How India Exports Nystatin to the World

In the United States, nystatin is approved for various formulations, including oral suspensions and topical powders. For instance, UDL Laboratories, Inc. received approval for Nystatin Oral Suspension USP under ANDA 64-142 on June 25, 1998. Additionally, the FDA has issued product-specific guidance for generic nystatin topical powders, emphasizing the need for comparative physicochemical and structural characterization to establish pharmaceutical equivalence.

The substantial number of Indian exporters (223) supplying nystatin to the U.S. underscores the competitive landscape and the importance of adhering to FDA regulations to maintain market access.

In the European Union, marketing authorization for nystatin requires compliance with the European Medicines Agency (EMA) standards, including Good Manufacturing Practice (GMP) guidelines. Similarly, in the United Kingdom, the Medicines and Healthcare products Regulatory Agency (MHRA) oversees the approval process, ensuring that products meet safety, quality, and efficacy standards. Manufacturers must obtain the necessary marketing authorizations and demonstrate adherence to EU GMP requirements to distribute nystatin within these markets.

Nystatin is included in the World Health Organization's (WHO) Model List of Essential Medicines, highlighting its significance in treating fungal infections. The drug is also recognized in various pharmacopoeias, including the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP), ensuring standardized quality and efficacy across different regions.

In India, nystatin 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) regulates the pricing of essential medicines; however, as of March 2026, nystatin is not listed under the Drug Price Control Order (DPCO), allowing manufacturers to set prices based on market dynamics. For exports, the Directorate General of Foreign Trade (DGFT) mandates a No Objection Certificate (NOC) to ensure compliance with international standards and regulations.

Nystatin, first discovered in the 1950s, is no longer under patent protection, facilitating the production and export of generic versions by multiple manufacturers. This has led to a competitive market with numerous Indian exporters supplying nystatin globally.

In August 2021, the FDA issued revised draft guidance for generic nystatin topical powders, emphasizing the need for comparative physicochemical and structural characterization to establish pharmaceutical equivalence.

In June 2023, the WHO updated its Model List of Essential Medicines, reaffirming the inclusion of nystatin for the treatment of fungal infections, underscoring its continued global importance.

In January 2024, the Indian Ministry of Health and Family Welfare announced plans to streamline the export NOC process for pharmaceuticals, aiming to reduce approval times and enhance the competitiveness of Indian exporters in the global market.

In March 2024, the EMA released updated GMP guidelines, affecting the manufacturing standards for nystatin and other pharmaceuticals intended for the European market.

In December 2024, the NPPA conducted a review of essential medicines pricing, though nystatin remained outside the purview of price controls, allowing market-driven pricing to continue.

India is a leading producer of Active Pharmaceutical Ingredients (APIs), including Nystatin. However, the production of APIs often relies on Key Starting Materials (KSMs), which are predominantly sourced from China. According to the U.S. Pharmacopeia, 41% of KSMs used in U.S.-approved APIs are solely sourced from China, highlighting a significant dependency. This reliance poses a risk, as any disruption in the supply of KSMs from China can directly impact API production in India.

Recent geopolitical tensions have exacerbated these risks. In February 2026, military strikes in the Middle East led to the closure of the Strait of Hormuz, a critical maritime chokepoint. This disruption has significantly affected global shipping routes, including those essential for transporting raw materials necessary for pharmaceutical manufacturing. The United Nations Conference on Trade and Development (UNCTAD) reported that the closure has led to a sharp decline in maritime transit, affecting about 20% of the world's daily oil supply and significant volumes of liquefied natural gas (LNG). Such disruptions can delay the delivery of essential KSMs to India, thereby impacting the production and export of Nystatin.

The export market for Nystatin from India is notably concentrated. The top five exporters—AGOG PHARMA LIMITED, ZYDUS LIFESCIENCES LIMITED, LINCOLN PHARMACEUTICALS LTD, MEDLEY PHARMACEUTICALS LIMITED, and TORRENT PHARMACEUTICALS LTD—collectively account for 60.1% of total exports. AGOG PHARMA LIMITED alone holds a 20.4% share. This high level of supplier concentration increases the risk of supply chain disruptions, as issues affecting any of these key players could significantly impact the availability of Nystatin in international markets.

To mitigate such risks, the Indian government has implemented the Production Linked Incentive (PLI) scheme, aimed at boosting domestic manufacturing of critical APIs and reducing dependency on imports. The scheme has attracted significant investment, with commitments exceeding ₹4,570 crore in 2025. While this initiative is a positive step towards enhancing supply chain resilience, its impact on reducing supplier concentration in the Nystatin market remains to be seen.

The closure of the Strait of Hormuz in February 2026 has had profound implications for global trade. The Strait is a vital passage for approximately 20% of the world's daily oil supply. The disruption has led to a sharp decline in maritime transit, with tanker traffic dropping by approximately 70% and over 150 ships anchoring outside the strait to avoid risks. This situation has caused oil prices to surge, with Brent crude surpassing $100 per barrel on March 8, 2026, for the first time in four years. The increased costs and delays in shipping have directly impacted the pharmaceutical supply chain, leading to higher production costs and potential shortages of essential medicines, including Nystatin.

Additionally, the ongoing Red Sea crisis, which began in November 2023, has further complicated shipping routes. The simultaneous disruptions in both the Strait of Hormuz and the Red Sea have forced shipping companies to reroute vessels, leading to longer transit times and increased costs. These geopolitical tensions underscore the vulnerability of global supply chains to regional conflicts and the need for diversified sourcing and logistics strategies.

• Diversify Supplier Base: Encourage the development of additional Nystatin suppliers to reduce reliance on a concentrated group of exporters.

• Enhance Domestic Production: Leverage the PLI scheme to boost domestic manufacturing of KSMs and APIs, reducing dependency on imports.

• Develop Alternative Shipping Routes: Invest in infrastructure and partnerships to establish alternative shipping routes that bypass high-risk areas like the Strait of Hormuz and the Red Sea.

• Strengthen Inventory Management: Implement robust inventory management practices to maintain adequate stockpiles of critical raw materials and finished products.

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

RISK_LEVEL: HIGH