How India Exports Artesunate to the World

As of March 2026, artesunate has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the immediate treatment of malaria. The designation was approved on March 28, 2006, with marketing approval granted on May 26, 2020. The approved indication specifies that artesunate for injection is indicated for the initial treatment of severe malaria in adult and pediatric patients, to be followed by a complete treatment course of an appropriate oral antimalarial regimen. The exclusivity period for this indication extends until May 26, 2027.

Currently, there are no import alerts related to artesunate listed by the FDA. This absence indicates compliance with U.S. regulatory standards, facilitating the entry of artesunate into the U.S. market. Given the substantial number of active Indian exporters (441) and the extensive shipment records (6,110), the U.S. market presents a significant opportunity for Indian manufacturers.

In the European Union, artesunate has been recognized for its therapeutic potential in treating severe malaria. The European Medicines Agency (EMA) granted orphan designation to artesunate for the treatment of malaria on December 7, 2007. (ema.europa.eu) Subsequently, on November 22, 2021, the EMA approved Artesunate Amivas for the initial treatment of severe malaria in adults and children. (ema.europa.eu)

The United Kingdom, having exited the EU, aligns its regulatory framework with the EMA's standards. Medicines and Healthcare products Regulatory Agency (MHRA) approvals are required for marketing artesunate in the UK. Compliance with EU Good Manufacturing Practice (GMP) requirements is mandatory for manufacturing facilities. These standards ensure the quality and safety of artesunate products entering the European and UK markets.

Artesunate is included in the World Health Organization's (WHO) Model List of Essential Medicines, underscoring its critical role in treating severe malaria. The WHO Prequalification Programme evaluates artesunate products to ensure they meet global standards for quality, safety, and efficacy. Compliance with pharmacopoeial standards such as the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP) is essential for artesunate manufacturers to meet international quality benchmarks.

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

Artesunate, being a derivative of artemisinin, is generally considered off-patent, allowing for generic competition. This status enables multiple manufacturers to produce and export artesunate, contributing to its widespread availability and competitive pricing in the global market.

In August 2023, the EMA adopted a positive opinion for Artesunate Amivas, recommending its approval for the initial treatment of severe malaria in adults and children. (ema.europa.eu) This development enhances the availability of artesunate in the European market.

In December 2022, B & O Pharm withdrew its application for marketing authorization of Garsun, an artesunate product intended for the treatment of severe malaria. (ema.europa.eu) The withdrawal indicates challenges in meeting regulatory requirements or market considerations.

These developments reflect the dynamic nature of the artesunate market, influenced by regulatory decisions and market dynamics.

India's pharmaceutical industry heavily relies on China for Key Starting Materials (KSMs) essential in Active Pharmaceutical Ingredient (API) production. According to the U.S. Pharmacopeia, 41% of KSMs used in U.S.-approved APIs are solely sourced from China, highlighting a significant dependency. This reliance poses risks, as disruptions in Chinese supply chains can directly impact Indian API manufacturing. For instance, in July 2018, environmental regulations led to the shutdown of several Chinese chemical plants, causing a ripple effect that increased KSM prices and affected global API production.

To mitigate such vulnerabilities, the Indian government has implemented the Production Linked Incentive (PLI) Scheme for Pharmaceuticals, initiated in March 2021. This scheme aims to bolster domestic production of critical KSMs, DIs, and APIs, reducing import dependence. By July 2025, 48 projects had been approved under this scheme, with investments surpassing initial commitments, indicating a proactive approach to strengthening the domestic pharmaceutical supply chain.

The Artesunate export market from India exhibits significant supplier concentration, with the top five exporters controlling 66.2% of the market share. IPCA LABORATORIES LIMITED alone accounts for 42.9%, indicating a high dependency on a single supplier. Such concentration poses risks, as any operational disruptions within these key companies could lead to substantial supply shortages.

The PLI Scheme for Pharmaceuticals, approved in March 2021, aims to diversify the supplier base by encouraging more manufacturers to produce critical pharmaceutical components. This initiative is expected to enhance competition and reduce single-source dependency, thereby strengthening the resilience of the supply chain.

Global shipping routes, including the Red Sea and the Strait of Hormuz, are susceptible to geopolitical tensions that can disrupt maritime transport. Such disruptions can delay shipments of critical pharmaceuticals like Artesunate, affecting global health initiatives. Additionally, escalating U.S.-China trade tensions have led to increased tariffs and regulatory scrutiny, potentially impacting the availability and cost of KSMs and APIs sourced from China.

Regulatory bodies like the FDA and EMA have issued shortage alerts for various medications due to supply chain disruptions. For example, in October 2025, the FDA highlighted shortages in antibiotics linked to API supply issues, underscoring the interconnectedness of global pharmaceutical supply chains.

• Diversify Supplier Base: Encourage the development of multiple suppliers for Artesunate to reduce dependency on a limited number of exporters.

• Enhance Domestic Production: Leverage the PLI Scheme to boost domestic manufacturing of KSMs and APIs, decreasing reliance on imports.

• Strengthen Supply Chain Monitoring: Implement robust tracking systems to identify and address potential disruptions promptly.

• Develop Alternative Shipping Routes: Establish contingency plans for alternative shipping routes to mitigate risks associated with geopolitical tensions.

• Engage in Strategic Stockpiling: Maintain strategic reserves of critical pharmaceuticals to buffer against supply chain interruptions.

RISK_LEVEL: MEDIUM