How India Exports Heparin to the World

Heparin, a critical anticoagulant, is extensively utilized in the United States, which accounts for 42.1% of India's heparin exports. The U.S. Food and Drug Administration (FDA) has approved numerous Abbreviated New Drug Applications (ANDAs) for heparin sodium injections, indicating a competitive market with multiple generic manufacturers. The FDA's Orange Book lists several approved ANDAs for heparin sodium, reflecting its widespread acceptance and use.

The regulatory pathway for heparin involves stringent compliance with Current Good Manufacturing Practices (cGMP) and adherence to the United States Pharmacopeia (USP) standards. Indian exporters, totaling 391 active entities, must ensure their manufacturing processes meet these requirements to maintain market access. Notably, the top exporter, GLAND PHARMA LIMITED, holds a 35.6% share of the export value, underscoring the significance of regulatory compliance in sustaining market leadership.

In the European Union (EU) and the United Kingdom (UK), heparin products require marketing authorization from the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA), respectively. These agencies mandate compliance with the European Pharmacopoeia (EP) standards and adherence to EU Good Manufacturing Practice (GMP) guidelines. Indian exporters must obtain Certificates of Suitability (CEP) to demonstrate compliance with EP monographs, facilitating smoother market entry.

Heparin is included in the 24th edition of the WHO Model List of Essential Medicines, published in September 2025, highlighting its critical role in healthcare systems worldwide. This inclusion underscores the necessity for heparin to meet international pharmacopoeial standards, including those set by the USP, British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP). Compliance with these standards ensures the quality and efficacy of heparin products in global markets.

In India, heparin is classified as a Schedule H drug under the Drugs and Cosmetics Act, requiring a prescription for its dispensation. The National Pharmaceutical Pricing Authority (NPPA) regulates its pricing to ensure affordability. For exports, the Directorate General of Foreign Trade (DGFT) mandates a No Objection Certificate (NOC), ensuring that domestic supply is not adversely affected by international demand.

Heparin, being a naturally derived product, is not subject to patent protection, allowing for the production and export of generic versions. This lack of exclusivity has led to a competitive market landscape, with multiple manufacturers supplying heparin globally.

In May 2025, the WHO Expert Committee on Selection and Use of Essential Medicines updated the Model List to its 24th edition, reaffirming heparin's status as an essential medicine. This update emphasizes the ongoing global reliance on heparin for anticoagulation therapy.

In February 2026, the WHO published the report of the 25th Expert Committee on Selection and Use of Essential Medicines, providing comprehensive guidance on the selection and use of essential medicines, including heparin. This report serves as a critical resource for policymakers and healthcare providers worldwide.

These developments highlight the dynamic regulatory environment surrounding heparin and the importance of continuous compliance with international standards to maintain market access and ensure patient safety.

India's pharmaceutical industry, including heparin production, heavily relies on China for Key Starting Materials (KSMs). This dependency poses a strategic risk, as disruptions in China's supply chain can halt API synthesis, leading to drug shortages. The 2025 Strait of Hormuz crisis exemplified this vulnerability, with geopolitical tensions causing significant supply chain disruptions.

To mitigate such risks, India has implemented the Production Linked Incentive (PLI) Scheme, aiming to bolster domestic API and KSM manufacturing. This initiative seeks to reduce reliance on imports and enhance supply chain resilience. (pharmanow.live)

Our data indicates that the top five Indian exporters account for 82.6% of heparin exports, with GLAND PHARMA LIMITED leading at 35.6%. This high concentration increases the risk of supply disruptions if any major supplier faces operational issues. The PLI Scheme is designed to diversify the supplier base by incentivizing new entrants into API manufacturing, thereby reducing single-source dependency. (pharmanow.live)

Recent geopolitical events, such as the closure of the Strait of Hormuz in March 2026, have severely impacted global shipping routes. This disruption has led to increased transportation costs and delays, affecting the timely export of pharmaceuticals, including heparin. Additionally, tensions in the Red Sea and US-China relations have further strained supply chains, emphasizing the need for diversified shipping strategies.

• Diversify API and KSM Sources: Encourage the development of alternative suppliers within India and other regions to reduce dependency on a single country.

• Enhance Domestic Manufacturing: Leverage the PLI Scheme to strengthen local production capabilities for APIs and KSMs.

• Develop Alternative Shipping Routes: Establish and utilize multiple shipping pathways to mitigate risks associated with geopolitical disruptions.

• Implement Robust Risk Management: Adopt comprehensive risk assessment frameworks to proactively identify and address potential supply chain vulnerabilities.

• Strengthen Supplier Relationships: Foster strong partnerships with multiple suppliers to ensure flexibility and resilience in the supply chain.

RISK_LEVEL: HIGH