How India Exports Pyrantel to the World

In the United States, pyrantel is approved for human use primarily as pyrantel pamoate, an over-the-counter (OTC) medication for treating pinworm infections. The FDA's Orange Book lists multiple approved Abbreviated New Drug Applications (ANDAs) for pyrantel pamoate, indicating a well-established generic market. As of March 2026, there are no active FDA import alerts specifically targeting pyrantel or its manufacturers. However, importers should remain vigilant, as the FDA maintains broad import alerts, such as Import Alert 66-41, which addresses unapproved new drugs promoted in the U.S. Given the presence of 70 active Indian exporters, compliance with FDA regulations is crucial to ensure market access and avoid potential detentions.

In the European Union and the United Kingdom, pyrantel is primarily utilized in veterinary medicine. For instance, the UK's Veterinary Medicines Directorate (VMD) has authorized products like VetUK Flavoured Dog Wormer Tablets, containing pyrantel, praziquantel, and febantel, since March 2015. (vmd.defra.gov.uk) The European Medicines Agency (EMA) has also addressed pyrantel-containing products; in June 2012, the Committee for Medicinal Products for Veterinary Use (CVMP) concluded a referral procedure for several combination products, harmonizing indications across member states. (ema.europa.eu) Manufacturers exporting to these markets must adhere to EU Good Manufacturing Practice (GMP) standards, ensuring product quality and safety.

Pyrantel is included in the World Health Organization's (WHO) Model List of Essential Medicines, underscoring its importance in treating parasitic infections. The drug is recognized in major pharmacopoeias, including the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP), which provide standardized quality specifications. While pyrantel itself is not listed in the WHO Prequalification Programme, adherence to these pharmacopoeial standards is essential for global market acceptance.

In India, pyrantel is classified as a Schedule H drug under the Drugs and Cosmetics Act, requiring a prescription for human use. The National Pharmaceutical Pricing Authority (NPPA) has not set a ceiling price for pyrantel, allowing market-driven pricing. For exports, the Directorate General of Foreign Trade (DGFT) mandates a No Objection Certificate (NOC) for certain pharmaceutical products; however, pyrantel is not currently listed among those requiring an export NOC.

Pyrantel's primary patents have expired, leading to a competitive generic market. This expiration has facilitated the entry of multiple manufacturers, contributing to the 70 active Indian exporters and a repeat buyer rate of 61.4%. The absence of patent restrictions allows for broader market access and competitive pricing.

In August 2025, the NPPA conducted a review of essential medicines pricing, but pyrantel remained unaffected due to the absence of a ceiling price. In October 2025, the FDA updated Import Alert 66-66, focusing on misbranded active pharmaceutical ingredients (APIs), emphasizing the need for accurate labeling and compliance. In January 2026, the EMA initiated a review of anthelmintic resistance patterns, potentially impacting pyrantel's usage guidelines in the future. In February 2026, the WHO released updated guidelines on soil-transmitted helminthiasis, reaffirming pyrantel's role in treatment protocols. In March 2026, the FDA issued Import Alert 68-19, targeting unapproved finished new animal drugs, which may affect pyrantel products intended for veterinary use.

These developments highlight the dynamic regulatory environment surrounding pyrantel, necessitating continuous monitoring to ensure compliance and market access.

India's pharmaceutical industry, including the production of Active Pharmaceutical Ingredients (APIs) like Pyrantel, heavily depends on Key Starting Materials (KSMs) sourced from China. Approximately 60–70% of KSMs used in Indian API manufacturing are imported from China, making the supply chain vulnerable to disruptions. This dependency was highlighted during the COVID-19 pandemic, when Chinese factory shutdowns led to significant shortages and price surges in essential drugs. For instance, the price of paracetamol API increased from Rs 900 per kg during the pandemic to Rs 250 per kg post-pandemic.

Efforts to reduce this reliance have been initiated, such as the Indian government's Production Linked Incentive (PLI) scheme launched in February 2021, aimed at bolstering domestic production of APIs and KSMs. However, challenges persist, including higher production costs in India due to stringent environmental regulations and infrastructure limitations. As of November 2024, two greenfield plants were inaugurated under the PLI scheme to manufacture critical molecules like Penicillin G and Clavulanic Acid, marking a step towards reducing import dependence.

The export market for Pyrantel is notably concentrated, with the top five exporters accounting for 75.2% of total exports. KUSUM HEALTHCARE PRIVATE LIMITED leads with a 22.5% share, followed by IPCA LABORATORIES LIMITED (19.5%), OXFORD LABORATORIES PRIVATE LIMITED (16.5%), SAVA HEALTHCARE LIMITED (11.7%), and MEPRO PHARMACEUTICALS PRIVATE LIMITED (5.1%). This concentration poses a risk, as disruptions affecting any of these key suppliers could significantly impact the global supply of Pyrantel.

The PLI scheme aims to diversify and strengthen the supplier base by incentivizing domestic production of APIs and KSMs. While progress has been made, the full impact on reducing supplier concentration is yet to be realized, and continuous monitoring is essential to assess the effectiveness of these initiatives.

Global shipping routes, including the Red Sea and the Strait of Hormuz, are critical for the transportation of pharmaceutical products. Geopolitical tensions in these regions can lead to shipping delays and increased costs. Additionally, trade tensions between the U.S. and China have the potential to disrupt the supply of KSMs and APIs, further impacting the pharmaceutical supply chain. The U.S. Pharmacopeia's Medicine Supply Map indicates that 41% of KSMs used in U.S.-approved medicines are solely sourced from China, highlighting the vulnerability to geopolitical disruptions.

While there have been no specific FDA or EMA shortage alerts for Pyrantel as of March 2026, the interconnected nature of the pharmaceutical supply chain means that disruptions in one area can have cascading effects, potentially leading to shortages and increased prices.

• Diversify Supplier Base: Encourage the development of alternative suppliers for Pyrantel and its raw materials to reduce dependency on a limited number of exporters and countries.

• Enhance Domestic Production: Support initiatives like the PLI scheme to bolster domestic manufacturing of APIs and KSMs, thereby decreasing reliance on imports.

• Strengthen Supply Chain Monitoring: Implement robust monitoring systems to detect early signs of disruptions in the supply chain, allowing for proactive measures to mitigate risks.

• Develop Strategic Reserves: Establish reserves of critical APIs and KSMs to buffer against short-term supply disruptions.

• Foster International Collaboration: Engage in international partnerships to share information and resources, enhancing global supply chain resilience.

RISK_LEVEL: MEDIUM