Who Supplies Apixaban to India from THAILAND

To import finished pharmaceutical formulations containing Apixaban into India, obtaining an import license from the Directorate General of Foreign Trade (DGFT) and registration with the Central Drugs Standard Control Organisation (CDSCO) is mandatory. The registration process involves submitting Form CT-20/40/41, which includes detailed product information, manufacturing details, and compliance with the Drugs and Cosmetics Act and Rules. The timeline for import drug registration can vary, but it typically ranges from 6 to 12 months, depending on the completeness of the application and regulatory reviews. For formulations under HS Code 30049099, specific requirements include proof of Good Manufacturing Practice (GMP) compliance, stability data (preferably ICH Zone IV), and a No Objection Certificate (NOC) from the manufacturer.

Imported pharmaceutical formulations must undergo quality testing at CDSCO-approved laboratories. Batch-wise testing is required, with each batch accompanied by a Certificate of Analysis (CoA) confirming compliance with Indian Pharmacopoeia standards. Stability data, particularly for ICH Zone IV conditions, is essential to demonstrate the product's shelf-life in India's climate. Port inspections by customs drug inspectors are conducted to verify the authenticity and quality of the imported products.

Between 2024 and 2026, the CDSCO has implemented stricter regulations for imported medicines to ensure quality and safety. The introduction of the Production-Linked Incentive (PLI) scheme has impacted the import of finished formulations, encouraging domestic manufacturing and reducing dependency on imports. Bilateral agreements with Thailand have facilitated smoother trade relations, including mutual recognition of GMP standards, thereby streamlining the import process for pharmaceutical products.

India imports finished Apixaban formulations primarily due to the presence of patented or branded products not manufactured domestically, specific dosage forms required by the market, and the need to meet therapeutic demands that domestic production cannot fulfill. The market size for Apixaban in India is substantial, with a growing demand for anticoagulant therapies. The import dependency is influenced by factors such as the availability of generic versions, pricing, and the capacity of domestic manufacturers to produce these formulations.

The total landed duty for importing pharmaceutical formulations under HS Code 30049099 into India is 17.10%, comprising a Basic Customs Duty (BCD) of 10.00%, Education Cess of 2.00%, Secondary Higher Education Cess of 1.00%, and a Countervailing Duty (CVD) of 6.00%. Additionally, the Integrated Goods and Services Tax (IGST) is applicable, which varies based on the product's classification and current tax rates. Anti-dumping duties may also apply if the imported products are found to be sold at unfairly low prices. Exemption notifications can reduce or eliminate certain duties under specific conditions, such as for products meeting certain criteria or under Free Trade Agreements (FTAs).

India sources finished Apixaban formulations from Thailand due to competitive advantages such as the availability of patented formulations, specialized dosage forms, and high-quality manufacturing standards. Thailand's share in supplying these formulations is significant, offering products that may not be available from other suppliers like China, Germany, or the United States. The competitive position is bolstered by Thailand's adherence to international quality standards and its established trade relations with India.

India imports finished Apixaban formulations from Thailand due to strategic reasons such as the availability of patented formulations, specialized dosage forms, and technology-licensed products. Thailand supplies specific formulations that India does not manufacture domestically, fulfilling market needs and therapeutic demands.

When compared to other origins like China, the European Union, and the United States, Thailand offers competitive pricing, high-quality products, and reliable regulatory compliance. Thailand's unique advantage lies in its adherence to international quality standards and its established trade relations with India, making it a preferred source for finished Apixaban formulations.

Indian importers face potential supply chain risks such as single-source dependency, currency fluctuations, regulatory changes, quality incidents, and shipping disruptions. Past shortages have been minimal, but it is advisable for importers to maintain diversified sourcing strategies and robust risk management plans to mitigate these potential issues.

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. 4Minimum Order Quantities (MOQs): Clarify MOQs with suppliers to ensure flexibility in procurement.
5. 5Supplier Qualification: Conduct thorough due diligence on suppliers, including audits and quality assessments, to ensure compliance with regulatory standards.

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 Organisation.
3. 3Form CT-20/40/41: Submit the required forms with detailed product