UP Drug License in Uttar Pradesh: A Complete Guide

Introduction

A UP Drug License is a mandatory requirement for businesses engaged in the sale, distribution, and manufacturing of pharmaceuticals in Uttar Pradesh. It is issued by the Food Safety and Drug Administration (FSDA), Uttar Pradesh, under the Drugs and Cosmetics Act, 1940. The license ensures that medicines and pharmaceutical products meet quality standards and are sold through authorized entities. This guide provides a detailed overview of the UP Drug License, its types, eligibility, application process, documentation, and how Agile Regulatory can assist businesses in obtaining it smoothly.

Types of Drug Licenses in Uttar Pradesh

The type of drug license required depends on the nature of the pharmaceutical business. The key categories include:

1. Retail Drug License (RDL)

Issued to medical stores, pharmacies, and hospital dispensaries for selling medicines directly to customers.

2. Wholesale Drug License (WDL)

Required for businesses that supply medicines in bulk to retailers, hospitals, and clinics.

3. Manufacturing Drug License

Mandatory for pharmaceutical companies involved in the manufacturing of drugs and medicines.

4. Loan License

Granted to entities that manufacture drugs in another company’s facility under their own brand name.

5. Import License

Required for businesses importing drugs and medicines from foreign countries.

Eligibility Criteria for UP Drug License

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

• Qualified Personnel: Retail pharmacies require a registered pharmacist, while wholesale businesses must have a competent person with relevant experience.

• Premises Requirement: Retail drug stores need a minimum of 10 sq. meters, and wholesale drug stores require at least 15 sq. meters of space.

• Storage Facilities: The facility should include cold storage equipment such as refrigerators and air conditioning for temperature-sensitive medicines.

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

Documents Required for UP Drug License

To apply for a drug license, the following documents are typically required:

• Application form (Form 19, 19A, or as applicable)

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

• Pharmacist’s qualification certificate and State Pharmacy Council registration

• Ownership/rental proof of business premises

• Storage facility details and proof of temperature control measures

• Affidavit confirming pharmacist’s or competent person’s responsibility

• Blueprint of the premises layout

• Identity and address proof of the proprietor, partners, or directors

• NOC from municipal authorities (if applicable)

Step-by-Step Application Process for UP Drug License

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

1. Online Registration

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

2. Payment of Fees

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

3. Inspection by Drug Inspector

A drug inspector will visit the business premises to verify storage conditions, infrastructure, and documentation.

4. Approval and License Issuance

If all requirements are met, the application is approved, and the drug license is issued.

Validity and Renewal of UP Drug License

A UP Drug License is typically valid for five years. Businesses must apply for renewal before its expiration to avoid operational disruptions. The renewal process involves submitting updated documents and paying the prescribed renewal fee.

Common Reasons for Drug License Rejection

To avoid rejection, applicants must ensure their application is complete and meets all regulatory requirements. Common reasons for rejection include:

• Incomplete or incorrect documentation

• Non-compliance with premises and storage requirements

• Failure to appoint a qualified pharmacist or competent person

• Providing misleading or incorrect information in the application

How Agile Regulatory Can Help

Agile Regulatory provides end-to-end assistance in obtaining a UP Drug License, ensuring a smooth and hassle-free process. Our services include:

• Guidance on regulatory compliance to prevent application errors and delays

• Assistance with documentation and application submission

• Coordination with FSDA authorities for inspections and approvals

• Renewal support to maintain continuous compliance

Conclusion

A UP Drug License is a crucial regulatory requirement for businesses involved in pharmaceuticals in Uttar Pradesh. Understanding the eligibility criteria, application process, and documentation is essential to secure the license without delays. With Agile Regulatory’s expert assistance, businesses can navigate the licensing process effortlessly and ensure full compliance with state regulations. Contact us today to get started on your UP Drug License application!