The demand for Active Pharmaceutical Ingredients (APIs) has surged in recent years due to cost efficiency, supply chain reliability, and regulatory confidence. Among global suppliers, India has emerged as the most strategic hub for sourcing high-quality APIs, earning its reputation as the "Pharmacy of the World." With thousands of manufacturers offering GMP-compliant products and a strong regulatory framework, India provides an ideal environment for international API procurement.
This article offers a practical guide for global buyers looking to source GMP-certified APIs from India—covering key certifications, sourcing steps, verification tips, cost factors, and more.
Why India Is a Top API Sourcing Hub
With the highest growth spectacle in GDP, India has also conquered the pharmaceutical world by positioning itself as the bulk drug (API) manufacturer. Here are a few key features that set it apart.
- Cost-effectiveness: APIs manufactured in India are less expensive than those produced in Europe and the United States.
- Global Market Access: Indian manufacturers produced approximately 20% of the total global API production.
- Skilled Workforce: An educated pool of skilled workers helps the operation scale up.
- Regulatory Approvals: More than 3000 pharmaceutical companies have WHO-GMP certification, which has been approved by the EMA, the US FDA, the MHRA, and the TGA.
- Government Support: India's PLI (Production Linked Incentive) scheme encourages API production and eliminates all intermediaries.
India Specific Process for GMP Certification
GMP certification ensures efficacy, purity, safety, and traceability of API ensuring a high-quality standard. India has several companies with GMP certifications. Here are a few GMP certifications relevant to India.
- WHO-GMP: Recognized in most developing countries
- CDSCO GMP: Essential for local manufacturing and domestic distribution.
- EU GMP: Essential for sale in Europe
- US FDA GMP: Required for exports in the U.S.
Steps-by-Step Process to Source GMP Certified APIs from India
Step 1: State your requirement-
Therapeutic category, dosage, volume, regulatory target market, and others.
Step 2: Shortlist GMP-certified manufacturers-
Utilize the directories to shortlist the GMP-producing companies and check for certification.
Step 3: Verify details-
Cross-verify certificates, audit reports, regulatory filings, and others.
Step 4: Evaluate quality standards-
Conduct in-house or third-party quality checks and check accreditation of GLP, ISO, and pharmacopoeia compliance (USP/EP/IP).
Step 5: Supplier cross-check-
Conduct supplier verification.
Step 6: Negotiate and finalize contracts-
Minimum order quantity and pricing model adjustments.
Step 7: Custom clearance for APIs-
Ensure logistics and regulatory compliance are in place.
Supplier Verification Checklist
Before sourcing API from India, follow the checklist:
- Check certifications and documents.
- Follow regulatory filings.
- Audit report and track record.
- Quality systems and financial health
- Site visit
Compliance & regulatory notes
For smooth internation trade and high product quality, it is essential to understand regulatory compliances. Here is a detailed overview of certificates required for GMP-certified APIs.
- CDSCO: Issues GMP certifications which defines minimum manufacturing standard. It is mandatory for Indian manufacturing.
- WHO-GMP: Widely recognized across Asia, the Middle East, Africa and other countries. It ensures that APIs are monitored, validated, and standardized.
- US FDA & EMA: Must pass the rigorous procedure for FDA and EMA approval. These certificates are mandatory for the U.S. and European markets.
Cost, lead time & Incoterm tips
While global buyers are swiftly choosing India for GMP-certified APIs, it is essential to understand pricing, shipping terms, and production.
Price factors:
-
An advanced biotech API or oncology are expensive due to special requirement.
- Batch sized play a vital role in pricing.
- APIs manufacturers must have the requires approvals and certificates for unhindered selling.
- Raw material cost also influence the price especially if imported from other countries.
Lead time:
-
Standard production: 6-12 weeks
- Regulatory review: 3-6 months for overall approvals and validation processes
- Shipping:
- Air: 7-10 days (urgent and small consignments)
- Sea: 3-5 weeks (large shipments)
Incoterm tip:
Picking the right incoterm can directly affect the cost.
- FOB (Free on Board): The buyer handles insurance and freight after the goods are loaded.
- CIF (Cost, Insurance, and Freight): The supplier arranges shipping and insurance.
- DAP/DDP (Delivered at Place/Delivered Duty Paid): For door-to-door delivery and recommended for buyers who prefer convenience over logistics management.
Submitting Request for Quotation (RFQ)
A well-structured RFQ helps API suppliers with accurate pricing and quick turnaround.
- Product name
- Pharmacopoeia Standard
- Purity & COA Specs
- Quality & batch size
- Packaging requirement
- Shipping preference
- Target Market
- Certification needed
- Payment Terms
Conclusion
The healthcare landscape in India is evolving to offer affordability and scalability. In addition to government support, Indian suppliers are widely accepted in global markets and have a long history of meeting expectations. International buyers can establish long-term trusted partnerships and a sustainable supply chain for GMP-certified APIs by implementing viable sourcing practices.
