How India Exports Semaglutide to the World

As of March 2026, the U.S. Food and Drug Administration (FDA) has approved several New Drug Applications (NDAs) for semaglutide products, including Ozempic® (approved in December 2017), Rybelsus® (approved in September 2019), and Wegovy® (approved in June 2021). These approvals are listed in the FDA's Orange Book. Currently, there are no approved Abbreviated New Drug Applications (ANDAs) for generic versions of semaglutide, indicating that the market remains exclusive to branded formulations. The absence of generic competition underscores the importance of understanding the regulatory pathways for potential market entry.

Given the substantial number of Indian exporters (140) involved in semaglutide shipments, it is crucial for these entities to navigate the FDA's regulatory framework effectively. This includes compliance with the Drug Master File (DMF) submission process, adherence to Current Good Manufacturing Practices (cGMP), and the potential pursuit of ANDA approvals to introduce generic versions into the U.S. market. Staying informed about FDA guidelines and maintaining rigorous quality standards are essential for successful market penetration.

In the European Union, the European Medicines Agency (EMA) has granted marketing authorizations for semaglutide-containing products such as Ozempic® and Rybelsus®. Notably, in January 2026, the EMA's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the conditional marketing authorization of Kayshild, a semaglutide product intended for the treatment of adults with non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH). This development reflects the expanding therapeutic applications of semaglutide within the EU.

The United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) continues to align with EMA standards post-Brexit, ensuring that semaglutide products meet stringent safety and efficacy criteria. Compliance with EU Good Manufacturing Practice (GMP) requirements is mandatory for manufacturers exporting to these markets. Indian exporters must ensure that their manufacturing facilities are EU GMP-certified to facilitate seamless entry into the European and UK markets.

As of the 24th edition of the WHO Model List of Essential Medicines, published in September 2025, semaglutide is not included. The list comprises over 520 medicines selected based on public health relevance, evidence of efficacy and safety, and comparative cost-effectiveness. While semaglutide's exclusion may influence its prioritization in certain health systems, its proven benefits in managing type 2 diabetes and obesity continue to drive its global demand.

Semaglutide formulations are standardized according to various pharmacopoeias, including the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP). Adherence to these standards ensures the quality, safety, and efficacy of semaglutide products across different markets.

In India, semaglutide is classified under Schedule H of the Drugs and Cosmetics Act, indicating that it is a prescription-only medication. This classification mandates that semaglutide can only be dispensed with a valid prescription from a registered medical practitioner. As of March 2026, semaglutide is not listed under the Drug Price Control Order (DPCO) by the National Pharmaceutical Pricing Authority (NPPA), meaning it is not subject to government-imposed price ceilings.

For export purposes, Indian manufacturers must obtain a No Objection Certificate (NOC) from the Directorate General of Foreign Trade (DGFT). This requirement ensures that the export of semaglutide complies with national regulations and international trade agreements.

Semaglutide is protected by patents held by Novo Nordisk, the original developer. These patents grant exclusivity rights, preventing the manufacture and sale of generic versions until their expiration. The primary patent for semaglutide is set to expire in 2031, after which generic competition may enter the market. Until then, the market remains exclusive to Novo Nordisk's branded products, influencing pricing and availability.

In June 2024, the World Health Organization (WHO) issued a medical product alert regarding the increased reports of falsified semaglutide products across various regions. Healthcare professionals and regulatory authorities were advised to remain vigilant and ensure the authenticity of semaglutide products to safeguard patient safety.

In June 2025, the WHO highlighted the risk of non-arteritic anterior ischemic optic neuropathy (NAION) associated with semaglutide use. The European Medicines Agency (EMA) recommended updating the product information for semaglutide-containing medicines to include NAION as a very rare side effect. Healthcare providers were advised to monitor patients for visual disturbances and counsel them on this potential risk.

In January 2026, the EMA's CHMP adopted a positive opinion recommending the conditional marketing authorization of Kayshild, a semaglutide product for treating adults with non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH). This development signifies the expanding therapeutic applications of semaglutide beyond diabetes and obesity management.

In February 2026, the WHO published the 24th edition of the Model List of Essential Medicines, which did not include semaglutide. The list comprises over 520 medicines selected based on public health relevance, evidence of efficacy and safety, and comparative cost-effectiveness. While semaglutide's exclusion may influence its prioritization in certain health systems, its proven benefits in managing type 2 diabetes and obesity continue to drive its global demand.

In March 2026, the FDA approved a new indication for semaglutide, expanding its use to include the treatment of adolescents with type 2 diabetes. This approval reflects the growing recognition of semaglutide's efficacy and safety profile across different patient populations.

These developments underscore the dynamic regulatory landscape surrounding semaglutide, highlighting the importance for stakeholders to stay informed and adapt to evolving standards and guidelines.

India's pharmaceutical industry, renowned as 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 vulnerabilities, as any disruption in Chinese supply can lead to shortages and price volatility in the Indian pharmaceutical sector.

The COVID-19 pandemic underscored these risks when Chinese factory shutdowns led to immediate scarcities of essential APIs and KSMs, causing price surges for common medications. This situation highlighted the fragility of the supply chain and the urgent need for India to bolster domestic production capabilities to mitigate such dependencies.

Analysis of TransData Nexus's proprietary trade data from 2022 to 2026 reveals that the top five exporters of Semaglutide from India account for 59.8% of the total export value, with KARDI TRADING PRIVATE LIMITED alone contributing 24.3%. This high supplier concentration poses a significant risk, as disruptions affecting these key exporters could severely impact the global supply of Semaglutide.

To address such vulnerabilities, the Indian government has implemented the Production Linked Incentive (PLI) scheme, inaugurated in October 2024, aiming to reduce import dependence on KSMs and APIs by promoting domestic manufacturing. This initiative seeks to diversify the supplier base and enhance the resilience of the pharmaceutical supply chain.

Recent geopolitical tensions have further strained the pharmaceutical supply chain. In February 2026, the closure of the Strait of Hormuz disrupted the movement of oil tankers and cargo ships, leading to significant delays and increased costs for global trade, including pharmaceuticals. This blockade has caused widespread logistical challenges, affecting the timely delivery of essential goods.

Additionally, the ongoing conflict in the Red Sea region has compelled shipping companies to reroute vessels around Africa's Cape of Good Hope, adding substantial transit times and costs. These disruptions have led to shortages and price increases for various goods, including pharmaceuticals, highlighting the need for robust risk mitigation strategies in the supply chain.

• Diversify API and KSM Sources: Encourage the development of alternative suppliers in different geographic regions to reduce dependency on a single country.

• Enhance Domestic Production: Invest in local manufacturing capabilities for critical APIs and KSMs to strengthen supply chain resilience.

• Strengthen Supplier Relationships: Foster long-term partnerships with multiple suppliers to ensure a stable and reliable supply chain.

• Implement Advanced Manufacturing Technologies: Adopt innovative production methods to improve efficiency and reduce reliance on external sources.

• Develop Contingency Plans: Establish comprehensive strategies to address potential disruptions, including alternative shipping routes and inventory management practices.

RISK_LEVEL: HIGH