India’s exports to the U.S. rose significantly to around $86.51 billion, representing an 11.6% increase over the previous year. Looking ahead, India’s exports are forecast to see a steep decline to around $60.6 billion, due to new U.S. “reciprocal” tariffs of 25%, potentially rising to 50% and significantly raising costs and posing major challenges for competitiveness. That said, pharmaceuticals and electronics may be somewhat insulated, as they often enjoy exemptions or lower tariffs.
Here are the main FDA Compliance Challenges for Indian Manufacturers and Exporters.
Indian manufacturers and exporters often face significant challenges in maintaining U.S. Food and Drug Administration (FDA) compliance. These challenges stem from a mix of regulatory complexity, infrastructural gaps, and quality assurance standards. Here’s a breakdown.
Pharmaceuticals
India remains a dominant supplier of generics to the U.S., with over 700 FDA‑registered facilities, the highest number outside the U.S. The sector is currently exempt from tariffs, as generic medicines are crucial for affordable healthcare. Between January and June 2025, $3.7 billion worth of drugs were exported to the U.S. Regulatory environment. Indian drug facilities face increasing surprise FDA inspections following a U.S. executive order aiming to tighten oversight. The industry is urged to pivot toward complex generics, biologics, Contract Development and Manufacturing Organization (CDMOs), and Contract Research Organizations (CROs) services, representing future growth areas, beyond traditional bulk generics. A small percentage of Indian pharma shipments get refused by the FDA, typically due to Current Good Manufacturing Practice (cGMP) violations or non-approved drugs. Since October 2020, about 1 in 1,500 shipments have been rejected, concentrated among a few firms.
Food Products
FDA compliance extends far beyond pharma. For foods and beverages, Indian exporters must register their facilities. Renewal is required every two years. They must also implement Hazard Analysis & Risk-Based Preventive Controls (HARPC), accurate labeling, ensure Foreign Supplier Verification Program (FSVP) protocols are in place. Provide Prior Notice to FDA before shipping. Refusal data is alarming. More than 2,600 line‑item refusals for food products between Jan 2024 and Apr 2025 occurred for reasons like Salmonella, pesticide residues, unsanitary conditions, mislabeling, or FSVP issues.
Medical Devices
India’s medical device exports as a whole are projected to reach approximately $10 billion by the end of 2025, which would be a significant increase. The United States is a primary market for Indian medical devices, with India emerging as a potential alternative to China in the US MedTech market. The top categories typically include Endoscopes, Orthopedic implants, MRI equipment, Diagnostic equipment, In-vitro diagnostics, Surgical instruments, Patient aids and homecare devices. Both the Indian manufacturer and the U.S. importer must be registered with the FDA. Depending on the device’s classification (Class I, II, or III), a premarket notification (510(k)) or Premarket Approval (PMA) may be required to demonstrate safety and effectiveness. Manufacturers must comply with the FDA’s Quality System Regulation, which includes good manufacturing practices. Device labeling must adhere to specific FDA standards, including providing intended use, proper disposal instructions, and warnings.
Cosmetics
The United States emerged as the largest importer of Indian cosmetics, accounting for 17% of total cosmetics exports, with 2,909 shipments. Total cosmetics exports from India to the United States in 2024 amounted to approximately $484.57 million. India is well-known for herbal cosmetics. Exported items include Ayurvedic facial oils (often for skin rejuvenation), Hair care products (oils, shampoos, conditioners), Herbal face masks. Ayurvedic skincare and personal care items such as soaps, scrubs, oils, and cleansers are increasingly exported, often aligned with wellness-oriented consumer trends. Sandalwood Oil (including Mysore Sandalwood Oil), known worldwide for its premium quality and used in perfumes, soaps, and aromatherapy products, is a protected geographical indication (GI) for Karnataka state in southwest India. Furthermore, Indian jasmine oil is a key ingredient in many celebrated luxury global perfumes.
U.S. Agent Requirement
Foreign companies, including those from India, are required to appoint a U.S. Agent. This agent plays a crucial role in maintaining communication and compliance with the FDA. Key Responsibilities of a U.S. Agent. Assisting with Communications. Acting as a liaison to help the FDA communicate with the foreign establishment. This includes receiving and forwarding all FDA correspondence, especially emergency communications and deficiency letters. Responding to FDA Inquiries. Answering questions from the FDA about the foreign establishment’s devices that are imported or offered for import into the U.S. Scheduling Inspections. Assisting the FDA in scheduling and coordinating inspections of the foreign establishment’s facilities. It’s important to note that a U.S. Agent is a distinct role from an “Official Correspondent,” though a foreign company can appoint the same person or entity to serve in both roles. The Official Correspondent is responsible for managing the company’s registration and device listing information with the FDA.
Choosing a U.S. Agent. Indian companies should carefully select a U.S. Agent. While a company’s distributor or importer can serve as an agent, many foreign manufacturers opt for an independent, third-party regulatory consulting firm to avoid potential conflicts of interest. When choosing an agent, look for strong understanding of FDA regulations, foreign language skills, additional “value-added” services such Live Support Chat, mock inspections, audit support, and guidance on regulatory submissions. The Appointment Process. After a company submits the registration, the FDA will email the designated agent to confirm their agreement to act on the company’s behalf. This confirmation must be completed within 10 business days for the registration to be finalized.
Adverse Event Reporting
The U.S. Food and Drug Administration requires timely reporting of serious adverse events associated with its regulated products, including drugs, biologics, devices, cosmetics and certain foods. The definition of a “serious adverse event” varies slightly by product but generally includes death, life-threatening events, hospitalization, significant disability, congenital anomalies, or events requiring intervention to prevent these outcomes. Responsible parties (manufacturers, packers, or distributors) are required to report these events promptly, with specific timeframes and formats for drugs, devices, and cosmetics. Your product label must include a domestic address or toll-free phone number for serious adverse event reports. This isn’t just a suggestion, it’s federal law. If your label is missing this info, the product is officially misbranded. That could mean recalls or other regulatory action. The requirement applies to whoever is named on the label, the manufacturer, packer, distributor, or retailer. The bottom line? Double-check your labels for a U.S. toll-free number or address before your product goes anywhere near the market. Protect your business, your customers, and your reputation. Don’t skip this compliance step!
Avoiding FDA Detention
When FDA obtains information that an FDA-regulated product poses a risk to the public health, its first priority is to determine whether the product should be removed from the marketplace and if so, to take swift action to ensure public notification and removal. This is typically accomplished most expeditiously by voluntary corrective efforts by the responsible firm(s). FDA can utilize advisory actions, administrative actions and enforcement actions including Suspension of Facility or Establishment Registration, Warning Letters, Import Refusals, when a firm’s voluntary action is not rapid, complete, or the firm is uncooperative. FDA-regulated products can be refused entry into the U.S. if they do not comply with FDA’s laws and regulations. Product appears to be adulterated, meaning the product is contaminated, is not safe, or does not otherwise meet applicable standards. Product is misbranded, meaning the labels contain false or misleading information. Product is an unapproved new drug. Product is forbidden or restricted for sale. Moreover, the refusal to permit inspection of a foreign facility or reasonable access to FDA’s inspectors, combined with other evidence, provides an appearance that the firm’s products are manufactured, processed, or packed under insanitary conditions. Therefore, the products manufactured or exported by that facility, will be subject to refusal of admission into the United States. If you are unable to overcome the appearance of a violation, your products will be refused admission and you can work with U.S. Customs and Border Protection (CBP) and the FDA to destroy the products or export them from the U.S within 90 days of the refusal.
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