How to Get a Drug License in Haryana – Step-by-Step Guide

If you're planning to start a pharmaceutical business in Haryana, obtaining a drug license is not just a formality—it’s a legal requirement. Whether you’re involved in the manufacturing, sale, or distribution of medicines or cosmetics, you must comply with the Drugs and Cosmetics Act, 1940, which mandates proper licensing and regulation to ensure public safety and drug quality.

In this blog, we’ll guide you through everything you need to know about drug license registration in Haryana, including types of licenses, eligibility criteria, required documents, and how PSR Compliance can assist you through the process.

What is a Drug License?

A drug license is an official permit issued by the State Drug Control Department that allows individuals or businesses to manufacture, distribute, or sell drugs and cosmetics in India. It ensures that pharmaceutical activities are carried out in compliance with the law and public health standards.

• Types of Drug Licenses in Haryana

There are several types of drug licenses, depending on the nature of your business:

1. Retail Drug License (RDL)

• For pharmacies or medical shops selling drugs to end consumers.

• Must be supervised by a qualified pharmacist.

2. Wholesale Drug License (WDL)

• For distributors and suppliers selling drugs to retailers or hospitals.

• Requires experience in drug distribution or a degree in pharmacy.

3. Manufacturing Drug License

• For units manufacturing allopathic, ayurvedic, or cosmetic drugs.

• Issued by both state and central drug authorities depending on the product.

4. Loan License

• For those who do not own a manufacturing facility but intend to manufacture using another licensed manufacturer’s plant.

5. Import License

• For importing medicines or raw drug materials from other countries.

Eligibility Criteria for Drug License in Haryana

To apply for a drug license in Haryana, you must fulfill these basic requirements:

• Premises: The minimum area required is 10 square meters for a retail or wholesale license. For combined operations, 15 square meters is necessary.

• Storage Facility: Must have a refrigerator and air conditioner to store temperature-sensitive drugs.

• Qualified Staff:

• Retail License: Requires a full-time registered pharmacist.

• Wholesale License: Requires a person with a degree/diploma in pharmacy or relevant experience.

• Business Registration: Your firm must be registered (as proprietorship, partnership, LLP, or company).

• Compliance: The business should comply with the Drugs and Cosmetics Act, 1940.

Documents Required for Drug License Application

Here is a list of standard documents needed:

• Application form in the prescribed format

• Covering letter with applicant details

• Site plan and key plan of premises

• Rent agreement or ownership proof of premises

• Constitution documents (Partnership Deed / MOA / AOA / LLP Agreement)

• Photo ID and address proof of owner and pharmacists

• Qualification certificate and registration of pharmacist

• Refrigerator bill and electricity bill

• Affidavit for non-conviction of proprietor and staff

• Proof of business registration (GST certificate, incorporation certificate, etc.)

Note: Additional documents may be required based on the type of license.

Steps to Apply for Drug License in Haryana

1. Prepare Documents: Collect and prepare all documents as per the checklist.

2. Online Application: Visit the official Haryana drug license portal and fill out the application form.

3. Fee Payment: Pay the prescribed government fee online.

4. Inspection: A Drug Inspector will visit the premises to verify details.

5. Approval & Issuance: Once verified, the license is issued within 30–45 days.

Validity and Renewal

A drug license is usually valid for 5 years. Renewal must be applied for before the expiry date, along with updated documents and applicable fees. Failing to renew may lead to cancellation or penalties.

Common Reasons for Drug License Rejection

• Incomplete documentation

• Improper premises or lack of infrastructure

• Unqualified staff

• Non-compliance with statutory norms

Avoid delays or rejections by consulting a professional compliance partner like PSR Compliance.

Why Choose PSR Compliance?

At PSR Compliance, we specialize in helping businesses navigate complex government registrations and licensing in India. Our experienced professionals make the drug license process smooth, error-free, and fully compliant with Haryana's drug control laws.

We assist with:

• Document preparation & verification

• Online application filing

• Liaison with Drug Department authorities

• Post-license compliance and renewal

Psr Compliance is a leading consultancy firm specializing in regulatory compliance, certifications, and licensing for businesses across India.