In India, the business entity who works in the health care sector such as medicines, drugs or cosmetics shall obtain the Drug License from the appropriate authority. As per the Drugs and Cosmetics Act, License is issued by State/Central Drug Standard Control Organization. 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.

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.


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.

Business entities dealing in medicines or drugs would need different types of drug licenses based on their business. Drug License being region-specific needs to be obtained by a single drug dealer having its multiple units in more than one state. Other than a migrant vendor, drug license shall be applied for every place where drugs are stocked and sold. Drug license holders have to make sure it complies with the terms and conditions. The license issued overlooking these terms and conditions can get cancelled or suspended. Authorities shall be notified about any change or modification if occurred in business.

How to Get Drug License?

Following is the basic procedure to get Drug License in India:

Documents Required

Additional documents if the applicant is registered pharmacist:

Service Charges

Rs 4999 (Government charges extra)

Service Charges

Rs 4999 (Government charges extra)