How India Exports Lactulose to the World

In the United States, lactulose is approved for medical use and is available in generic forms. The FDA's Orange Book lists multiple approved Abbreviated New Drug Applications (ANDAs) for lactulose solution, indicating a well-established generic market. For instance, ANDA 75-911 was approved on February 21, 2002, for Lactulose Solution USP, 10 g/15 mL, submitted by Apotex Corp. The regulatory pathway for lactulose involves demonstrating bioequivalence to the reference listed drug, as per FDA guidelines. Given the substantial number of Indian exporters, compliance with FDA regulations, including Good Manufacturing Practices (GMP) and accurate labeling, is crucial for market entry and sustainability.

In the European Union, lactulose is subject to marketing authorization by national competent authorities or the European Medicines Agency (EMA) for centralized procedures. The EMA conducted a Periodic Safety Update Report Single Assessment (PSUSA) for lactulose, concluding in November 2025, which led to updates in product information regarding hypersensitivity reactions. (ema.europa.eu) Manufacturers must adhere to EU Good Manufacturing Practice (GMP) guidelines, ensuring product quality and safety. In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) oversees the authorization and monitoring of medicinal products, including lactulose, requiring compliance with similar GMP standards.

Lactulose is included in the World Health Organization's Model List of Essential Medicines, underscoring its importance in basic healthcare systems. The specific edition of inclusion should be verified from the latest WHO publications. While lactulose may not be listed under the WHO Prequalification Programme, it must comply with international pharmacopoeia standards, including the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP), to ensure global quality standards.

In India, lactulose is classified under Schedule H of the Drugs and Cosmetics Act, indicating it is a prescription drug. The National Pharmaceutical Pricing Authority (NPPA) regulates the pricing of essential medicines; however, as of March 2026, lactulose is not listed under the Drug Price Control Order (DPCO), allowing market-driven pricing. For exports, the Directorate General of Foreign Trade (DGFT) mandates a No Objection Certificate (NOC) for certain pharmaceuticals, but lactulose is generally permitted for export without specific restrictions, facilitating its international trade.

Lactulose is off-patent, allowing multiple manufacturers to produce and market generic versions globally. This has led to significant generic competition, contributing to its widespread availability and affordability.

In August 2025, the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) recommended updates to lactulose product information to include warnings about hypersensitivity reactions, including rash, pruritus, and urticaria, based on post-marketing surveillance data. (ema.europa.eu)

In January 2026, the Indian Ministry of Health and Family Welfare announced a revision of the National List of Essential Medicines (NLEM), considering the inclusion of additional formulations of lactulose to enhance accessibility for hepatic encephalopathy treatment.

In March 2026, the NPPA initiated a review of non-DPCO drugs, including lactulose, to assess market prices and ensure affordability, signaling potential future price regulations.

These developments highlight the dynamic regulatory environment surrounding lactulose, emphasizing the need for manufacturers and exporters to stay informed and compliant with evolving standards and requirements.

India's pharmaceutical industry has historically relied heavily on China for Key Starting Materials (KSMs) and Active Pharmaceutical Ingredients (APIs), with imports accounting for approximately 70% of its API needs. This dependency has exposed the sector to supply chain vulnerabilities, particularly during periods of geopolitical tension or regulatory changes in China. For instance, in recent years, environmental regulations in China have led to the shutdown of several API manufacturers, causing supply disruptions and cost escalations for Indian pharmaceutical companies.

In response, the Indian government launched the Production Linked Incentive (PLI) scheme to bolster domestic API and KSM manufacturing. This initiative aims to reduce import dependence by providing financial incentives for local production. As of November 2024, two greenfield plants were inaugurated under this scheme to produce critical molecules like Penicillin G and Clavulanic Acid, which had not been manufactured domestically for over two decades. While these efforts are steps toward self-reliance, the transition to domestic production is gradual, and the industry remains susceptible to external supply chain disruptions in the interim.

Our proprietary trade data indicates that the top five exporters of lactulose from India account for 67.3% of the total export value, with STERLING LAB leading at 31.0%. This high supplier concentration poses a significant single-source risk, as any operational or financial issues within these key companies could disrupt the supply chain. The PLI scheme is designed to mitigate such risks by encouraging a broader base of domestic manufacturers to enter the API market, thereby reducing reliance on a limited number of suppliers. However, the effectiveness of this scheme in diversifying the supplier base will depend on its successful implementation and the industry's response to these incentives.

Recent geopolitical events have further strained global supply chains. In March 2026, the closure of the Strait of Hormuz due to military conflicts led to significant disruptions in maritime transit, affecting approximately 20% of the world's daily oil supply and causing a surge in shipping costs. Additionally, instability in the Red Sea and Suez Canal has forced shipping companies to reroute vessels around Africa's Cape of Good Hope, adding delays and increasing fuel expenses. These disruptions have had a cascading effect on the pharmaceutical supply chain, leading to delays in the delivery of raw materials and finished products. While there have been no specific FDA or EMA shortage alerts for lactulose as of March 2026, the potential for such shortages remains if these geopolitical tensions persist.

• Diversify Supplier Base: Encourage the development of additional domestic API manufacturers under the PLI scheme to reduce reliance on a concentrated group of suppliers.

• Strengthen Domestic Production: Accelerate the establishment and scaling of domestic API and KSM production facilities to decrease dependency on imports, particularly from geopolitically sensitive regions.

• Enhance Supply Chain Visibility: Implement advanced tracking and monitoring systems to gain real-time insights into supply chain operations, enabling proactive responses to potential disruptions.

• Develop Contingency Plans: Establish strategic reserves of critical APIs and KSMs and identify alternative shipping routes to mitigate the impact of geopolitical and logistical disruptions.

• Engage in Policy Advocacy: Collaborate with industry associations and government bodies to advocate for policies that support supply chain resilience, such as infrastructure improvements and trade agreements that facilitate diversified sourcing.

RISK_LEVEL: MEDIUM