UP Drug License: A Comprehensive Guide

[Agile Regulatory]

Introduction

A UP Drug License is a legal requirement for businesses involved in the sale, distribution, and manufacturing of pharmaceutical products in Uttar Pradesh. The license is issued by the Food Safety and Drug Administration (FSDA), Uttar Pradesh, under the Drugs and Cosmetics Act, 1940. This guide provides a detailed overview of the types of drug licenses, eligibility criteria, application process, required documents, and how Agile Regulatory can assist in obtaining a UP Drug License efficiently.

Types of Drug Licenses in Uttar Pradesh

The UP Drug License is categorized based on the type of pharmaceutical business:

1. Retail Drug License (RDL)

Issued to pharmacies, chemist shops, and hospital dispensaries that sell medicines directly to consumers.

2. Wholesale Drug License (WDL)

Required for businesses engaged in the wholesale distribution of pharmaceutical products to retailers and hospitals.

3. Manufacturing Drug License

Issued to pharmaceutical manufacturers involved in the production of medicines. The facility must comply with Good Manufacturing Practices (GMP) under the Drugs and Cosmetics Act.

4. Loan License

Issued to manufacturers who use another licensed manufacturer’s facility to produce medicines under their brand.

5. Import License

Required for businesses importing pharmaceutical products from foreign countries.

Eligibility Criteria for UP Drug License

To qualify for a drug license in Uttar Pradesh, applicants must meet the following requirements:

• Qualified Pharmacist: For a retail drug license, the applicant must be a registered pharmacist or have a competent person with a pharmacy degree.

• Business Premises: The premises should have a minimum area of 10 square meters for retail and 15 square meters for wholesale drug businesses.

• Storage Facilities: The facility must include refrigeration and temperature-controlled storage for medicines.

• Registered Business Entity: The applicant must have a registered business entity, such as a proprietorship, partnership, or private limited company.

Documents Required for UP Drug License

Applicants must submit the following documents for a UP Drug License:

• Duly filled application form (Form 19, 19A, or relevant forms)

• Business registration proof (GST certificate, company incorporation certificate, etc.)

• Pharmacist’s qualification certificate and State Pharmacy Council registration

• Proof of ownership or rental agreement of premises

• Storage facility details (including refrigeration for temperature-sensitive drugs)

• Affidavit of the pharmacist or competent person

• Layout plan of the business premises

• Identity and address proof of directors or partners

• NOC from the local municipal authority (if applicable)

Application Process for UP Drug License

The process for obtaining a drug license in Uttar Pradesh involves the following steps:

1. Online Registration

Applicants must register on the FSDA Uttar Pradesh website and submit an online application along with scanned documents.

2. Payment of Fees

A prescribed government fee must be paid online, and the receipt should be retained for reference.

3. Inspection by Drug Inspector

The FSDA assigns a drug inspector to visit the premises and verify the infrastructure, documentation, and storage conditions.

4. Approval and Issuance of License

Once the inspection is cleared, the FSDA processes the application, and the drug license is issued.

Validity and Renewal of UP Drug License

The UP Drug License is generally valid for five years. License holders must apply for renewal before expiry to continue operations without disruption. The renewal process involves submitting an updated application and prescribed fees.

Common Reasons for Drug License Rejection

To avoid rejection, applicants must ensure accuracy and completeness in their application. Common reasons for rejection include:

• Incomplete or incorrect documentation

• Non-compliance with infrastructure requirements

• Absence of a qualified pharmacist or competent person

• Providing false information in the application form

How Agile Regulatory Can Help

Agile Regulatory simplifies the process of obtaining a UP Drug License by offering:

• End-to-end support, from document preparation to final approval

• Regulatory compliance guidance to prevent application rejections

• Assistance with government coordination for inspections and approvals

• Hassle-free renewal services to ensure business continuity

Conclusion

Obtaining a UP Drug License is crucial for businesses dealing with pharmaceutical products in Uttar Pradesh. Compliance with FSDA regulations ensures smooth operations and legal security. Agile Regulatory provides expert assistance to streamline the licensing process, helping businesses obtain approvals without unnecessary delays. Contact us today to get started with your UP Drug License application.