How India Exports Melatonin to the World

As of March 2026, the U.S. Food and Drug Administration (FDA) has not approved any Abbreviated New Drug Applications (ANDAs) for melatonin, as it is not listed in the FDA's Orange Book. Melatonin is classified as a dietary supplement in the United States, and therefore, it does not require FDA approval for marketing. However, manufacturers are responsible for ensuring the safety and labeling accuracy of their products. The FDA has issued import alerts in the past for melatonin products that do not meet regulatory standards, emphasizing the importance of compliance with Good Manufacturing Practices (GMP).

Despite the absence of FDA-approved ANDAs, India has been a significant exporter of melatonin to the U.S., accounting for 7.5% of its total melatonin exports. This trade involves 116 active Indian exporters and 165 buyers, with a repeat buyer rate of 56.4%, indicating a stable demand. The average Free on Board (FOB) unit price stands at $2.49, reflecting competitive pricing in the U.S. market.

In the European Union (EU), melatonin is regulated as a medicinal product. The European Medicines Agency (EMA) has approved several melatonin-containing medicines, such as Circadin, for the short-term treatment of primary insomnia in patients aged 55 years and over. In December 2025, the EMA recommended the authorization of Melatomed, a prolonged-release melatonin tablet, in Germany, Austria, Denmark, and Sweden. (ema.europa.eu)

The United Kingdom (UK) follows a similar regulatory approach, requiring marketing authorization for melatonin products. The Medicines and Healthcare products Regulatory Agency (MHRA) oversees the approval process, ensuring compliance with EU Good Manufacturing Practice (GMP) standards. Manufacturers exporting melatonin to the EU and UK must adhere to these stringent requirements to gain market access.

As of the 23rd edition published in July 2023, melatonin is not included in the World Health Organization's (WHO) Model List of Essential Medicines. (test-cms.who.int) Consequently, it has not undergone WHO Prequalification. However, melatonin is recognized in various pharmacopoeias, including the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP), which establish quality standards for its production and use.

In India, melatonin is classified as an over-the-counter (OTC) product, allowing its sale without a prescription. The Central Drugs Standard Control Organization (CDSCO) does not list melatonin under Schedules H, H1, or X, which are categories for prescription drugs. The Drug Price Control Order (DPCO) and the National Pharmaceutical Pricing Authority (NPPA) have not set a ceiling price for melatonin, indicating no price regulation as of March 2026. For export purposes, manufacturers must obtain a No Objection Certificate (NOC) from the Directorate General of Foreign Trade (DGFT), ensuring compliance with export regulations.

Melatonin is a naturally occurring hormone, and its synthetic forms are not subject to patent protection. This lack of exclusivity has led to a competitive market with multiple manufacturers producing generic versions, contributing to the affordability and widespread availability of melatonin products globally.

In December 2025, the EMA recommended the authorization of Melatomed, a prolonged-release melatonin tablet, in Germany, Austria, Denmark, and Sweden, expanding the availability of melatonin-based treatments in the EU. (ema.europa.eu)

In May 2025, melatonin prices in the United States reached approximately $86,551 per metric ton, reflecting strong pharmaceutical and nutraceutical demand, alongside steady production costs. Limited raw material availability and ongoing regulatory adjustments contributed to this price trend.

In July 2023, the WHO published the 23rd edition of its Model List of Essential Medicines, which did not include melatonin, indicating that it is not considered essential for priority healthcare needs globally. (test-cms.who.int)

In September 2024, the WHO emphasized the importance of essential medicines being available, affordable, and of assured quality at all times, highlighting the need for countries to develop and update national essential medicine lists. (test-cms.who.int)

In December 2025, the EMA completed a review of Melatomed following a disagreement among EU Member States regarding its authorization, concluding that the benefits of Melatomed outweigh its risks, and that the marketing authorization can be granted in the concerned Member States. (ema.europa.eu)

India's pharmaceutical industry, including melatonin production, heavily relies on Active Pharmaceutical Ingredients (APIs) and Key Starting Materials (KSMs) imported from China. Approximately 70% of India's API and KSM requirements are sourced from China, underscoring a significant dependency on Chinese suppliers. This reliance exposes the supply chain to potential disruptions stemming from geopolitical tensions, trade policy changes, or environmental regulations affecting Chinese manufacturing.

In recent years, China's enforcement of stringent environmental standards has led to the shutdown of numerous chemical plants, including those producing KSMs. For instance, over the past year, nearly 145 API manufacturers in China ceased operations due to non-compliance with pollution norms, causing supply shortages and price escalations for Indian pharmaceutical companies. Such disruptions highlight the vulnerability of India's melatonin supply chain to external factors affecting Chinese production.

Our proprietary trade data indicates that the top five Indian exporters account for 65.9% of melatonin exports, with GRACURE PHARMACEUTICALS LIMITED alone contributing 24.8%. This high supplier concentration poses a significant risk, as any operational issues within these key companies could disrupt the entire supply chain.

To mitigate such risks, the Indian government introduced the Production Linked Incentive (PLI) scheme for bulk drugs, aiming to bolster domestic manufacturing of critical APIs and KSMs. As of September 2025, the scheme has attracted investments of ₹4,763.34 crore, surpassing the initial commitment of ₹4,329.95 crore over six years. While this initiative shows promise, its impact on reducing supplier concentration in the melatonin export sector remains to be fully realized.

Global shipping routes, including the Red Sea and the Strait of Hormuz, are susceptible to geopolitical tensions that can disrupt maritime transport. Such disruptions can delay shipments of melatonin exports from India, affecting delivery schedules and increasing costs. Additionally, escalating tensions between the United States and China have led to increased scrutiny and potential trade restrictions, which could indirectly impact India's pharmaceutical exports.

Regulatory bodies like the FDA and EMA have issued alerts regarding drug shortages resulting from supply chain disruptions. For example, in July 2024, the FDA highlighted shortages of certain medications due to supply chain vulnerabilities, emphasizing the need for diversified sourcing strategies. Such alerts underscore the importance of proactive risk management in the pharmaceutical supply chain.

• Diversify Supplier Base: Expand the network of melatonin suppliers beyond the top five exporters to reduce dependency on a limited number of sources.

• Enhance Domestic Production: Leverage the PLI scheme to strengthen domestic manufacturing capabilities for melatonin APIs and KSMs, reducing reliance on imports.

• Monitor Geopolitical Developments: Establish a dedicated team to track geopolitical events that could impact shipping routes and implement contingency plans accordingly.

• Strengthen Regulatory Compliance: Ensure adherence to international quality standards to mitigate risks associated with regulatory alerts and maintain market access.

• Develop Alternative Shipping Routes: Explore and establish alternative logistics pathways to circumvent potential disruptions in traditional shipping lanes.

RISK_LEVEL: MEDIUM