UP Drug License: Everything You Need to Know

Introduction

The Uttar Pradesh Drug License is a mandatory approval for businesses engaged in the manufacturing, distribution, and sale of pharmaceutical products in the state. Governed by the Drugs and Cosmetics Act, 1940, the license ensures that all drug-related activities comply with regulatory standards, safeguarding public health. Whether you are a retailer, wholesaler, or manufacturer, obtaining a drug license is essential for legal operations. In this article, we will cover the types of drug licenses, eligibility criteria, required documents, application procedures, and how Agile Regulatory can help streamline the process.

Types of Drug Licenses in Uttar Pradesh

Depending on the nature of business operations, different types of drug licenses are issued:

1. Retail Drug License (RDL)

Required for pharmacies and medical stores that sell medicines directly to consumers. Hospital pharmacies and chain drugstores also need this license.

2. Wholesale Drug License (WDL)

Mandatory for businesses engaged in the wholesale distribution of pharmaceutical products. This license permits the supply of medicines to retailers, hospitals, and dispensaries.

3. Drug Manufacturing License

Issued to pharmaceutical manufacturers who produce drugs for commercial sale. The facility must comply with Good Manufacturing Practices (GMP) and regulatory standards.

4. Loan License

This license is granted to businesses that manufacture pharmaceutical products using another licensed manufacturer’s facilities.

5. Import License

Required for entities involved in importing drugs and pharmaceutical products into India.

Eligibility Criteria for UP Drug License

Businesses applying for a drug license in Uttar Pradesh must meet the following eligibility requirements:

• Qualified Pharmacist or Competent Person: Retail drug licenses require a registered pharmacist, while wholesale licenses need a competent person with a relevant qualification.

• Minimum Area Requirements: Retail businesses must have at least 10 square meters of space, while wholesale establishments require at least 15 square meters.

• Storage Facilities: The premises must have appropriate storage conditions, including refrigeration for temperature-sensitive drugs.

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

Documents Required for UP Drug License

The list of documents required for obtaining a drug license varies based on the type of license. Common documents include:

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

• Business registration certificate (GST, Incorporation Certificate, etc.)

• Pharmacist’s qualification certificate and State Pharmacy Council registration

• Ownership or rental agreement of business premises

• Storage facility details and proof of cold storage (if applicable)

• Affidavit of the responsible pharmacist or competent person

• Site layout plan of the premises

• Identity and address proof of the owner(s) or directors

• NOC from the local municipal authority (if applicable)

Application Process for UP Drug License

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

1. Online Application Submission

The applicant must visit the Food Safety and Drug Administration (FSDA) Uttar Pradesh portal and submit the application along with scanned documents.

2. Government Fee Payment

The prescribed application fee must be paid online, and the payment receipt should be kept as proof.

3. Inspection by Drug Inspector

A designated drug inspector will inspect the premises to verify compliance with infrastructure and storage requirements.

4. Approval and License Issuance

Once the inspection is successfully cleared, the regulatory authority processes the application and issues the license.

Renewal and Validity of UP Drug License

A UP Drug License is typically valid for five years. To ensure uninterrupted business operations, it must be renewed before its expiry. The renewal process requires an updated application, payment of renewal fees, and submission of relevant documents.

Reasons for Drug License Application Rejection

Common reasons why a drug license application may be rejected include:

• Incomplete or incorrect documentation

• Failure to meet the infrastructure requirements

• Lack of a qualified pharmacist or competent person

• Discrepancies in the application details

To avoid rejection, applicants must ensure all requirements are met and provide accurate information.

How Agile Regulatory Can Help

Agile Regulatory specializes in assisting businesses in obtaining their UP Drug License without hassles. Our services include:

• Comprehensive documentation support to ensure accuracy and compliance

• Guidance on meeting regulatory standards to prevent application rejection

• Coordination with authorities for inspections and approvals

• Assistance with license renewal to maintain uninterrupted business operations

Conclusion

Securing a UP Drug License is a crucial step for businesses involved in pharmaceuticals. Compliance with regulatory requirements ensures smooth business operations and legal protection. With expert guidance from Agile Regulatory, applicants can navigate the licensing process efficiently and avoid unnecessary delays. Contact us today for expert assistance with your UP Drug License application!