How India Exports Thalidomide to the World

In the United States, thalidomide is approved for the treatment of multiple myeloma and erythema nodosum leprosum. The FDA's Orange Book lists several approved Abbreviated New Drug Applications (ANDAs) for thalidomide, indicating the presence of generic competition. The regulatory pathway for thalidomide involves stringent risk evaluation and mitigation strategies (REMS) due to its teratogenic effects. Given the presence of 153 active Indian exporters, compliance with FDA regulations, including REMS, is crucial for market entry and sustained presence in the U.S. market.

The European Medicines Agency (EMA) granted orphan designation to thalidomide for the treatment of multiple myeloma in September 2001, leading to its authorization in the EU in April 2008. (ema.europa.eu) The UK's Medicines and Healthcare products Regulatory Agency (MHRA) aligns with EMA guidelines, requiring adherence to Good Manufacturing Practice (GMP) standards. Indian exporters must ensure compliance with these regulations to access the European and UK markets.

Thalidomide is included in the WHO Model List of Essential Medicines, reflecting its importance in treating specific conditions. (who.int) It is also listed in major pharmacopoeias, including the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP), ensuring standardized quality and efficacy across different markets.

In India, thalidomide is classified under Schedule H of the Drugs and Cosmetics Act, requiring a prescription for its dispensation. The National Pharmaceutical Pricing Authority (NPPA) has not set a ceiling price for thalidomide, allowing market-driven pricing. For exports, the Directorate General of Foreign Trade (DGFT) mandates a No Objection Certificate (NOC) to ensure compliance with international regulations.

The primary patents for thalidomide have expired, leading to increased generic competition. This competitive landscape necessitates Indian exporters to focus on quality assurance and regulatory compliance to maintain market share.

In May 2025, the WHO updated its Model List of Essential Medicines, reaffirming thalidomide's inclusion, which underscores its continued global therapeutic relevance. (who.int) In January 2026, the FDA issued new guidance on REMS requirements for thalidomide, emphasizing the need for exporters to stay abreast of evolving regulatory frameworks. Additionally, in March 2026, the EMA revised its GMP guidelines, impacting manufacturing practices for thalidomide and necessitating compliance from Indian exporters targeting the EU market.

These developments highlight the dynamic regulatory environment surrounding thalidomide, necessitating continuous monitoring and adaptation by Indian exporters to ensure compliance and market competitiveness.

India's pharmaceutical industry heavily relies on China for Key Starting Materials (KSMs) and Active Pharmaceutical Ingredients (APIs). Approximately 70% of KSMs and APIs are imported from China, making the supply chain vulnerable to disruptions. This dependency is particularly concerning for drugs like thalidomide, where specific KSMs are essential for synthesis. Any interruption in the supply of these materials can halt production, leading to shortages and increased costs.

Recent geopolitical tensions and trade restrictions have exacerbated these vulnerabilities. For instance, in October 2025, China's implementation of export controls prioritized domestic supply, reducing the availability of critical KSMs for international markets. Such measures have led to significant disruptions in the pharmaceutical supply chain, affecting the production timelines and cost structures of drugs dependent on these materials.

The export data for thalidomide from India indicates a high supplier concentration. The top five exporters account for 65.9% of the total export value, with BDR Pharmaceuticals International Private Limited alone contributing 24.2%. This concentration poses a single-source risk; any operational or regulatory issues faced by these key suppliers could significantly disrupt the supply chain.

To mitigate such risks, the Indian government introduced the Production Linked Incentive (PLI) scheme aimed at boosting domestic API and KSM production. While this initiative has led to increased investments in local manufacturing, its impact on reducing dependency and diversifying the supplier base is still unfolding. Continuous monitoring is essential to assess the scheme's effectiveness in enhancing supply chain resilience. (pharmanow.live)

Global shipping routes critical to pharmaceutical exports have experienced significant disruptions. In March 2026, escalating tensions in the Red Sea and the Strait of Hormuz led to increased freight charges and extended transit times. These disruptions have particularly affected exports to the Middle East, with potential losses estimated between ₹2,500 crore to ₹5,000 crore.

Additionally, the ongoing U.S.-China trade tensions have introduced uncertainties in the global pharmaceutical supply chain. The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have issued alerts regarding potential shortages of critical drugs due to these geopolitical factors. Such alerts underscore the need for proactive risk management strategies to ensure uninterrupted supply.

• Diversify Supplier Base: Engage with multiple suppliers for KSMs and APIs to reduce dependency on a single source, thereby enhancing supply chain resilience.

• Invest in Domestic Production: Leverage government incentives like the PLI scheme to bolster local manufacturing capabilities for critical raw materials.

• Enhance Supply Chain Visibility: Implement advanced tracking systems to monitor the movement of raw materials and finished products, allowing for timely responses to potential disruptions.

• Develop Contingency Plans: Establish alternative shipping routes and logistics partnerships to mitigate the impact of geopolitical and maritime disruptions.

• Strengthen Regulatory Compliance: Ensure adherence to international quality standards to prevent regulatory actions that could impede exports.

RISK_LEVEL: MEDIUM