How India Exports Domperidone to the World

As of March 2026, domperidone is not approved by the U.S. Food and Drug Administration (FDA) for general use due to concerns over serious cardiac side effects, including QT interval prolongation and arrhythmias. Consequently, there are no approved Abbreviated New Drug Applications (ANDAs) for domperidone listed in the FDA's Orange Book. However, in September 2011, the FDA granted orphan drug designation to domperidone for the treatment of hypoprolactinemia in breastfeeding mothers, though this indication has not received FDA approval.

Given the absence of FDA approval, the importation of domperidone into the United States is generally prohibited. Exceptions are made under the FDA's Expanded Access Program, which allows the importation of domperidone for patients with severe gastrointestinal motility disorders unresponsive to standard treatments. This program requires a physician's application and FDA authorization. The stringent regulatory environment in the U.S. is reflected in the export data, where the United States does not appear among the top destination countries for Indian domperidone exports.

In the European Union, domperidone is authorized for the treatment of nausea and vomiting. However, in March 2014, the European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) recommended restricting its use due to concerns over cardiac side effects. The recommended changes included limiting the dose to 10 mg up to three times daily for adults and adolescents weighing 35 kg or more, and restricting the duration of use to a maximum of one week. These recommendations were endorsed by the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) in April 2014. (ema.europa.eu)

In the United Kingdom, the Medicines and Healthcare products Regulatory Agency (MHRA) has implemented similar restrictions in line with the EMA's recommendations. Manufacturers exporting domperidone to the EU and UK must comply with Good Manufacturing Practice (GMP) standards as outlined in EU Directive 2003/94/EC, ensuring product quality and safety.

Domperidone is not listed in the World Health Organization's (WHO) Model List of Essential Medicines. Consequently, it has not undergone the WHO Prequalification of Medicines Programme, which aims to ensure the quality, safety, and efficacy of medicines supplied to low- and middle-income countries. Regarding pharmacopoeial standards, domperidone is included in the British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP), providing standardized quality specifications for its production and quality control.

In India, domperidone is classified as a Schedule H drug under the Drugs and Cosmetics Rules, 1945, indicating that it is a prescription-only medication. The National Pharmaceutical Pricing Authority (NPPA) has not set a ceiling price for domperidone, allowing market-driven pricing. For export purposes, the Directorate General of Foreign Trade (DGFT) does not require a No Objection Certificate (NOC) for domperidone, facilitating its export by Indian manufacturers.

Domperidone's primary patents have expired, leading to the availability of generic versions globally. The absence of active patents has resulted in significant generic competition, contributing to the relatively low average FOB unit price of $1.71 for Indian exports.

In August 2025, the EMA's CMDh issued scientific conclusions and grounds for variation concerning domperidone, leading to amendments in the product information to enhance safety measures. (ema.europa.eu)

In September 2025, the EMA published a list of nationally authorized medicinal products containing domperidone, reflecting ongoing regulatory oversight and harmonization efforts across EU member states. (ema.europa.eu)

These developments underscore the continuous regulatory scrutiny of domperidone to ensure its safe and effective use in the global market.

India's pharmaceutical industry, including the production of Domperidone, heavily relies on Active Pharmaceutical Ingredients (APIs) and Key Starting Materials (KSMs) imported from China. Approximately 60–70% of these critical components are sourced from China, highlighting a significant dependency. This reliance poses a risk, as any disruption in the supply chain from China can directly impact the availability and production of Domperidone in India.

Recent geopolitical tensions have exacerbated this vulnerability. In February 2026, escalating conflicts in the Middle East led to the closure of the Strait of Hormuz, a vital maritime route for global trade. This blockade has disrupted shipping routes, causing delays and increased costs for raw material imports. The United Nations Conference on Trade and Development (UNCTAD) reported that the closure has significantly affected global supply chains, including the pharmaceutical sector.

The export market for Domperidone from India is notably concentrated. The top five exporters—COMBITIC GLOBAL CAPLET PRIVATE LIMITED (14.7% share), INNOVA CAPTAB LIMITED (8.7%), VANTAGE INTERNATIONAL (INDIA) INC (7.6%), MACLEODS PHARMACEUTICALS LTD (6.5%), and CADILA PHARMACEUTICALS LIMITED (5.8%)—collectively account for 43.3% of total exports. This concentration indicates a potential risk, as disruptions affecting these key players could significantly impact the overall supply chain.

To mitigate such risks, the Indian government has implemented the Production Linked Incentive (PLI) scheme, aiming to boost domestic manufacturing of APIs and reduce dependency on imports. However, the effectiveness of this initiative in diversifying the supplier base for Domperidone remains to be fully realized.

The closure of the Strait of Hormuz in February 2026 has had profound implications for global shipping and trade. The strait, through which approximately 20% of the world's daily oil supply passes, has been effectively blocked due to military escalations. This disruption has led to a sharp decline in maritime transit, with tanker traffic dropping by approximately 70% initially and eventually nearing zero.

Major shipping companies, including Maersk, CMA CGM, and Hapag-Lloyd, have suspended transits through the Strait of Hormuz and related routes such as the Red Sea. This suspension has forced rerouting of shipments, adding significant delays and costs to global supply chains. The pharmaceutical industry, reliant on timely deliveries of raw materials and finished products, is particularly vulnerable to these disruptions.

• Diversify API and KSM Sources: Reduce dependency on a single country by sourcing APIs and KSMs from multiple countries to mitigate risks associated with geopolitical tensions.

• Enhance Domestic Production: Invest in domestic manufacturing capabilities for APIs and KSMs to decrease reliance on imports and strengthen supply chain resilience.

• Strengthen Supplier Relationships: Develop strategic partnerships with multiple suppliers to ensure a steady supply of raw materials and reduce the impact of disruptions affecting a single supplier.

• Implement Robust Risk Management Strategies: Establish comprehensive risk assessment and management protocols to proactively identify and address potential supply chain vulnerabilities.

• Monitor Geopolitical Developments: Stay informed about global political events and assess their potential impact on supply chains to enable timely adjustments and contingency planning.

RISK_LEVEL: HIGH