Obtaining a Drug License Haryana is a mandatory compliance requirement for businesses involved in the sale, distribution, or manufacture of medicines and pharmaceutical products. Whether you are planning to establish a retail medical store, wholesale drug outlet, or a pharmaceutical manufacturing unit, securing the license under the Drugs and Cosmetics Act, 1940 is the first and most important step. This licence ensures that businesses follow proper standards while dealing with DRUG as a service, maintaining public health and consumer safety.
In this article, we discuss the eligibility criteria, essential documentation, and the timeline involved in receiving a Drug License Haryana, along with how Agile Regulatory can support you throughout the process.
Eligibility Criteria for Drug License in Haryana
Before applying, it is important to review the eligibility requirements. The criteria may slightly vary depending on the category of license such as retail, wholesale, or manufacturing, but the general conditions remain similar:
1. Qualified Pharmacist / Competent Person
For a retail drug licence:
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A registered pharmacist with a valid Haryana Pharmacy Council registration is required.
For a wholesale drug licence:
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A competent person with a degree/diploma in pharmacy or adequate experience as per the rules.
2. Adequate Premises
The premises should meet the minimum area requirements:
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Retail: Minimum 10 sq. meters
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Wholesale: Minimum 15 sq. meters
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Combined retail & wholesale: 15 sq. meters
Proper storage conditions like refrigeration, temperature control, and hygienic setup are mandatory.
3. Proper Infrastructure
Storage conditions for sensitive medicines, presence of refrigerator, air-conditioning if needed, and a clean environment are essential to meet inspection requirements.
Documents Required for Drug License Haryana
A complete set of documents must be submitted online to the Haryana Food & Drugs Administration (FDA). The common documents include:
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Application Form duly filled
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Identity & Address Proof of the proprietor, partners, or directors
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Ownership Proof / Rent Agreement of the premises
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Site Plan & Key Plan of the premises
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Electricity Bill or utility document
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Pharmacist Registration Certificate (for retail licenses)
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Qualification Certificates of the competent person
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Appointment Letter & Joining Letter of the pharmacist/competent person
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Affidavits as per state requirements
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Refrigerator Purchase Bill (if needed)
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Board Resolution (for company applicants)
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Photographs of the premises and applicant
Submitting accurate documents ensures a smoother approval process and avoids unnecessary delays.
Approval Timeline for Drug License Haryana
Once the application is submitted online through the Haryana FDA portal, the approval process generally follows this timeline:
1. Document Review – 3 to 5 Days
Officials verify the uploaded documents for accuracy and completeness. Any discrepancy may lead to a resubmission request.
2. Site Inspection – 5 to 10 Days
A Drug Inspector visits the premises to inspect the infrastructure, storage facilities, equipment, and compliance with regulatory norms.
3. Final Approval – 10 to 15 Days
If the premises satisfy the standards and documents are in order, the authority issues the Drug License Haryana digitally.
Overall Timeline: Approximately 20 to 30 days, depending on the category of license and response to queries, if any.
How Agile Regulatory Helps You Get Drug License Haryana
Agile Regulatory simplifies the entire licensing procedure with expert handling and end-to-end services. Our team manages the documentation, application filing, follow-ups with the Haryana FDA, and preparation for the site inspection. As consultants specializing in DRUG as a service, we ensure that your business complies with regulatory norms without any hassle. We aim to make the licensing process faster, transparent, and convenient for new as well as existing pharma businesses.
Conclusion
Securing a Drug License Haryana is an essential requirement for any business dealing with pharmaceuticals. Understanding the eligibility, preparing the complete documentation, and following the correct procedure ensures a seamless approval process. With professional support from Agile Regulatory, you can obtain your license without delays and start your operations confidently and legally.