Introduction

A UP Drug License is a legal requirement for businesses involved in the sale, distribution, and manufacturing of pharmaceutical products in Uttar Pradesh. Issued by the Food Safety and Drug Administration (FSDA), Uttar Pradesh, this license ensures compliance with the Drugs and Cosmetics Act, 1940. It plays a crucial role in maintaining the quality, safety, and efficacy of drugs available in the market. 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 the license.

Types of Drug Licenses in Uttar Pradesh

Different types of drug licenses are issued based on the nature of business operations. These include:

1. Retail Drug License (RDL)

This license is required for pharmacies, medical stores, and chemists that sell medicines directly to consumers. It ensures that the sale of drugs is regulated and managed by a qualified pharmacist.

1. Wholesale Drug License (WDL)

Businesses involved in the wholesale distribution of pharmaceutical products require this license. It permits the supply of medicines to retailers, hospitals, and other healthcare facilities.

1. Manufacturing Drug License

Pharmaceutical companies engaged in the manufacturing of drugs must obtain this license. It is issued only to facilities that comply with Good Manufacturing Practices (GMP) as per the Drugs and Cosmetics Act.

1. Loan License

A manufacturer without a production facility can apply for a loan license to use another licensed manufacturer’s facility for producing drugs under its own brand.

1. Import License

Companies or individuals importing medicines and pharmaceutical products from other countries must obtain an import drug license.

Eligibility Criteria for UP Drug License

To apply for a UP Drug License, applicants must fulfill specific eligibility requirements:

Qualified Pharmacist or Competent Person: Retail drug license applicants must have a registered pharmacist, while wholesale businesses require a competent person with relevant experience.

Adequate Business Premises: A minimum area of 10 square meters is required for retail and wholesale businesses, while businesses combining both require at least 15 square meters.

Storage Facilities: Proper storage conditions, including refrigeration and air-conditioning, must be available for temperature-sensitive drugs.

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

Documents Required for UP Drug License

Applicants must submit the following documents to obtain a drug license in Uttar Pradesh:

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

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

Qualification and registration certificate of the pharmacist or competent person

Ownership or rental agreement of business premises

Site layout plan of the premises

Proof of cold storage facilities (if applicable)

Identity and address proof of directors/partners/proprietor

Affidavit of the pharmacist or competent person handling drug sales

No Objection Certificate (NOC) from the local authority (if required)

Application Process for UP Drug License

The UP Drug License application involves several steps:

1. Online Registration

Applicants must register on the official FSDA Uttar Pradesh website and fill out the application form, uploading all necessary documents.

1. Fee Payment

The applicable government fee must be paid online. A payment receipt should be kept for future reference.

1. Inspection by Drug Inspector

A designated drug inspector visits the premises to verify compliance with legal requirements, infrastructure standards, and storage conditions.

1. Approval and License Issuance

Once the inspection is completed and the application is approved, the UP Drug License is issued.

Validity and Renewal of UP Drug License

A UP Drug License is generally valid for five years. To continue operations, businesses must apply for renewal before the expiration date. The renewal process requires the submission of updated documents, renewal fees, and compliance verification.

Common Reasons for Drug License Rejection

Applicants should ensure accuracy and completeness in their applications to avoid rejection. Common reasons for rejection include:

Incomplete or incorrect documentation

Failure to meet premises or infrastructure requirements

Non-compliance with pharmacist or competent person requirements

Incorrect information in the application form

How Agile Regulatory Can Assist

Agile Regulatory provides expert consultancy services to simplify the process of obtaining a UP Drug License. Our services include:

End-to-end support, from documentation to final approval

Compliance guidance to prevent rejections and delays

Coordination with regulatory authorities for smooth processing

Assistance with license renewal and compliance maintenance

Conclusion

Obtaining a UP Drug License is essential for any business dealing with pharmaceuticals in Uttar Pradesh. Ensuring compliance with regulatory requirements and submitting an accurate application can help businesses secure the license without unnecessary delays. With Agile Regulatory’s expert assistance, businesses can navigate the licensing process efficiently and hassle-free. Contact us today to get started with your UP Drug License application!