Drug License Application Process in Haryana?

Drug License Application Process in Haryana?

The pharmaceutical industry in India has grown quickly in recent years. In states like Haryana, this growth has created many new opportunities for drug manufacturing and retail. But running a pharmacy, wholesaling medicines, or making drugs is not something a person can do freely. You need approval from the authorities. This approval comes in the form of a drug license, and getting one is not just a formality. This is a legal requirement under the Drugs and Cosmetics Act, 1940

For businesses and individuals in Haryana who want to deal with medicines, whether for selling, stocking, distributing, or manufacturing, having a valid drug license is a must. Without it, not only do operations become illegal, but it also puts people’s health at risk. This article gives you a full breakdown of how to apply for a drug license in Haryana

What Is a Drug License?

A Drug License is a legal permit given to individuals or businesses to manufacture, sell, stock, distribute, or import medicines or cosmetics. This license is governed by the Drugs and Cosmetics Act, 1940. In Haryana, the State Drug Control Department grants and monitors these licenses.

The purpose of the license is to ensure that only qualified people handle drugs and that the storage and sale meet safety standards. Without a drug license, handling any pharmaceutical product is a punishable offense.

Who Can Apply for a Drug License?

Not everyone can apply for a drug license. There are conditions you must meet:

• Qualification: For retail licenses, the person must have a degree or diploma in pharmacy. For wholesale licenses, the person must have experience in drug distribution or a related qualification.
• Premises: The premises must be clean and have a minimum area—usually 10 square meters for wholesale or retail, and 15 square meters for combined operations.
• Storage: The place must have facilities like refrigerators and air conditioners for temperature-sensitive drugs.
• Ownership proof: You must show ownership papers or rent agreement of the shop or storage space.
• Business registration: The business must be legally registered under relevant laws like GST, Shops & Establishments Act, or Company Act.

Documents Required for Drug License Application in Haryana

You must submit the correct documents to avoid delays. Here is a list of documents usually required:

For Retail or Wholesale Drug License:

1. Application form in the prescribed format
2. Cover letter with intent to apply
3. Constitution of the business (proprietorship, partnership, company)
4. Proof of premises: rent agreement or ownership deed
5. Site plan and key plan
6. Pharmacist’s qualification and registration certificate (for retail)
7. Experience certificate (for wholesale)
8. Photo ID and address proof of applicant and pharmacist
9. Affidavit regarding non-conviction
10. Electricity bill or water bill of the premises
11. Refrigerator bill or invoice for cold storage drugs
12. Registration with GST or Professional Tax

For Manufacturing License:

1. Detailed site plan and layout of the unit
2. List of machinery and equipment
3. Name and qualification of technical staff
4. NOC from Pollution Control Boar
5. Stability and safety data of drugs to be manufactured
6. Product details and formulations
7. Proof of compliance with Good Manufacturing Practices (GMP)

Steps to Apply for Drug License in Haryana

The drug license application in Haryana can be submitted online through the Haryana FDA portal. Here is the process in simple steps:

Step 1: Register on the Online Portal

Visit the official website of the Food and Drugs Administration (FDA), Haryana. Create an account through a valid email ID and mobile number.

Step 2: Select License Type

After login, choose the type of license you want—retail, wholesale, or manufacturing. Fill in the required information correctly.

Step 3: Upload Documents

Scan and upload all required documents. Make sure the files are clear and in PDF format.

Step 4: Pay the Fees

The portal will show the fee based on the type of license. Pay using the online payment gateway.

Step 5: Inspection of Premises

Once you submit the application, the Drug Inspector will visit the site. The inspector will check:

• Storage conditions
• Space
• Records and registers
• Pharmacist’s presence

Make sure everything is in order before inspection.

Step 6: Approval or Rejection

After the inspection report is submitted, the licensing authority will make a decision. If approved, the license will be issued. If not, you may be asked to make corrections.

How Long Does It Take to Get a Drug License?

If all documents are correct and the inspection goes smoothly, the license is usually granted in 20 to 30 working days. However, delays can happen if:

• The documents are incomplete
• The site is not ready
• There are objections raised during inspection

Final Thoughts

Applying for a Drug License in Haryana is not just about filling a form. It’s about proving that you are capable, qualified, and ready to handle medicines in a safe and legal way. With the right documents, clean premises, and correct understanding of rules, the process becomes much easier.

The Haryana Drug Control Department has made the system more transparent and online. But you still need to take care at each step to avoid mistakes. Whether you are opening a retail medical store or setting up a manufacturing unit, this guide should help you prepare well.