Introduction:

A drug license in India is an essential requirement for any person or entity involved in trade, sale, or manufacturing of drugs in India. The type of drug license applicable depends upon the type of activity the applicant is involved and the type of drugs dealing with. The license is issued by their respective state food and drug authority when abided to their terms and conditions.

A drug license from the state Food and Drug Authority is a permission to the person or entity involved in sale, trade, and import, or manufacture any pharmaceutical products in India. 

The license ensures that the activities being carried out at the applicant are in compliance with the terms and conditions of the drugs and cosmetic act in the supervision of a technical person example a registered pharmacist having valid license number. 

Also as per the drugs and cosmetic act, all the medical devices in India will be regulated as drugs only. Hence any person or entity involved in business activities like sale, stock, or distribution of medical devices in India also needs to apply for drug sale and wholesale license to further apply for medical device import or manufacturing.

It is one of the mandatory requirements by the Central Drugs Standard Control Organization for the medical device applications.

Depending upon the type of business activity, the drug license is categorized into 4 different types.

Drug Manufacturing License:

This license is granted to those entities involved in the manufacturing of allopathic, homeopathic, and other drugs. 

The said license is issued by the state Food and Drug Authority of India under the drugs and cosmetic acts 1940.

The various license which can be availed by the applicant under the manufacturing activity is,

Manufacturing of Allopathic Drug license under Form 25

Manufacturing of Homoeopathic Drug license under Form 25 C

Manufacturing of Cosmetic products under Form 32 

Drug Loan License: 

This license is granted to those entities who are willing to manufacture drugs but do not own a manufacturing site of their own. In that scenario, they are ready to do an agreement with any existing manufacturer having their own manufacturing site along with the license to manufacture their product (drug/ cosmetic) using the resources of the manufacturer. 

The said license is also issued by the respective state drug and food authority of India under the drugs and cosmetic act 1940.

The various license which can be availed by the applicant under the loan license are listed below

Loan License for manufacturing of Allopathic drugs under form 25 A

Loan License for manufacturing of Cosmetic products under form 32 A

Import drug license:

Any entity that is importing drugs from outside India and further selling it into India or making a new drug out of it is required to have an import license in order to import the drugs in India.

The import license is issued by the Central Drugs Standard Control Organization of India.  

Read Our Blog: CDSCO Process for Permission to Import New Drug in India

Further, the import license, if the importer is willing to sale the drugs in India. He must also have a Drug sale license from the state Food and Drug Authority of India.

Drug Sale License: 

This license is entitled to applicants who are into the activity of sale of pharmaceutical products in India under the drugs and cosmetic act 1940. The license is granted in three forms as per the type of business activity they are into. 

Wholesale License: The license is issued to entities who are into the wholesale business activity of pharmaceutical products in India. Any person who wish to obtain the said license must have a technical person holding a B. Pharma degree along with a valid pharmacist license. 

Also, the person must be holding a knowledge of pharmaceutical products regulated in India.

Retailer License: The license is issued to entities who are into the retailing business activity of pharmaceutical products in India. Any person who wishes to obtain the said license must have a technical person holding a B. Pharma degree along with a valid pharmacist license. 

Also, the person must be holding the knowledge of pharmaceutical products regulated in India.

Restricted Drug License: The said license is issued to those applicants who wish to sell drugs in India without any supervision of technical person i.e. a pharmacist.