How India Exports Furosemide to the World

In the United States, furosemide is approved under multiple Abbreviated New Drug Applications (ANDAs), indicating a well-established generic market. The FDA's Orange Book lists numerous approved ANDAs for furosemide, reflecting its widespread acceptance and use. The regulatory pathway for importing furosemide into the U.S. requires compliance with FDA standards, including facility registration, product listing, and adherence to current Good Manufacturing Practices (cGMPs). Importers must file an entry notice and bond with U.S. Customs, and the FDA verifies compliance upon importation. As of March 2026, there are no specific import alerts related to furosemide from India, indicating a favorable compliance status for Indian exporters.

In the European Union, furosemide is subject to marketing authorization by the European Medicines Agency (EMA). A notable case is the EMA's assessment of Furosemide Vitabalans, where the Committee for Medicinal Products for Human Use (CHMP) concluded in October 2012 that the benefits did not outweigh the risks, leading to a refusal of marketing authorization in several member states. This underscores the stringent evaluation processes within the EU. Manufacturers exporting to the EU and UK must comply with Good Manufacturing Practice (GMP) standards, ensuring product quality and safety. (ema.europa.eu)

Furosemide is included in the World Health Organization's Model List of Essential Medicines, highlighting its critical role in healthcare systems worldwide. It is also listed in major pharmacopoeias, including the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP), ensuring standardized quality and efficacy across different regions.

In India, furosemide is classified under Schedule H of the Drugs and Cosmetics Act, indicating it is a prescription-only medication. The National Pharmaceutical Pricing Authority (NPPA) regulates its price to ensure affordability. Exporters must obtain a No Objection Certificate (NOC) from the Directorate General of Foreign Trade (DGFT) for exporting furosemide, ensuring compliance with national regulations.

Furosemide's patents have long expired, leading to a robust generic market with significant competition. This has resulted in widespread availability and competitive pricing globally.

In June 2025, the FDA issued import alerts for certain medical devices manufactured in Japan by Olympus Medical Systems Corporation due to quality system regulation violations. While not directly related to furosemide, this highlights the FDA's stringent oversight on imported medical products.

In September 2024, the FDA requested Azurity Pharmaceuticals Inc. to stop distributing unapproved drugs marketed as "Unit-of-Use Prescription Compounding Kits," emphasizing the agency's commitment to ensuring that all marketed drugs have proven safety and efficacy.

These developments underscore the importance of regulatory compliance and the FDA's proactive stance in safeguarding public health.

India's pharmaceutical industry, renowned as the "pharmacy of the world," heavily relies on China for Active Pharmaceutical Ingredients (APIs) and Key Starting Materials (KSMs). Approximately 70% of India's imported bulk drugs, including APIs and KSMs, originate from China. This dependency is particularly concerning for essential medications like Furosemide, where the supply chain's upstream components are predominantly sourced from Chinese manufacturers.

The COVID-19 pandemic in early 2020 exposed the vulnerabilities of this reliance. Disruptions in Chinese manufacturing led to significant shortages and price volatility in APIs, impacting global pharmaceutical production. Despite initiatives like India's Production Linked Incentive (PLI) scheme, launched in July 2020 to bolster domestic API and KSM production, the industry continues to grapple with challenges such as cost competitiveness and infrastructure limitations.

Our proprietary trade data indicates that the top five Indian exporters account for 58.0% of Furosemide exports, with BAXTER PHARMACEUTICALS INDIA PRIVATE LIMITED leading at a 25.2% share. This concentration poses a significant risk, as disruptions affecting these key suppliers could severely impact global Furosemide availability.

The PLI scheme, initiated in July 2020, aims to reduce such dependencies by incentivizing domestic production of critical APIs and KSMs. However, the effectiveness of this initiative remains to be fully realized, as the industry continues to face challenges in scaling up production to meet both domestic and international demand.

Geopolitical tensions and shipping disruptions have further exacerbated supply chain risks. Incidents in strategic maritime routes, such as the Red Sea and the Strait of Hormuz, have led to delays and increased shipping costs. Additionally, ongoing U.S.-China trade tensions have introduced uncertainties in the procurement of essential raw materials. These factors collectively contribute to the volatility in the supply chain of critical medications like Furosemide.

Regulatory bodies, including the FDA and EMA, have issued alerts regarding potential shortages of essential drugs due to these disruptions. For instance, in February 2025, the FDA issued warning letters to API manufacturers in China and India for significant deviations from current Good Manufacturing Practice (cGMP), highlighting ongoing quality concerns and the global dependence on these suppliers.

• Diversify Supplier Base: Engage with a broader range of suppliers to reduce dependency on a limited number of exporters, thereby mitigating risks associated with supplier concentration.

• Enhance Domestic Production: Accelerate the implementation of the PLI scheme to strengthen domestic manufacturing capabilities for APIs and KSMs, reducing reliance on imports.

• Strengthen Regulatory Compliance: Ensure strict adherence to cGMP standards among domestic manufacturers to maintain product quality and avoid regulatory sanctions.

• Develop Alternative Shipping Routes: Identify and establish alternative logistics pathways to circumvent geopolitical hotspots, ensuring uninterrupted supply chains.

• Monitor Geopolitical Developments: Stay informed about international trade policies and geopolitical events that could impact the pharmaceutical supply chain, allowing for proactive risk management.

RISK_LEVEL: HIGH