DRUG LICENSE IN INDIA

Updated on : 2020-Nov-08 22:02:06 | Author :

DRUG LICENSE

DEFINITION

TYPES OF DRUG LICENSE

HOW TO APPLY FOR DRUG LICENSE

 

You should take your drugs or medicines for a healthy condition while you are sick.

But how can you be sure that the medicine you bought from the medical store is genuine?

The first and foremost thing that any person should check while buying medicines from the pharmacy/drug store is that it is Drug Licensed or not, With a perspective to give this is an edge, the Indian Government has laid down strict laws and regulations for the manufacturing and distribution of drugs and medicines across the drug stores and pharmacies in our country. Here we will describe how anyone can obtain a Drug License in India.

 

DEFINITION OF DRUG LICENSE:

 

The permission given by the Government of the owner of the pharmacy or a drugstore is called a Drug License. The Drugs and the Cosmetics Act, 1940 governs the licensing of the drugs in India under which provisions are made to carry out the business of drugs, medicines, or cosmetics.

Drug license is an order allowed by the computable Authority or Central Government under the Drugs or Medicines and Cosmetic as per Act 1940, to complete a business regarding Drugs or Medicines.

Who wants to start a business with medicines and Drugs mandatory to apply for a drug license at the drug regulating authority?

The drug includes Medicines and devices that are made for internal or external use to diagnose, treat, alleviate, destroy, or prevent any disease in human beings or animals.

Drug license registration is mandatory for starting a business that deals with Ayurvedic medicines, Allopathic drugs, and Homeopathic drugs to Manufacturer, Distributes, or sell the Medicines.

Drug license is an official paper that certifies that you are compatible with the manufacturing, sale, purchase of pharmaceutical products in the place mentioned in the license. There are particular limitations that are attached in getting drug licenses such as premises establishment and the person who shall be dealing with the product etc.

If the drug business is leading more than two states, Drug licenses to be needed for every state where the drug business continues. The drug License is location-specific.

Access to drugs and medicines are essential to ensure the better health of a Nation. However, access to drugs and medicines must be restricted to ensure that such things are not abused or misused by a person. Thus, the government has enacted strict laws and regulations for the production and distribution of medicines and drugs in India. The regulation of the production and sale of drugs is regulated by the Drugs and Cosmetics Act, 1940, and is regulated therein. Controls on medicines from the raw material stage to the time of manufacture, sale, distribution, and delivery to a patient or consumer by a pharmacist in a retail pharmacy, hospital, or dispensary. In 1964, Ayurvedic and Unani medicines were incorporated under the Medicines and Cosmetics Act, 1940. However, a certain business existence may require different types of drug licenses based on their business. In this article, we look at the process of obtaining a drug license in India.

 

TYPES OF DRUG LICENSE:

The type of drug license is based on the business nature and transaction.

The characteristics of the drug license in India are mentioned below:

  • It is necessary to be owned by all kinds of Drugs and Cosmetics business.

  • Every medicine (drugs and cosmetics) business needs to comply with the terms and conditions of the license.

  • The sales drug license can be granted by two premises: commercial premises and residential premises.

  • The license is displayed at the center of the premises.

  • It is mandatory to own a drug license in every state if your business operates in two or more places.

  • The migrants will need to fill another form.

 

The Authorities is issued the drug license at the following two levels:

 

1. State Drugs Standard Control Organization (SDSCO)

 

As per the rule of Drugs and Cosmetics Act, 1940, the sales, distribution, and manufacture of drugs are Systematic by the state authorities.

 

2. Central Drugs Standard Control Organization (CDSCO)

 

As per rules to the Drugs and Cosmetics Act of 1940, the CDSCO is liable for approving the recently made drugs and clinical tests of the said drugs in the country. The quality of the drugs imported and coordinated also controls with the SDSCO.

 

But we do not know about the difference between drugstores and pharmacies. Here we will discuss details about the drug license in India.

 

Details about Drug License and Drug License Registration –

 

Drugs are used in the formulation of medicines in the proportions defined as a treatment for the healing of a person's health. So the specific standards have been set up by the State and Central Drug Standard Organization for using the correct amount of drugs that do not harm the body.

 

DRUG LICENSE HAS MANY TYPES FOR THE PHARMACEUTICALS BUSINESS. THEY ARE

 

  1. MANUFACTURING DRUG LICENSE

  2. LOAN DRUG LICENSE

  3. SALE DRUG LICENSE

  4. IMPORT DRUG LICENSE

  5. MULTI DRUG LICENSE

  6. WHOLESALE DRUG LICENSE

  7. RETAIL DRUG LICENSE

 

How to apply for a Drug License?

 

The following steps must be followed to apply for a drug license:-

 

  • The applicant should have an active email id and mobile number for the process of applying for the drug license.

  • The Drug License is Register on Online Drug Store Registration & Licensing System.

  • The spelling of the applicant's name should be spelled correctly in the application as it appears in the license.

  • Upon successful registration, the system will generate a unique registration number for each and every application that will be used for subsequent processing and reference.

  • As part of this, the necessary "forms" will be printed out and the fee invoice and supported documents will be attached (which will be different from case to case) Submit the application to the District Licensing Authority office within 15 days from the date of submission of the online application.

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