How India Exports Velpatasvir to the World

As of March 2026, the FDA's Orange Book lists multiple approved Abbreviated New Drug Applications (ANDAs) for the combination of sofosbuvir and velpatasvir, indicating a competitive generic market. The most recent approval was granted in January 2026. There are no current import alerts related to velpatasvir, suggesting compliance with FDA standards. The regulatory pathway for velpatasvir involves demonstrating bioequivalence to the reference listed drug, Epclusa, and adherence to Current Good Manufacturing Practices (CGMP). Given the presence of 103 active Indian exporters, it is imperative for each to maintain stringent quality controls to meet FDA requirements.

The European Medicines Agency (EMA) granted marketing authorization for the sofosbuvir/velpatasvir combination under the brand name Epclusa in July 2016. The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has similarly approved this combination. Manufacturers exporting to these markets must comply with EU Good Manufacturing Practice (GMP) guidelines, which encompass quality management, personnel, premises, equipment, documentation, production, quality control, and self-inspection. Adherence to these standards is crucial for market access and sustained presence in the EU and UK.

The World Health Organization (WHO) included the sofosbuvir/velpatasvir combination in its Model List of Essential Medicines in June 2017, recognizing its efficacy across all HCV genotypes. Additionally, the WHO Prequalification Programme has prequalified velpatasvir, with Matrix Pharmacorp Private Limited's product achieving this status in December 2020. Velpatasvir is also listed in major pharmacopoeias, including the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP), ensuring standardized quality benchmarks globally.

In India, velpatasvir is classified under Schedule H, indicating it is a prescription-only medication. The Drug Price Control Order (DPCO), enforced by the National Pharmaceutical Pricing Authority (NPPA), has not set a ceiling price for velpatasvir as of March 2026. For exports, the Directorate General of Foreign Trade (DGFT) mandates a No Objection Certificate (NOC) to ensure compliance with national regulations and to monitor the export of pharmaceutical products.

The primary patents for the sofosbuvir/velpatasvir combination, marketed as Epclusa by Gilead Sciences, are set to expire between 2028 and 2034. This timeline suggests a gradual increase in generic competition, particularly in markets where patent protections have lapsed or compulsory licenses have been issued. Indian exporters should monitor these developments to strategically position themselves in the global market.

In April 2025, the WHO updated its Essential Medicines List, reaffirming the inclusion of the sofosbuvir/velpatasvir combination, underscoring its continued importance in HCV treatment protocols. In June 2025, the EMA approved a new generic version of the sofosbuvir/velpatasvir combination, enhancing market competition within the EU. In September 2025, the NPPA conducted a review of antiviral drug prices, including velpatasvir, to assess affordability and accessibility, though no price ceiling was imposed. In November 2025, the FDA issued updated guidance on the manufacturing of direct-acting antivirals, emphasizing the need for stringent quality controls, which is pertinent for Indian exporters targeting the US market. In January 2026, the CDSCO introduced a streamlined process for the export NOC of HCV medications, aiming to facilitate faster approvals for compliant manufacturers.

These developments highlight the dynamic regulatory landscape surrounding velpatasvir, necessitating continuous vigilance and adaptability from Indian exporters to maintain and expand their global market presence.

India's pharmaceutical industry heavily relies on China for Key Starting Materials (KSMs), the essential chemical precursors for Active Pharmaceutical Ingredients (APIs). Approximately 60–70% of KSMs used in Indian API production are imported from China. This dependency poses a significant risk, as any disruption in Chinese supply chains can directly impact India's pharmaceutical manufacturing capabilities. For instance, in September 2025, China reduced the prices of 41 APIs and KSMs by 40–50%, affecting the competitiveness of Indian API manufacturers.

Despite efforts to reduce reliance on Chinese imports, such as the inauguration of two greenfield plants under the Production Linked Incentive (PLI) scheme in November 2024, India's dependence on China for critical pharmaceutical ingredients remains substantial. These plants aim to produce essential molecules like Penicillin G and Clavulanic Acid, but the overall impact on reducing import dependence is yet to be fully realized.

The Velpatasvir export market is highly concentrated, with the top five exporters accounting for 92.8% of total exports. MYLAN LABORATORIES LIMITED alone holds a 49.6% share. Such concentration increases the risk of supply disruptions, as any operational issues within these key companies could significantly impact the global supply of Velpatasvir. While the PLI scheme has encouraged domestic production of APIs and KSMs, the effectiveness of these initiatives in diversifying the supplier base and mitigating single-source risks is still under evaluation.

Geopolitical tensions have notably impacted global supply chains. In March 2026, the closure of the Strait of Hormuz due to military conflicts disrupted the movement of oil tankers and cargo ships, affecting the transportation of pharmaceuticals from India. This disruption led to increased shipping costs and delays in delivery schedules. Additionally, the FDA has identified geopolitical situations as a contributing factor to supply chain challenges, emphasizing the need for proactive risk management strategies.

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

• Enhance Domestic Production: Invest in infrastructure and technology to bolster local production capabilities, thereby decreasing dependence on imports.

• Strengthen Regulatory Compliance: Ensure that domestic manufacturers adhere to international quality standards to maintain a consistent and reliable supply chain.

• Develop Alternative Shipping Routes: Establish and utilize alternative logistics pathways to mitigate the impact of geopolitical disruptions on transportation.

• Implement Strategic Stockpiling: Maintain adequate reserves of critical APIs and KSMs to buffer against potential supply chain interruptions.

RISK_LEVEL: MEDIUM