When is Drug License Required

Posted by Enterslice India on February 10th, 2018

As per DRUGS AND COSMETICS ACT, 1940 every individual or entity involved in manufacture, sale, purchase, distribution etc. of any drugs or cosmetics is required to get drug license before starting their business. These licenses can are irrespective of the nature of drugs i.e. for allopathic, homoeopathic, ayurvedic, unani or any other nature of medicines license requirement is mandatory.

Who need to apply for Drug License

In order to determine who is required to apply for Drug license we first have to understand why drug license required. The main object of drug license is to regulate the medicine industry and to make sure that no one is illegally dealing with drugs.

Anyone who is involved with drugs or cosmetics in any capacity like, manufacturer, distributor, seller etc is required to register and apply for drug license. Following is the  list of people who need to apply for license:

1. Manufacturer of drugs and cosmetics
2. Importer of drugs and cosmetics
3. Carrying and Forwarding Agents
4. Pharmaceutical Distributors and Stockiest
5. Wholesale and Retail Pharmacies

Exception

 One exceptional person who is not required to apply for drug license is a registered medical practitioner. If any qualified and registered medical practitioner is dispensing medicines to their patients, they are not required to apply for drug license for the same. However, there are certain conditions that are required to be satisfied. They are:

1. The medicines are procured from a licensed dealer or manufacturer.
2. Not perating an open shop
3. They are not selling the drugs across the counter
4. They are not involved in import, manufacture, distribution or sale of drugs as per the provision of Chapter IV of the Drugs and Cosmetics Act.

Types of drug License

Those who are required to be registered and apply for drug license have an option to apply in any of the following mentioned categories depending upon the nature of their work:

1. License for import of drugs and cosmetics
2. Manufacturing License
3. Sale License

-          Wholesale Drug License

-          Retail Drug License