How India Exports Cetirizine to the World

In the United States, cetirizine is approved for over-the-counter (OTC) use, with numerous Abbreviated New Drug Applications (ANDAs) listed in the FDA's Orange Book. The first ANDA for cetirizine hydrochloride capsules (5 mg and 10 mg) was approved for Banner Pharmacaps, Inc. on July 23, 2009. The FDA has not issued any import alerts specific to cetirizine, indicating compliance with regulatory standards. The substantial number of Indian exporters (649) underscores India's significant role in supplying cetirizine to the U.S. market.

In the European Union, cetirizine is authorized for marketing, with harmonized indications and posology across member states. The European Medicines Agency (EMA) conducted a referral procedure to harmonize the Summary of Product Characteristics (SPC) for cetirizine-containing products, concluding in October 2007. (ema.europa.eu) Manufacturers exporting to the EU and UK must comply with Good Manufacturing Practice (GMP) requirements as outlined by the EMA and the UK's Medicines and Healthcare products Regulatory Agency (MHRA).

Cetirizine is included in the World Health Organization's (WHO) Model List of Essential Medicines, recognizing its importance in treating allergic conditions. It is also listed in major pharmacopoeias, including the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP), ensuring standardized quality and efficacy globally.

In India, cetirizine is classified as a Schedule H drug under the Drugs and Cosmetics Act, requiring a prescription for sale. The National Pharmaceutical Pricing Authority (NPPA) has not set a ceiling price for cetirizine, allowing market-driven pricing. Exporters must obtain a No Objection Certificate (NOC) from the Directorate General of Foreign Trade (DGFT) for cetirizine exports, ensuring compliance with national regulations.

The primary patents for cetirizine have expired, leading to a competitive generic market. This has facilitated the entry of multiple manufacturers, including Indian companies, into global markets.

In June 2025, the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) recommended updating the product information for cetirizine-containing products to include warnings about potential oculogyration (involuntary eye movement). (ema.europa.eu) In February 2026, the EMA's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Dupixent (dupilumab) for the treatment of chronic spontaneous urticaria, a condition often treated with antihistamines like cetirizine. (ema.europa.eu) These developments may influence the prescribing patterns and market dynamics for cetirizine.

Overall, cetirizine maintains a strong regulatory standing across major markets, with Indian exporters playing a pivotal role in its global supply chain.

India's pharmaceutical industry, including the production of Cetirizine, heavily relies on Active Pharmaceutical Ingredients (APIs) and Key Starting Materials (KSMs) imported from China. China controls approximately 70–80% of the global KSM supply and 60–70% of the global intermediate supply, making it a dominant player in this sector. This dependency poses significant risks, as any disruption in Chinese supply chains can directly impact Indian pharmaceutical manufacturing.

Recent geopolitical tensions and regulatory changes have exacerbated these vulnerabilities. For instance, in early 2024, environmental regulations in China led to the shutdown of several chemical plants, causing a shortage of essential KSMs and subsequent price increases for APIs. Such events highlight the fragility of the supply chain and the need for diversification.

Our proprietary trade data indicates that the top five exporters of Cetirizine from India account for 36.4% of the total export value, with FOURRTS (INDIA) LABORATORIES PRIVATE LIMITED leading at a 10.7% share. This concentration suggests a moderate risk, as disruptions affecting these key suppliers could significantly impact the overall supply chain.

To mitigate such risks, the Indian government introduced the Production-Linked Incentive (PLI) scheme in 2021, aiming to boost domestic manufacturing of APIs and reduce reliance on imports. By 2025, the scheme had attracted investments exceeding ₹4,570 crore, reflecting a strong commitment to enhancing self-sufficiency in API production. However, the effectiveness of this initiative in fully addressing supply chain vulnerabilities remains to be seen.

Geopolitical tensions have significantly disrupted global supply chains. The ongoing conflict in the Middle East, particularly the Iran war, has severely impacted shipping routes through the Strait of Hormuz, a critical passage for global commerce. This disruption has led to delays and increased costs for pharmaceutical exports from India.

Additionally, the U.S.-China trade tensions have resulted in reciprocal tariffs and export restrictions, affecting the availability and cost of raw materials essential for pharmaceutical manufacturing. These factors contribute to an unpredictable supply chain environment, necessitating proactive risk management strategies.

• Diversify Supplier Base: Identify and qualify alternative suppliers for APIs and KSMs in regions less affected by geopolitical tensions to reduce dependency on a single source.

• Enhance Domestic Production: Leverage government incentives like the PLI scheme to invest in domestic manufacturing capabilities for critical raw materials, thereby reducing reliance on imports.

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

• Develop Contingency Plans: Establish comprehensive risk management frameworks that include scenario planning for geopolitical events, ensuring preparedness for potential disruptions.

• Engage in Strategic Partnerships: Collaborate with international stakeholders to secure stable supply chains and share best practices in risk mitigation.

RISK_LEVEL: MEDIUM