How to Import APIs from China to India: 2026 Pharma Guide | BEFACH International
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How to Import APIs from China to India: 2026 Pharma Compliance Guide
February 19, 2026
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How to Import APIs from China to India: 2026 Pharma Compliance Guide
How to Import APIs from China to India: Pharmaceutical Import Guide 2026
How to Import APIs from China to India: Pharmaceutical Import Guide 2026
Reading time: 8 minutes | Last updated: February 2026
Learning how to import APIs from China to India pharmaceutical operations requires navigating strict regulatory frameworks. Active Pharmaceutical Ingredients (APIs) face enhanced scrutiny under Indian drug regulations, making compliance essential for avoiding shipment seizures and penalties.
This guide covers the complete process for importing APIs from China to India in 2026, from obtaining pharmaceutical import licenses to clearing customs. Whether you're a pharmaceutical manufacturer or API trader, you'll find actionable steps backed by current CDSCO and customs regulations.
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India's pharmaceutical industry relies heavily on Chinese APIs due to cost advantages and manufacturing scale. Understanding this landscape helps importers make informed decisions:
Domestic supply gaps: India imports approximately 70% of its API requirements from China
Cost efficiency: Chinese APIs often cost 20-30% less than domestic or European alternatives
Volume availability: China maintains large-scale production capacity for bulk pharmaceutical chemicals
> Regulatory Alert: The Central Drugs Standard Control Organization (CDSCO) and Directorate General of Foreign Trade (DGFT) actively monitor API imports. Verify current CDSCO notifications and DGFT pharmaceutical policies before ordering.
Prerequisites for Pharmaceutical API Imports
Before importing APIs from China, establish these foundational elements. Missing documentation results in immediate shipment rejection at Indian ports.
1. Import Export Code (IEC)
The IEC is your mandatory 10-digit identification number for all API imports, issued by DGFT.
Submit PAN card, address proof, and bank account details
Pay ₹500 application fee
Receive IEC within 2-7 working days
> Compliance Note: Your IEC remains valid for lifetime but requires annual updates through the DGFT portal (between April-June each year). Deactivation may occur without yearly updates.
2. GST Registration
Valid GST registration is mandatory to claim input tax credit on imported APIs. Ensure your registration covers pharmaceutical trading or manufacturing categories.
3. Pharmaceutical Import License (Form 10)
APIs require specific licensing under the Drugs and Cosmetics Act:
License Type
Issuing Authority
Validity
Requirement
**Import License (Form 10)**
CDSCO State Licensing Authority
3 years
Mandatory for all APIs
**Registration Certificate**
CDSCO
3 years
For APIs not listed in Indian Pharmacopoeia
Required documents for Form 10:
Cover letter with product details
Manufacturing license from China (GMP certificate)
API specifications and testing methods
Stability data
Process flow diagram
Site master file of Chinese manufacturing facility
4. Digital Signature Certificate (DSC)
Class 3 DSC is required for:
Filing customs documents through ICEGATE
Signing Bills of Entry for API shipments
Accessing CDSCO online portals
Import Duty Structure for Pharmaceutical APIs
Understanding duty calculations is critical for pricing APIs competitively while maintaining margins.
Types of Import Duties on APIs
Duty Type
Description
Typical Rate for APIs
**Basic Customs Duty (BCD)**
Primary duty on import value
0% - 10% (most APIs: 0-5%)
**Social Welfare Surcharge (SWS)**
10% of BCD
10% of BCD
**Integrated GST (IGST)**
Applied on (Assessable Value + BCD + SWS)
12% or 18% for APIs
**Health Cess**
Specific to medical/health products
5% on certain medical devices (not typically on APIs)
Landed Cost Calculation Example
For importing APIs worth $50,000 (₹41,50,000 at ₹83/USD):
Step 1: Assessable Value
FOB Value: ₹41,50,000
Freight (5%): ₹2,07,500
Insurance (1.125%): ₹46,688
Assessable Value: ₹44,04,188
Step 2: Basic Customs Duty (BCD at 0% for most APIs)
BCD = ₹0
Step 3: Social Welfare Surcharge
SWS = ₹0 (10% of BCD)
Step 4: Integrated GST (IGST at 18%)
IGST Base = ₹44,04,188
IGST = ₹44,04,188 × 18% = ₹7,92,754
Total Landed Cost:
Component
Amount (₹)
Assessable Value
44,04,188
BCD
0
SWS
0
IGST
7,92,754
**TOTAL**
**₹51,96,942**
> Cost Alert: Budget additional 3-5% for CHA fees (₹5,000-15,000), port handling (₹5,000-25,000), testing fees (₹10,000-50,000 for API quality testing), and inland transportation.
