Drugs are used in the formation of medicines in a medically defined ratio. Drugs are used in #medicines that cure disease and are used as per the needs to ensure the well-being of human beings. Therefore the preparation and use of such drugs in medicines is restrictive, and the standards are set for using the correct amount of drugs that don't harm the body by its overdose.

Therefore any violation in the medically defined terms and limits will have a serious effect on health of the person consuming it and in order to protect the consumers having medication, government is regulating medicines manufacturing by imposing strict and stringent laws and regulations which are to be followed by distributor and manufacturer of drugs and medicines in India.

Types of #DrugLicenses Issued in India

Following are the different types of licenses issued depending upon the type of business for which the license is obtained:
• Manufacturing Drug License
All the manufacturers of allopathic, cosmetics, ayurvedic products or any other medications or drugs as specified under the Drugs and Cosmetics Act 1940. This is the state license that is issued by the particular state government where the unit is situated.
• Loan Drug License
The manufacturer of drugs who don't possess land on his own rather willing to manufacture using his brand name on the land to which license is already issued.
• Import Drug License
Any dealer importing the products for the manufacturing of drugs or is engaged in the business of importing drugs in India shall obtain this license.
• Multi-Drug License
Multi-Drug license is acquired by the entity operating in more than one state having multiple units.
• Sale Drug License
Sale drug license is acquired by the entity engaged in whether wholesale or retail business for distribution of drugs in India.
• Wholesale Drug License
Wholesalers doing the business of pharmaceuticals shall obtain wholesale drug license from the central drugs standard control organization. Wholesale drug license specifies certain minimum requirement on the person applying for this license such as:
1. Degree and diploma in pharmacy
2. Minimum 1-year experience in drug dealing
• Retail Drug License
This license is obtained by retailers engaged in the business of pharmaceuticals, stand-alone pharmacists, etc. by applying to the State Pharmacy Council.

Key-Requirement to Obtain Drug License in India

Following are the essential key-factors to be kept in mind before applying for Drug License:
• Premise Area
Minimum area of 10 sq. meters is required for setting up a medical shop or retail pharmacy. However, if they are operating with the wholesale business along with retail, the minimum area required shall be 15 sq. meters.
• Storage
Proper storage facility should be in-housed by the implementation of cold storage, refrigerators or similar places for the storage of medicines and vaccines as they shall be restored in cool places.
• Technical And Expert Staff
Retail pharmacy shall have a qualified and technical staff with thorough knowledge of the same.

Documentation

Following is the list of documents required for applying for drug license in India:
• Application form duly signed which has already been filed
• Copy of Challan as proof of depositing the requisite fee
• Identity proof such as PAN, Voter Id, Driving license, Passport, etc. in case an applicant is a proprietor
• In case the applicant is a partnership firm, Id proof of every partner along with the copy of partnership deed
• Copy of MOA, AOA, and COI in case of private/public/OPC
• CTC of Board Resolution for authorizing the company for obtaining the license.
• Appointment letter of the person who is being authorized by the company
• Proof of availability of storage space such as cold storage, refrigerator, etc.

How to Get Drug License?

Following is the basic procedure to get Drug License in India:
• Based on business entity and type of license, the applicant shall apply online for registration
• Once the application form is done and registration is completed, the system will auto-generate unique registration number which can be used for future reference.
• Within 15 days of registration, necessary documents shall be submitted to the officer of the Drug Licensing Authority of a concerned district in hard copy.

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