Who Supplies Ezetimibe to India from TURKEY

To import finished pharmaceutical formulations containing Ezetimibe (HS Code 30049099) into India, the foreign manufacturer must obtain a Drug Import License from the Directorate General of Foreign Trade (DGFT). The product must be registered with the Central Drugs Standard Control Organisation (CDSCO), which involves submitting Form 40/41, along with a No Objection Certificate (NOC) from the Ministry of Health and Family Welfare. The registration process typically takes 6–12 months. The Indian buyer, such as Torrent Pharmaceuticals Ltd, must also obtain an Importer License from DGFT. The product must comply with the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945. Ezetimibe formulations must meet the standards set by the Indian Pharmacopoeia.

Imported Ezetimibe formulations must undergo quality testing at CDSCO-approved laboratories in India. Each batch requires a Certificate of Analysis (CoA) confirming compliance with Indian Pharmacopoeia standards. Stability data must be provided, demonstrating the product's shelf-life under ICH Zone IV conditions. Port inspection by customs drug inspectors is mandatory to verify compliance with regulatory requirements.

Between 2024 and 2026, the CDSCO has implemented stricter regulations for the import of pharmaceutical formulations, including Ezetimibe. The Production Linked Incentive (PLI) scheme has been expanded to encourage domestic manufacturing, potentially affecting the volume of finished formulation imports. Bilateral agreements between India and Turkey have facilitated smoother trade processes, but no specific concessions have been granted for Turkish-origin products.

India imports finished Ezetimibe formulations due to the demand for branded products, specific dosage forms, and formulations not manufactured domestically. The market size for Ezetimibe formulations in India is substantial, with a total export market of $514.5 million across 169 exporters to 85 countries. Domestic capacity may not meet the entire demand, leading to reliance on imports.

The Basic Customs Duty (BCD) for 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 12%, calculated on the sum of the CIF value plus customs duties. No anti-dumping duty is currently applicable. Exemption notifications are not available for this product.

India sources Ezetimibe formulations from Turkey due to competitive advantages such as patented formulations, specialized dosage forms, and high-quality manufacturing standards. Other suppliers include China, Germany, and the United States. Turkey's share in the Indian market is growing, with a year-on-year growth of 5%.

India imports Ezetimibe formulations from Turkey due to the availability of patented formulations, specialized dosage forms, and high-quality manufacturing standards. Turkey supplies formulations that India does not manufacture domestically, fulfilling specific market needs.

Compared to other sources like China, the European Union, and the United States, Turkey offers competitive pricing, high-quality products, and compliance with international regulatory standards. Turkey's unique advantage lies in its ability to provide specialized formulations not available from other suppliers.

Potential risks include single-source dependency, currency fluctuations, regulatory changes, quality incidents, and shipping disruptions. There have been no significant shortages reported in the past.

1. 1Engage in dual-sourcing strategies to mitigate supply chain risks.
2. 2Implement robust inventory planning to manage demand fluctuations.
3. 3Negotiate favorable payment terms, such as Letters of Credit (LC), Documents Against Acceptance (DA), or Documents Against Payment (DP).
4. 4Establish clear Minimum Order Quantities (MOQs) with suppliers.
5. 5Conduct thorough supplier qualification processes to ensure compliance with regulatory standards.

1. 1Obtain a Drug Import License from DGFT.
2. 2Register the product with CDSCO by submitting Form 40/41.
3. 3Secure a No Objection Certificate (NOC) from the Ministry of Health and Family Welfare.
4. 4Ensure compliance with the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945.
5. 5Verify that the product meets Indian Pharmacopoeia standards.

1. 1Certificate of Analysis (CoA).
2. 2Certificate of Pharmaceutical Product (CoPP).
3. 3Good Manufacturing Practice (GMP) certificate.
4. 4Drug Master File (DMF).
5. 5Stability data under ICH Zone IVa/IVb conditions.
6. 6Free Sale Certificate.
7. 7Manufacturer authorization letter.

Upon arrival, customs drug inspectors collect samples for mandatory batch testing. The testing process includes verifying compliance with Indian Pharmacopoeia standards and assessing stability data. If a batch fails, it may be rejected, leading to potential delays and additional costs. Common quality issues from Turkish imports include discrepancies in labeling and packaging.

1. 1Renew CDSCO registration annually.
2. 2Conduct periodic audits of the Turkish manufacturing facility.
3. 3Implement change control procedures for product modifications.
4. 4Establish a pharmacovigilance system for post-market monitoring.
5. 5Maintain import records as per the Drugs and Cosmetics Act, 1940.