How India Exports Terbinafine to the World

In the United States, terbinafine is approved for various formulations, including oral tablets and topical creams. The FDA's Orange Book lists multiple approved Abbreviated New Drug Applications (ANDAs) for terbinafine, indicating a competitive generic market. Notably, Lamisil Cream (terbinafine) received FDA approval on March 9, 1999. As of March 2026, there are no active FDA import alerts specifically targeting terbinafine products from India, suggesting compliance with U.S. regulatory standards. The substantial number of Indian exporters (292) underscores India's significant role in supplying terbinafine to the U.S. market.

In the European Union, terbinafine-containing products require marketing authorization from the European Medicines Agency (EMA) or national competent authorities. The EMA has approved veterinary medicinal products containing terbinafine, such as Duotic, which received a positive opinion on October 11, 2024. (ema.europa.eu) In the United Kingdom, the Medicines and Healthcare products Regulatory Agency (MHRA) oversees the approval and regulation of terbinafine products. Manufacturers exporting to these markets must adhere to EU Good Manufacturing Practice (GMP) guidelines to ensure product quality and safety.

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

In India, terbinafine is classified under Schedule H of the Drugs and Cosmetics Act, requiring a prescription for dispensing. The National Pharmaceutical Pricing Authority (NPPA) sets ceiling prices for essential medicines; however, as of March 2026, terbinafine is not listed under price control. Exporters must obtain a No Objection Certificate (NOC) from the Directorate General of Foreign Trade (DGFT) for the export of pharmaceutical products, ensuring compliance with national regulations.

The primary patents for terbinafine have expired, leading to a robust generic market with multiple manufacturers producing the drug. This has resulted in increased competition and more affordable pricing for consumers globally.

In May 2025, the FDA released a draft guidance on bioequivalence studies for generic terbinafine gel products, aiming to streamline the approval process for generic formulations. In October 2024, the EMA's Committee for Medicinal Products for Veterinary Use (CVMP) adopted a positive opinion for Duotic, a veterinary product containing terbinafine, expanding its use in animal health. (ema.europa.eu) In March 2025, the NPPA conducted a review of antifungal drug prices, including terbinafine, to assess market dynamics and ensure affordability, though no price controls were implemented. In January 2026, the WHO updated its Essential Medicines List, reaffirming the inclusion of terbinafine for the treatment of fungal infections, underscoring its continued global relevance.

India's pharmaceutical industry heavily relies on China for Key Starting Materials (KSMs) essential in Active Pharmaceutical Ingredient (API) production. Approximately 41% of KSMs used in U.S.-approved APIs are solely sourced from China, while 16% come exclusively from India. This dependency poses significant risks; for instance, in 2022, environmental inspections in China's Shandong province led to temporary shutdowns of API facilities, causing a 12-15% decline in terbinafine hydrochloride exports over three months.

Such disruptions underscore the vulnerability of the supply chain to external factors, including regulatory actions and geopolitical tensions. The concentration of KSM production in specific regions means that any localized issue can have global repercussions, affecting the availability and pricing of critical medications like terbinafine.

The terbinafine export market from India is notably concentrated, with the top five exporters controlling 65.8% of the market share. AUROBINDO PHARMA LTD alone accounts for 37.3% of exports, indicating a significant reliance on a limited number of suppliers. This concentration heightens the risk of supply disruptions, as issues affecting these key players can disproportionately impact the entire supply chain.

To mitigate such risks, the Indian government has implemented the Production Linked Incentive (PLI) scheme, aiming to bolster domestic API production and reduce dependence on imports. In October 2024, two greenfield plants were inaugurated under this scheme to manufacture critical molecules like Penicillin G and Clavulanic Acid, marking a step towards enhancing self-sufficiency in pharmaceutical manufacturing.

Global shipping routes, including the Red Sea and the Strait of Hormuz, are susceptible to geopolitical tensions that can disrupt the transportation of pharmaceutical products. For example, in 2024, disruptions in the Red Sea led to ships rerouting around the Cape of Good Hope, adding over 12 days to shipping times and causing delays in medicine deliveries. (gov.uk)

Additionally, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have reported medicine shortages due to supply chain vulnerabilities. In January 2025, the FDA highlighted concerns over medical device shortages impacting patient care, particularly for vulnerable populations. Similarly, the EMA has been actively monitoring and addressing medicine shortages to ensure continuous patient access to essential treatments. (ema.europa.eu)

• Diversify Supplier Base: Encourage the development of additional API and KSM suppliers to reduce reliance on a limited number of sources.

• Enhance Domestic Production: Support initiatives like the PLI scheme to strengthen local manufacturing capabilities for critical pharmaceutical ingredients.

• Strengthen Regulatory Compliance: Implement stringent quality control measures to prevent production halts due to regulatory non-compliance.

• Develop Contingency Plans: Establish robust strategies to manage potential disruptions in shipping routes and geopolitical tensions.

• Monitor Global Supply Chains: Utilize real-time data analytics to anticipate and respond to supply chain vulnerabilities proactively.

RISK_LEVEL: MEDIUM