Is License Compulsory For Starting Pharmaceutical Business In India?

April 4, 2023 by
Tansy Molequle

Yes, obtaining a license is compulsory for starting a pharmaceutical business in India. The license requirements vary depending on the type of business and activities you intend to undertake in the pharmaceutical industry.

Here are some of the common licenses required to start a pharmaceutical business in India:

1. Drug License: 

A drug license is mandatory for any business that involves the manufacture, distribution, and sale of drugs and medicines in India. The drug license is issued by the State Drugs Control Department, and it is necessary to comply with the Drugs and Cosmetics Act, 1940, and Rules, 1945.

2. Goods and Services Tax (GST) Registration: 

The GST registration is mandatory for any business with an annual turnover of more than Rs. 20 lakhs in India. The GST registration enables you to pay and collect taxes on goods and services.

3. Trade License:

 A trade license is mandatory for any business operating in a particular municipal corporation or council area. It is issued by the local municipal corporation or council, and it is necessary to comply with the local laws and regulations.

4. Shop and Establishment Registration: 

The Shop and Establishment registration is mandatory for any business establishment operating within a particular state or union territory in India. It is issued by the local government authority and is necessary to comply with the Shops and Establishments Act of the respective state or union territory.

5. Manufacturing License:

A manufacturing license is mandatory for any business that intends to manufacture drugs and medicines in India. It is issued by the State Drugs Control Department and is necessary to comply with the Drugs and Cosmetics Act, 1940, and Rules, 1945.

6. Import-Export License: 

An import-export license is mandatory for any business that intends to import or export drugs and medicines in India. It is issued by the Directorate General of Foreign Trade (DGFT) and is necessary to comply with the Foreign Trade Policy of India.

In conclusion, obtaining a license is mandatory for starting a pharmaceutical business in India. The license requirements vary depending on the type of business and activities you intend to undertake in the pharmaceutical industry. It is important to comply with the laws and regulations to avoid any legal issues and penalties.


Tansy Molequle April 4, 2023
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