How India Exports Insulin to the World

As of March 2026, the U.S. Food and Drug Administration (FDA) has approved numerous Abbreviated New Drug Applications (ANDAs) for insulin products, facilitating the entry of generic versions into the market. The FDA's Orange Book provides a comprehensive list of these approved applications, reflecting the agency's commitment to increasing competition and accessibility in the insulin market.

Regarding import alerts, the FDA issues these to prevent the entry of products that appear to violate U.S. laws and regulations. Import alerts can lead to detention without physical examination (DWPE) of products from specific manufacturers or countries. As of March 2026, there are no active import alerts specifically targeting insulin products from India. However, exporters must remain vigilant, as the FDA regularly updates its import alert list. For instance, on March 9, 2026, the FDA issued Import Alert 66-80, concerning the detention of certain pharmaceutical products due to compliance issues.

The regulatory pathway for insulin products in the U.S. involves demonstrating bioequivalence to a reference product through the ANDA process. Given the presence of 188 active Indian exporters and a repeat buyer rate of 66.4%, maintaining stringent compliance with FDA regulations is imperative to ensure uninterrupted market access.

In the European Union (EU), insulin products require marketing authorization from the European Medicines Agency (EMA). The EMA assesses applications to ensure that medicines meet EU standards for safety, efficacy, and quality. For example, on February 26, 2026, the EMA's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the granting of marketing authorization for Bysumlog, a biosimilar insulin lispro intended for the treatment of diabetes mellitus. (ema.europa.eu)

In the United Kingdom, the Medicines and Healthcare products Regulatory Agency (MHRA) oversees the approval of medicinal products. Post-Brexit, the UK has established its own regulatory framework, though it remains aligned with EU standards in many aspects. Compliance with Good Manufacturing Practice (GMP) requirements is mandatory in both jurisdictions, ensuring that insulin products are consistently produced and controlled according to quality standards.

Insulin is included in the World Health Organization's (WHO) Model List of Essential Medicines, underscoring its critical role in managing diabetes. The WHO Prequalification Programme evaluates medicines to ensure they meet global standards for quality, safety, and efficacy, facilitating their procurement by international agencies.

Insulin products must comply with pharmacopoeial standards, such as those outlined in the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP). These standards specify the quality requirements for insulin, including its identity, purity, and potency, ensuring consistency across different markets.

In India, insulin is classified under Schedule H of the Drugs and Cosmetics Act, indicating that it is a prescription-only medication. The Drug Price Control Order (DPCO), enforced by the National Pharmaceutical Pricing Authority (NPPA), regulates the pricing of essential medicines, including insulin. The NPPA periodically reviews and sets ceiling prices to ensure affordability; the latest revision occurred in January 2026.

For exports, the Directorate General of Foreign Trade (DGFT) mandates a No Objection Certificate (NOC) for certain pharmaceutical products. Exporters must comply with these requirements to facilitate the smooth export of insulin products from India.

The patent landscape for insulin is complex, with various formulations and delivery methods protected by patents. However, many original patents have expired, leading to increased generic competition. This competitive environment is reflected in the presence of 188 active Indian exporters supplying insulin to 111 destination countries, indicating a robust market for generic insulin products.

In February 2026, the EMA's CHMP adopted positive opinions for two biosimilar insulin products: Bysumlog (insulin lispro) and Dazparda (insulin aspart), both intended for the treatment of diabetes mellitus. (ema.europa.eu)

In January 2026, the NPPA revised the ceiling prices for insulin products under the DPCO, aiming to enhance affordability for patients in India.

In March 2026, the FDA issued Import Alert 66-80, concerning the detention without physical examination of certain pharmaceutical products due to compliance issues.

In April 2023, the European Commission withdrew the marketing authorization for Inpremzia (insulin human (rDNA)) at the request of the marketing authorization holder, Baxter Holding B.V., which decided not to market the product in the EU for commercial reasons. (ema.europa.eu)

In February 2025, the FDA issued a safety communication alerting patients to regularly check diabetes-related smartphone device alert settings, especially following phone hardware or software changes, to prevent missed alerts that could lead to serious harm.

India's insulin production heavily relies on Active Pharmaceutical Ingredients (APIs) and Key Starting Materials (KSMs) imported from China. This dependency exposes the supply chain to significant risks, as evidenced by past disruptions. For instance, in 2025, China's implementation of the "Dual Circulation" policy prioritized domestic supply, leading to a 40% reduction in insulin intermediate exports. This policy shift caused global shortages and highlighted the vulnerabilities associated with overreliance on a single source for critical raw materials.

To mitigate such risks, the Indian government has initiated measures to bolster domestic API and KSM production. In November 2025, the Department of Pharmaceuticals launched the sixth application round under the Production Linked Incentive (PLI) scheme for bulk drug manufacturing. This initiative aims to reduce import dependence by encouraging local production of essential pharmaceutical ingredients. As of August 2025, 32 pharmaceutical firms have been selected for greenfield projects, with 48 projects approved across 33 APIs, DIs, and KSMs.

Our proprietary trade data indicates a high supplier concentration in India's insulin export market. The top five exporters account for 87.4% of total exports, with Wockhardt Limited alone contributing 47.3% ($35.9 million). Such concentration poses a significant single-source risk, as any disruption within these key suppliers could severely impact the global insulin supply chain.

The PLI scheme for bulk drugs has been instrumental in reducing import dependence and enhancing domestic manufacturing capabilities. By March 2025, the scheme led to import savings of Rs 1,362 crore, demonstrating its effectiveness in strengthening India's pharmaceutical sector.

Geopolitical tensions and shipping disruptions have further exacerbated supply chain vulnerabilities. The Red Sea and Strait of Hormuz, critical maritime routes for global trade, have experienced increased instability due to regional conflicts. Additionally, escalating tensions between the U.S. and China have led to export restrictions and trade barriers, impacting the availability of essential pharmaceutical ingredients. These factors have contributed to API shortages, prompting regulatory agencies like the FDA and EMA to issue alerts regarding potential drug shortages.

• Diversify Supplier Base: Encourage the development of alternative suppliers, both domestically and internationally, to reduce reliance on a limited number of exporters.

• Enhance Domestic Production: Continue to support and expand initiatives like the PLI scheme to strengthen local manufacturing of APIs and KSMs, thereby reducing import dependence.

• Strengthen Regulatory Frameworks: Implement robust quality control measures and regulatory oversight to ensure the reliability and safety of domestically produced pharmaceutical ingredients.

• Develop Strategic Reserves: Establish and maintain reserves of critical APIs and KSMs to buffer against potential supply chain disruptions.

• Monitor Geopolitical Developments: Stay informed about international trade policies and geopolitical events that could impact the pharmaceutical supply chain, allowing for proactive risk management.

RISK_LEVEL: HIGH