How India Exports Mercaptopurine to the World

In the United States, mercaptopurine has been approved by the FDA in both tablet and oral suspension forms. The brand name Purinethol (mercaptopurine tablet) received FDA approval prior to January 1, 1982, with subsequent generic approvals granted to manufacturers such as Dr. Reddy's Laboratories SA (February 11, 2004), Hikma (February 13, 2004), and Mylan (July 1, 2005). Additionally, the oral suspension form, branded as Purixan, was approved on April 28, 2014, with a generic version approved for Hikma on February 26, 2025.

The presence of multiple approved Abbreviated New Drug Applications (ANDAs) for mercaptopurine underscores a competitive market landscape in the U.S. This competition may present challenges for Indian exporters, given the substantial number of domestic manufacturers. However, the absence of current FDA import alerts related to mercaptopurine suggests a favorable regulatory environment for compliant foreign manufacturers.

In the European Union, mercaptopurine has been authorized for the treatment of acute lymphoblastic leukemia. Notably, the oral suspension form, Xaluprine, received EU authorization on March 9, 2012. (ema.europa.eu) The European Medicines Agency (EMA) mandates adherence to Good Manufacturing Practice (GMP) standards for all medicinal products, including mercaptopurine. Similarly, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) enforces stringent GMP requirements, ensuring that manufacturing processes meet high-quality standards.

Mercaptopurine is listed in the WHO Model List of Essential Medicines, reflecting its critical role in treating priority health conditions. The 23rd edition, published in July 2023, includes mercaptopurine, underscoring its global importance. (who.int) This inclusion facilitates its adoption into national essential medicines lists, promoting broader access. Furthermore, mercaptopurine is recognized in major pharmacopoeias, including the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP), ensuring standardized quality benchmarks across different regions.

In India, mercaptopurine 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) oversees the pricing of essential medicines; however, as of March 2026, mercaptopurine is not listed under the Drug Price Control Order (DPCO), allowing manufacturers to set prices based on market dynamics. For export purposes, the Directorate General of Foreign Trade (DGFT) requires a No Objection Certificate (NOC) for pharmaceuticals, ensuring compliance with national regulations and monitoring of drug exports.

Mercaptopurine's primary patents have expired, leading to the availability of generic versions globally. This expiration has intensified market competition, particularly in regions with established generic pharmaceutical industries. For Indian exporters, this scenario presents both opportunities and challenges, as they must navigate competitive pricing while adhering to international quality standards.

In February 2025, the FDA approved a generic version of Purixan (mercaptopurine oral suspension) for Hikma Pharmaceuticals, expanding the availability of this formulation in the U.S. market.

In May 2025, the WHO's 25th Expert Committee on Selection and Use of Essential Medicines convened to update the Model List of Essential Medicines, reaffirming the inclusion of mercaptopurine due to its continued relevance in treating acute lymphoblastic leukemia. (who.int)

In September 2025, the WHO published the 24th edition of the Model List of Essential Medicines, maintaining mercaptopurine's status as an essential medicine, thereby reinforcing its global therapeutic significance. (who.int)

These developments highlight the dynamic regulatory and market landscape for mercaptopurine, emphasizing the need for Indian exporters to stay informed and compliant with international standards to effectively compete in the global market.

India's pharmaceutical industry, while robust in manufacturing Active Pharmaceutical Ingredients (APIs), remains heavily reliant on China for Key Starting Materials (KSMs). Approximately 60–70% of KSMs used in Indian API production are imported from China. This dependency poses a significant risk, as any disruption in Chinese supply chains can directly affect India's ability to produce APIs, including those for mercaptopurine.

Recent geopolitical tensions have exacerbated this vulnerability. In February 2026, the closure of the Strait of Hormuz due to military conflicts disrupted the supply of raw materials essential for pharmaceutical manufacturing. This blockade led to delays and increased costs in procuring necessary chemicals, highlighting the fragility of the supply chain for critical medications.

Our proprietary data indicates that the top five Indian exporters of mercaptopurine account for 59.7% of total exports, with BETA DRUGS LIMITED alone contributing 39.7%. Such concentration heightens the risk of supply disruptions, as issues affecting these key suppliers—be it operational challenges, regulatory actions, or geopolitical events—can significantly impact global availability.

To mitigate this risk, the Indian government has implemented the Production Linked Incentive (PLI) scheme, aiming to bolster domestic production of critical APIs and reduce reliance on imports. Since its inception, the PLI scheme has led to the establishment of new manufacturing units, with investments exceeding ₹4,570 crore by 2025. While this initiative shows promise, its effectiveness in diversifying the supplier base for mercaptopurine remains to be fully realized.

The closure of the Strait of Hormuz in February 2026 has had profound implications for global supply chains. This strategic chokepoint is vital for the transportation of oil and raw materials essential for pharmaceutical manufacturing. The blockade resulted in significant delays and increased costs, affecting the timely production and distribution of medications, including mercaptopurine.

Additionally, tensions in the Red Sea and the Strait of Hormuz have disrupted shipping routes, leading to rerouted shipments and extended delivery times. These disruptions have strained the pharmaceutical supply chain, causing delays in the availability of critical drugs.

To enhance the resilience of the mercaptopurine supply chain, the following actions are recommended:

• Diversify Supplier Base: Encourage the development of alternative suppliers for both APIs and KSMs to reduce dependency on a limited number of sources.

• Strengthen Domestic Production: Accelerate initiatives like the PLI scheme to boost local manufacturing capabilities for critical pharmaceutical components.

• Enhance Supply Chain Transparency: Implement robust tracking systems to monitor the flow of raw materials and finished products, enabling proactive responses to potential disruptions.

• Develop Strategic Reserves: Establish stockpiles of essential APIs and KSMs to buffer against short-term supply interruptions.

• Foster International Collaboration: Engage in partnerships with other nations to share resources and information, enhancing collective resilience against global supply chain challenges.

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