Drug License Registration in Delhi - Online Process, Fees & Documents

A drug license is mandatory for selling and manufacturing any kind of pharmaceutical product in Delhi. You could get into serious trouble with the authorities if you don't have one. You must apply for a drug license before opening a pharmacy or Cosmetic store. The requirement of a drug license isn't just limited to a medical store or a pharma store. You need a drug license to manufacture medicines, import medicines and cosmetics from other countries, import medical equipment, and export medicines from India.

Drug and Cosmetics Act 1940 and Rules 1945  made it mandatory for everyone involved in manufacturing, distributing, and selling drugs to obtain a drug license. The Act is intended to increase safety and reduce the number of adverse events associated with medications. It will require pharmaceutical companies to provide detailed information about their products, including ingredients, dosage instructions, and warnings about possible side effects or interactions with other drugs or foods.

This law is important because it protects consumers from unsafe medications and helps ensure that doctors have all the information they need to prescribe.

Drug License Certificate Sample

  • Form-20B
  • Form-21B
Drug License Certificate Sample
Drug License Certificate Sample

How to Apply for Drug License in Delhi?

The online registration process for Drug license application in Delhi is carried out in the following steps:

How to apply for drug license
  • Online application for drug license: Applications must be submitted with all the required information through the Delhi government's online portal at https://drugs.delhi.gov.in/ .
  • Login ID and password: Applicants can get login ID and credentials from the Drug Control Department by submitting a request letter in person at the zonal office.
  • Upload Required Documents : Scanned documents should be uploaded using the ID and password.
  • Approval of drug license: Applicants generally receive a confirmation SMS about the grant of drug license within 45-60 days. A drug license with valid e-signature and official seal is issued to the applicant. Timelines may extend if inspection raises queries, or additional documents are required.
  • Physical inspection by the authority: The documents provided by the applicant will be checked by the inspection authority, and they may also ask for some additional documents as per the requirement.Inspection is typically scheduled within 10-15 working days of application submission .
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Documents Required for Drug License Registration in Delhi

The following documents are required to apply for a Drug License in Delhi.

  • Covering Letter stating purpose of the Application
  • The firm's constitution (MOA & AOA for Company and Partnership Deed for Firm/LLP)
  • For Retail & Wholesale license - Affidavit from the Regd. pharmacist/competent person
  • Property Paper (Registry Deed/ Lease Deed/ POA in case of owned Property)
  • Board Resolution, List of Directors, Certificate of Incorporation (in case of company)
  • The key plan and the site plan of the premises ( Blue Print).
  • One Invoice copy of Refrigerator/ Air conditioner purchased for use
  • Copy of Rent agreement / Rent Receipt (in case of rented premises)
  • ID proof of Directors/ Partners/ Proprietor
  • Non-Conviction Affidavit declaring that the proprietor, partners, or directors of the firm have not been convicted under the Drugs & Cosmetics Act, 1940

Note: All application forms (Form 19/19-A/19-B/19-C) are system-generated from the Delhi Drug licensing portal — applicants cannot use manually prepared forms

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Eligibility for Drug License in Delhi

To obtain a drug license in Delhi, applicants must meet the Delhi Drug Department’s eligibility criteria.

  • For grant of a license in Form 20 or Form 21 (Retail Drug License), the premises area must not be less than 10 sq. Metres
  • For license in form 20-B or 21-B (Wholesale Drug License), the premises are of an area of not less than 10 square meters and
  • For grant of license in Form 20 or Form 21 and Form 20-B or 20-B or both, the premises should be of an area of not less than 15 square meters.
  • Refrigerator & storage facilities
  • For retail license, a registered pharmacist with a B.Pharm or D.Pharm degree, registered with the Delhi Pharmacy Council, must be appointed full-time
  • For wholesale drug license, A person with experience in the drug trade (not necessarily a pharmacist) with minimum qualification of B.Sc. or Pharmacy and 1 year experience
  • Valid rent agreement/ownership proof
  • Clean and hygienic environment
  • For premises located on DDA-allotted residential plots, flats, or buildings, a drug license is not granted unless the premises comply with the Master Plan of Delhi 2021 (MPD-2021).
  • Applicants must provide an affidavit regarding compliance with MPD-2021 along with the conversion charge receipt issued by MCD
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Drug License Registration Fees in Delhi

The total fee for obtaining a Wholesale Drug License in Delhi is ₹35,000, inclusive of GST and government fees. For a Retail Drug License in Delhi, the total fee is ₹40,000, inclusive of GST and government fees.

Type of Drug License Total Fees
Wholesale Drug license Rs. 35,000/-
Retail Drug license Rs. 40,000/-
Manufacturer license Rs. 35,000 /-

Note: The aforementioned fees are inclusive of applicable GST and government charges.

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Documents Required for Drug License Renewal in Delhi

The following documents are required to apply for a Drug License in Delhi.

  • System-generated renewal application form (Form 19 or applicable)
  • Online fee deposit receipt
  • MCD conversion charge receipt with MPD-2021 compliance documents if premises are on commercial road
  • Current pharmacist registration certificate
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Who Issues Drug Licenses in Delhi?

Delhi's Drug Control Department issues drug licenses in Delhi. It is a regulatory department that controls the production of medicines and cosmetics and their sales. Businesses must complete the prescribed drug license registration process before commencing operations, as mandated by the regulatory authority. Delhi State has been split into two divisions to enforce various drug laws. Two Zones make up each Division, which is led by a Drugs Controller.

