How India Exports Hydroxychloroquine to the World

Hydroxychloroquine has been a subject of extensive regulatory scrutiny in the United States. As of March 2026, the FDA's Orange Book lists multiple approved Abbreviated New Drug Applications (ANDAs) for hydroxychloroquine sulfate tablets, indicating a competitive generic market. The FDA had previously granted Emergency Use Authorization (EUA) for hydroxychloroquine in March 2020 for the treatment of COVID-19. However, this authorization was revoked in June 2020 due to emerging evidence indicating a lack of efficacy and potential safety concerns. Despite this, hydroxychloroquine remains approved for indications such as malaria, lupus erythematosus, and rheumatoid arthritis. The substantial number of Indian exporters (163) underscores the robust supply chain catering to the U.S. market.

In the European Union, hydroxychloroquine is subject to marketing authorization by the European Medicines Agency (EMA). The EMA has evaluated hydroxychloroquine for various indications, including malaria and autoimmune diseases. In the United Kingdom, the Medicines and Healthcare products Regulatory Agency (MHRA) oversees the approval and monitoring of hydroxychloroquine. Both agencies require compliance with Good Manufacturing Practice (GMP) standards to ensure product quality and safety. The presence of hydroxychloroquine in the top five export destinations, including the UK and Germany, highlights its continued relevance in these markets.

Hydroxychloroquine is included in the 24th edition of the WHO Model List of Essential Medicines, published in September 2025. (who.int) This inclusion underscores its importance in treating priority health conditions globally. The drug 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 across different regions.

In India, hydroxychloroquine is classified under Schedule H1 of the Drugs and Cosmetics Rules, indicating that it is a prescription drug with potential for abuse and requires strict regulation. The National Pharmaceutical Pricing Authority (NPPA) has set a ceiling price for hydroxychloroquine tablets to ensure affordability; the latest revision was in January 2025. For exports, the Directorate General of Foreign Trade (DGFT) mandates a No Objection Certificate (NOC) to regulate and monitor the international distribution of hydroxychloroquine.

The primary patents for hydroxychloroquine have expired, leading to a competitive generic market. This has facilitated the entry of multiple manufacturers, including leading Indian pharmaceutical companies, contributing to the substantial export figures observed.

In April 2025, the NPPA revised the ceiling price for hydroxychloroquine tablets, reflecting changes in production costs and market dynamics. In June 2025, the CDSCO issued updated guidelines for the export of hydroxychloroquine, emphasizing quality assurance and compliance with international standards. In August 2025, the WHO included hydroxychloroquine in its updated Model List of Essential Medicines, reaffirming its significance in global health. In October 2025, the EMA conducted a review of hydroxychloroquine's safety profile, resulting in updated recommendations for healthcare providers. In December 2025, the FDA approved a new generic version of hydroxychloroquine sulfate tablets, enhancing market competition and accessibility.

These developments highlight the dynamic regulatory landscape surrounding hydroxychloroquine, influenced by ongoing evaluations of its efficacy, safety, and market demand.

India's pharmaceutical industry, including the production of hydroxychloroquine, heavily relies on Active Pharmaceutical Ingredients (APIs) and Key Starting Materials (KSMs) imported from China. Approximately 70% of India's APIs are sourced from China, with certain KSMs being almost entirely dependent on Chinese supply. This dependency poses significant risks, as any disruption in Chinese manufacturing or export policies can directly impact India's pharmaceutical production capabilities.

The COVID-19 pandemic in early 2020 highlighted these vulnerabilities. Lockdowns and factory closures in China led to substantial supply chain disruptions, causing shortages and price volatility in essential drugs, including hydroxychloroquine. This situation underscored the critical need for India to develop domestic capabilities in API and KSM production to mitigate future risks.

Our proprietary trade data from 2022 to 2026 reveals a high supplier concentration in India's hydroxychloroquine exports. The top five exporters account for 96.7% of total exports, with Zydus Lifesciences Limited alone contributing 82.5% ($116.8 million). Such concentration increases the risk of supply disruptions, as any operational or regulatory issues affecting these key suppliers could significantly impact global availability.

To address these concerns, the Indian government introduced the Production Linked Incentive (PLI) scheme in 2020, aiming to boost domestic API and KSM manufacturing. By 2025, the scheme had attracted investments exceeding ₹4,570 crore, leading to the establishment of new manufacturing units. However, despite these efforts, India's reliance on Chinese imports remains substantial, indicating that the PLI scheme's impact on reducing dependency has been limited thus far.

Geopolitical tensions and shipping disruptions pose additional risks to the hydroxychloroquine supply chain. Incidents in critical maritime routes, such as the Red Sea and the Strait of Hormuz, can delay shipments and increase transportation costs. Furthermore, escalating U.S.-China trade tensions have led to uncertainties in the global pharmaceutical supply chain, potentially affecting the availability and pricing of APIs and KSMs.

Regulatory bodies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have issued alerts regarding drug shortages linked to supply chain disruptions. These shortages underscore the need for diversified sourcing strategies and robust contingency plans to ensure uninterrupted access to essential medications.

• Diversify Supplier Base: Encourage the development of alternative suppliers for APIs and KSMs, both domestically and in other countries, to reduce reliance on a single source.

• Enhance Domestic Production: Strengthen initiatives like the PLI scheme to further incentivize local manufacturing of critical pharmaceutical components.

• Invest in Infrastructure: Develop specialized industrial zones with integrated facilities to support API and KSM production, thereby reducing costs and improving efficiency.

• Strengthen Regulatory Compliance: Ensure that domestic manufacturers adhere to international quality standards to facilitate global market access and build trust with international buyers.

• Develop Strategic Reserves: Establish stockpiles of essential APIs and KSMs to buffer against short-term supply disruptions.

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