How India Exports Raltegravir to the World

In the United States, the FDA has approved multiple Abbreviated New Drug Applications (ANDAs) for generic versions of raltegravir. Notably, on May 6, 2025, Lupin Ltd. received FDA approval for a 600 mg tablet formulation of raltegravir potassium. This approval signifies the FDA's commitment to expanding access to essential HIV treatments through the introduction of generics. However, as of January 2026, these generic versions have not yet been made available in the U.S. market, likely due to ongoing patent protections or exclusivity rights.

The presence of 29 active Indian exporters of raltegravir underscores India's significant role in the global supply chain for this medication. Despite this, Indian manufacturers must navigate the FDA's stringent regulatory pathways, including compliance with Current Good Manufacturing Practices (cGMP) and successful ANDA approvals, to access the U.S. market. Additionally, they must remain vigilant regarding FDA import alerts, which can impact the importation of pharmaceutical products into the United States.

In the European Union, the European Medicines Agency (EMA) granted a conditional marketing authorization for Isentress (brand name for raltegravir) on December 20, 2007, which was converted to a full authorization on July 14, 2009. (ema.europa.eu) This authorization allows for the marketing of raltegravir across EU member states, provided that manufacturers adhere to the EU's Good Manufacturing Practice (GMP) standards.

In the United Kingdom, the Medicines and Healthcare products Regulatory Agency (MHRA) approved the first generic versions of raltegravir on July 19, 2024. These approvals were granted to Lupin Healthcare (UK) Limited and Zentiva Pharma UK Limited, marking a significant step in increasing the availability of generic HIV treatments in the UK market. (gov.uk)

Raltegravir is included in the World Health Organization's (WHO) Model List of Essential Medicines, underscoring its importance in global health. The WHO updates this list biennially to guide countries in developing their national essential medicines lists. (test-cms.who.int) In 2015, Merck entered into a collaboration with the Medicines Patent Pool to expand access to pediatric formulations of raltegravir in developing countries, highlighting efforts to make this essential medicine more accessible globally.

Regarding pharmacopoeial standards, raltegravir is recognized in major compendia, including the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP). Compliance with these standards ensures the quality, safety, and efficacy of raltegravir formulations produced and distributed worldwide.

In India, raltegravir is classified under Schedule H of the Drugs and Cosmetics Rules, indicating that it is a prescription-only medication. This classification mandates that raltegravir can only be dispensed with a valid prescription from a registered medical practitioner. As of March 2026, raltegravir is not listed under the Drug Price Control Order (DPCO) by the National Pharmaceutical Pricing Authority (NPPA), meaning it does not have a government-mandated ceiling price. For export purposes, Indian manufacturers are required to obtain a No Objection Certificate (NOC) from the Directorate General of Foreign Trade (DGFT), ensuring compliance with national export regulations.

The primary compound patent for raltegravir expired in 2022, opening the market to generic competition. However, secondary patents, such as those covering the potassium salt form of raltegravir, are set to expire in December 2025. (cdn.who.int) These secondary patents can delay the full entry of generics into certain markets, affecting the global availability and pricing of raltegravir.

In July 2024, the UK's MHRA approved the first generic versions of raltegravir for both adult and pediatric patients, granted to Lupin Healthcare (UK) Limited and Zentiva Pharma UK Limited. (gov.uk) This approval is expected to enhance the accessibility of HIV treatments in the UK.

In May 2025, the FDA approved Lupin Ltd.'s ANDA for a 600 mg tablet formulation of raltegravir potassium. This approval marks a significant step towards increasing the availability of generic raltegravir in the U.S. market.

In February 2023, Viatris withdrew its application for marketing authorization of Raltegravir Viatris in the European Union. (ema.europa.eu) The reasons for this withdrawal were not specified but may impact the availability of generic raltegravir in the EU market.

In February 2015, Merck announced a collaboration with the Medicines Patent Pool to expand access to pediatric formulations of raltegravir in developing countries. This agreement aims to improve access to raltegravir for HIV-infected children in regions with high disease burden.

In 2023, the WHO updated its Model List of Essential Medicines, reaffirming the inclusion of raltegravir as a critical component in the treatment of HIV-1 infection. (test-cms.who.int) This inclusion underscores the global recognition of raltegravir's importance in HIV therapy.

These developments reflect the dynamic nature of the pharmaceutical industry and the ongoing efforts to enhance the accessibility and affordability of essential medicines like raltegravir worldwide.

India's pharmaceutical industry, often termed 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 exposes the supply chain to risks stemming from geopolitical tensions, trade disputes, or disruptions in Chinese manufacturing.

In recent years, the Indian government has initiated the Production Linked Incentive (PLI) scheme to bolster domestic API and KSM production, aiming to reduce this dependency. However, as of March 2026, the scheme's impact remains limited, with the industry still facing challenges in achieving self-sufficiency.

Our proprietary trade data indicates a high supplier concentration for Raltegravir exports from India. The top five exporters account for 96.0% of the total export value, with HETERO LABS LIMITED alone contributing 50.8%. This concentration poses a significant risk; any operational disruptions at these key suppliers could severely impact global Raltegravir availability.

While the PLI scheme aims to diversify and strengthen the supplier base, its current status suggests that the market remains heavily reliant on a few major players. This lack of diversification increases vulnerability to supply chain disruptions.

The closure of the Strait of Hormuz since February 28, 2026, due to escalating conflicts involving Iran, the United States, and Israel, has severely disrupted global shipping routes. This strategic chokepoint, through which approximately 20% of the world's daily oil supply transits, has seen a dramatic decline in maritime traffic, with tanker movements dropping by about 70% initially and eventually nearing zero. Major shipping companies have suspended operations in the region, leading to increased shipping costs and delays.

While the Red Sea and the Strait of Hormuz are not primary routes for Raltegravir exports from India, the broader impact on global shipping has led to increased freight rates and insurance premiums. These factors contribute to higher transportation costs and potential delays in delivering pharmaceutical products to international markets.

• Diversify Supplier Base: Encourage the development of additional API and KSM manufacturers within India to reduce reliance on a limited number of suppliers.

• Enhance Domestic Production: Accelerate the implementation and effectiveness of the PLI scheme to strengthen domestic production capabilities for APIs and KSMs.

• Develop Alternative Shipping Routes: Identify and establish alternative shipping routes to mitigate risks associated with geopolitical disruptions in key maritime chokepoints.

• Strengthen Inventory Management: Increase buffer stocks of critical pharmaceuticals to cushion against supply chain disruptions.

• Monitor Geopolitical Developments: Implement a robust monitoring system to stay informed about geopolitical events that could impact supply chains, enabling proactive risk management.

RISK_LEVEL: MEDIUM