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
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:
- Login ID and password: Applicants can get a Login ID and password by giving a request letter in person with the details of the firm.
- Online application for drug license: All the information must be filled in correctly and precisely to avoid rejection.
- Upload Required Documents : Scanned documents should be uploaded using the ID and password.
- 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.
- Approval of drug license: You will receive a confirmation SMS about the grant of your drug license. After that, you will receive the drug license with a valid e-signature and official seal.
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
- Incase of Retail License: Registered Pharmacist's degree certificate, Registration certificate with State Pharmacy Council and Appointment Letter and Bio-data.
- Incase of Wholesale License: Competent person's degree certificate, Experience Certificate in medicine job and Appointment Letter and Bio-data.
- For Manufacturing: List of Technical Staff and their proof of Education Qualification, Experience Certificate, Biodata, Appointment Letter, three photographs.
- For manufacturer: Affidavit of Non Conviction, List of Equipment and Machineries for manufacturing and List of Equipment Provided for Testing
Drug License Registration Fees in Delhi
The drug license fees in Delhi is ₹39,999 for a wholesale drug license, ₹49,999 for a retail drug license (Medical store/ pharmacy shop), and ₹99,999 for a manufacturing drug license.
It takes around 45-60 days for approval. The above cost includes document preparation, online application, and assistance in the inspection by the authority.
| Type of Drug License | Total Fees |
|---|---|
| Wholesale Drug license | Rs. 39,999/- |
| Retail Drug license | Rs. 49,999/- |
| Manufacturer license | Rs. 99,999/- |
Note: The aformentioned Fees is exclusive of GST.
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.
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.
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.
It must be renewed before the expiration date. A new drug license will be issued by the Drugs Controller when you apply for your drug license renewal.
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 .
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
Speak Directly to our Expert Today
Reliable
Affordable
Assured
.svg)
