Drug License In Delhi: Apply, Documents, And Fees
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A drug license is a legal permit provided by competent government regulatory authorities allowing an individual or entity to manufacture, sell, distribute, or import drugs and cosmetics. Acquiring a drug license is mandatory for engaging in any pharmaceutical business. Operating any kind of Pharmaceutical unit without a Drug license in Delhi will cause many legal problems.
The entire process is governed by the Drugs and Cosmetics Act, 1940, and the relevant rules, to ensure that any medicine supplied to the public is safe, efficacious, and of high quality.
The licensing authority is the Central Drugs Standard Control Organisation (CDSCO) for new drugs and imports, and the State Drugs Standard Control Organisation (SDSCO) for the sale and distribution of drugs in a state. The term "Drug" includes Allopathic, Homoeopathic, Ayurvedic, Siddha, and Unani medicines.
Why Is A drug license In Delhi Important?
A drug license is necessary to protect public safety and the reputation of businesses for several reasons:
Legal Compliance
It is a legal requirement that makes it illegal to operate a pharmaceutical firm without a valid license.
Public Safety
By controlling the business, this license system prevents the spread of counterfeit, inferior, and dangerous medications, safeguarding the public's health.
Business Credibility
A legitimate license assures suppliers, medical experts, and consumers that pharmaceuticals are authentic and of high quality, fostering trust and dependability.
Accountability
It ensures that authorities can readily hold the appropriate company accountable when issues arise by offering a legal response mechanism for the pharmaceuticals created and sold.
Prevent Penalties
Licenses shield companies from the severe negative effects of the law, including severe financial penalties, incarceration, and permanent business closure.
Business Growth
Obtaining a license is frequently necessary in order to offer medications to sizable establishments like hospitals, other government health programs, and state public health initiatives, creating substantial business prospects.
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Types Of Drug Licenses In Delhi 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 In-Vitro 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 applying Delhi Drug License online.
Benefits Of Obtaining A Drug License In Delhi
Legal Authorisation
This protects the owner from any legal claims while granting the official authorisation to conduct pharmaceutical business.
Improved Reputation
This shows that the company is upholding compliance and quality standards, which enhances perception among customers 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 record-keeping and storage procedures, guaranteeing the quality of pharmaceuticals.
Business Scalability
Licensing also serves as the foundation for expanding a company by opening more locations or branching out into production or wholesale.
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Get Expert Guidance NowEligibility Criteria For Drug license In Delhi
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 must conform to the National Building Code, 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
Eligibility Criteria for the MD42 license In Delhi
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 Conditionerto 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 Delhi
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.
Personnel 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:
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:
Appointment Letter and Bio-data.
4. Documents Required for the MD-42 License in Delhi
To avoid objections or delays, the following documents must be prepared and uploaded correctly:
1Application & 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
2Premises Documents
Ownership proof (Sale Deed / Conveyance Deed / GPA)
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)
3Storage & Infrastructure Proof
Purchase invoice of Refrigerator (mandatory)
Purchase invoice of Air Conditioner
Undertaking for compliance with storage temperature norms
4Personnel / Authorised Signatory Documents
ID proof (Aadhaar / PAN) of proprietor / partner / director
Authorisation letter for the signatory
Bio-data of the responsible person
5Affidavits
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 Delhi
The application process is now online in most states and follows these steps:
Online Portal Registration
The applicant must first register on the official Delhi 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 dpi, black and white) as per the instructions.
Fee Payment
Pay the prescribed fee via the online portal.
Premises Inspection
After submission of the application, a Drug Inspector will be assigned to conduct a physical inspection of the premises to verify the particulars and ascertain compliance with all of the requirements.
Scrutiny and Grant 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 SMS upon approval or rejection.
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Druglicense.in can ease your Drug license application process with professional guidance. Call now to hire our expert Drug License consultants Delhi.
Application Forms For Sale Licenses
Application Forms For Sale Licenses
| License Purpose | Application Form |
|---|---|
| Retail sale of Allopathic Drugs (not in Sch C, CI, 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
Standard licensing fee
Restricted License
Reduced fee for general stores
License for Schedule X Drugs
(additional)
Manufacturing License
(plus any inspection fees)
Renewal Fee
Same amount as the original license fee
MD-41
The government fee depends on the risk classification of the medical device.
