How India Exports Hydrocortisone to the World

In the United States, hydrocortisone is approved for various indications, including adrenal insufficiency and inflammatory conditions. The FDA's Orange Book lists multiple approved Abbreviated New Drug Applications (ANDAs) for hydrocortisone formulations, reflecting a competitive generic market. Notably, on September 29, 2020, the FDA approved ALKINDI® SPRINKLE, a hydrocortisone formulation indicated as replacement therapy in pediatric patients with adrenocortical insufficiency.

The substantial number of Indian exporters (597) underscores India's significant role in supplying hydrocortisone to the U.S. market. However, exporters must navigate the FDA's stringent regulatory framework, including compliance with Current Good Manufacturing Practices (cGMP) and potential import alerts. As of March 2026, there are no active FDA import alerts specifically targeting hydrocortisone products from India, indicating a favorable compliance status.

In the European Union, hydrocortisone is subject to the European Medicines Agency's (EMA) marketing authorization process. For instance, Efmody, a hydrocortisone formulation, received a positive opinion from the EMA's Committee for Medicinal Products for Human Use (CHMP) on January 29, 2026, recommending its use for the treatment of adrenal insufficiency and congenital adrenal hyperplasia in adolescents aged 12 years and over and adults. (ema.europa.eu)

The United Kingdom, post-Brexit, maintains its own regulatory framework through the Medicines and Healthcare products Regulatory Agency (MHRA). Hydrocortisone products require MHRA approval, adhering to standards analogous to those of the EMA. Compliance with EU Good Manufacturing Practice (GMP) guidelines is mandatory for manufacturing facilities supplying these markets.

Hydrocortisone is included in the World Health Organization's (WHO) Model List of Essential Medicines, underscoring its critical role in healthcare systems worldwide. The WHO Prequalification Programme evaluates medicines like hydrocortisone to ensure they meet global standards of quality, safety, and efficacy. Additionally, hydrocortisone formulations are standardized in various pharmacopoeias, including the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP), ensuring consistent quality across different markets.

In India, hydrocortisone 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; however, as of March 2026, hydrocortisone is not listed under the Drug Price Control Order (DPCO), allowing market-driven pricing. Exporters must obtain a No Objection Certificate (NOC) from the Directorate General of Foreign Trade (DGFT) for the export of pharmaceutical products, ensuring compliance with national regulations.

Hydrocortisone, being an established pharmaceutical compound, is generally off-patent, facilitating the production and export of generic formulations. This lack of patent protection has led to a competitive market with multiple manufacturers and suppliers, both domestically and internationally.

In September 2025, Laboratoire Aguettant withdrew its application for marketing authorization of Hydrocortisone Aguettant, intended for the prevention of bronchopulmonary dysplasia in preterm infants, following feedback from the EMA indicating that the benefits did not outweigh the risks. (ema.europa.eu)

On January 29, 2026, the EMA's CHMP adopted a positive opinion recommending a change to the terms of the marketing authorization for Efmody, expanding its indication to include the treatment of adrenal insufficiency in adolescents aged 12 years and over and adults. (ema.europa.eu)

In June 2025, the EMA published a list of nationally authorized medicinal products containing hydrocortisone, following a periodic safety update report single assessment (PSUSA/00010855/202408), ensuring continued pharmacovigilance and safety monitoring. (ema.europa.eu)

These developments highlight the dynamic regulatory landscape surrounding hydrocortisone, emphasizing the importance of continuous monitoring and compliance for stakeholders involved in its production and distribution.

India's pharmaceutical industry, often referred to as the "pharmacy of the world," heavily relies on China for Active Pharmaceutical Ingredients (APIs) and Key Starting Materials (KSMs). Approximately 70% of APIs used in Indian drug manufacturing are imported from China. This dependency poses significant risks, as evidenced during the COVID-19 pandemic when Chinese factory shutdowns led to immediate shortages and price surges for essential drugs.

To mitigate this vulnerability, the Indian government has initiated the Production Linked Incentive (PLI) scheme, aiming to bolster domestic API and KSM production. In October 2024, two greenfield plants were inaugurated under this scheme to manufacture critical molecules like Penicillin G and Clavulanic Acid, which had not been produced domestically for over two decades. These efforts are part of a broader strategy to reduce import dependence by half for essential pharmaceutical ingredients.

The export market for hydrocortisone from India is moderately concentrated, with the top five exporters accounting for 36.1% of total exports. STRIDES PHARMA SCIENCE LIMITED leads with a 13.9% share, followed by LINCOLN PHARMACEUTICALS LTD at 8.2%. While this concentration indicates a degree of diversification, the reliance on a limited number of suppliers still presents a risk. Any operational disruptions among these key players could significantly impact the global supply chain.

The PLI scheme is a proactive measure to address such risks by encouraging domestic production of APIs and KSMs. By reducing dependence on imports and promoting a more diversified supplier base, the scheme aims to enhance the resilience of India's pharmaceutical supply chain.

Recent geopolitical tensions have further complicated the pharmaceutical supply chain. In February 2026, military actions in the Middle East led to the effective shutdown of the Strait of Hormuz, a critical chokepoint through which approximately 20% of global oil passes. This disruption has caused significant delays and increased costs for shipping routes, impacting industries reliant on timely deliveries, including pharmaceuticals.

Additionally, the Red Sea and the Bab al-Mandab Strait have experienced disruptions due to regional conflicts, further straining global shipping lanes. These geopolitical events underscore the vulnerability of supply chains to regional instabilities and the importance of developing alternative routes and strategies to mitigate such risks.

• Diversify API and KSM Sources: Expand sourcing beyond China by investing in domestic production and exploring alternative international suppliers to reduce dependency.

• Strengthen Domestic Manufacturing: Accelerate initiatives like the PLI scheme to enhance local production capabilities for critical pharmaceutical ingredients.

• Develop Alternative Shipping Routes: Identify and establish alternative maritime and overland routes to circumvent geopolitical hotspots and ensure uninterrupted supply chains.

• Enhance Inventory Management: Maintain strategic stockpiles of essential APIs and KSMs to buffer against supply disruptions.

• Monitor Geopolitical Developments: Implement robust monitoring systems to anticipate and respond swiftly to geopolitical events that may impact supply chains.

RISK_LEVEL: MEDIUM