Get Started By paying Rs. 1000/-
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.
Advantages of Drug License
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
Business Premises Proof
Bio data along with an appointment letter.
Experience certificate (if any)
Affidavit with regard of compliance of MPD 2021 (if premises are located on DDA residential flat/ plot/ building)
certificate of registration with state council depending upon the region
ID proof of proprietor/partner or director
Site Plan and key plan of the premises
Refrigerator invoice and its details
Additional wholesale documents for wholesale drug license.
Sole proprietor, partners or directors Qualification proof in form of degrees, certificates or mark sheets.
Receipts of refrigerator and air conditioner use for storage purpose.
Process of Obtaining Drug License
Complete the Application Form
Filing of Application
Document Processing
Issuance of License
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
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.
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.
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.
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.
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.
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.