How India Exports Lenalidomide to the World

In the United States, lenalidomide is approved for the treatment of multiple myeloma and myelodysplastic syndromes. The FDA's Orange Book lists multiple approved Abbreviated New Drug Applications (ANDAs) for lenalidomide, indicating a competitive generic market. The high concentration of exports to the U.S. underscores the importance of compliance with FDA regulations, including adherence to Current Good Manufacturing Practices (cGMP) and the Drug Supply Chain Security Act (DSCSA). Indian exporters must ensure rigorous quality control and regulatory compliance to maintain market access.

In the European Union, lenalidomide has been subject to various regulatory actions. For instance, on June 8, 2023, the European Commission withdrew the marketing authorization for Lenalidomide Krka d.d. at the request of the marketing authorization holder, KRKA, d.d., Novo mesto, due to commercial reasons. This withdrawal does not preclude the presence of other generic versions of lenalidomide in the EU market. Manufacturers exporting to the EU and UK must comply with the European Medicines Agency (EMA) and the UK's Medicines and Healthcare products Regulatory Agency (MHRA) requirements, including obtaining marketing authorizations and adhering to EU Good Manufacturing Practice (GMP) standards.

Lenalidomide is included in the WHO Model List of Essential Medicines, reflecting its importance in treating priority health conditions. The WHO Model List serves as a guide for countries to develop their own national essential medicines lists, ensuring the availability of critical medications. Compliance with international pharmacopoeia standards, such as the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP), is essential for manufacturers to meet global quality expectations.

In India, lenalidomide is classified under Schedule H of the Drugs and Cosmetics Act, indicating that it is a prescription-only medication. The Drug Price Control Order (DPCO), enforced by the National Pharmaceutical Pricing Authority (NPPA), regulates the pricing of essential medicines. Manufacturers must obtain a No Objection Certificate (NOC) from the Directorate General of Foreign Trade (DGFT) for the export of pharmaceuticals, ensuring compliance with national regulations.

The patent landscape for lenalidomide has evolved, with original patents held by Celgene Corporation expiring, leading to increased generic competition. This has facilitated the entry of multiple generic manufacturers into the market, intensifying competition and potentially impacting pricing and market dynamics.

In May 2025, the WHO convened the 25th Expert Committee on Selection and Use of Essential Medicines to update the Model List of Essential Medicines, reflecting the latest therapeutic advancements and public health priorities. In April 2025, the WHO launched the National Essential Medicines Lists (nEMLs) repository, a centralized digital platform compiling 150 national essential medicines lists from six global regions, enhancing access to critical healthcare data. In February 2025, the WHO published the 24th edition of the Model List of Essential Medicines, providing updated guidance on essential medicines for countries worldwide. In July 2023, the WHO released the 23rd edition of the Model List of Essential Medicines, reflecting the latest evidence-based recommendations for essential medicines. In March 2026, the WHO published a list of National Regulatory Authorities (NRAs) operating at maturity levels 3 and 4, indicating their capacity to ensure the quality, safety, and efficacy of medicines.

These developments underscore the dynamic nature of the pharmaceutical regulatory landscape and the importance of staying informed about global standards and guidelines.

India's pharmaceutical industry heavily relies on China for Key Starting Materials (KSMs) and intermediates essential for Active Pharmaceutical Ingredient (API) production. China controls approximately 70–80% of the global KSM supply and 60–70% of the global intermediate supply, making it a dominant player in this sector. This dependency poses significant risks, as any disruption in China's supply chain can directly impact India's API manufacturing capabilities.

Recent environmental regulations in China have led to the shutdown of numerous chemical manufacturing facilities, causing supply chain disruptions. For instance, in February 2019, over 140 API manufacturers in the Beijing-Tianjin-Hebei region ceased operations due to effluent violations. Such events underscore the vulnerability of India's pharmaceutical supply chain to external regulatory changes and highlight the need for diversification in sourcing raw materials.

The export market for Lenalidomide from India is highly concentrated, with the top five exporters accounting for 98.9% of total exports. SUN PHARMACEUTICAL INDUSTRIES LIMITED alone holds a 54.5% share, amounting to $481.0 million USD. This high concentration increases the risk of supply disruptions, as any operational issues within these key companies could significantly impact global supply.

To mitigate such risks, the Indian government has implemented the Production Linked Incentive (PLI) scheme aimed at reducing dependency on imports for critical pharmaceutical ingredients. In October 2024, two greenfield plants were inaugurated under this scheme to manufacture essential molecules like Penicillin G and Clavulanic Acid, marking a significant step towards self-reliance in API production. However, the effectiveness of this initiative in diversifying the supplier base for Lenalidomide remains to be seen.

Geopolitical tensions and shipping disruptions pose additional risks to the Lenalidomide supply chain. Incidents in critical maritime routes, such as the Red Sea and the Strait of Hormuz, have led to delays and increased shipping costs. For example, disruptions in the Red Sea have resulted in ships rerouting around the Cape of Good Hope, adding over 12 days to shipping times. (gov.uk) Such delays can affect the timely delivery of pharmaceutical products, including Lenalidomide.

Furthermore, regulatory bodies like the FDA and EMA have been actively monitoring and addressing medicine shortages. In January 2025, the FDA issued guidance on notifying the agency of manufacturing interruptions to prevent shortages. Similarly, the EMA has been working to strengthen the supply chain of critical medicines, including radiopharmaceuticals, by issuing strategic recommendations in April 2025. These efforts highlight the importance of proactive measures in mitigating supply chain risks.

• Diversify Raw Material Sources: Reduce dependency on Chinese KSMs by developing alternative sources, either domestically or from other countries, to ensure a more resilient supply chain.

• Expand Supplier Base: Encourage the growth of smaller pharmaceutical manufacturers to decrease reliance on a few major exporters, thereby mitigating the risks associated with supplier concentration.

• Enhance Domestic Production: Invest in domestic manufacturing capabilities for critical APIs and intermediates to reduce import dependency and strengthen supply chain resilience.

• Monitor Geopolitical Developments: Establish a dedicated team to track geopolitical events and assess their potential impact on shipping routes and supply chains, enabling timely responses to disruptions.

• Strengthen Regulatory Compliance: Collaborate with regulatory bodies to ensure compliance with international standards, thereby minimizing the risk of supply chain disruptions due to regulatory issues.

RISK_LEVEL: MEDIUM