faced issues with mislabelling and additives. Sun Pharma and Cipla were flagged for unapproved drugs and CGMP violations. Patanjali topped cosmetic refusals for unsafe ingredients and labelling issues. Hindustan Unilever and Himalaya also saw notable rejections. India's overall FDA refusal rate rose from 0.21% in FY22 to 0.41% in FY24, with India making up 17% of global FDA refusals.