How India Exports Ivermectin to the World

In the United States, ivermectin is approved for human use primarily for the treatment of parasitic infections. The FDA's Orange Book lists multiple approved Abbreviated New Drug Applications (ANDAs) for ivermectin, indicating a competitive generic market. As of March 2026, there are no active FDA import alerts specifically targeting ivermectin products from India, suggesting compliance with U.S. regulatory standards. However, the FDA maintains vigilance through import alerts to ensure that imported drugs meet safety and efficacy standards. Given that 15.4% of India's ivermectin exports are destined for the U.S., it is imperative for Indian exporters to adhere strictly to FDA regulations to maintain market access.

In the European Union and the United Kingdom, ivermectin is authorized for both human and veterinary use. The European Medicines Agency (EMA) has evaluated ivermectin-containing products, particularly for veterinary applications, to ensure their safety and efficacy. For instance, in December 2007, the EMA reviewed injectable veterinary products containing ivermectin for cattle, addressing concerns about varying withdrawal periods across member states. (ema.europa.eu) Manufacturers exporting to the EU and UK must comply with Good Manufacturing Practice (GMP) requirements and obtain appropriate marketing authorizations from the EMA or the UK's Medicines and Healthcare products Regulatory Agency (MHRA).

Ivermectin is included in the World Health Organization's (WHO) Model List of Essential Medicines, underscoring its importance in treating parasitic infections. The 24th edition of the list, updated in September 2025, continues to feature ivermectin. (who.int) This inclusion reflects its critical role in global health. Additionally, ivermectin is recognized in various pharmacopoeias, including the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP), ensuring standardized quality across different markets.

In India, ivermectin is classified as a Schedule H drug under the Drugs and Cosmetics Act, requiring a prescription for dispensing. The National Pharmaceutical Pricing Authority (NPPA) has not set a ceiling price for ivermectin, allowing market-driven pricing. For exports, the Directorate General of Foreign Trade (DGFT) mandates a No Objection Certificate (NOC) to ensure that domestic supply is not adversely affected by export activities.

The primary patents for ivermectin have expired, leading to a robust generic market with multiple manufacturers producing the drug. This has resulted in increased competition and more affordable pricing globally.

In August 2024, the WHO released guidelines on the public health control of human strongyloidiasis, emphasizing the use of ivermectin as a standard treatment. (who.int) This development is likely to increase global demand for ivermectin.

In September 2025, the WHO updated its Model List of Essential Medicines, reaffirming the inclusion of ivermectin, which may influence procurement policies worldwide. (who.int)

In March 2026, the FDA issued Import Alert 68-19, focusing on unapproved finished new animal drugs, including certain ivermectin products. While this alert primarily targets veterinary applications, it underscores the importance of compliance with FDA regulations for all ivermectin products.

These developments highlight the dynamic regulatory landscape for ivermectin, necessitating continuous monitoring by exporters to ensure compliance and capitalize on emerging opportunities.

Ivermectin's production heavily relies on Active Pharmaceutical Ingredients (APIs) and Key Starting Materials (KSMs). India, while a significant producer of APIs, depends on China for approximately 60–70% of its KSMs. This dependency exposes the supply chain to potential disruptions stemming from geopolitical tensions, trade restrictions, or environmental regulations in China. For instance, in recent years, several Chinese API manufacturers faced shutdowns due to non-compliance with pollution norms, leading to supply disruptions and cost escalations.

The COVID-19 pandemic further highlighted these vulnerabilities. During the crisis, China's factory shutdowns led to immediate shortages of essential APIs in India, underscoring the risks of over-reliance on a single country for critical raw materials.

Our proprietary trade data indicates that the top five Indian exporters of Ivermectin account for 49.7% of the total export value, with SAVA HEALTHCARE LIMITED alone contributing 27.0%. Such concentration poses a significant risk; any operational or compliance issues within these key suppliers could disrupt the entire supply chain.

To mitigate this, the Indian government introduced the Production Linked Incentive (PLI) scheme, aiming to bolster domestic API and KSM production and reduce import dependence. As of November 2024, two greenfield plants were inaugurated under this scheme to manufacture critical molecules like Penicillin G and Clavulanic Acid, marking a step towards self-reliance.

Global shipping routes, including the Red Sea and the Strait of Hormuz, are susceptible to geopolitical tensions, piracy, and blockades, which can delay shipments and increase costs. Additionally, escalating US-China trade tensions have led to tariff impositions and export restrictions, further complicating the supply chain. The U.S. Pharmacopeia reported that 41% of KSMs used in U.S.-approved APIs are solely sourced from China, highlighting the potential impact of such geopolitical dynamics.

Regulatory bodies like the FDA have also flagged quality concerns with API manufacturers in China and India. In February 2025, the FDA issued warning letters to several API producers for significant deviations from current Good Manufacturing Practices (cGMP), emphasizing the need for stringent quality controls.

• Diversify Supplier Base: Engage with multiple API and KSM suppliers across different regions to reduce dependency on a single source.

• Strengthen Domestic Production: Leverage government initiatives like the PLI scheme to enhance local manufacturing capabilities for critical APIs and KSMs.

• Enhance Quality Assurance: Implement rigorous quality control measures and conduct regular audits to ensure compliance with international standards.

• Monitor Geopolitical Developments: Establish a dedicated team to track global political events and assess their potential impact on the supply chain.

• Develop Contingency Plans: Create robust strategies to address potential disruptions, including alternative shipping routes and emergency stockpiling.

RISK_LEVEL: MEDIUM