How India Exports Acetylsalicylic to the World

In the United States, acetylsalicylic acid is classified as an over-the-counter (OTC) medication and is not subject to the Abbreviated New Drug Application (ANDA) process typically required for prescription drugs. Consequently, it is not listed in the FDA's Orange Book, which catalogs approved drug products with therapeutic equivalence evaluations. This OTC status facilitates a streamlined regulatory pathway for Indian exporters aiming to enter the U.S. market. However, compliance with FDA regulations, including adherence to Current Good Manufacturing Practices (cGMP), is mandatory to ensure product quality and safety. Given the 68 active Indian exporters, maintaining rigorous quality standards is essential to meet FDA requirements and sustain market access.

In the European Union (EU) and the United Kingdom (UK), acetylsalicylic acid is widely used and is available both as a standalone product and in combination with other active substances. For instance, the European Medicines Agency (EMA) granted marketing authorization for Clopidogrel/Acetylsalicylic acid Mylan on January 9, 2020, for the prevention of atherothrombotic events in adults. This combination product is indicated for patients already taking both clopidogrel and acetylsalicylic acid as separate tablets. Manufacturers exporting to these regions must comply with EU Good Manufacturing Practice (GMP) guidelines, which ensure that products are consistently produced and controlled according to quality standards. Additionally, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) oversees the authorization and monitoring of medicines, requiring adherence to similar GMP standards.

Acetylsalicylic acid is included in the World Health Organization's (WHO) Model List of Essential Medicines, underscoring its importance in a basic health system. This inclusion signifies its critical role in treating various conditions and its necessity for meeting the health needs of populations. Furthermore, acetylsalicylic acid is recognized in major pharmacopoeias, including the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP). These standards provide specifications for the quality, purity, strength, and consistency of the drug, ensuring its safety and efficacy for global use.

In India, acetylsalicylic acid is classified under Schedule H of the Drugs and Cosmetics Act, indicating that it is a prescription drug and should be dispensed only with a prescription from a registered medical practitioner. The National Pharmaceutical Pricing Authority (NPPA) regulates the pricing of essential medicines, including acetylsalicylic acid, to ensure affordability. As of the latest notification in March 2025, the ceiling price for acetylsalicylic acid has been set to maintain accessibility for patients. For exports, the Directorate General of Foreign Trade (DGFT) mandates a No Objection Certificate (NOC) to ensure that domestic needs are met before permitting international shipments.

Acetylsalicylic acid, first synthesized in the late 19th century, is no longer under patent protection, allowing for widespread generic production and export. This lack of exclusivity has led to significant generic competition, enabling multiple manufacturers to produce and distribute the drug globally. The competitive market has contributed to the affordability and accessibility of acetylsalicylic acid worldwide.

In November 2025, the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) recommended updates to the product information for acetylsalicylic acid-containing medicines, highlighting the risk of ischaemic colitis associated with pseudoephedrine combinations. This led to variations in marketing authorizations to include warnings about this potential adverse effect. In March 2026, the EMA published a Periodic Safety Update Report (PSUR) single assessment for acetylsalicylic acid, resulting in further updates to the safety information to enhance patient safety. Additionally, in September 2025, the NPPA revised the ceiling price for acetylsalicylic acid to reflect changes in production costs and ensure continued affordability for patients. These developments underscore the dynamic regulatory environment surrounding acetylsalicylic acid and the importance of ongoing vigilance in monitoring its safety and pricing.

India's pharmaceutical industry, including the production of acetylsalicylic acid (aspirin), heavily relies on Key Starting Materials (KSMs) imported from China. Approximately 60–70% of KSMs used in Indian pharmaceutical manufacturing are sourced from China, making the supply chain vulnerable to disruptions. This dependency was highlighted during the COVID-19 pandemic, when Chinese factory shutdowns led to shortages and price surges for essential drugs. Additionally, environmental regulations in China have resulted in the closure of several API manufacturers, further impacting the supply chain.

The Indian government has initiated measures to reduce this reliance, such as the Production Linked Incentive (PLI) scheme launched in 2024, aimed at boosting domestic API and KSM production. Despite these efforts, the industry continues to face challenges, including higher manufacturing costs and infrastructure limitations, which hinder the rapid establishment of a self-sufficient supply chain.

Our proprietary trade data indicates that the top five Indian exporters of acetylsalicylic acid account for 49.2% of total exports, with AUROBINDO PHARMA LTD leading at 17.0%. This concentration poses a risk, as disruptions affecting these key suppliers could significantly impact global supply. The PLI scheme has encouraged investment in domestic API production, with commitments exceeding ₹4,570 crore by 2025. However, the effectiveness of these initiatives in diversifying the supplier base remains to be fully realized.

Recent geopolitical events have further strained the pharmaceutical supply chain. The Iran-US tensions in February 2026 led to the closure of the Strait of Hormuz, a critical passage for global trade, causing significant disruptions in the transportation of pharmaceuticals from India. Additionally, increased instability in the Red Sea and Suez Canal has forced shipping companies to reroute vessels, resulting in delays and increased costs. These disruptions have led to shortages and price increases for various goods, including pharmaceuticals.

• Diversify Supplier Base: Encourage the development of alternative suppliers for KSMs and APIs to reduce dependency on a single country or supplier.

• Enhance Domestic Production: Accelerate the implementation of the PLI scheme and similar initiatives to bolster domestic manufacturing capabilities for APIs and KSMs.

• Strengthen Supply Chain Resilience: Develop strategic reserves of critical raw materials and finished products to buffer against supply disruptions.

• Monitor Geopolitical Developments: Establish a dedicated task force to assess and respond to geopolitical events that may impact supply chains.

• Invest in Infrastructure: Improve domestic logistics and transportation infrastructure to mitigate the impact of international shipping disruptions.

RISK_LEVEL: HIGH