13-07-2025
Seven brands account for 1 in 7 US FDA refusals of Indian food, drug, cosmetic shipments
Seven domestic manufacturers – Haldiram, Sun Pharma, Nestlé, Cipla, Patanjali, Hindustan Unilever, and Himalaya Wellness – account for one in seven (14 per cent) of all India-origin shipments refused entry into the United States by the US Food and Drug Administration (FDA) since October 2020.
As of early July, the US FDA has refused 4,089 India-origin shipments in the ongoing US fiscal year 2025 (October 2024 to September 2025) – already exceeding the 3,648 refusals recorded in all of FY24, according to data from the top public health regulator.
Haldiram Snacks Food – in which Singapore's Temasek acquired a 10 per cent stake earlier this year at a $10 billion valuation – recorded the highest number of US FDA refusals, with 731 shipments containing Haldiram-manufactured products denied entry since October 2020. Notably, 94 per cent of these rejections occurred in FY24 and the ongoing FY25, the data shows.
Haldiram's refusal rate – the share of shipments denied over total shipments sent – rose to 1.7 per cent in FY24 and FY25 (till July), a sharp jump from below 0.1 per cent in FY22 and FY23 combined. The rejected consignments primarily consisted of snack foods, including fried items, flagged for alleged unsanitary manufacturing conditions and the presence of salmonella, a disease-causing pathogen.
Haldiram and Temasek did not respond to requests for comment.
Nestlé noodles flagged for unsafe additives, mislabelling
In the food products category, which accounts for 55 per cent of all US FDA refusals since October 2020, Haldiram was followed by Nestlé India, with 300 shipments rejected. Most of the consignments contained Nestlé-manufactured noodles, and were refused entry for misbranding, mislabelling, or containing unsafe additives or filth.
Nearly two-thirds of these rejections occurred in FY24 and the ongoing FY25, with Nestlé recording a refusal rate of 25 per cent – more than five times the 4 per cent in FY22 and FY23. While the US FDA data lists Nestlé India as the firm behind these consignments, a company spokesperson told The Indian Express that these exports were not made by Nestlé India and that no refusals have been recorded in the recent past.
The refusal rate of all food consignments from India stands at 0.32 per cent in FY25, up from 0.15 per cent in FY22.
Sun Pharma, Cipla face FDA heat
In the drugs and biologics category, Sun Pharma led with 335 shipment rejections since October 2020 – mostly for exporting unapproved drugs or failing to meet good manufacturing standards. Its refusal rate between FY22 and the ongoing FY25 stands at 1.8 per cent.
In June 2025, the US FDA issued a warning letter to Sun Pharmaceutical Industries Ltd over 'significant violations' of Current Good Manufacturing Practice (CGMP) regulations for finished drugs. The letter followed a December 2023 inspection of the company's Dadra facility, which found that some exported products were adulterated due to non-compliance with CGMP norms.
Sun Pharma is followed by Cipla, which has recorded 244 rejections since October 2020, primarily for exporting unapproved drugs. Cipla's refusal rate between FY22 and the ongoing FY25 stands at 1.5 per cent. In November 2023, the US FDA had issued a warning letter to Cipla Ltd, too, for non-compliance with CGMP norms.
The refusal rate of all drugs and biologics shipments from India has risen in recent years, from 0.7 per cent in FY22 to 1.06 per cent so far in FY25. These consignments account for 39 per cent of all refusals since October 2020, the second-largest category after food products.
Sun Pharma and Cipla did not respond to requests for comment.
Patanjali tops cosmetic refusals
While cosmetic shipment rejections by the US FDA make up a small share – just 3 per cent, with 136 refusals so far in FY25, trailing 156 in FY24 – Patanjali Ayurved has recorded a high refusal rate of 11 per cent since FY22, data shows.
Of the 548 India-origin cosmetic shipments refused since October 2020, nearly 20 per cent contained Patanjali-manufactured products – mostly shampoos, toothpastes and powders, and hair tonics. The most common reasons for rejection include the use of unsafe colour additives, unapproved ingredients, and labelling violations. In addition to cosmetics, Patanjali shipments have also faced rejections in the drugs (44) and food (35) categories.
Hindustan Unilever and Himalaya Wellness have faced 51 and 54 shipment rejections, respectively, since October 2020, with refusal rates of 2.1 per cent and 1.2 per cent since FY22. Most of their consignments were flagged for containing unsafe colour additives or unapproved drugs. Hindustan Unilever also recorded 23 refusals in the food category and 8 in drugs.
Patanjali, Hindustan Unilever, and Himalaya did not respond to requests for comment.
The overall refusal rate for Indian cosmetic shipments rose from 0.16 per cent in FY22 to 0.48 per cent in FY24, before easing to 0.2 per cent so far in FY25.
The refusal rate for India-origin shipments across all categories has climbed in recent years – from 0.21 per cent in FY22 to 0.41 per cent in FY24, before easing slightly to 0.36 per cent so far in FY25.
In the ongoing US fiscal, India accounts for 17 per cent of all FDA refusals – second only to Sweden at 18 per cent. Swedish shipments, largely consisting of tobacco products, had a notably high refusal rate of 1.7 per cent. China followed with a 12 per cent share of total rejections, but its overall refusal rate was just 0.01 per cent.
Aggam Walia is a Correspondent at The Indian Express, reporting on power, renewables, and mining. His work unpacks intricate ties between corporations, government, and policy, often relying on documents sourced via the RTI Act. Off the beat, he enjoys running through Delhi's parks and forests, walking to places, and cooking pasta. ... Read More
