Drug License in Haryana: Apply, Documents And Fees
A drug license is a legal authorisation granted by government regulatory bodies that permits a person or organisation to produce, market, import, or distribute pharmaceuticals, medical devices, and cosmetics. To operate a pharmaceutical firm or medical equipment firm, one must obtain a drug license. Operating any type of pharmaceutical facility without a drug license in Haryana will result in numerous legal issues.
The Drugs and Cosmetics Act of 1940 and the applicable regulations oversee the entire process to guarantee that any medication delivered to the public is high-quality, safe, and effective.
Apply Drug license online Haryana through the expert guidance of Druglicense.in.
Why Drug License in Haryana Important?
A Drug license is important to ensure the safety of the consumers and the reputation of businesses for several reasons:
Legal Compliance
It is against the law to run a pharmaceutical business without a current license.
Public Safety
This licensing system protects the public's health by preventing the distribution of harmful, subpar, and counterfeit drugs.
Business Credibility
A valid license promotes trust and dependability by guaranteeing suppliers, medical professionals, and customers that drugs are genuine and of superior quality.
Accountability
By providing a legal response mechanism for the drugs produced and marketed, it guarantees that authorities can easily hold the relevant corporation accountable when problems develop.
Prevent Penalties
Licenses shield businesses against the harsh consequences of the law, such as hefty fines, jail time, and permanent company closure.
Commercial Growth
Obtaining a license is sometimes required to provide pharmaceuticals to large institutions such as hospitals, other government health programs, and state public health initiatives, hence generating significant commercial opportunities.
Through our professional services drug license Haryana becomes easy and fast to obtain.
Types Of Drug Licenses In Haryana Provided By Us
A variety of different licenses will be required based on the type of pharmaceutical operation. However, these are the types of Drug licenses provided by Druglicense.in:
MD 42 License
A manufacturing license is issued to businesses that manufacture, sell, stock, exhibit, or distribute medical devices, including Diagnostic Devices.
Sale License
A sale license applies to the sale of drugs and is categorised into two main types.
Retail Drug License (RDL):
Required for pharmacies and chemist shops selling medicines directly to consumers.
Wholesale Drug License (WDL):
Needed for distributors selling medication in bulk to retailers, hospitals, or any licensed institution.
Druglicense.in professionals can help you with online application for drug license in Haryana.
Benefits Of Obtaining A Drug License In Haryana
Legal Authorisation
This protects the owner from any legal claims while granting the official authorisation to conduct a pharmaceutical business.
Improved Reputation
This shows that the company is upholding compliance and quality standards, which enhances reputation among clients and business associates.
Market Access
This gives them the chance to participate in tenders for the distribution of medications to government agencies and hospitals, as well as to lawfully obtain and buy medications from approved producers and distributors.
Quality Assurance
Licensing controls proper sourcing and storage procedures, guaranteeing the quality of pharmaceuticals.
Business Scalability
Licensing controls proper sourcing and storage procedures, guaranteeing the quality of pharmaceuticals. Licensing offers the foundation for expanding a company by opening more locations or branching out into production or wholesale.
Eligibility Criteria For Drug license In Haryana
The applicants must meet certain conditions regarding the premises, the storage, and the personnel:
Space Requirement:
For a retail or wholesale license: Minimum of 10 sq. m.
For combined retail and wholesale license: Minimum of 15 sq. m.
Clear height of premises must conform to the National Building Code of India, 2005.
Storage Facility:
The premises must have adequate storage facilities such as a refrigerator and air-conditioner for storing drugs that need special temperature conditions, such as vaccines, sera, and insulin.
Qualified Personnel
For Retail License:
Requires a registered pharmacist who has either a Diploma in Pharmacy (D.Pharm) or Bachelor of Pharmacy (B. Pharm).
For Wholesale License:
Operations must be supervised by a "competent person" who is either a graduate with at least one year of experience in drug sales or an individual with at least four years of experience.
