How India Exports Darunavir to the World

In the United States, Darunavir is approved under the brand name Prezista. The FDA's Orange Book lists multiple approved Abbreviated New Drug Applications (ANDAs) for generic versions of Darunavir, indicating a competitive market landscape. Notably, the FDA approved an ANDA for Darunavir tablets on March 15, 2025. The regulatory pathway for Darunavir involves demonstrating bioequivalence to the reference listed drug, Prezista, and compliance with current Good Manufacturing Practices (cGMP). Given that 28 Indian exporters are actively involved in the Darunavir market, adherence to FDA regulations is crucial to maintain market access and avoid import alerts.

In the European Union, Darunavir is marketed under various brand names, including Rezolsta, which combines Darunavir with cobicistat. The European Medicines Agency (EMA) granted marketing authorization for Rezolsta on December 12, 2014. However, the marketing authorization for Darunavir Krka d.d., a generic version, expired on January 22, 2023, as the marketing authorization holder did not apply for renewal due to commercial reasons. In the United Kingdom, the Medicines and Healthcare products Regulatory Agency (MHRA) oversees the approval and regulation of Darunavir-containing products. Compliance with EU Good Manufacturing Practice (GMP) guidelines is mandatory for manufacturers exporting to these markets.

Darunavir is included in the WHO Model List of Essential Medicines, reflecting its critical role in HIV treatment. The 24th edition of the list, published on September 5, 2025, continues to feature Darunavir, underscoring its importance in global health. Manufacturers are expected to comply with international pharmacopoeia standards, including those set by the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP), to ensure product quality and efficacy.

In India, Darunavir 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) sets ceiling prices for essential medicines; however, as of March 2026, Darunavir is not listed under the Drugs (Prices Control) Order (DPCO), and thus, its pricing is not regulated by the NPPA. For exports, Indian manufacturers must obtain a No Objection Certificate (NOC) from the Directorate General of Foreign Trade (DGFT), ensuring compliance with national regulations and facilitating international trade.

The primary patents for Darunavir have expired, leading to increased generic competition in global markets. This has resulted in a more competitive pricing environment and expanded access to the medication. Indian pharmaceutical companies have capitalized on this opportunity, becoming significant players in the global supply of generic Darunavir.

In April 2025, the WHO unveiled a global repository for National Essential Medicines Lists (nEMLs), aiming to harmonize and improve access to essential medicines worldwide. This initiative is expected to streamline procurement processes and enhance the availability of medications like Darunavir in low- and middle-income countries.

In February 2025, the WHO published the 24th edition of the Model List of Essential Medicines, reaffirming the inclusion of Darunavir. This underscores the ongoing global recognition of Darunavir's importance in HIV treatment protocols.

In May 2025, the 25th WHO Expert Committee on Selection and Use of Essential Medicines convened to review and update the Model List of Essential Medicines. The committee's recommendations continue to influence national policies and procurement strategies, impacting the global supply chain for medications like Darunavir.

In March 2025, the FDA approved a new generic version of Darunavir tablets, further increasing competition in the U.S. market and potentially affecting pricing dynamics for Indian exporters.

In January 2026, the WHO released a fact sheet on essential medicines, highlighting the ongoing challenges in ensuring universal access to essential medications, including antiretrovirals like Darunavir. The report emphasizes the need for sustained efforts to improve availability and affordability globally.

These developments reflect a dynamic regulatory and market environment for Darunavir, with implications for Indian exporters in terms of compliance, competition, and market access.

India's pharmaceutical industry, including the production of Darunavir, heavily relies on Active Pharmaceutical Ingredients (APIs) and Key Starting Materials (KSMs) imported from China. Approximately 70% of India's APIs are sourced from China, creating a significant dependency on Chinese suppliers. This reliance exposes the supply chain to risks associated with geopolitical tensions, trade disputes, and regulatory changes in China.

Recent disruptions have highlighted these vulnerabilities. In October 2025, the U.S. Pharmacopeia reported that 41% of KSMs used in U.S.-approved APIs are solely sourced from China, underscoring the global dependence on Chinese suppliers. Such concentration increases the risk of supply chain interruptions, which can lead to shortages and increased costs for manufacturers relying on these materials.

Our proprietary trade data indicates that the top five Indian exporters account for 90.0% of Darunavir exports, with HETERO LABS LIMITED alone contributing 27.7% ($16.7 million). This high supplier concentration poses a significant risk; any operational or regulatory issues affecting these key exporters could disrupt the global supply of Darunavir.

To mitigate such risks, the Indian government has implemented the Production Linked Incentive (PLI) scheme aimed at boosting domestic manufacturing of critical KSMs, DIs, and APIs. As of December 2025, the PLI scheme has led to the establishment of manufacturing capacity for 26 KSMs/APIs, resulting in cumulative sales of ₹2,315 crore and avoiding imports worth ₹1,807 crore. While this initiative is a positive step towards reducing import dependency, its impact on Darunavir's supply chain remains to be fully realized.

Global shipping routes, including the Red Sea and the Strait of Hormuz, are critical for the transportation of pharmaceutical ingredients and finished products. Any geopolitical tensions or conflicts in these regions can lead to shipping delays, increased costs, and supply chain disruptions. Additionally, ongoing U.S.-China trade tensions have the potential to affect the availability and pricing of APIs and KSMs sourced from China, further impacting the pharmaceutical supply chain.

Regulatory actions also play a role in supply chain stability. In February 2025, the FDA issued warning letters to API manufacturers in China and India for significant deviations from current Good Manufacturing Practices (cGMP), highlighting ongoing quality concerns and the risks associated with dependence on these suppliers. Such regulatory interventions can lead to production halts and supply shortages, emphasizing the need for diversified sourcing strategies.

• Diversify Supplier Base: Engage with multiple suppliers across different regions to reduce dependency on a limited number of exporters and mitigate risks associated with supplier concentration.

• Enhance Domestic Production: Invest in domestic manufacturing capabilities for APIs and KSMs to decrease reliance on imports, leveraging government initiatives like the PLI scheme.

• Strengthen Quality Assurance: Implement robust quality control measures and conduct regular audits of suppliers to ensure compliance with cGMP standards, reducing the risk of regulatory actions and supply disruptions.

• Monitor Geopolitical Developments: Stay informed about geopolitical events and trade policies that may impact supply chains, allowing for proactive adjustments to sourcing and logistics strategies.

• Develop Contingency Plans: Establish comprehensive risk management plans, including alternative sourcing options and inventory buffers, to maintain supply continuity during disruptions.

RISK_LEVEL: MEDIUM