  • One Division is made up of the North-West Zones, and
  • The other Division is made up of the South-East Zones.

Until January 1986, the Drugs Control Organization was an underlying office under the directorate of health services. After that, The Drugs Control Organization was transformed into a separate Department with the Drugs Controller serving as the Department Head.

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Types of Drug Sale Licenses in Delhi

The type of drug license required depends upon the nature of medicines sold and the mode of business operation. Table given below outlines the applicable application and license forms for different types of drug sale license in Delhi.

Category Sale Type Application Form License Form
Drugs other than those specified in Schedule C&C (1)&X Whole Sale 19 20-B
Retail Sale 19 20
Restricted (General Store) 19-A 20-A
Drugs specified in Schedule C&C (1) but excluding those specified in Schedule ‘X’ Whole Sale 19 21-B
Retail Sale 19 21
Restricted (General Store) 19-A 21-A
Drugs specified in Schedule ‘X’ Whole Sale 19-C 20-G
Retail Sale 19-C 20-F
Sale of Drugs from motor vehicles (1) Drugs other than those specified in Schedule C&C (1) (2) Drugs specified in Schedule C&C (1) Whole Sale 19-AA 20-BB
Whole Sale 19-AA 21-BB R-62-D R
Homoeopathic Medicines Whole Sale 19-B 20-D
Retail Sale 19-B 20-C
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Types of Drug Licenses Registration in Delhi

There are many types of licenses for drugs. They include a manufacturing license, sales license, and loan license. The type of license you need depends on what kind of activity you want to do with your drugs. A sales license is needed if you want to sell your drugs in any way. A loan license is needed if you want to let people use your drugs by borrowing them (for example, from a hospital). And a manufacturing license is needed if you want to make your own drugs or have someone else make them for you (for example, at a factory or pharmacy).

  • Manufacturing Drug License: A manufacturing license is needed to make the drugs in the first place. A manufacturing drug license allows both manufacturing and distribution of drugs at large scales; however, its cost is higher than that of other licenses because it requires more stringent regulatory standards than other licenses do.
  • Wholesale Drug License: A wholesale drug license is a sales license that allows you to distribute medicines and cosmetics at a wholesale price.
  • Retail Drug License: A retail license is required to open and run a medical shop/pharmacy store. For obtaining a retail drug license registration, applicants must comply with the prescribed eligibility criteria and documentation requirements.
  • Loan License: Loan License is an agreement between two Individuals who have been granted the rights by the licensing authority to the applicant who does not have a production facility or any other arrangements for production but can use other’s facilities and infrastructure for manufacturing the device with the mutual consent of Individuals involved. Required documents for loan license include a loan agreement with the principal manufacturer and separate quality control arrangements.
Types of Drug License
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Drug License Validity and Renewal in Delhi

A drug license is valid for five years unless the drug department suspends or cancels it. The renewal can be done by visiting the relevant drug controlling website, entering the drug license number, filling out the renewal application, and submitting the documents along with the prescribed fee for renewal of the drug license.

The renewal process must be initiated at least 90 days (3months) before the license expires. Online National Drugs Licensing System (ONDLS) looks after the renewal process. Failure to renew before the expiry date may attract penalties, including cancellation of the license. Late renewal beyond 6 months may require a fresh application.

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Get Drug License in Delhi with Professional Utilities

Drug license is an essential prerequisite for businesses that are engaged in the business of manufacturing, distribution, and sale of pharmaceutical and cosmetic products. It is an official authorization issued by the concerned authority to ensure the safety and quality assurance of products. Procuring a drug license not only enhances customer confidence but is also important to ensure business growth.

Professional Utilities provides extensive assistance in procuring a drug license in Delhi, thus making the whole process smooth and hassle-free. Be it a retailer, distributor, or manufacturer, we assist you in the whole process of documentation, filing, and coordination with the authorities for procuring a drug license in Delhi. With our extensive network of service locations across the country, we also help businesses in complying with state-specific requirements, including obtaining a drug license in Maharashtra .

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FAQ’s On Drug License Registration in Delhi

Is it necessary to obtain drug license prior to commencement of the drug business?

Yes, before you start any business dealing in drugs, whether it is Allopathic Drugs, Ayurvedic Medicine, Homeopathy or Unani, to manufacture, distribute or sell the drugs It is mandatory to obtain a license as per the nature of business by applying to the controller of the drugs and cosmetics

What are different types of Licenses Issued for the Pharmaceutical Business?

Based on the requirements of the pharmaceutical business, an applicant must apply for the appropriate type of drug license. There are various types of licenses, for example:

  • Drug Manufacturing License
  • Wholesale Drug License
  • Retail Drug License
  • Import of Drugs or Cosmetics
  • Import of Medical Equipment
  • Export of Medicines
Is it true that for grant of a drug license my shop must be located at a commercial premises?

Licenses for the sale of drugs can be granted only at premises which is commercial premises or other premises independent of residence, also known as mixed land use. For this purpose state drug office issues guidance which may be referred to.

How to import Drugs or Cosmetics?

Drugs and Cosmetic Act aims at ensuring safety, effectiveness and conformity of the drugs and cosmetics sold in India to the state quality standards. Drugs or cosmetics of schedule X can be imported into India only after obtaining a License

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