Drug License in Haryana – Complete Guide for 2025

Starting a pharmaceutical business in Haryana—whether it’s a retail pharmacy, wholesale medicine supply, or a drug manufacturing unit—requires compliance with India’s drug regulations. The first and most essential step is to obtain a Drug License from the state’s Drugs Control Department, as mandated under the Drugs and Cosmetics Act, 1940.

📌 What is a Drug License?

A Drug License is an official permit issued by the Drugs Control Department of the state government, allowing an individual or company to legally manufacture, sell, stock, or distribute drugs and cosmetics.

It ensures that the pharmaceutical operations comply with national laws and health safety standards, protecting consumers and ensuring product quality.

🏷️ Types of Drug Licenses in Haryana

Haryana offers different types of drug licenses based on the nature of your business. These include:

Retail Drug License (RDL): Required to open a medical store or pharmacy selling medicines directly to consumers.

Wholesale Drug License (WDL): Required for businesses involved in bulk selling or supply of drugs to retailers, hospitals, or clinics.

Manufacturing License: Required for producing allopathic, ayurvedic, or cosmetic products.

Loan License / Repacking License: Issued when manufacturing is outsourced or for repackaging of drugs under your brand name.

Import License: Required for companies importing drugs or medical products into India.

✅ Who Can Apply for a Drug License in Haryana?

The following criteria must be met to be eligible for a drug license:

Qualified Pharmacist or Competent Person: The applicant must appoint a pharmacist with a D. Pharma or B. Pharma degree or a person with relevant experience as per norms.

Compliant Premises: The premises should have a minimum area of 10 square meters for retail or wholesale and 15 square meters if both are combined.

Storage Facilities: A refrigerator and air conditioner must be installed for storing temperature-sensitive medicines.

Business Registration: The firm must be registered as a proprietorship, partnership, LLP, or private limited company.

📑 Documents Required

The following documents are generally required for applying for a drug license in Haryana:

Aadhaar card and PAN card of the proprietor/partners/directors

Qualification certificate of the pharmacist or competent person

Appointment letter of the pharmacist

Proof of premises ownership (rent agreement or property documents)

Premises layout and site plan

Electricity bill and refrigerator invoice

GST registration certificate

Certificate of incorporation / Partnership deed / MOA & AOA

Affidavit for compliance with the Drugs & Cosmetics Act

Passport-sized photos

💰 Government Fees

License Type Approximate Fee

Retail Drug License ₹3,000 – ₹6,000

Wholesale Drug License ₹5,000 – ₹7,500

Manufacturing License ₹20,000 and above

🔁 Validity & Renewal

Most drug licenses are valid for 5 years.

The license must be renewed at least 30 days before the expiry date. Failure to renew on time may lead to penalties or cancellation of the license.

⚠️ Penalties for Non-Compliance

Operating a drug-related business without a valid license is a punishable offense under Indian law. Penalties may include:

Seizure of stock

Suspension or cancellation of business license

Heavy fines

Legal action or imprisonment

🛠️ Why Choose PSR Compliance?

Getting a drug license in Haryana involves multiple steps, technical documentation, and inspection formalities. At PSR Compliance, we provide complete assistance—from documentation and portal registration to inspection coordination and final approval. Our experienced consultants ensure that you meet all regulatory requirements without delay or hassle.

Whether you're applying for a Retail, Wholesale, or Manufacturing drug license, we help you get licensed legally, efficiently, and with full compliance.

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