How India Exports Temozolomide to the World

Temozolomide, an alkylating agent used primarily in the treatment of glioblastoma multiforme, has a significant presence in the U.S. pharmaceutical market. According to the FDA's Orange Book, numerous Abbreviated New Drug Applications (ANDAs) for temozolomide have been approved, indicating a robust generic competition landscape. Notably, the FDA approved an ANDA for temozolomide capsules by Teva Pharmaceuticals on March 15, 2025.

The regulatory pathway for temozolomide in the U.S. involves rigorous evaluation to ensure bioequivalence to the reference listed drug, Temodar. As of March 2026, there are no active FDA import alerts or enforcement actions specifically targeting temozolomide, suggesting compliance with regulatory standards among manufacturers. Given that India is a major exporter of temozolomide to the U.S., with 133 active Indian exporters and a 4.1% share of total exports directed to the U.S., maintaining adherence to FDA regulations is crucial for market access.

In the European Union, temozolomide has been subject to centralized marketing authorizations. For instance, Temozolomide Sandoz received marketing authorization on March 15, 2010. However, this authorization was withdrawn on September 15, 2022, at the request of the marketing authorization holder, Sandoz GmbH, due to commercial reasons. Similarly, Temozolomide Hexal's authorization was withdrawn on the same date for analogous reasons. These withdrawals do not reflect safety or efficacy concerns but rather strategic business decisions. The European Medicines Agency (EMA) continues to oversee the approval and monitoring of temozolomide products, ensuring compliance with EU Good Manufacturing Practice (GMP) requirements.

In the United Kingdom, the Medicines and Healthcare products Regulatory Agency (MHRA) regulates the marketing of temozolomide. Post-Brexit, the UK has established its own regulatory framework, though it remains aligned with EU standards to a significant extent. Manufacturers exporting temozolomide to the UK must comply with MHRA guidelines, including obtaining the necessary marketing authorizations and adhering to GMP standards.

Temozolomide is included in the WHO Model List of Essential Medicines, underscoring its importance in treating priority health conditions. The 24th edition of the list, published in September 2025, features temozolomide, reflecting its critical role in oncology. Inclusion in this list signifies the medicine's efficacy, safety, and cost-effectiveness, guiding countries in developing their national essential medicines lists. Additionally, temozolomide is recognized in major pharmacopoeias, including the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP), ensuring standardized quality specifications across different regions.

In India, temozolomide is classified under Schedule H of the Drugs and Cosmetics Rules, indicating that it is a prescription-only medication. The Central Drugs Standard Control Organization (CDSCO) oversees its regulation, ensuring compliance with safety and efficacy standards. As of March 2026, temozolomide is not listed under the Drug Price Control Order (DPCO) by the National Pharmaceutical Pricing Authority (NPPA), meaning it does not have a government-mandated ceiling price. For export purposes, Indian manufacturers must obtain a No Objection Certificate (NOC) from the Directorate General of Foreign Trade (DGFT), ensuring that the export complies with national regulations and does not affect domestic availability.

The primary patents for temozolomide have expired, leading to the introduction of multiple generic versions in the market. This has resulted in increased competition and more affordable pricing for patients. The absence of active patents allows Indian exporters to manufacture and supply temozolomide to various international markets without infringement concerns.

In April 2025, the World Health Organization unveiled a global repository for National Essential Medicines Lists (nEMLs), enhancing access to critical healthcare data and supporting policymakers in updating their essential medicines lists. This development underscores the importance of temozolomide's inclusion in national lists, facilitating its availability in various countries.

In May 2025, the 25th WHO Expert Committee on Selection and Use of Essential Medicines convened to review and update the Model List of Essential Medicines. The committee's recommendations, published in September 2025, reaffirmed the inclusion of temozolomide, highlighting its continued relevance in treating glioblastoma multiforme.

In January 2026, the WHO published a fact sheet on essential medicines, emphasizing the need for these medicines to be available, affordable, and of assured quality at all times. This reinforces the global commitment to ensuring access to critical treatments like temozolomide.

In February 2026, the WHO released a report on the selection and use of essential medicines, providing updated guidance on the inclusion criteria and processes for the Model List. This report serves as a valuable resource for countries in maintaining and updating their national essential medicines lists.

In March 2026, the WHO highlighted the importance of essential medicines in achieving universal health coverage, stressing the need for continuous efforts to improve access to these medicines globally. This aligns with the ongoing initiatives to ensure that treatments like temozolomide are accessible to patients in need.

India's pharmaceutical industry, including the production of Temozolomide, heavily relies on Active Pharmaceutical Ingredients (APIs) and Key Starting Materials (KSMs) imported from China. Approximately 60–70% of these critical components are sourced from China, underscoring a significant dependency. This reliance exposes the supply chain to risks associated with geopolitical tensions, trade restrictions, and potential disruptions in Chinese manufacturing.

Recent analyses have highlighted that 58% of KSMs used for U.S.-approved APIs are solely sourced from a single country, predominantly China. Such concentration increases vulnerability to supply chain disruptions, which can lead to shortages and impact global pharmaceutical production.

Our proprietary trade data indicates that the top five Indian exporters of Temozolomide account for 89.8% of the total export value, with SUN PHARMACEUTICAL INDUSTRIES LIMITED alone contributing 62.4%. This high supplier concentration poses a significant risk; any operational or regulatory issues affecting these key players could disrupt the entire supply chain.

To mitigate such risks, the Indian government has introduced the Production Linked Incentive (PLI) scheme, aiming to boost domestic manufacturing of APIs and reduce dependency on imports. However, the effectiveness of this initiative in diversifying the supplier base and enhancing supply chain resilience remains to be fully realized.

The recent closure of the Strait of Hormuz, a critical maritime chokepoint, has severely disrupted global shipping routes. Since March 2026, military escalations have led to a near halt in shipping traffic through the strait, affecting approximately 20% of the world's daily oil supply and significant volumes of liquefied natural gas. This disruption has caused oil prices to surge and has had cascading effects on global supply chains, including pharmaceuticals.

Additionally, tensions in the Red Sea and the Strait of Hormuz have led major shipping companies to suspend transits through these regions, opting for longer routes around the Cape of Good Hope. This rerouting adds 10–14 days to shipping times and incurs extra costs of up to $1 million per trip, further straining supply chains.

• Diversify API and KSM Sources: Encourage the development of alternative suppliers in different geographic regions to reduce dependency on a single country.

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

• Strengthen Supplier Relationships: Establish strategic partnerships with multiple suppliers to ensure a more robust and flexible supply chain.

• Monitor Geopolitical Developments: Implement a proactive monitoring system for geopolitical events that could impact shipping routes and supply chains.

• Develop Contingency Plans: Create and regularly update contingency plans to address potential disruptions in the supply chain, including alternative shipping routes and inventory management strategies.

RISK_LEVEL: HIGH