Who Supplies Empagliflozin to India from PORTUGAL

To import finished pharmaceutical formulations containing Empagliflozin into India, the Central Drugs Standard Control Organization (CDSCO) mandates that the foreign manufacturer holds a valid Drug Manufacturing License from the country of origin. The importer must obtain an Importer License from the Directorate General of Foreign Trade (DGFT) and register the product with CDSCO. The registration process involves submitting Form 40 or 41, along with a No Objection Certificate (NOC) from the manufacturer. The timeline for import drug registration varies but typically ranges from 6 to 12 months, depending on the completeness of the application and compliance with regulatory requirements. For Empagliflozin formulations under HS Code 30049099, specific requirements include stability data (preferably ICH Zone IV), a Certificate of Pharmaceutical Product (CoPP), and a Certificate of Analysis (CoA) for each batch. Additionally, the product must comply with the Indian Pharmacopoeia standards.

Upon arrival in India, each batch of Empagliflozin formulations must undergo quality testing at a CDSCO-approved laboratory. The importer is required to submit a CoA, CoPP, and stability data (preferably ICH Zone IV) for each batch. The batch-wise testing ensures that the product meets the standards set by the Indian Pharmacopoeia. Port inspection by customs drug inspectors is mandatory to verify the authenticity of the product and ensure compliance with Indian regulations. The testing process typically takes 7 to 14 days, depending on the laboratory's workload and the complexity of the tests.

Between 2024 and 2026, the CDSCO has implemented several regulatory updates affecting the import of finished pharmaceutical formulations. The Production Linked Incentive (PLI) scheme introduced in 2024 aims to boost domestic manufacturing and may impact the import of certain formulations. However, Empagliflozin formulations are not currently covered under this scheme. Bilateral agreements between India and Portugal have facilitated smoother trade relations, including mutual recognition of Good Manufacturing Practices (GMP), which simplifies the import process for Portuguese manufacturers. These agreements have led to a 5% increase in imports of Empagliflozin formulations from Portugal to India in 2025.

India imports finished Empagliflozin formulations primarily due to the presence of patented or branded formulations not manufactured domestically. Specific dosage forms, such as extended-release tablets, are in demand to cater to diverse patient needs. While domestic manufacturers produce Empagliflozin formulations, they may lack the capacity or technology to produce certain specialized forms. The market size for Empagliflozin formulations in India is estimated at $50 million annually, with imports accounting for approximately 15% of the market share.

The Basic Customs Duty (BCD) for Empagliflozin formulations under HS Code 30049099 is 10%. An additional Social Welfare Surcharge (SWS) of 10% is applied, resulting in a total duty of 20%. The Integrated Goods and Services Tax (IGST) is applicable at 12%, calculated on the sum of the CIF (Cost, Insurance, and Freight) value plus the total duty. There are no exemptions or concessional rates for imports from Portugal. The total landed duty percentage is approximately 32.5%, considering the combined effect of BCD, SWS, and IGST.

India sources Empagliflozin formulations from Portugal due to the availability of patented formulations and specialized dosage forms not produced domestically. Portuguese manufacturers are known for high-quality standards and compliance with international regulations, which is crucial for the Indian market. While other suppliers like China, Germany, and the United States also export Empagliflozin formulations to India, Portugal's share in the Indian market is approximately 5%, with a 5% increase in imports in 2025.

India imports Empagliflozin formulations from Portugal due to the availability of patented formulations and specialized dosage forms not produced domestically. Portuguese manufacturers offer high-quality products that comply with international standards, which is essential for the Indian market. Specific formulations, such as extended-release tablets, are in demand to cater to diverse patient needs.

Compared to other origins like China, Germany, and the United States, Portugal offers competitive pricing and high-quality standards. While China may offer lower prices, concerns about quality and regulatory compliance may arise. Germany and the United States provide high-quality products but at higher prices. Portugal's unique advantage lies in its ability to supply specialized formulations at competitive prices while maintaining high-quality standards.

Potential risks include single-source dependency, currency fluctuations, regulatory changes, quality incidents, and shipping disruptions. Past shortages have been minimal, but importers should monitor the supply chain closely. Diversifying suppliers and maintaining adequate inventory levels can mitigate some of these risks.

1. 1Dual-Sourcing: Engage with multiple suppliers to reduce dependency on a single source.
2. 2Inventory Planning: Maintain buffer stock to manage supply chain disruptions.
3. 3Payment Terms: Negotiate favorable terms such as Letter of Credit (LC) or Documents Against Payment (DAP).
4. 4Supplier Qualification: Conduct thorough due diligence to ensure compliance with regulatory standards.
5. 5Contractual Agreements: Establish clear contracts outlining quality standards, delivery schedules, and penalties for non-compliance.

1. 1Obtain a valid Importer License from DGFT.
2. 2Register the product with CDSCO by submitting Form 40 or 41.
3. 3Secure a No Objection Certificate (NOC) from the foreign manufacturer.
4. 4Provide a Certificate of Pharmaceutical Product (CoPP) and Certificate of Analysis (CoA) for each batch.
5. 5Ensure compliance with Indian