An Overview of Drug License

A Drug License, also known as a Pharmaceutical License, is required for all businesses involved in the distribution of pharmaceutical supplements and medicines. Drugs, according to Section 3(b) of the Drugs and Cosmetics Act of 1940, include all devices and medication for animals as well as humans, either internally or externally, as well as all substances proposed to be used for or in the mitigation, treatment, diagnosis, or prevention of any disorder or disease in humans or animals. In 1964, the definition was expanded to include Ayurvedic and Unani drugs. To conduct business in the field of drugs and cosmetics in India, a drug license is required. The Drugs and Cosmetics Act, 1940, which applies throughout India, includes a provision for this.

If a company has an operating unit in two or more states, it must obtain a license for each state in which the company operates. Drug license registration varies by location. It means that if the drugs are stocked or sold for sale and distribution in more than one location, an application must be made to each state, and a license must be issued for each location except for migrant vendors.

Types of Drug Licenses 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.

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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