How India Exports Ketorolac to the World

In the United States, ketorolac is approved for various formulations, including ophthalmic solutions and systemic injections. The FDA's Orange Book lists multiple approved Abbreviated New Drug Applications (ANDAs) for ketorolac products, indicating a competitive generic market. For instance, the FDA approved Acular LS (ketorolac tromethamine ophthalmic solution) under NDA #021528 on May 30, 2003. Additionally, a tentative approval was granted to Par Sterile Products, LLC for Phenylephrine and Ketorolac Intraocular Solution (ANDA 208417) on April 3, 2019. The substantial number of active Indian exporters (351) underscores the significance of the U.S. market for Indian ketorolac manufacturers.

In the European Union, ketorolac-containing products require marketing authorization from the European Medicines Agency (EMA) or national competent authorities. For example, Omidria, a combination of phenylephrine and ketorolac, received EMA approval on July 28, 2015, for use in intraocular lens replacement surgery. (ema.europa.eu) The EMA also conducted a periodic safety update report single assessment (PSUSA) for systemic formulations of ketorolac, resulting in a variation to the marketing authorization in May 2023. (ema.europa.eu) Manufacturers exporting to the EU and UK must comply with Good Manufacturing Practice (GMP) standards as outlined by the EMA and the UK's Medicines and Healthcare products Regulatory Agency (MHRA).

Ketorolac is included in the World Health Organization's (WHO) Model List of Essential Medicines, highlighting its importance in pain management. The drug is also recognized in various pharmacopoeias, including the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP), ensuring standardized quality and efficacy across different regions.

In India, ketorolac is classified as a Schedule H drug under the Drugs and Cosmetics Act, requiring a prescription for dispensing. The National Pharmaceutical Pricing Authority (NPPA) regulates the pricing of essential medicines; however, specific ceiling prices for ketorolac formulations are subject to periodic revisions. Exporters must obtain a No Objection Certificate (NOC) from the Directorate General of Foreign Trade (DGFT) for the export of pharmaceutical products, ensuring compliance with national regulations.

Ketorolac's primary patents have expired, leading to a robust generic market with multiple manufacturers producing various formulations. This competitive landscape has contributed to the widespread availability and affordability of ketorolac products globally.

In May 2023, the EMA's Committee for Medicinal Products for Human Use (CHMP) recommended variations to the marketing authorizations for systemic ketorolac formulations following a periodic safety update report assessment. (ema.europa.eu) Additionally, in April 2019, the FDA issued a tentative approval for a combination of phenylephrine and ketorolac intraocular solution, indicating ongoing regulatory activities in the ketorolac market.

These developments underscore the dynamic regulatory environment surrounding ketorolac, necessitating continuous monitoring by stakeholders to ensure compliance and market competitiveness.

India's pharmaceutical industry heavily relies on China for Key Starting Materials (KSMs) essential in Active Pharmaceutical Ingredient (API) production. According to the US Pharmacopeia, 41% of KSMs used for U.S.-approved APIs are solely sourced from China, while 16% come from India. This dependency poses significant risks, as any disruption in Chinese supply chains can directly impact Indian API manufacturing capabilities.

To mitigate this vulnerability, the Indian government launched the Production Linked Incentive (PLI) Scheme for Bulk Drugs in July 2020, aiming to promote domestic manufacturing of critical KSMs, DIs, and APIs. As of September 2025, the scheme has led to the establishment of production capacities for 26 KSMs/APIs, resulting in cumulative sales of ₹2,315 crore and avoiding imports worth ₹1,807 crore.

The Ketorolac export market from India is highly concentrated, with the top five exporters accounting for 81.9% of the total export value. GLAND PHARMA LIMITED alone contributes 24.3% of this share. Such concentration increases the risk of supply disruptions, as issues affecting these key players could significantly impact global Ketorolac availability.

The PLI Scheme for Pharmaceuticals, initiated in March 2021, aims to enhance India's manufacturing capabilities and reduce dependency on a limited number of suppliers. By September 2025, the scheme had attracted a committed investment of ₹17,275 crore, surpassing the initial target, and achieved cumulative sales of ₹2,615 crore.

Global shipping routes, including the Red Sea and the Strait of Hormuz, are susceptible to geopolitical tensions that can disrupt maritime transport. Such disruptions can delay the delivery of raw materials and finished pharmaceutical products, affecting supply chains. Additionally, ongoing U.S.-China trade tensions may impact the availability and cost of KSMs sourced from China, further stressing the supply chain.

Regulatory bodies like the FDA and EMA have previously issued shortage alerts for various pharmaceuticals due to supply chain disruptions. While specific alerts for Ketorolac are not currently noted, the interconnected nature of global supply chains means that any upstream issues can have cascading effects on drug availability.

• Diversify Supplier Base: Encourage the development of additional Ketorolac manufacturers to reduce reliance on a few key exporters.

• Strengthen Domestic API Production: Continue to invest in domestic manufacturing of KSMs and APIs to lessen dependency on imports, particularly from China.

• Enhance Supply Chain Transparency: Implement robust tracking systems to monitor the sourcing and movement of raw materials and finished products, enabling quicker responses to potential disruptions.

• Develop Contingency Plans: Establish strategic reserves of critical raw materials and finished products to buffer against supply chain interruptions.

• Engage in International Collaboration: Work with global partners to ensure diversified and secure supply chains, reducing the impact of geopolitical tensions on pharmaceutical imports and exports.

RISK_LEVEL: MEDIUM