Eligibility Criteria for the MD42 license In Haryana
Eligible Business Entities
The following entities are eligible to apply for an MD-42 License:
Proprietorship Firm
Partnership Firm
Limited Liability Partnership (LLP)
Private Limited Company
Public Limited Company
The entity must be legally registered and possess a valid GST registration.
2. Premises Requirements
The applicant must have a commercial premises approved for medical device storage and distribution.
Minimum area requirement:
Retail / Wholesale Medical Device Unit: Minimum 10 sq. meters
Combined Operations: Minimum 15 sq. meters
The premises must comply with the National Building Code and local municipal regulations.
Clear demarcation of:
Storage area
Dispatch area
Office or administrative area
3. Storage & Infrastructure Requirements
Adequate storage space to prevent damage, contamination, or deterioration of devices.
Mandatory facilities:
Refrigerator (especially for temperature-sensitive devices)
Air Conditioner to maintain a controlled room temperature
Proper shelving, racks, and labelling systems.
Compliance with manufacturer-recommended storage conditions.
4. Personnel / Authorised Person Requirements
Appointment of a Responsible Person / Authorised Signatory to oversee operations.
The person must:
Be authorised through a board resolution or authorization letter
Have adequate knowledge of medical device handling and regulatory compliance
A registered pharmacist is NOT mandatory for the MD-42 License.
5. Device Classification Eligibility
Applicants must clearly identify the risk class of medical devices intended to be handled:
Class A & B: Low to moderate risk (State Licensing Authority)
Class C & D: Moderate-high to high risk (CDSCO – Central Authority)
6. Regulatory & Compliance Conditions
Applicant must not have been convicted under:
Drugs & Cosmetics Act, 1940
Medical Device Rules, 2017
Compliance with:
Storage and distribution norms
Record-keeping and traceability requirements
Willingness to allow inspection by:
Drug Inspector
CDSCO officials (if applicable)
7. Quality & Certification Requirements (If Applicable)
ISO 13485 certification may be required for certain devices.
Additional approvals or test reports may be demanded based on the device's nature.
Documents Required for Drug license In Haryana
The documentation varies according to the kind of license, either for sale (retail/wholesale) or for Medical devices.
1. For Sale Licenses (Retail and Wholesale)
The following documents are usually required in the application (both for retail and wholesale):
Application & Fees: Completed application form (e.g. Form 19 for Allopathic drugs) along with the challan/receipt of fee payment.
Business Entity Documents: Documents related to the firm's constitution, such as the Certificate of Incorporation, MOA, and AOA for a company, or the Partnership Deed for a partnership firm.
Personal Documents: ID and address proof (PAN card, Aadhaar card, etc.) of the proprietor, partners, or directors need to be submitted.
Premises Documents:
Evidence of ownership (such as a sale deed) or a rental/lease agreement for the premises.
Rent Agreement along with the ownership proof of the landlord / Rent Agreement.
Site plan and key plan (blueprint) of the premises.
Evidence of adequate storage facilities, such as the purchase invoice for a refrigerator and air conditioner.
Affidavits:
Affidavit of non-conviction from the proprietor, partners, or directors under the Drugs & Cosmetics Act, 1940.
Affidavit from the employed Registered Pharmacist or Competent Person.
2. Additional Documents for Retail License
In addition to the general documents, you'll need to provide the following documents when applying for a retail license:
Proof of Qualification: Final degree or diploma certificate in Pharmacy (B.Pharm/D.Pharm) along with mark sheets.
Registration Certificate: Valid registration certificate issued by the State Pharmacy Council.
Appointment Letter and Bio-data.
3. Additional Documents for Wholesale License
Documents for the Competent Person are needed for the wholesale license:
Proof of Qualification: Degree or diploma certificate.
Experience Certificate: at least one year of experience for a graduate or four years for a non-graduate in dealing with drugs.
Appointment Letter and Bio-data.
4. Documents Required for the MD-42 License in Haryana
To avoid objections or delays, the following documents must be prepared and uploaded correctly:
1. Application & Business Documents
System-generated MD-42 application form
Challan/receipt of government fee payment
Constitution of the firm:
Company: Certificate of Incorporation, MOA, AOA
Partnership: Partnership Deed.
