Legal Requirements for Establishment and Maintenance of Drug Store

If a community needs a pharmacy, the analysis should be done in terms of evaluating various alternatives that are available for satisfying it. Such alternatives provide the opportunity for improving services to the community while promoting the most efficient use of professional personnel and facilities.

Following are some of the legal requirements to be fulfilled for opening a retail drug store or a wholesale drug store.


i) General Licenses: These licenses are granted to an individual having premises for the business and who may employ or may himself be a qualified person to supervise the sale of a drug store. Form 20 deals with licenses for the retail sale of the drug store, other than those specified in Schedule C, C1, and X. For drugs specified in Schedule C, C1 excluding those specified in Schedule X is governed through Form 21, and for Schedule X in 20F.

The conditions applicable for general licenses are:

  • a) The owner should display the license in a prominent place within the premises allowing the public to see it.
  • b) The license should fulfill all the provisions of the Drug and Cosmetics Act and Rules.
  • c) Any change in the staff should be brought to the knowledge of the Licensing Authority within a month.
  • d) Schedule C and C1 drugs should be stored as per the precautions prescribed by the Licensing Authority.
  • e) The owner should get permission from the License Authority for the sale of additional categories of drugs listed in Schedule C and C1, excluding X.

ii) Restricted Licenses: These licenses are granted for the restricted sale of drugs other than those specified in Schedule C, C1, and X, and those specified in Schedule C and C1, excluding X, are governed by forms 20A and 21A, respectively.

The conditions for restricted licenses are:

  • a) The drug should be sold in its original container.
  • b) The license should fulfill all the provisions of the Drugs and Cosmetics Acts and Rules.
  • c) The drug should be purchased from a duly licensed dealer.
  • d) The licenser should bear premises equipped with required storage facilities for drugs.

Minimum Qualifications

The minimum qualification for starting a wholesale drug store is matriculation with four years‟ of experience in selling drugs in a chemist shop on a salary basis or a Diploma in Pharmacy and also should be a Registered Pharmacist with the State Pharmacy Council. The minimum qualification to get registered with the State Pharmacy Council is a Diploma in Pharmacy from a recognized institution. A person who has sufficient capital and is interested in starting a drug store can also do so by appointing a „Registered Pharmacist‟ on whole time basis.

Minimum Space

Though, there is no minimum prescribed area mentioned in the Drugs and Cosmetics Act and Rules, 1945, the minimum desirable area to open a new retail as well as wholesale drug store is 10 sq. meters. However, the minimum desirable area to open a new combined wholesale and retail drug store is 15 sq. meters.

Store Arrangements

There should be a sufficient number of racks to store drugs and pharmaceutical preparations. For storage of antibiotics, vitamin products, vaccines, sera, and enzymatic preparations, which are required to be stored at a temperature between 2-8°C, a refrigerator is necessary.

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