The Renewal Process of Drug License In Delhi
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 used for 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 constitution, premises, or staff during the tenure.
Pay Retention Fee:
The fee is usually equivalent to the fresh license fee.
Validity Extension:
Upon payment and verification, the validity of your drug license certificate is extended in the system. You might not get a new physical paper; the receipt acts as proof of renewal.
Timelines
Processing Time
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 a term of 1-3 years and a fine of at least ₹5,000.
Manufacturing/Selling Adulterated Drugs
The penalties are much more severe 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 in not only 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.
Important Warning
Operating without a valid drug license or selling adulterated drugs can result in severe legal consequences, including imprisonment and heavy fines. Always ensure full compliance with the Drugs and Cosmetics Act, 1940.
Ensure Compliance - Contact UsWhy Choose Us?
Choosing us to register your drug license in Delhi would streamline the application procedure and reduce the likelihood of rejection. You will receive confirmation from us in:
Application for a Drug License
Complete support for obtaining your manufacturing, wholesale, or retail drug license under the 1940 Drugs & Cosmetics Act.
Regulatory Compliance
We make sure your pharmacy or facility complies fully with all operational, record-keeping, and storage regulations.
Documentation Assistance
To ensure a zero-error submission, our professionals will help prepare and verify the necessary affidavits, blueprints, and personnel documentation.
Government Department Coordination
To enable prompt inspections and license applications, we work with the State Drug Control Department.
Renewals & Audit Support
You may feel confident knowing that you are getting timely help for all of your renewals and support throughout regulatory audit procedures to guarantee ongoing compliance.
Ready to Get Started?
Let our expert team handle your drug license application process from start to finish.
FAQs
Frequently asked questions about drug licensing in Delhi
Q1. How to get a drug licence in Delhi?
Ans. Documents required To Obtain Drugs Licence for the manufacturing of drugs
- Application Form.
- Online payment: Fees of Lic. ...
- Declaration Form.
- Proof of Constitution of Firm in case of Partnership / Pvt. ...
- Copy of Resolution passed by Board of Directors.
- Key Plan and Site Plan in Blueprint / Ammonia Print.
Q2. How much does a drug license cost in India?
Ans. The cost of a drug license in India varies by type (retail, wholesale, manufacturing) and state, with basic application costs typically 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.
Q3. What are 20 and 21 in a drug licence?
Ans. In India's drug licensing system, Form 20 is for the retail sale of general allopathic medicines (non-specialised), while Form 21 is for the retail sale of Schedule C & C(1) drugs, which are special medicines like vaccines, insulin, and sera, requiring specific storage and handling. Both are Retail Drug Licenses issued by state authorities for pharmacies selling directly to consumers, with Form 20 for everyday drugs and Form 21 for regulated ones.
Q4. 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 be 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)
Q5. Can I sell medicines without a license?
Yes, you absolutely need a license to sell pharmaceuticals, as it's legally required for manufacturing, distributing, importing, and retail sale of drugs, ensuring safety and quality, with different licenses (like retail or wholesale) depending on the specific activity and jurisdiction, often issued by national and state regulatory authorities.
Q6. How much is the licence fee?
Ans. A "license fee" varies greatly depending on the type of license (driving, business, copyright, etc.) and the jurisdiction (country, state, city); for example, in India, a new driving license is around ₹200-₹300 plus test fees, while a FSSAI food business license costs ₹7500 for a year, and a copyright license for a work can be ₹200-₹2000. To get an accurate cost, you need to specify what license you're asking about and where you are located.
Q7. How many types of drug licenses are there?
Ans. Types of drug licence
Manufacturing Licence: For drug production. Sale Licence: For selling drugs, retail or wholesale. Import Licence: For importing drugs.
Q8. Can a doctor get a drug licence?
Ans. While registered doctors are allowed to stock and dispense medicines to their own patients, they cannot sell drugs for commercial purposes without a license. 🩺 If a doctor's clinic acts like a pharmacy—charging separately for medicines—a drug license is mandatory.