Proprietorship: Proprietor declaration
GST Registration Certificate
2. Premises Documents
Ownership proof (Sale Deed / Conveyance Deed / GPA) OR
Rent Agreement along with the ownership proof of the landlord / Rent Agreement
Site plan and key plan (layout of premises)
Photographs of premises (storage area, entrance, refrigerator, racks)
3. Storage & Infrastructure Proof
Purchase invoice of Refrigerator (mandatory)
Purchase invoice of Air Conditioner
Undertaking for compliance with storage temperature norms
4. Personnel / Authorised Signatory Documents
ID proof (Aadhaar / PAN) of proprietor / partner / director
Authorisation letter for the signatory
Bio-data of the responsible person
5. Affidavits
Affidavit of non-conviction under the Drugs & Cosmetics Act, 1940
Declaration of compliance with Medical Device Rules, 2017
Undertaking regarding storage and distribution practices
Steps To Apply for A Drug License In Haryana
The application process is now online in most states and follows these steps:
Online Portal Registration:
The applicant must first register on the official Haryana drug licensing portal to obtain a User ID and Password.
Application Filing:
Log in and complete the appropriate online application form.
Document Upload:
Scan and upload the required documents in the specified format (typically 100 sq. black and white) as per the instructions.
Fee Payment:
Pay the prescribed fee online or offline as per the portal's instructions.
Premises Inspection:
After submission of the application, a Drug Inspector will be assigned to inspect the premises. The inspector will verify the physical setup, storage particulars and ascertain compliance with all of the requirements.
Scrutiny and Issue of License:
Once the inspector issues a satisfactory report and all documents have been assessed, the Drug Controller will approve the application and issue the drug license. Applicants will often be informed of the outcome via email or upon logging into the portal.
Application Forms For Sale Licenses
| License Purpose | Application Form |
|---|---|
| Retail sale of Allopathic Drugs( not in Sch C, Cl, X) | Form 19 |
| Retail Sale of Restricted Allopathic Drugs | Form 19A |
| Wholesale of Allopathic drugs (not in Sch C, C1, X) | Form 19 |
| Retail Sale of Homoeopathic medicines | Form 19B |
| Retail Sale of Drugs in Schedule C&C (1) | Form 19 |
| Wholesale of Drugs in Schedule C&C (1) | Form 19 |
| Retail or Wholesale sale of Drugs in Schedule X | Form 19-C |
Application Form for Medical Device License
| License Purpose | Application Form |
|---|---|
| Sale / Stock / Distribution of Medical Devices | MD-41 |
| Grant of License for Medical Devices | MD-42 |
Fee Structure For Drug License
Government fees for a drug license vary depending on the type of license. The approximate fee structure is:
Retail or Wholesale License: ₹3,000.
Restricted License (for general drugs): ₹1,000.
License for Schedule X Drugs: ₹500 (additional).
Manufacturing License: ₹7,500 (plus any late inspection fees).
Renewal Fee: Same amount as the original license fee.
MD-41: The actual fees may depend on the risk classification of the medical device.
The Renewal Process Of Drug License In Haryana
If you miss the expiry date, you have to pay a late fee. If you delay too long (usually 6 months post-expiry), the license is cancelled, and you have to apply for a fresh one—a nightmare scenario involving fresh inspections.
Step-by-Step Drug Licence Renewal Online:
Log in to the Portal: Use the same user ID as the initial application.
Select 'Renewal': Click on the link for drug licence renewal online against your license number.
No-Change Affidavit: You generally need to upload an affidavit stating there has been no change in the constitution, premises, or staff during the tenure.
Submit Renewal Fee: Pay the renewal fee online.
Validity Extension: Upon payment and verification, the validity of your drug licence certificate is extended in the database. You might still have to make a physical visit to collect the new receipt acts as proof of renewal.
