How India Exports Melphalan to the World

In the United States, melphalan is approved for the treatment of multiple myeloma and ovarian cancer. The FDA's Orange Book lists multiple approved Abbreviated New Drug Applications (ANDAs) for melphalan, indicating a competitive generic market. Notably, on August 14, 2023, the FDA approved Hepzato (melphalan) for the treatment of uveal melanoma with unresectable hepatic metastases. This approval underscores the ongoing therapeutic relevance of melphalan in oncology. Given that 153 Indian exporters are actively involved in melphalan exports, compliance with FDA regulations, including adherence to Current Good Manufacturing Practices (cGMP) and obtaining necessary approvals, is imperative for market access.

Within the European Union, melphalan is authorized for use in multiple myeloma and ovarian cancer treatments. The European Medicines Agency (EMA) granted marketing authorization for Phelinun (melphalan hydrochloride) on November 16, 2020. This authorization is valid across all EU member states, including the United Kingdom at that time. Post-Brexit, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) continues to recognize EMA approvals; however, UK-specific regulatory requirements may apply. Manufacturers exporting to these regions must comply with EU Good Manufacturing Practice (GMP) standards to ensure product quality and safety.

Melphalan is included in the World Health Organization's (WHO) Model List of Essential Medicines, highlighting its critical role in healthcare systems worldwide. This inclusion facilitates its adoption and procurement by various countries, especially those relying on WHO guidelines for essential medicines. Additionally, melphalan is recognized in major pharmacopoeias, including the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP), ensuring standardized quality parameters across different jurisdictions.

In India, melphalan 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, melphalan is not listed under the Drug Price Control Order (DPCO), allowing manufacturers to set prices based on market dynamics. For exports, the Directorate General of Foreign Trade (DGFT) mandates a No Objection Certificate (NOC) to ensure compliance with national and international regulations.

The primary patents for melphalan have expired, leading to a robust generic market with multiple manufacturers producing the drug. This competitive landscape has contributed to its widespread availability and affordability. However, specific formulations or novel delivery methods may still be under patent protection, necessitating due diligence by exporters to avoid infringement.

In August 2023, the FDA approved Hepzato (melphalan) for the treatment of uveal melanoma with unresectable hepatic metastases, expanding the therapeutic applications of melphalan. In September 2023, the EMA's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for a variation to the marketing authorization of Pepaxti (melphalan flufenamide), indicating ongoing regulatory activities concerning melphalan derivatives. These developments reflect the dynamic regulatory landscape and the importance of staying informed about policy changes and approvals affecting melphalan's market presence.

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 India's API and KSM requirements are imported from China, creating a significant dependency. This reliance poses substantial risks, as any disruption in Chinese supply chains can directly impact India's pharmaceutical production capabilities.

Recent geopolitical tensions have exacerbated these vulnerabilities. In February 2026, the U.S. and Israel launched military operations against Iran, leading to Iran's blockade of the Strait of Hormuz—a critical maritime chokepoint. This blockade has severely disrupted global supply chains, including the transportation of pharmaceutical raw materials. The closure of the strait has been described as the largest disruption to the energy supply since the 1970s energy crisis, significantly affecting the availability and cost of essential inputs for drug manufacturing.

Our proprietary trade data indicates a high supplier concentration for Melphalan exports from India. The top five exporters account for 86.9% of the total export value, with EMCURE PHARMACEUTICALS LIMITED alone contributing 69.3%. Such concentration increases the risk of supply disruptions, as reliance on a limited number of suppliers can lead to significant vulnerabilities if any of these entities face operational challenges.

To mitigate this risk, the Indian government has implemented the Production Linked Incentive (PLI) scheme, aiming to boost domestic production of APIs and reduce dependence on imports. 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. While these initiatives are steps toward self-sufficiency, the pharmaceutical sector continues to face challenges from global supply chain vulnerabilities and competition.

The blockade of the Strait of Hormuz in March 2026 has had profound implications for global trade, particularly affecting the pharmaceutical supply chain. The strait's closure disrupted the transportation of oil and other essential goods, leading to increased shipping costs and delays. Major shipping companies, including Maersk, suspended operations in the region, further complicating logistics. (lemonde.fr) Additionally, the conflict has led to attacks on vessels, causing a sharp decline in maritime transit and affecting about 20% of the world's daily oil supply.

These disruptions have cascading effects on the pharmaceutical industry, including potential shortages of critical drugs and increased production costs. The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have issued alerts regarding potential drug shortages due to these supply chain interruptions. The FDA, for instance, has highlighted the risk of shortages for essential medications, emphasizing the need for proactive measures to ensure continued supply.

• Diversify Supplier Base: Engage with a broader range of API and KSM suppliers to reduce dependency on a limited number of sources, thereby enhancing supply chain resilience.

• Enhance Domestic Production: Accelerate initiatives under the PLI scheme to bolster domestic manufacturing of critical APIs and KSMs, reducing reliance on imports.

• Strengthen Inventory Management: Increase buffer stocks of essential raw materials and finished products to mitigate the impact of supply chain disruptions.

• Develop Alternative Logistics Routes: Identify and establish alternative shipping routes and transportation methods to circumvent geopolitical hotspots and ensure continuity in supply chains.

• Monitor Regulatory Developments: Stay informed about international regulatory alerts and adapt compliance strategies accordingly to maintain uninterrupted market access.

RISK_LEVEL: HIGH