Wholesale Drug License

Top 5 Wholesale Drug License Prerequisites In India

In India, no person can start a business in the field of Pharma, Medical Devices, or Cosmetics if they do not have an appropriate license to operate their business. Thus, if you are a business person who is going to or planning to start a business or going to deal in Pharma, you need to obtain the required Wholesale Drug license from the regulatory authority of India. State Licensing Authority (SLA)is the regulatory authority under the CDSCO, which regulates the different licenses for sale and distribution assigned to different Pharma, Medical Device, or Cosmetic businesses. The main aim of SLA is to control the quality, safety, and efficiency of products being marketed in India. Since drugs directly impact the health of a country’s population, it is important to strictly regulate them so that they don’t harm them.

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What Are Drugs?

  • As per the Drug and Cosmetic Act,1940, section 3 (b) of the act, a drug is defined as;
    • “All the medicines intended for external or internal use for humans or animals and all the substances intended to be used for the diagnosis, treatments or prevention of any diseases or disorder in humans or animals, including creams or liquids used to apply on skin to repel mosquitoes.”
    • As per this definition, any non-food substance that can affect the structure and function of the human body or destroys the insects that cause disease is treated as a drug. Components like empty gelatin capsules also fall under this category.
    • Anything humans or animals can consume is called food, which can fight microorganisms. The Food, Drug, and Cosmetics Act also covers powder and capsules used as drugs. As per Amendments made in 1964, this term also includes Ayurveda and Unani medicines.
  • Drug and Cosmetic Act of 1940 made prescription mandatory to purchase drugs under the substance control act consolidated drugs, cosmetics, pharmacy laws, and medication legislation to form the Drug department. The CDSCO heads the Drug Administration (DCGI) and is primarily responsible for drug registration in India.
    • Central Drug Standard Control Organization
    • State Licensing Authority (SLA)
  • The originality of a company depends on the availability of the drug license for wholesale business; below mentioned are the rules and regulations to obtain a drug license:
    • Every pharmaceutical company has to adhere to the license rules and regulations.
    • The applicant should display the license in his premises.
    • Drug businesses shall have the facility to get the license.
    • In the case of a business corporation, they can obtain a drug license at a commercial or non-residential location.
    • For facility transfer or anything, one must fill out the form beforehand.

A Brief About Wholesale Drug License

  • Anyone who decides to go for a drug wholesale business requires a wholesale drug license. Wholesalers are those people who sell drugs to retailers in large quantities. For this kind of sale, one needs permission in the form of a license from the regulatory authority of India and  the permission which the wholesaler receives to continue the business is a wholesale drug license.
  • For each location a separate wholesale license is required, so if one wants to do business in more than one state, one needs to apply for a wholesale license in that particular state.
  • If one is found to do business in a state without a license, they have to pay the penalty.

What Are Wholesale Drug License Prerequisites In India

Wholesale drug license essentials are mentioned below –
  • Competency
  • Space Of The Facility
  • Storage Facility
  • Competent Person
  • GST Number
  1. Competency – Only those people who are competent pharmacists or have required qualification mentioned in the drugs and cosmetic act can apply for a wholesale license to sell drugs.
  2. Space – For retail and wholesale drug business, the carpet area of the pharmacy must be 15 sq. meters, free from any rodents, clean, with proper hygiene, proper ventilation, and no contamination.
    • The carpet area must be 10 sq. meters for all other cases.
    • The height of the sales area shall be by the National Building Code of India, 2005.
  1. Storage facility – There are many drugs, and every Drug needs different storage conditions. Few require low temperature; few needs freezing temperature, few need room temperature, and few may require a slightly high temperature. Thus, AC and refrigerator is a must to have a retail and wholesale drug business.
  2. Technical staff member – The wholesale and retail drug business member must have the required knowledge, experience, and qualification. It is one of the important prerequisites to applying for a drug license.
  3. GST number – Before starting a wholesale pharma business, one must have the GST number per the Government of India’s rules and regulations.

Benefits Of A Wholesale Drug License

  • It gives a sense of safety to customers that drugs are safe to use.
  • It gives the liability of drugs to the wholesaler.
  • Regulates the brand and helps in easy traceability in case something goes wrong.
  • Wholesale drug licenses will put a full stop to the adulteration of drugs, as after getting a permit, the wholesaler will be on the list of government agencies.
  • As the license is given to those who have proper storage facility thus, drugs are stored properly, and no damage would be done.


Getting a wholesale drug license is not easy, as the government of India has now made stricter rules to obtain any license. There is n number of formalities that one has to complete along with documents before they get their wholesale drug license. One simple mistake can delay or reject a license and lead to more rework. Thus, when applying, make sure you understand all the requirements.

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