Depending on Druglicense.in can be a hassle-free process, which can become easy with the help of professional assistance. We make sure that you never miss a license applying process or renewal date.
Timelines
It usually takes between 30 and 60 days to get a drug license after applying, depending on the completion of documentation and the inspection schedule.
Penalties
If drugs and cosmetics are not in compliance with the Indian Drugs and Cosmetics Act of 1940, serious penalties will apply:
Selling Drugs Without a License:
This is a punishable offense which can lead to imprisonment for 1 year and a fine of at least ₹5,000.
Manufacturing/Selling Adulterated Drugs:
The penalties for these types of offences:
Selling adulterated drugs has a 1-3 year imprisonment and a minimum fine of ₹1 lakh.
Death or serious bodily injury by an adulterated drug has a minimum punishment of 10 years or life in prison, and a minimum fine of ₹10 lakh.
Other Consequences:
Non-compliance can also result not only in the confiscation of the entire stock of medicines, but there may be heavy penalties, permanent cancellation of the license and total restriction from carrying on any pharmaceutical business.
Why Choose Us?
Selecting us to register your Haryana drug license would expedite the application process and make the entire process hassle-free. We will send you a confirmation in:
Application for a Drug License:
Full assistance for acquiring a 1940 Drugs & Cosmetics Act production, wholesale, or retail drug license.
Adherence to Regulations:
We ensure that all operating, record-keeping, and storage requirements are met by your pharmacy or facility.
Support for Documentation:
Our experts will assist with preparing and verifying the required affidavits, blueprints, and personnel data to guarantee a zero-error submission.
Coordination with Government:
We collaborate with the Haryana State Drug Control Department to facilitate timely license applications and inspections.
Renewals & Audit Support:
You can rest easy knowing that you will receive prompt assistance with all of your renewals and support during regulatory audit procedures to guarantee continuous compliance throughout the year.
Ready to Get Started?
Let our expert team handle your drug license application process from start to finish.
FAQs
Q1.How to apply for a drug licence in Haryana?
Ans. Steps to Apply for a Drug License in Haryana
Step 1: Register on the Online Portal. Visit the official website of the Food and Drugs Administration (FDA), Haryana.
Step 2: Select License Type. ...
Step 3: Upload Documents. ...
Step 4: Pay the Fees. ...
Step 5: Inspection of Premises. ...
Step 6: Approval or Rejection.
Q2. Who is eligible for a drug license in India?
Ans. This license is issued to pharmacies selling drugs to consumers. Qualified Pharmacist: The applicant must have a registered pharmacist with a valid registration under the State Pharmacy Council. Premises Area: The pharmacy premises must have a minimum area of 10 square meters (approximately 107 square feet).
Q3. What is the cost of a drug license in India?
Ans. The cost of a drug license in India varies by type (retail, wholesale, manufacturing) and state, with basic application fees often ranging from ₹1,500 to ₹3,000 for sales licenses and ₹5,000+ for manufacturing, plus potential consultant fees (₹10,000-₹60,000) and inspection costs, with licenses typically valid for five years.
Q4. What is the validity of a drug license in Haryana?
Ans. Most drug licenses are valid for 5 years from the date of issuance, subject to timely renewal.
Q5. Is GST registration compulsory for drug license application?
Ans. Yes. GST registration is mandatory for applying for any retail, wholesale, or manufacturing drug license in India.
Q6. Can a single premises have both retail and wholesale drug licenses?
Ans. Yes. A combined retail and wholesale license can be issued if the premises area is at least 15 square meters and all conditions conditions are met.
Q7. How long does it take to get a drug license in Haryana?
Ans. It typically takes 30 to 60 days to obtain a retail or wholesale drug license in Haryana, depending on document accuracy and inspection scheduling. Manufacturing licenses take longer, usually 4-6 months.
Q8. Is online application mandatory for a drug license in Haryana?
Ans. Yes. Haryana follows a fully online application process through the Food and Drugs Administration (FDA) Haryana portal. Physical submissions are not accepted.