Setting up a wholesale DRUG business in Haryana requires strict adherence to regulatory norms, primarily acquiring a valid Drug License Haryana. The pharmaceutical sector is tightly governed to ensure that medicines reaching the public are safe, genuine, and handled by qualified professionals. Whether you are dealing in allopathic, homeopathic, ayurvedic, or veterinary medicines, obtaining the correct license is the foundation of your operations. This guide covers essential compliance requirements, documents, eligibility criteria, and how Agile Regulatory can support you in a smooth licensing process.
Understanding Drug License Haryana for Wholesale Business
A wholesale DRUG business deals with bulk distribution of medicines to retailers, hospitals, medical institutions, and other healthcare facilities. To operate legally, you must obtain a Drug License Haryana, issued under the Drugs and Cosmetics Act, 1940. In Haryana, licensing is regulated by the Food and Drugs Administration Department (FDA Haryana), ensuring that all wholesale dealers meet prescribed standards for storage, qualification, and documentation.
Types of Drug Licenses for Wholesale Business
For wholesale operations, the following license categories apply:
Wholesale Drug License (WDL) – For selling and distributing pharmaceutical drugs in bulk.
Restricted Wholesale License – For applicants without the required pharmacy qualification but fulfilling other conditions.
Homeopathic or Ayurvedic Wholesale License – For dealing in traditional medicines.
Choosing the correct category depends on the types of products you plan to distribute.
Eligibility Criteria for Wholesale Drug License Haryana
Getting a Drug License Haryana requires meeting specific criteria laid down by the FDA:
1. Qualified Person (QP) Requirement
You must appoint a competent person to supervise drug handling and distribution. The QP must have:
A degree in Pharmacy (B.Pharm)
Or a Diploma in Pharmacy (D.Pharm)
Or at least one year of experience dealing in drugs, in case of a registered practitioner
This is one of the key conditions for a wholesale DRUG license.
2. Premises Requirement
The wholesale premises must meet minimum infrastructure guidelines:
Minimum area of 15 sq. meters
Adequate storage facilities such as racks, cabinets, and proper ventilation
Refrigerator and air-conditioning for temperature-sensitive medicines
Hygienic surroundings and pest control
3. Business Structure
Your business should be legally registered:
Proprietorship
Partnership firm
Private Limited / LLP
GST registration recommended for wholesale transactions
Documents Required for Drug License Haryana
Applicants must submit a complete set of documents to avoid delays. Required documents include:
PAN & Aadhar of owner/partners/directors
Qualification certificates of the pharmacist/QP
Experience certificate (if applicable)
Rent agreement/ownership proof of premises
Site plan & key plan of business premises
Electricity bill and NOC (if rented)
Incorporation documents (for company/LLP)
copyright-size photographs
Refrigerator invoice
Undertaking as per FDA Haryana guidelines
Incomplete documentation is one of the most common reasons for rejection, so ensure all forms are accurate.
Procedure to Obtain a Wholesale Drug License in Haryana
The licensing process involves the following steps:
Step 1: Online Application Submission
Applicants must register on the official portal of FDA Haryana and upload all required documents along with the applicable government fee.
Step 2: Document Verification
The authority reviews the documents to ensure eligibility and compliance.
Step 3: Inspection of Premises
A Drug Inspector visits the premises to verify:
Storage conditions
Qualified person availability
Temperature-controlled equipment
Infrastructure compliance
Step 4: Approval and Issuance
After successful inspection, the Drug License Haryana is granted. The license is generally valid for 5 years.
Key Compliance Requirements After License Issuance
Holding a license is not enough—compliance must continue throughout operations:
Maintain purchase and sales records for all medicines
Ensure the qualified person remains employed full-time
Follow proper storage guidelines and maintain temperature logs
Renew the license on time
Report any changes in premises, partners, or QP to the licensing authority
Failure to comply can result in suspension or cancellation of the license.
How Agile Regulatory Helps You
Agile Regulatory offers expert assistance for obtaining Drug License Haryana for wholesale businesses. From document preparation to online filing and compliance advisory, our team ensures a hassle-free process. With experience in handling DRUG licensing and pharmaceutical regulatory matters, we help businesses avoid delays and meet all statutory obligations effortlessly.
Final Thoughts
Starting a wholesale DRUG business in Haryana requires careful planning and adherence to legal guidelines. Understanding the compliance requirements and getting professional support can make the licensing process much smoother. With reliable partners like Agile Regulatory, businesses can focus on growth while the regulatory work is managed by experts.