How India Exports Praziquantel to the World

In the United States, praziquantel is approved for human use under the brand name Biltricide. The FDA's Orange Book lists multiple approved Abbreviated New Drug Applications (ANDAs) for generic versions of praziquantel, indicating a competitive market landscape. As of March 2026, there are no active FDA import alerts specifically targeting praziquantel imports from India. However, the FDA maintains vigilance over imported pharmaceuticals to ensure compliance with regulatory standards. Given that 6.8% of India's praziquantel exports are directed to the U.S., Indian exporters must adhere to stringent FDA regulations, including Good Manufacturing Practices (GMP) and proper labeling requirements.

In the European Union, praziquantel is authorized for both human and veterinary use. The European Medicines Agency (EMA) has approved veterinary medicinal products containing praziquantel, such as Prazivetin, with the initial marketing authorization documents published on March 14, 2025. Additionally, the EMA adopted a positive scientific opinion on arPraziquantel, a pediatric formulation, on February 7, 2024. The EU's GMP requirements mandate that manufacturers exporting to the EU comply with stringent quality standards. In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) oversees the authorization and regulation of medicinal products, ensuring they meet safety, quality, and efficacy standards.

Praziquantel is included in the WHO Model List of Essential Medicines, underscoring its importance in treating parasitic infections. The WHO has prequalified multiple active pharmaceutical ingredient (API) manufacturers for praziquantel, including Solara Active Pharma Sciences Limited in India, which received prequalification on October 21, 2025. This prequalification facilitates global procurement and distribution, particularly in regions with high prevalence of schistosomiasis. Praziquantel is also recognized in major pharmacopoeias, including the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP), ensuring standardized quality across different markets.

In India, praziquantel is classified under Schedule H of the Drugs and Cosmetics Act, indicating that it is a prescription-only medication. The National Pharmaceutical Pricing Authority (NPPA) regulates the pricing of essential medicines; however, as of March 2026, praziquantel is not listed under the Drugs (Prices Control) Order (DPCO), and thus, its price is not subject to government-mandated ceilings. For exports, the Directorate General of Foreign Trade (DGFT) requires a No Objection Certificate (NOC) for certain pharmaceutical products, ensuring that domestic needs are met before permitting exports.

Praziquantel's primary patents have expired, leading to the availability of generic versions globally. This patent expiration has fostered a competitive market, with multiple manufacturers producing and exporting the drug. The absence of active patents allows for broader access and affordability, particularly in developing countries where schistosomiasis is prevalent.

In February 2024, the EMA adopted a positive scientific opinion on arPraziquantel, a pediatric formulation developed by the Pediatric Praziquantel Consortium, marking a significant advancement in treating schistosomiasis in children under five years old. In July 2025, the EMA reported a shortage of Biltricide, a praziquantel-containing medication, due to the manufacturer's decision to cease production for commercial reasons. This shortage affected multiple EU member states, prompting regulatory bodies to seek alternative sources. In October 2025, Solara Active Pharma Sciences Limited, an Indian API manufacturer, received WHO prequalification for praziquantel, enhancing its credibility and facilitating global distribution. In March 2026, the FDA updated Import Alert 68-19, which pertains to the detention without physical examination of unapproved finished new animal drugs, emphasizing the agency's ongoing efforts to monitor and regulate pharmaceutical imports. These developments highlight the dynamic nature of the praziquantel market and the importance of regulatory compliance for Indian exporters.

India's pharmaceutical industry, often referred to as the "pharmacy of the world," heavily relies on China for Key Starting Materials (KSMs) essential in Active Pharmaceutical Ingredient (API) production. Approximately 60–70% of these critical inputs are imported from China, creating a significant dependency. This reliance poses risks, as any disruption in Chinese supply chains can directly impact India's API manufacturing capabilities.

Recent geopolitical tensions have exacerbated these vulnerabilities. In February 2026, the closure of the Strait of Hormuz due to military conflicts disrupted the supply of raw materials to Asia's petrochemical industry, affecting the availability of essential chemicals for API production. Such events underscore the fragility of the supply chain and the potential for significant disruptions in pharmaceutical manufacturing.

Analysis of TransData Nexus's proprietary trade data from 2022 to 2026 reveals that the top five Indian exporters of Praziquantel account for 43.6% of total exports, with LOB INTERNATIONAL alone contributing 25.4%. This concentration indicates a moderate risk, as reliance on a limited number of suppliers can lead to supply chain disruptions if any of these key players face operational challenges.

To mitigate such risks, the Indian government has implemented the Production Linked Incentive (PLI) scheme aimed at boosting domestic API production and reducing dependency on imports. In October 2024, two greenfield plants were inaugurated under this scheme to manufacture critical molecules used in antibiotics, marking a significant step towards self-reliance.

The pharmaceutical supply chain is susceptible to geopolitical tensions and shipping disruptions. The closure of the Strait of Hormuz in February 2026 halted oil tanker movements and disrupted the supply of pharmaceuticals from India, leading to potential shortages and increased prices. Additionally, the Red Sea conflict has posed risks to the shipping of key pharmaceutical ingredients, affecting the timely delivery of APIs and other essential chemicals. (pharmasource.global)

Regulatory bodies like the FDA have been actively monitoring these situations to prevent and mitigate drug shortages. In April 2024, the U.S. Department of Health and Human Services released a white paper highlighting steps taken to address such shortages and proposing additional solutions for policymakers.

• Diversify Supplier Base: Engage with a broader range of suppliers to reduce dependency on a limited number of exporters.

• Enhance Domestic Production: Invest in domestic API and KSM manufacturing facilities to decrease reliance on imports, leveraging government initiatives like the PLI scheme.

• Strengthen Supply Chain Monitoring: Implement robust systems to monitor geopolitical developments and shipping routes, allowing for proactive adjustments to supply chain strategies.

• Develop Contingency Plans: Establish alternative logistics and transportation plans to navigate potential disruptions in key shipping routes.

• Collaborate with Regulatory Bodies: Maintain open communication with regulatory agencies to stay informed about potential shortages and compliance requirements.

RISK_LEVEL: MEDIUM