How India Exports Pembrolizumab to the World

As of March 2026, pembrolizumab is approved in the United States under the brand name Keytruda, manufactured by Merck & Co., Inc. The FDA Orange Book lists no approved Abbreviated New Drug Applications (ANDAs) for pembrolizumab, indicating the absence of generic competition. The regulatory pathway for pembrolizumab involved a Biologics License Application (BLA), reflecting its status as a biologic product. Given the absence of generic approvals, Indian exporters face limited opportunities in the U.S. market for pembrolizumab.

In the European Union, the European Medicines Agency (EMA) granted marketing authorization for pembrolizumab (Keytruda) in July 2015. The United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) continued this authorization post-Brexit. Manufacturers exporting to these markets must comply with EU Good Manufacturing Practice (GMP) standards, ensuring product quality and safety.

The World Health Organization (WHO) included pembrolizumab in its 24th Model List of Essential Medicines, published in September 2025. This inclusion underscores pembrolizumab's significance in treating priority health conditions globally. 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 ensure product quality and facilitate international trade.

In India, pembrolizumab is classified under Schedule H of the Drugs and Cosmetics Act, requiring a prescription for dispensing. The National Pharmaceutical Pricing Authority (NPPA) has not set a ceiling price for pembrolizumab, allowing market-driven pricing. Exporters must obtain a No Objection Certificate (NOC) from the Directorate General of Foreign Trade (DGFT) for exporting pembrolizumab, ensuring compliance with national regulations.

Pembrolizumab's primary patents are held by Merck & Co., Inc., with expirations anticipated in 2028. This patent protection currently limits the entry of generic versions into the market, maintaining Merck's exclusivity.

In May 2025, the WHO Expert Committee on Selection and Use of Essential Medicines included pembrolizumab in the 24th Model List of Essential Medicines, highlighting its importance in global health. In April 2025, the WHO launched the National Essential Medicines Lists (nEMLs) repository, providing a centralized platform for essential medicines data, which includes pembrolizumab. In February 2025, the WHO published the 2025 annual report of the Department of Regulation and Prequalification, detailing regulatory activities related to essential medicines like pembrolizumab. In January 2025, the WHO released a fact sheet on essential medicines, emphasizing the need for access to treatments such as pembrolizumab. In December 2024, the WHO updated its guidelines on the selection and use of essential medicines, incorporating recent data on pembrolizumab's efficacy and safety.

These developments reflect the evolving regulatory landscape for pembrolizumab, influencing its global availability and accessibility.

India's pharmaceutical industry heavily relies on China for Key Starting Materials (KSMs) and Active Pharmaceutical Ingredients (APIs). Approximately 60–70% of KSMs and APIs are imported from China, making the supply chain vulnerable to disruptions. This dependency is particularly concerning for complex biologics like pembrolizumab, where consistent quality and supply of raw materials are critical.

Recent geopolitical tensions have exacerbated these vulnerabilities. In February 2026, the Strait of Hormuz was effectively blockaded following military actions involving Iran, the United States, and Israel. This blockade halted maritime traffic in the Persian Gulf, severely disrupting global trade routes and affecting the transportation of pharmaceutical ingredients. The crisis led to a significant drop in tanker traffic and increased shipping costs, impacting the timely delivery of essential raw materials to manufacturing hubs in India. (lemonde.fr)

The export market for pembrolizumab from India is concentrated among a few suppliers. The top five exporters account for 54.6% of the total export value, with GNH India Pharmaceuticals Limited leading at 14.8%. Such concentration poses a risk, as any operational or compliance issues within these key suppliers could disrupt the supply chain.

To mitigate these risks, the Indian government has implemented the Production Linked Incentive (PLI) scheme, aiming to boost domestic manufacturing of critical APIs and reduce import dependence. In October 2024, two greenfield plants were inaugurated under this scheme to produce essential molecules like Penicillin G and Clavulanic Acid, marking a significant step toward self-reliance in pharmaceutical manufacturing.

The blockade of the Strait of Hormuz in February 2026 has had profound implications for global shipping and trade. The strait is a critical chokepoint for international shipping, especially for the export of oil, fertilizer components, and goods heading to or from the Middle East. Countries like Bahrain, Kuwait, Qatar, UAE, and Saudi Arabia are particularly affected due to their heavy dependence on maritime trade and limited alternative infrastructure. (lemonde.fr)

Additionally, the ongoing U.S.-China trade tensions have introduced further uncertainties. The U.S. supply chain for key starting materials (KSMs), the building blocks needed to manufacture active pharmaceutical ingredients (APIs), is at risk due to America’s reliance on countries such as China and India for these critical chemicals. According to US Pharmacopeia, 58% of KSMs used for U.S.-approved APIs are sole sourced from a single country, with 41% of such KSMs from China and 16% from India.

• Diversify Supplier Base: Expand the network of raw material suppliers beyond China to reduce dependency and enhance supply chain resilience.

• Enhance Domestic Production: Invest in domestic manufacturing capabilities for KSMs and APIs to decrease reliance on imports and improve self-sufficiency.

• Strengthen Regulatory Compliance: Implement stringent quality control measures to ensure compliance with international standards, reducing the risk of export bans due to regulatory violations.

• Develop Alternative Shipping Routes: Explore and establish alternative logistics and shipping routes to mitigate the impact of geopolitical disruptions on transportation.

• Monitor Geopolitical Developments: Establish a dedicated team to monitor global geopolitical events and assess their potential impact on the pharmaceutical supply chain, enabling proactive risk management.

RISK_LEVEL: HIGH