What Are the Documents Required for a Drug License?

Last Updated at: Feb 02, 2021
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Documents Required for a Drug license

The business of drug licensing is a vital one, especially in the face of a pandemic that we’re experiencing today. Its seriousness can be gauged from the stringent licensing process and regulation. It is important to know that a drug license is location-specific. The key regulation that is upon the entire lifecycle of drugs is as the Drugs and Cosmetics Act, 1940.

According to Section 3(b) of the aforementioned Act, a drug is defined as the following:

“all medicines for internal or external use of human beings or animals and all substances intends to be for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, including preparations applied on the human body for the purpose of repelling insects like mosquitoes.”

The definition explains to include any non-food substance that can affect the structure and function of the human body. Any substance which destroys disease-causing vermin or insects is also as a drug. Components of medicines like empty gelatin capsules are also under its ambit. The definition also includes Ayurvedic and Unani medicine as per the amendments made in 1964.

Drug license is issued for the following categories:

  • Manufacturing license
  • Sales license – this can take the following sub-forms:
  1. Wholesale license
  2. Retail license
  3. Restricted license (general stores which sell medicines)
  • Loan license
  • Multi-dug license

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Requirements for Obtaining a Drug License

There are certain prerequisites for those intending to procure a drug license. Given the low success rate of the grant of licenses, especially for retail sales, it is important to ensure their availability. The three primary requirements are as under:

Availability of requisite space: This refers to the area of the pharmacy or place of sale in case of a wholesale unit.

  • In case of either a wholesale or retail operation, the area of the premises has to be at least 10 square meters.
  • In case both wholesale and retail operations conducting by a unit, the area of the premises has to be at least 15 square meters.
  • The premises have to adequately ventilate.
  • The height of the premises being used for drug sales has to be in line with the National Building Code of India, 2005.
Adequate storage facility for drugs: Certain medicines have to be stored at low temperatures to maintain their efficacy. These include insulin doses, vaccines, and various sera. Because of this, cooled storage facilities like refrigerators and air conditioners are essential before applying for a license.

Trained and qualified staff: Having competent personnel on board is required before applying for a license. The outline of the requirement is as follows:

  • For a wholesale operation – Sales can be made under the supervision of a registered pharmacist. A graduate with an experience of at least 1 year in dealing with drugs can suffice in lieu of a pharmacist. If either is unavailable, an individual with SSLC qualification and experience of four years in dealing with drugs needs. This should approve by the department of drug control. Any of these individuals is as a competent person.
  • For a retail operation – Retail stores need to undertake sales in the presence of a registered pharmacist only. This qualified individual has to be present throughout the working hours of a store.

Once the above requirements meet, one can begin the process of applying for a drug license.

Documents Required for a Drug License

The availability of suitable premises, cooling facilities, and competent personnel meet the basic criteria for applying for a drug license. The application has to back by some documents as well. The primary document required is a completed Form 19. This form seeks approval for a grant or renewal of a license to sell, stock, exhibit, or offer for the sale or distribution of drugs. These drugs cannot be those specified in Schedule X.

Those dealers who intend to sell drugs in a retail setup without the services of a qualified individual need to fill up Form 19A. Those who want to stock, sell or distribute homoeopathic medicines need Form 19B. Meanwhile, those who want to sell drugs specified in Schedule X need to fill up Form 19C.

  • A challan of Rs 3,000
  • Affidavit of the proprietor on Rs 20 stamp paper
  • Self-attested copies of education certificate and identity proof of proprietor
  • Affidavit of a registered pharmacist or competent person
  • Self-attested copies of education certificate and identity proof of registered pharmacist or competent person
  • Experience certificate of a competent person
  • Blueprint of a plan layout of proposed premises
  • Electricity bill of proposed premises
  • Copy of refrigerator bill
  • Either rent agreement or ownership document of the premises
  • Covering letter
  • 5 photos each of proprietor, and either the registered pharmacist or competent person