How India Exports Chloroquine to the World

In the United States, chloroquine is approved for the treatment of malaria and certain autoimmune diseases. The FDA's Orange Book lists multiple approved Abbreviated New Drug Applications (ANDAs) for chloroquine phosphate tablets, indicating a competitive generic market. Notably, the FDA has issued import alerts in the past for specific manufacturers due to non-compliance with Good Manufacturing Practices (GMP), underscoring the importance of stringent quality control measures for Indian exporters. With 287 active Indian exporters and a buyer count of 774, maintaining compliance with FDA regulations is crucial to sustain market access and meet the expectations of repeat buyers, which currently stands at 47.8%.

In the European Union, chloroquine is authorized for malaria treatment and certain autoimmune conditions. The European Medicines Agency (EMA) has conducted periodic safety assessments, including a review in January 2022 (PSUSA/00000685/202104), which led to updates in product information regarding potential risks. The UK's Medicines and Healthcare products Regulatory Agency (MHRA) aligns with EMA guidelines, requiring compliance with EU GMP standards. Indian exporters must ensure adherence to these stringent quality and safety requirements to maintain market access in these regions.

Chloroquine is included in the World Health Organization's Model List of Essential Medicines, reflecting its importance in global health. The drug is subject to international pharmacopoeia standards, including the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP). Compliance with these standards is essential for Indian manufacturers to ensure product quality and facilitate international trade.

In India, chloroquine 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 set ceiling prices for chloroquine formulations to ensure affordability; for instance, the ceiling price for chloroquine phosphate tablets was revised in March 2025. Exporters must obtain a No Objection Certificate (NOC) from the Directorate General of Foreign Trade (DGFT) for chloroquine exports, ensuring compliance with national regulations.

Chloroquine's primary patents have long expired, leading to a robust generic market. This has resulted in significant competition among manufacturers, including Indian exporters, who must focus on maintaining high-quality standards and cost-effective production to remain competitive in the global market.

In November 2020, the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) recommended updating the product information for chloroquine to include warnings about potential psychiatric disorders and suicidal behavior, following a review of available data. In January 2022, the EMA conducted a periodic safety update report (PSUR) assessment for chloroquine, leading to further updates in product information regarding cardiovascular risks associated with its use. In March 2025, the NPPA revised the ceiling price for chloroquine phosphate tablets to ensure continued affordability and accessibility in the Indian market. In April 2025, the WHO updated its Model List of Essential Medicines, reaffirming the inclusion of chloroquine for the treatment of malaria. In June 2025, the DGFT issued new guidelines for the export of chloroquine, streamlining the NOC process to facilitate exports while ensuring compliance with international quality standards.

These developments highlight the dynamic regulatory environment surrounding chloroquine, emphasizing the need for Indian exporters to stay informed and compliant with both domestic and international regulations to maintain and expand their market presence.

Chloroquine's production is heavily reliant on Active Pharmaceutical Ingredients (APIs) and Key Starting Materials (KSMs), with India and China being dominant suppliers. China controls approximately 70–80% of the global KSM supply and 60–70% of the global intermediate supply, making it a global leader in this sector. This concentration poses a significant risk, as any disruption in China's supply chain can directly impact the availability of Chloroquine APIs.

Recent disruptions have underscored this vulnerability. In October 2025, the U.S. Pharmacopeia reported that 58% of KSMs used for U.S.-approved APIs are sole-sourced from a single country, with 41% from China and 16% from India. Such dependencies highlight the fragility of the supply chain, where geopolitical tensions or regulatory actions in these countries can lead to significant shortages.

Our proprietary data indicates a high supplier concentration in Chloroquine exports from India. The top five exporters account for 93.8% of the total export value, with ZYDUS LIFESCIENCES LIMITED alone contributing 68.2%. This concentration amplifies the risk of supply disruptions, as any operational or regulatory issues affecting these key players could severely impact global Chloroquine availability.

To mitigate such risks, the Indian government has implemented the Production Linked Incentive (PLI) scheme for pharmaceuticals. As of December 2025, the scheme has led to the creation of domestic manufacturing capacity for 26 KSMs/APIs, resulting in cumulative sales of ₹2,315 crore and avoiding imports worth ₹1,807 crore. While this initiative aims to reduce dependency on imports and diversify the supplier base, its impact on Chloroquine's supply chain remains to be fully realized.

Geopolitical tensions and shipping disruptions pose additional risks to the Chloroquine supply chain. The Red Sea and Strait of Hormuz are critical maritime routes for pharmaceutical exports. Any instability in these regions can delay shipments and increase transportation costs. Furthermore, U.S.-China tensions have led to increased scrutiny and potential tariffs on pharmaceutical imports, affecting the cost and availability of raw materials.

Regulatory actions also contribute to supply chain vulnerabilities. In February 2025, the FDA issued warning letters to API manufacturers in China and India for significant deviations from current Good Manufacturing Practices (cGMP), leading to potential supply disruptions. Such regulatory interventions can result in temporary shutdowns or increased compliance costs, further straining the supply chain.

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

• Strengthen Domestic Manufacturing: Invest in local production facilities for critical APIs and KSMs to enhance self-reliance and buffer against international disruptions.

• Monitor Geopolitical Developments: Establish a dedicated team to track geopolitical events and assess their potential impact on the supply chain, enabling proactive risk management.

• Enhance Regulatory Compliance: Collaborate with suppliers to ensure adherence to international quality standards, minimizing the risk of regulatory actions that could disrupt supply.

• Develop Contingency Plans: Create and regularly update contingency strategies, including alternative shipping routes and emergency stockpiles, to maintain supply continuity during disruptions.

RISK_LEVEL: HIGH