Who Supplies Bevacizumab to India from CHINA

To import finished pharmaceutical formulations containing Bevacizumab into India, the following regulatory approvals are required:

1. Import License: An Importer-Exporter Code (IEC) issued by the Directorate General of Foreign Trade (DGFT) is mandatory for customs clearance.

2. CDSCO Registration: The Central Drugs Standard Control Organisation (CDSCO) requires registration of the imported drug. This involves:

• Form CT-20: Application for import license.

• Form CT-41: Certificate of Pharmaceutical Product (CoPP) from the exporting country.

• Form CT-22: Certificate of Free Sale.

3. DCGI Approval: The Drug Controller General of India (DCGI) must approve the import, ensuring the product meets Indian standards.

4. No Objection Certificate (NOC): If the product is patented, an NOC from the patent holder may be required.

The registration process typically takes 6 to 12 months, depending on the completeness of the application and compliance with regulatory requirements.

Imported Bevacizumab formulations must undergo quality testing to ensure compliance with Indian standards:

1. CDSCO-Approved Laboratory Testing: Samples are tested in laboratories approved by CDSCO to verify quality, safety, and efficacy.

2. Batch-Wise Requirements: Each batch must be accompanied by a Certificate of Analysis (CoA) detailing the product's specifications and test results.

3. Stability Data: Stability studies must be conducted under ICH Zone IV conditions to ensure the product's shelf-life in India's climate.

4. Indian Pharmacopoeia Standards: The product must conform to the standards set by the Indian Pharmacopoeia.

5. Port Inspection: Customs drug inspectors may conduct inspections at ports to verify compliance with regulatory standards.

Recent developments affecting the import of Bevacizumab formulations into India include:

1. CDSCO Regulatory Updates: The CDSCO has streamlined the import approval process for certain critical drugs, potentially reducing approval times.

2. PLI Scheme Impact: The Production Linked Incentive (PLI) scheme has incentivized domestic production of pharmaceutical formulations, leading to a decrease in imports of certain drugs, including Bevacizumab.

3. Bilateral Agreements with China: India and China have engaged in discussions to facilitate smoother trade in pharmaceutical products, including mutual recognition of Good Manufacturing Practices (GMP).

India imports finished Bevacizumab formulations due to:

1. Patented Formulations: Innovative formulations protected by patents are not manufactured domestically.

2. Specific Dosage Forms: Certain dosage forms, such as pre-filled syringes, are imported to meet patient needs.

3. Domestic Capacity vs. Import Dependency: Limited domestic production capacity necessitates imports to meet the growing demand for Bevacizumab.

4. Market Size: The Indian market for Bevacizumab formulations is substantial, with a total export market of $46.9 million across 196 exporters to 100 countries.

The import duty and customs structure for Bevacizumab formulations under HS Code 30021500 are as follows:

1. Basic Customs Duty (BCD): 10% of the assessable value.

2. Social Welfare Surcharge (SWS): 10% of the BCD.

3. Integrated Goods and Services Tax (IGST): 12% of the sum of assessable value, BCD, and SWS.

4. Total Landed Duty: Approximately 23.536% of the assessable value.

Exemptions or reductions may apply under specific trade agreements or government notifications.

India sources Bevacizumab formulations from China due to:

1. Competitive Pricing: China offers cost-effective pricing for Bevacizumab formulations.

2. Quality Assurance: Chinese manufacturers adhere to international quality standards, ensuring product reliability.

3. Regulatory Compliance: Chinese suppliers comply with international regulatory standards, facilitating smoother import processes.

4. Other Suppliers: While Germany and the US are alternative sources, China's competitive pricing and established trade relations make it a preferred choice.

5. China's Share: China holds a significant share in India's Bevacizumab import market, with top suppliers being M/S. Genscript Biotech (Singapore) Pte Ltd and Genscript Biotech (Singapore).