Drug License

 

For dealing in medicines and cosmetics

 

State wise registrations

 

Simple & Secure Online Process

 

Dedicated Professional

 

Hassle Free Process

 

Get License in 25-30 days

 

Introduction

Drug License is a permission from the government to deal with drugs, medicines and cosmetics. Drug License is issued by State Department, the business operating in two or more states are required to apply for drug License for each state in which the business is being carried on. It is important to take drug license in order to manufacture or deal in trading of the same. The license assures that the drugs are used in prescribed ratio as to be used for human or animal consumption.

Drug License also includes Ayurvedic and Unani drugs. Once the license is granted by the department, all the conditions in respect of the same shall be carried out during the course of business. If there are any changes and modifications, it should be informed to the authorities. The License can be issued for manufacturing, retail and wholesale of medicines and cosmetics. Drug license is issued subject to certain conditions attached to premises and the competent person who shall be dealing with drugs.

Legal Window will provide you all the necessary services relating drug license registration and also guide for other related compliances. You may get in touch with our team on 072407-51000 or email admin@legalwindow.in for obtaining drug license.

Advantages of Drug License

Drug license gives the permission to the dealer for sale, resale, market, manufacture, trade, etc. of drug and cosmetics.



Without drug license, one cannot do its pharmacy business or even start to associate with any dealings without having drug license.


Drug license also ensures that the drug and goods are not being misused or abused by any individuals



Dealing with drugs and cosmetics without a drug license is a cognizable offence. Every business person in the pharmacy industry needs to have drug incense to carry out their day-to-day business work.

Requirements for obtaining Drug License

Proper storage facility: Medicines and vaccines require proper cold storage facility. Therefore, a person dealing with it requires full storage facilities like air conditioners, refrigerators for the pharmacy business to obtain a drug license.

Proper area for setting up a pharmacy business: for opening a retail pharmacy or medical shop you will require minimum 10 square meter area and if your business is of retail and wholesale both, you will require minimum 15 square meter of land to obtain the license as per the rules and regulations of the drugs and cosmetic act.

Technical staff recruitment: The drug must be supervised the registered pharmacist which is graduated with the experience of at least one year in drug dealing or individual who is SSLC passed with at least four years of experience in drugs dealing.

Documents Required for Drug License

MOA and AOA of company

ID proof of proprietor/partner or director

Business Premises Proof

Site Plan and key plan of the premises

Bio data along with an appointment letter.

Refrigerator invoice and its details

Experience certificate (if any).

Additional wholesale documents for wholesale drug license.

Affidavit with regard of compliance of MPD 2021 (if premises are located on DDA residential flat/ plot/ building)

Sole proprietor, partners or directors Qualification proof in form of degrees, certificates or mark sheets.

The certificate of registration with state council depending upon the region

Receipts of refrigerator and air conditioner use for storage purpose.

Process of Obtaining Drug License

Complete the Application Form

You are requested to first fill the simple questionnaire provided by our expert team.

Document Processing

At the second step we will be requiring the documents in accordance with the questionnaire filled by you so that we can arrange them as per the requirement and for processing.

Filing of Application

We will apply for your application along with the documents required for drug license with the state government.

Issuance of License

After the processing and verification of application and inspection by the Drug Inspector, Drug License will be generated and will be communicated to you via mail and call.

Types of Drug License

Sale License : Sale license is issued to the persons or agencies engaged in the sales of drugs/medicines in any state. The sale license will be further classified into two types.

Retail License: It is granted to run and sell drugs or drug products in retail form.

Wholesales License: It is issued to persons or agencies engaged in wholesale of drugs and medicine.

Manufacturing License:  Manufacturing License is released to the persons or agencies involved in the manufacturing of drugs/medicines and cosmetics. Government also issue the manufacturing loan license. A manufacturing loan license will be issued to licensee or a person using the premises, equipment and staff of another drug licensee having a manufacturing license.

FAQs on Drug License

What is form 11 license?

The applicant’s shop/premises should have an adequate area of 10 sqr.mtrs or more and person must be a Registered Pharmacist/who has passed Matriculation or its equivalent with four year experience in dealing with Drugs or who holds a degree of a recognized university with one year’s experience in dealing with Drugs.The applicant’s shop/premises should have an adequate area of 10 sqr.mtrs or more and person must be a Registered Pharmacist/who has passed Matriculation or its equivalent with four year experience in dealing with Drugs or who holds a degree of a recognized university with one year’s experience in dealing with Drugs.

What are the essential requisites for obtaining wholesale Drugs Licence?

The applicant’s shop/premises should have an adequate area of 10 sqr.mtrs or more and person must be a Registered Pharmacist/who has passed Matriculation or its equivalent with four year experience in dealing with Drugs or who holds a degree of a recognized university with one year’s experience in dealing with Drugs.

How do I get DCGI approval?

Submit a complete report of clinical trials as per the approved protocol from the individual investigator duly signed by him along with his observations/remarks on the drug.

What are the essential requisites to obtain a retail sales drug license? 

The applicant’s shop/premises should have an adequate area of 10 sqr.mtrs or more and person must be a Registered Pharmacist/who has passed Matriculation or its equivalent with four year experience in dealing with Drugs or who holds a degree of a recognized university with one year’s experience in dealing with Drugs.

What is form 21C?

Wholesale License for sale or distribution of drugs under Drugs and Cosmetics Rules in Form 20B & 21B or its renewal in Form 21C is issued to the manufacturer (subsidiary office/representative of the parent company) or any other who want to sell, stock, exhibit or offer for sale or distribute drugs,  by the State Licensing Authority in India.

What is Blood bank license?

Blood bank license is to moderate a Blood Bank for the collection, storage and processing of whole human blood and/ preparation of blood components for sale or distribution.