Who Supplies Dapagliflozin to India from ISRAEL

To import finished pharmaceutical formulations containing Dapagliflozin into India, obtaining an import license from the Directorate General of Foreign Trade (DGFT) is mandatory. Additionally, the Central Drugs Standard Control Organization (CDSCO) requires registration of the product, which involves submitting Form 40/41 and obtaining a No Objection Certificate (NOC). The registration process includes providing stability data compliant with ICH Zone IV standards and ensuring the product meets the Indian Pharmacopoeia standards. The timeline for import drug registration can vary but typically ranges from 6 to 12 months, depending on the completeness of the application and regulatory reviews.

Imported batches of Dapagliflozin formulations must undergo quality testing at CDSCO-approved laboratories. Each batch requires a Certificate of Analysis (CoA) and stability data demonstrating compliance with ICH Zone IV standards. Port inspections by customs drug inspectors are conducted to verify the authenticity and quality of the products. If a batch fails to meet the required standards, it may be rejected, leading to potential delays and additional costs.

In April 2025, the CDSCO mandated that all imported drugs, including finished formulations containing Dapagliflozin, must obtain import registration and licenses as per the Drugs and Cosmetics Act and associated rules. This regulation aims to prevent the sale of unapproved or illegal medicines in the Indian market. Additionally, in November 2025, the National Pharmaceutical Pricing Authority (NPPA) fixed retail prices for 28 essential drug formulations, including Dapagliflozin-based combinations, under the Drugs (Prices Control) Order, 2013.

India imports finished Dapagliflozin formulations primarily due to the demand for patented and branded products, as well as specific dosage forms not manufactured domestically. The domestic capacity for producing these formulations is limited, leading to a reliance on imports to meet the therapeutic needs of patients. The market size for Dapagliflozin formulations in India is substantial, with a growing number of patients requiring treatment for type 2 diabetes.

The total landed duty for importing finished pharmaceutical formulations under HS Code 30049099 into India is 17.10%. This comprises a Basic Customs Duty (BCD) of 10%, an Education Cess of 2%, a Secondary Higher Education Cess of 1%, and a Countervailing Duty (CVD) of 6%. Additionally, the Goods and Services Tax (GST) at 12% is applicable on the import value. Exemptions or concessional rates may apply under specific trade agreements or government notifications.

India sources finished Dapagliflozin formulations from Israel due to the competitive advantages offered by Israeli manufacturers, such as patented formulations, specialized dosage forms, and high-quality standards. Israeli suppliers like Taro Pharmaceutical Industries Ltd. and Unipharm Ltd. have established a strong presence in the Indian market. While other countries like China, Germany, and the United States also supply these formulations, Israel's share in the Indian market remains significant due to its consistent quality and innovation.

India imports finished Dapagliflozin formulations from Israel due to the availability of patented formulations, specialized dosage forms, and high-quality manufacturing standards. Israeli manufacturers offer products that may not be produced domestically, fulfilling specific therapeutic needs in the Indian market. The consistent quality and regulatory compliance of Israeli products make them a preferred choice for Indian importers.

When compared to other origins like China, the European Union, and the United States, Israel offers a competitive advantage in terms of product quality, regulatory compliance, and innovation. Israeli manufacturers are known for their adherence to international standards and their ability to provide specialized formulations. While other countries may offer lower prices, Israel's focus on quality and compliance makes it a reliable source for finished pharmaceutical formulations.

Indian importers face potential risks when sourcing finished Dapagliflozin formulations from Israel, including single-source dependency, currency fluctuations, regulatory changes, quality incidents, and shipping disruptions. To mitigate these risks, importers should diversify their supplier base, monitor currency exchange rates, stay updated on regulatory developments, ensure robust quality assurance processes, and maintain contingency plans for shipping and logistics.

1. 1Dual-Sourcing: Engage multiple suppliers to reduce dependency on a single source.
2. 2Inventory Planning: Maintain optimal inventory levels to buffer against supply chain disruptions.
3. 3Payment Terms: Negotiate favorable payment terms, such as Letters of Credit (LC), Documents Against Acceptance (DA), or Documents Against Payment (DP).
4. 4Supplier Qualification: Conduct thorough due diligence to ensure suppliers meet quality and regulatory standards.
5. 5Regulatory Compliance: Stay informed about changes in import regulations and ensure all necessary licenses and registrations are in place.

1. 1DGFT Import License: Obtain an import license from the Directorate General of Foreign Trade.
2. 2CDSCO Registration: Register the product with the Central Drugs Standard Control Organization by submitting Form 40/41.