How India Exports Dexamethasone to the World

In the United States, dexamethasone is approved for various indications, including the treatment of severe COVID-19 cases. The FDA's Orange Book lists multiple approved Abbreviated New Drug Applications (ANDAs) for dexamethasone, reflecting its established presence in the market. Notably, the FDA has not issued any import alerts specific to dexamethasone products from India as of March 2026, indicating compliance with U.S. regulatory standards. Given that 62.7% of India's dexamethasone exports are directed to the U.S., it is imperative for Indian exporters to maintain stringent adherence to FDA regulations to ensure uninterrupted market access.

In the European Union, dexamethasone-containing products have secured marketing authorizations through the European Medicines Agency (EMA). For instance, Ozurdex received EU-wide approval on July 27, 2010, for treating macular edema and non-infectious uveitis. Similarly, Neofordex was authorized on March 16, 2016, for multiple myeloma treatment. The UK's Medicines and Healthcare products Regulatory Agency (MHRA) aligns with EMA standards, ensuring consistent regulatory requirements. Compliance with EU Good Manufacturing Practice (GMP) guidelines is mandatory for market entry, necessitating that Indian manufacturers adhere to these standards to facilitate exports to the EU and UK.

Dexamethasone has been included in the WHO Model List of Essential Medicines since 1977, underscoring its critical role in healthcare. The WHO has prequalified dexamethasone solutions for injection, produced by three manufacturers, for treating COVID-19, affirming its safety and efficacy. Additionally, dexamethasone formulations are standardized across major pharmacopoeias, including the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP), ensuring consistent quality benchmarks for global distribution.

In India, dexamethasone is classified as a Schedule H drug under the Drugs and Cosmetics Act, requiring a prescription for dispensation. The National Pharmaceutical Pricing Authority (NPPA) has not imposed a ceiling price on dexamethasone, allowing market-driven pricing. For exports, the Directorate General of Foreign Trade (DGFT) mandates a No Objection Certificate (NOC) to ensure compliance with international regulatory requirements, facilitating the smooth export of pharmaceutical products.

Dexamethasone is off-patent globally, enabling the production and export of generic versions without infringement concerns. This status has led to a competitive market with multiple manufacturers supplying dexamethasone, contributing to its widespread availability and affordability.

In April 2025, the WHO reiterated its recommendation for using dexamethasone in severe COVID-19 cases, emphasizing its life-saving potential. This endorsement has sustained global demand for dexamethasone, particularly in countries grappling with COVID-19. Additionally, the EMA approved a new indication for Sarclisa in November 2024, involving its combination with dexamethasone for treating newly diagnosed multiple myeloma patients ineligible for autologous stem cell transplant. This approval may influence demand dynamics for dexamethasone in the EU market.

These developments highlight the evolving regulatory and market landscape for dexamethasone, necessitating that Indian exporters remain vigilant and adaptable to maintain and expand their global market share.

India is a leading producer of Active Pharmaceutical Ingredients (APIs), including dexamethasone. However, the Indian pharmaceutical industry heavily relies on China for Key Starting Materials (KSMs) and intermediates essential for API production. This dependency exposes the supply chain to risks associated with geopolitical tensions, trade restrictions, and production disruptions in China.

Recent events have highlighted the vulnerability of this reliance. In March 2026, the closure of the Strait of Hormuz due to escalating conflicts disrupted global shipping routes, affecting the timely import of critical raw materials from China to India. This disruption underscores the need for diversification in sourcing strategies to mitigate such risks.

Our proprietary trade data indicates that the top five Indian exporters of dexamethasone account for 61.6% of total exports, with DR. REDDY'S LABORATORIES LTD leading at a 22.5% share. This high concentration poses a single-source risk, as any operational or regulatory issues affecting these key suppliers could significantly impact global supply.

To address such vulnerabilities, the Indian government has implemented the Production Linked Incentive (PLI) scheme, aiming to boost domestic production of APIs and reduce dependency on imports. While this initiative is a positive step, its effectiveness in diversifying the supplier base and mitigating concentration risks remains to be fully realized.

The recent closure of the Strait of Hormuz in March 2026, following military escalations involving Iran, the United States, and Israel, has severely disrupted global shipping routes. This strategic chokepoint is vital for the transportation of oil and other goods, and its blockage has led to significant delays and increased shipping costs. According to UNCTAD, the Strait carries around one quarter of global seaborne oil trade, and its disruption has raised concerns about ripple effects across global markets.

Additionally, tensions in the Red Sea and the Strait of Hormuz have prompted major shipping companies to suspend transits through these regions, further complicating logistics and supply chains. These disruptions have led to increased freight rates and insurance premiums, impacting the cost and reliability of pharmaceutical exports from India.

• Diversify Raw Material Sources: Reduce dependency on a single country for KSMs and intermediates by establishing alternative supply chains in other regions.

• Enhance Domestic Production: Accelerate the implementation and scaling of the PLI scheme to strengthen domestic API manufacturing capabilities.

• Develop Alternative Shipping Routes: Identify and invest in alternative maritime and overland routes to mitigate risks associated with chokepoints like the Strait of Hormuz.

• Strengthen Supplier Base: Encourage the growth of small and medium-sized enterprises in the pharmaceutical sector to reduce supplier concentration and enhance resilience.

• Implement Robust Risk Management: Develop comprehensive risk assessment and contingency plans to address potential geopolitical and logistical disruptions.

RISK_LEVEL: HIGH