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FDA License Cost Breakdown for Wholesalers, Retailers & Manufacturers

  • dsouzaemily64
  • 10 hours ago
  • 2 min read
FDA License Cost Breakdown for Wholesalers, Retailers & Manufacturers
FDA License Cost Breakdown for Wholesalers, Retailers & Manufacturers

What is an FDA License in India?

Under the 1940 Drugs and Cosmetics Act, the State Drug Control Department grants FDA (Food and Drug Administration) licenses. The authorization allows people or organizations to manufacture, distribute, and sell medications, cosmetics, and medical equipment.


The type of company will determine which categories the license falls under, such as:

  • Wholesale Drug License

  • Retail Drug License

  • Manufacturing License

FDA License Cost in India – Category-Wise Breakdown

Wholesale Drug License Cost

  • Application Fee: ₹3,000 (Form 20B and/or 21B)

  • Inspection Fee: ₹500 – ₹2,000 (varies by state)

  • Total Approximate Cost: ₹4,000 – ₹7,000

  • Professional/Consultant Fee (if availed): ₹5,000 – ₹15,000

  • State Variation: Maharashtra, Karnataka, and Delhi may have additional stamp duty or digital service fees.

Retail Drug License Cost

  • Application Fee: ₹3,000 (Form 20 and/or 21)

  • Inspection Fee: ₹500 – ₹1,500

  • Total Approximate Cost: ₹3,500 – ₹6,000

  • Additional Cost (for premises setup & pharmacist salary): Variable

Manufacturing Drug License Cost

  • Application Fee: ₹6,000 – ₹10,000 (Form 25, Form 28, depending on the product)

  • Site Inspection Fees: ₹5,000+

  • Laboratory Equipment Cost: ₹50,000+

  • Consultancy Charges: ₹25,000 – ₹1,00,000+ (based on scale)

Documents Needed for FDA License

  • Application Form (based on license type)

  • ID & Address Proof of proprietor/partners

  • Rent agreement or ownership proof of premises

  • Site plan/layout of the premises

  • Affidavit from registered pharmacist (for retail)

  • Qualification certificates

  • Cold storage details (if applicable)

  • GST and other trade registrations

FDA Certificate Cost in India

  • State regulations

  • Type of license

  • Business turnover

  • Technical staff availability

  • Infrastructure & storage conditions

Final Thoughts

Understanding the FDA license cost breakdown is essential for setting up a compliant pharmaceutical or healthcare business in India. While government fees are relatively fixed, the overall cost may increase depending on documentation, technical setup, and location.

 
 
 

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