How Companies in Kenya Can Source Pharma Products & CDMO Services from India

Kenya has become one of Eastern Africa's leading pharmaceutical markets. The ongoing growth in the number of chronic illness, an increase in the size of the population, and the growth of private healthcare services will increase the demand for high-quality and affordable drugs.

Kenyan distributors, importers, hospitals, pharmacies and government procurement agencies all rely upon India as their primary source of pharmaceutical supplies. India has the advantage of a lower cost structure, good manufacturing practices, large selection of products and a history of working with Kenya to meet their regulatory and compliance needs.

The purpose of this information guide is to show how Kenyan pharmaceutical buyers can efficiently, securely and economically procure pharmaceuticals, OPs, injectables, APIs, off-the-shelf products and CDMO services from suppliers in India.  (Read: Why global pharma companies choose India for CDMO)

Why Kenyan Companies Choose India for Pharma Sourcing

1. WHO-GMP Manufacturers With Proven Quality

Indian manufacturers hold certifications like:

• WHO-GMP
• USFDA
• EU-GMP
• MHRA
• PIC/S compliance

This ensures products meet Kenya’s quality expectations, especially for essential medicines.

2. Competitive and Transparent Pricing

With prices ranging 30% - 60% lower than many foreign suppliers in India, Kenyan companies will have a cost advantage over competitors on tenders and will remain price competitive in retail markets.

3. Broad Product Availability

India exports almost every medicine class needed in Kenya, including:

• Antibiotics
• Antimalarials
• Diabetes & hypertension therapy
• Pediatric formulations
• Gastrointestinal medicines
• Oncology (selected injectables)
• OTC and nutraceuticals

4. Familiarity With PPB (Pharmacy & Poisons Board) Requirements

Indian exporters understand:

• Dossier needs
• Stability data
• Labeling rules
• Artwork approvals
• Import permit procedures

This reduces regulatory friction.

5. Reliable Supply Chain & High Capacity

India provides a continuous stream of volume of essential pharmaceutical products and chronic medications required by the Kenyans. (Read: How Indian CDMOs Comply with USFDA, EU-GMP, and WHO-GMP Standards)

What Kenya Commonly Sources From India

1. Finished Pharmaceutical Formulations

• Tablets, capsules, syrups, suspensions
• Pediatric medicines
• Pain management drugs
• Antibiotics and anti-infectives
• GI & cardiovascular medicines

2. APIs for Local Manufacturing

Kenyan manufacturers often import APIs for local production, including:

• Metformin
• Diclofenac
• Omeprazole
• Azithromycin
• Cefuroxime

3. Injectables

India supplies:

• Small volume parenterals
• IV antibiotics
• Oncology injectables
• IV fluids and electrolyte solutions

4. OTC, Wellness, and Herbal Products

Growing demand includes:

• Vitamins
• Immunity supplements
• Herbal remedies
• Sports nutrition

5. Hospital & Medical Consumables

• Syringes
• IV sets
• Cannulas
• Bandages
• Gloves

Step-by-Step: How Kenyan Companies Can Source From India

Step 1: Define Requirements Clearly

Prepare details such as:

• Molecule name
• Strength & dosage form
• Pack size
• Monthly/annual volumes
• Registration requirement
• Private label needs (if any)

Step 2: Shortlist WHO-GMP Indian Manufacturers

Choose suppliers with:

• Prior Kenya export experience
• Strong compliance documentation
• Reliable supply history

Step 3: Request Product & Regulatory Documents

Key files include:

• Certificate of Analysis (COA)
• GMP certificate
• COPP
• Stability data
• Batch manufacturing records
• CTD dossier (if registering a product)

Step 4: PPB Registration (If Required)

Kenya’s Pharmacy & Poisons Board may require:

• CTD/ACTD dossier
• Samples for testing
• Artwork approval
• Stability zone IVB data
• API source documentation

Step 5: Agree on Commercial Terms

Discuss:

• MOQ
• Price (FOB/CIF)
• Payment terms
• Packaging
• Delivery schedules

Step 6: Plan Logistics & Shipping

Choose air freight (fast) or sea freight (economical) depending on urgency and volume. (Read: Explore top Indian CDMO manufacturers)

Logistics From India to Kenya

Logistics plays an important role in ensuring consistent and compliant supply. India has excellent connectivity to Kenya’s main ports and airports.

Major Indian Export Hubs

• Mumbai (JNPT / Nhava Sheva)
• Mundra
• Chennai
• Hyderabad & Delhi airports

Shipping Timelines

Air Freight:

• 3–6 days (Mumbai → Nairobi)
• Ideal for injectables, biologics, and emergency supplies

Sea Freight:

• 18–30 days (Nhava Sheva/Mundra → Mombasa)
• Best for large-volume orders (tablets, capsules, syrups)

Cold-Chain & Temperature Control

India supports:

• 2–8°C cold chain
• -20°C frozen shipping
• Controlled ambient (15–25°C)
• Temperature loggers inside shipments

Legal & Regulatory Overview (Kenya – PPB)

Kenya has a defined regulatory pathway for pharmaceutical imports under the Pharmacy & Poisons Board (PPB).

Product Registration Requirements

A typical PPB submission includes:

• CTD/ACTD dossier
• GMP certificates
• API information
• Stability data
• Samples for quality testing
• Local agent/technical representative

Fast-Track Options

For essential medicines, PPB may fast-track approvals, especially if:

• WHO prequalified
• EU-GMP/USFDA approved
• Already registered in peer African markets

Packaging & Labeling Rules

Labels must include:

• Batch number
• Manufacturing & expiry dates
• Storage conditions
• PPB-approved artwork
• Manufacturer details

India has mechanisms that are powerful to resolve such problems.

✅ Best Practices for Kenyan Buyers

• Work with suppliers that have CIS export experience
• Request GMP and last audit report
• Review dossier quality before registration
• Clarify artwork expectations in advance
• Use dual sourcing for critical medicines
• Plan procurement early to avoid delays

These steps help build long-term and stable India-Kenya pharma partnerships.

As Kenya’s most reliable source of pharmaceuticals, India provides WHO-GMP-certified product quality, extensive regulatory understanding, competitive pricing and a large manufacturing capacity to support the health care needs of Kenya across its entire spectrum of medications, including essential medications, APIs, injectables and CDMO services.

By sourcing pharmaceuticals in India, Kenyan companies can reduce supply chain costs, improve product availability, and build a strong stable supply chain with respect to the medications needed by their patients across the country.