The Drug License is mandatory under the Drugs & Cosmetics Act, 1940 and it is applicable to all over India. Drug license is the permission grant by the government to deal with pharmaceutical industries like drugs and cosmetics in India, doing this without the permission of the government is a cognizable offence. There are stringent regulations over manufacturing and distribution of drugs and medicines in India, in order to prevent their abuse and misuse, which are listed under the Drugs and Cosmetics Act, 1940. In 1964, Ayurvedic and Unani drugs were also included in this Act.
The time frame for obtaining and granting drug license by the authority is 30 days after becoming eligible under this act. Once the Entity has obtained Drug License, it is required to ensure the condition mentioned in license are duly complied during the course of business. All the records and registered required to be maintained in prescribed manner as mentioned by authorities and they must be informed of any changes in the business activities of license holder. Since the Drug Control Authorities are state governed, separate application should be made for each state. The retailer or wholesaler are required to have a self-occupied premise of atleast 15 sq. meters for being eligible for Drug License.
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Types of Sale Drug License
There are mainly two types of License that are issued for the Pharmaceutical business:
1.Retail Drug License (RDL)
It is granted for a Chemist or Standalone Pharmacy Shop awarded to people registered with state pharmacy council.
2. Wholesale Drug License (WDL)
It is granted to the people who are into wholesale distribution of drugs.
The other types of License are:
Restricted license for general stores on the basis of type of sale
If the business is operating in more than 2 state then obtain drug license for each state and they have to maintain all the registers records and forms in the manner specified by the authority.
Import Drug License
To obtain drug import license the person has to file the various forms such as Form 8, Form 9, and Form 10 at the CDSCO portal along with the prescribed fees.
Conditions for Drug License
Pharmacist with competency
Medicines should be handled by a competent person, therefore a qualified pharmacist will be given Retail license and wholesale license will be given to a graduate with 1 year experience and an undergraduate with 4 (Four) years.
Area of Premises
To apply for a retail license, the carpet area of premises must be of 10 square meters and for retail and wholesale both license, the minimum area should be 15 square meters with proper open areas.
Clean Storage for Drugs
Refrigerator facility is must for Drug license as few of the medicines specially vaccines need to be kept at freezing temperature. The drugs must be kept at a cool storage facility with clean ad properly ventilated premises.
When you apply for Drug License, the Drug Inspector of your jurisdiction will visit to verify the documents submitted and also check the premises where Drug is to be kept.