Step-by-Step Process: How to Import APIs from China to India
Follow this workflow to ensure compliant pharmaceutical imports.
Step 1: Verify API Importability and Regulations
Before ordering, confirm your specific API can be legally imported:
File advance Bill of Entry (within 30 days of arrival)
Submit Form 10 license number and CDSCO registration details
Customs clearance:
Declare correct HS code (Chapter 29 for organic chemicals/APIs)
Present all pharmaceutical documentation
CDSCO may request port inspection and sampling
Pay assessed duties (BCD + IGST) through ICEGATE
> Critical: APIs may be subject to mandatory testing at government-approved laboratories before release. Budget 7-14 days for testing clearance.
Step 6: Post-Clearance Compliance
After receiving your APIs:
Store APIs in licensed premises meeting CDSCO storage norms
Maintain batch records and traceability documentation
File monthly returns with CDSCO for imported APIs
Retain all import records for 5 years
Ensure compliance with Good Distribution Practices (GDP)
Frequently Asked Questions About Importing APIs from China to India
Q: What is the biggest regulatory challenge when importing APIs from China to India?
A: Obtaining the Form 10 Import License from CDSCO is typically the most time-consuming step. The documentation requirements are extensive, requiring GMP certificates, site master files, and stability data from Chinese manufacturers. Processing takes 45-90 days, so plan your procurement cycle accordingly.
Q: Are there any restrictions or bans on importing APIs from China currently?
A: While there is no blanket ban on Chinese APIs, certain specific APIs face restrictions under the Drugs and Cosmetics Act. Additionally, DGFT occasionally updates restricted lists based on domestic availability. Always verify current CDSCO and DGFT notifications before placing orders, as non-scheduled APIs may require additional registration.
Q: How long does the entire process take from ordering to receiving APIs from China?
A: The timeline typically spans 60-120 days: 45-90 days for Form 10 license processing (if not already held), 30-45 days for manufacturing and shipping from China, and 7-14 days for customs clearance including mandatory testing. Having an existing Import License and using air freight for urgent APIs can reduce this to 2-3 weeks.
Q: What quality certifications should I verify from Chinese API manufacturers?
A: Ensure your Chinese supplier holds a valid Drug Manufacturing License from China's NMPA (National Medical Products Administration) and GMP certification compliant with WHO or EU standards. The facility should have undergone inspection by CDSCO or acceptable foreign regulatory bodies. Request batch-specific CoAs (Certificates of Analysis) and stability data for each shipment.
Q: Can I claim IGST paid on imported APIs as input tax credit?
A: Yes, IGST paid on API imports is fully available as input tax credit against your GST output liability, provided you have the Bill of Entry and GST invoice. This applies to pharmaceutical manufacturers and traders with valid GST registration. Ensure proper documentation to support your claims during GST audits.
Conclusion: Your API Import Success Roadmap
Importing APIs from China to India offers significant cost advantages but demands strict regulatory adherence. Here's your action plan:
Immediate Actions:
Apply for Form 10 Import License through your state CDSCO office
Obtain your IEC and GST registration if not already held
Identify correct HS codes for your specific APIs (Chapter 29)
Verify Chinese suppliers' GMP certifications and CDSCO recognition
Before Your First Shipment:
Engage a customs house agent experienced in pharmaceutical imports
Set up ICEGATE registration with Class 3 DSC
Establish quality testing protocols with government-approved labs
Draft technical agreements covering API specifications
Ongoing Operations:
Monitor CDSCO and DGFT notifications for policy changes
Maintain 5-year records of all API imports and testing reports
Ensure compliance with Good Distribution Practices for storage
Conduct regular supplier audits and quality verification
By following these steps for how to import APIs from china to india pharmaceutical operations, you can build a compliant, cost-effective supply chain that supports your business growth while meeting all regulatory requirements.
Need help with this process? Befach handles the entire process end-to-end so you can focus on your business. Let us handle it
