Pharmacy business in India has good amount of profitability and irrespective of the economic condition of the Country the Pharmacy business always has its scope of having expansion as people in India or anywhere else in the world tend to spend money on their health. In India most of the pharmacy businesses are very small and being managed in an unorganized way and in order to provide scalability to pharmacy business one need to obtain Drug license.

DRUG License

Drug license is kind of licence which is required by any business dealing in pharmaceuticals or intends to start a business in the field of Pharma. As per Drugs and Cosmetics Act, 1940, every  person wishes to deal in pharma business, need to obtain this license . There are two types of drug license, one is Retail Drug License (RDL) and the other one is Wholesale Drug License (WDL).

Note: In most of the state’s Retail Drug License (RDL) is given to only those who possesses a degree or diploma in pharmacy.

Concerned Authority

The concerned authority for getting Drug license is Controller of Drugs and Cosmetic and as the drug license is location specific so it has to be obtained foe every state where business is being carried out.

Requirement for obtaining Drug License

Minimum Area Requirement – In case of wholesale outlet  or Medical Shop : Minimum area of 10 sq. meter. In case wholesale+ Retail: Minimum area of 15 sq. meter

Storage Facility: Refrigerator and air-conditioner in the premises is must.

Technical Staff: In case of whole sale business, the sale of Drug shall be made before the registered pharmacist or any graduate having an experience of not less than 1 year in dealing in Drugs or any person who has passed the intermediate level of schooling and having the experience of at least 4 years in dealing in drugs.

In case of Retail business the sale of Drugs must be made before registered pharmacist and presence of him should be there till the closure of working hours.

Documents Required for DRUG License

  1. Key plan of the premises.
  2. Site plan of the premises.
  3. Receipt of the refrigerator purchased.
  4. Copy of Diploma/ Degree of pharmacy degree.
  5. Address Proof of the Business premises.
  6. Appointment letter of the registered pharmacist.
  7. Proof of Constitution of Business.
  8. Affidavit by the Proprietor/Director/Partner’s.
  9.  Application form along with the covering letter and challan of fee deposited.

Procedure for obtaining Drug License

Submission of all the Documents to the office of Controller of Drugs and Cosmetics of the state in which the business is being carried out.

Advantage of DRUG License

a) With the rise of medical issues in recent times it is necessary for the government to take a control over those dealing in this sector so any entity if obtains Drug license can do their business without any fear of being caught.

b) Entity working in pharma sector can easily expand their wholesale business as no retailer will hesitate in dealing with person who has obtained the license with concerned authority.

How can we help you?

We, being team of highly experienced professional specilize in providing complete advisory regarding the licence, implementation, tax issues and other legal compliances of the business engaged in the pharmaceutical. Our processes are very transparent and strive to address the practical problems.

FAQ

What is Drug License?

Drug License is a permission under the Drugs and Cosmetics Act from a competent authority of the State Government to run a pharmacy business in India.

How many types of Drug Licenses are there?

There are two types of Drug License:

  1. Wholesale Drug License: Generally issued to a person or businesses engaged in wholesale of Drug and Medicines.
  2. Retail Drug License: Retail Drug License is the one issued to run Chemist Shop.
Why it is necessary to obtain Drug License?

To start a pharmacy business in India one need to take the Drug License. Without the permission from competent authority the sale of Drug in India is not legal.

Do I need to obtain Drug license in case of Chemist Shop?

Yes, the Chemist shop comes under the category of Retail Drug business so Drug license is mandatory.

 

Do I need to take Drug license in another states as I want to expand my Business in other states too?

Yes, the Drug License is a permission from a competent authority of a State Government so if Business is being carried out at more than one state then the license shall be taken for the respective state.

 

 

Do I need to take another Drug license if I own more than one Factory or Go down?

Yes, if the drugs are sold or manufactured at different locations then for each place separate Drug License is required.

 

 

Do I need Drug license in case of Import of Drugs?

Yes, in case where the Drugs you are going to import is mentioned in Schedule X of Drugs and Cosmetic Act which includes Narcotic and Psychotropic drugs. Drug license schedule X.PDF

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