In India, the procedure of obtaining a Drug License is straightforward but time-consuming. It is mandatory to know the Drug License Process when starting a pharmaceutical business. The drug license application procedure is the first stage in obtaining permission from the relevant state authority to open a pharmaceutical business and engage in pharmaceutical-related activities.

A person who does not have a drug license is unable to start a business that is related to the pharmaceutical industry, whether directly or indirectly. Failure to obtain a drug license in India can be a costly mistake with penalties and fines.

Furthermore, having access to pharmaceuticals and treatments is critical for safeguarding the nation’s health and preventing drug usage by individuals.

We will examine the Drug License Process, why a drug license is important for people working in the pharmaceutical industry, the many types of drug licenses issued by the authority, and the penalties for selling medicines without a drug license in this topic.

Importance of Drug License

Before a drug can be used by patients, it must go through a lengthy procedure that includes several tests and cost-effective observations, as well as various stages, such as laboratory, clinical test, marketing, and sampling. In India, the drug license process is required to start a firm in the pharmaceutical and cosmetics industries.

Manufacturers, retailers, wholesalers, and distributors who are in the pharmaceutical business/or conducting business operations connected to the pharmaceutical industry are awarded a drug license.

The license is issued by the State Drug License Authority in accordance with the 1940 Drugs and Cosmetics Act. The Drug and Cosmetics Act of 1940[1] combines all drug-related laws. The Act was revised in 1964 to include Ayurvedic and Unani medicines.

  •  Working Space- A minimum of 10 square meters is necessary to start a medical business or retail pharmacy. However, a minimum of 15 square meters is required for the pharmaceutical wholesale operation.
  • Proper Space for Storage-
    Some drugs and vaccines require adequate storage in cool environments,
    necessitating the use of air conditioning (AC) and refrigerators.
  •  Expertise Staff-
    The pharmaceutical business requires a trained and experienced worker to run it
    smoothly and efficiently.
  •  Proper License by the State Authority- The State Drug License Authority approves the drug license application once it is completed.

 

Types of Drug License in India

The different types of drug licenses are depended on the type of business. There are two kinds of drug licenses: prescription and non-prescription.

  •  Manufacturing License- Manufacturing Drug License is a license issued by the relevant State Authority/Government under the Drugs and Cosmetics Act, 1940 to allopathic, ayurvedic, and cosmetics product manufacturers. The part of the process of making, changing, labeling, and finishing any drug or drug-related product in the regular course of business is referred to as drug manufacturing.
  •  Sale and Loan License- A loan license is given to an applicant who does not have his own field of business but wants to use the production facilities that another licensee has been granted. Retailers and wholesalers involved in drug distribution in India must get a Sale Drug License, which is also known as a Wholesale Drug License and a Retail Drug License. A minimum of 10 sqr. mtrs. of floor space is necessary for a Sale Drug license, along with adequate storage.

 

Apart from the above-mentioned license, various categories of Drug Licenses are-

Import Drug License –
Import Drug Licenses are approved to applicants who use imported products in
the manufacture of drugs or who distribute imported drugs.

Multi-Drug License – 

 If you are selling in more than one state, you will need a multi-drug license. Because the drug license process is location-specific, a person cannot operate in more than one state without first obtaining a Multi-Drug License.  

 Steps involved in Drug License Process in India       

Following steps are required to complete the Drug License Process –

Though the process is lengthy and time-consuming, a person can apply for a drug license directly with the government.

1. To obtain a User ID and Password – The Applicant must request a user ID and password in person,
along with the firm’s information.

2.Submission of requisite documents –The candidate must scan and upload all of his or her documentation (100 dpi and shall be in the black and white form). The application must be filled out completely and submitted electronically. In the event that any document required for the Drug License process is missing, the government has the authority to request it.

Documents required along with the application
  • A Memorandum of Association/Article of Association is required if the applicant is a partnership.
    A partnership deed is required in the case of a company.
  • Applicant’s Identity proof and Address Proof.
  • Proof of Workplace (Owned Property (Property Papers)/Rental Agreement) (In case of lease Agreement)
  • Area Plan and layout plan of the premises
  • For storage (Details of Refrigerator)
  • In case the premise is situated on DDA residential flat/ plot/ building (Affidavit regarding the
    compliance of MPD 2021) is also to be attached.

Follow up with the Authority –

The applicant must follow up with the authority for any updates or
status. The money will be forfeited by the government if the application is rejected by the government.

Complete review of the Application – 

The department will need at least 45-60 working days to reviewand approve the entire application.

Punishment for selling of medicines without a Drug License-

Running a business without a drug license can be difficult and have a negative influence on the company. Non-compliances result in the person selling medicine without a Drug License being punished and imprisoned.

If a person sells any medicine without a Drug license and without following the Drug licensing process, he will be punished as provided in clause (c) of Section 18.

  • Imprisonment for not less than one year but not more than three years and in that case, the period of limitation will come under Section 468 (2)(c) of the Criminal Procedure Code in that case.
  • A fine of not less than Rs.5000/- shall be imposed.

 

Takeaway

The Drug License Process is required in order to obtain a Drug License and operate a business that deals with drugs and cosmetics. The drug licensing process help in the regulation of drug imports in India by preventing substandard products from entering the country. The sale and distribution of pharmaceuticals are under its control. Fines and penalties will be imposed if you operate a business without a drug license. Litigation, business shutdown, and a variety of penalties and sanctions can all result from a lack of a drug license. An inspection by an Authority representative/or a Drug Inspector is also part of the drug license process.

 

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