How India Exports Gabapentin to the World

In the United States, gabapentin is approved for the treatment of partial seizures and postherpetic neuralgia. The FDA's Orange Book lists numerous approved Abbreviated New Drug Applications (ANDAs) for gabapentin, indicating a competitive generic market. Notably, gabapentin enacarbil, marketed as Horizant, received orphan drug designation for the treatment of postherpetic neuralgia on June 7, 2011, with marketing approval granted on June 6, 2012. This approval underscores the FDA's recognition of gabapentin's therapeutic value in specific indications.

The substantial number of Indian exporters—369 active entities—supplying gabapentin to the U.S. market reflects the drug's established regulatory pathway and the FDA's acceptance of multiple generic formulations. This competitive landscape necessitates stringent adherence to FDA regulations to ensure market access and compliance.

Within the European Union, gabapentin is authorized for the treatment of epilepsy and neuropathic pain. The European Medicines Agency (EMA) has conducted periodic safety update report single assessments (PSUSAs) for gabapentin, with the most recent assessment completed in November 2025. (ema.europa.eu) These assessments are integral to the ongoing evaluation of the drug's safety profile.

In the United Kingdom, gabapentin was reclassified as a Class C controlled substance under the Misuse of Drugs Act 1971, effective April 1, 2019. (gov.uk) This reclassification imposes stricter controls on prescribing and dispensing practices, necessitating compliance with enhanced regulatory requirements for market access.

Gabapentin is included in the World Health Organization's Model List of Essential Medicines, highlighting its importance in global health. The drug is also recognized in major pharmacopoeias, including the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP), ensuring standardized quality specifications across different markets.

In India, gabapentin is classified as a Schedule H drug under the Drugs and Cosmetics Rules, 1945, indicating that it is available only by prescription. The National Pharmaceutical Pricing Authority (NPPA) has not set a ceiling price for gabapentin, allowing market-driven pricing. For export purposes, manufacturers must obtain a No Objection Certificate (NOC) from the Directorate General of Foreign Trade (DGFT), ensuring compliance with export regulations.

The primary patents for gabapentin have expired, leading to a robust generic market with significant competition. This competitive environment is reflected in the substantial number of Indian exporters and the diverse range of destination countries.

In August 2025, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) issued a call for evidence regarding the misuse and harms of gabapentin and pregabalin, indicating ongoing regulatory scrutiny. (gov.uk) Subsequently, in January 2026, the MHRA published a Public Assessment Report on improving information supplied with gabapentinoids, benzodiazepines, and z-drugs, emphasizing the need for enhanced patient information to mitigate risks associated with these medications. (gov.uk)

These developments underscore the importance of continuous monitoring and compliance with evolving regulatory requirements in key markets to ensure sustained market access and patient safety.

India's pharmaceutical industry, including the production of Gabapentin, heavily relies on Active Pharmaceutical Ingredients (APIs) and Key Starting Materials (KSMs) imported from China. Approximately 70-80% of India's API and KSM requirements are sourced from China, creating a significant dependency that poses risks to supply chain stability. This reliance has been highlighted during global disruptions, such as the COVID-19 pandemic, which exposed vulnerabilities in the supply chain due to over-dependence on a single country for critical raw materials.

To mitigate this risk, the Indian government introduced the Production Linked Incentive (PLI) scheme aimed at bolstering domestic API and KSM manufacturing. In November 2024, two greenfield plants were inaugurated under this scheme to produce essential molecules like Penicillin G and Clavulanic Acid, marking a significant step towards reducing import dependence. However, the effectiveness of these initiatives in achieving self-sufficiency for APIs like Gabapentin remains to be fully realized.

Our proprietary trade data indicates that the top five exporters account for 68.5% of Gabapentin exports from India, with ALKEM LABORATORIES LIMITED alone contributing 33.7% ($289.6M USD). This high supplier concentration poses a single-source risk, where disruptions affecting these key players could significantly impact global supply.

The PLI scheme, initiated to encourage domestic production of APIs and KSMs, has seen progress with the establishment of new manufacturing units. However, the scheme's impact on diversifying the supplier base for Gabapentin is still unfolding, and continuous monitoring is essential to assess its effectiveness in mitigating single-source risks.

Recent geopolitical tensions have led to significant disruptions in global shipping routes. In March 2026, the closure of the Strait of Hormuz, a critical chokepoint through which approximately 20% of the world's oil and natural gas transit, has caused substantial delays and increased shipping costs. This disruption has had a cascading effect on various industries, including pharmaceuticals, by delaying shipments and escalating transportation expenses.

Additionally, the Red Sea and the Suez Canal have experienced disruptions due to regional conflicts, further complicating shipping logistics. These geopolitical events underscore the vulnerability of global supply chains to regional instabilities, emphasizing the need for robust risk mitigation strategies.

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

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

• Strengthen Supplier Relationships: Foster partnerships with multiple suppliers to distribute risk and ensure a more resilient supply chain.

• Monitor Geopolitical Developments: Establish a dedicated team to track geopolitical events and assess their potential impact on supply chains, enabling proactive responses.

• Invest in Logistics Flexibility: Develop contingency plans that include alternative shipping routes and transportation methods to navigate around disrupted areas.

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