A drug License is permission/approval granted under the Drugs and Cosmetic Act of 1940 to carry out a drug/medicine or cosmetic business. A drug License is required for all types of drugs and cosmetics business and is issued by the State Drugs Standard Control Organization or the Central Drug Standard Control Organization.
Drugs and Cosmetics Act, 1940, section 3(b) says that “drug” includes all medicines and devices for internal or external use of human beings or animals and all substances proposed to be used for or in the diagnosis, mitigation, treatment, or prevention of any disorder or disease in animals or human beings, including preparations applied on the human body foto repel insects like mosquitoes; it also includes all substances that can be used for the destruction of insects and all components of a drug – like empty gelatin capsules.
In case a business is operating one or more states in India, it has to obtain a drug license for each state in which the business is being carried on. For example, if ABC company is operating Medical Store in Kerala and Tamil Nadu. The company is responsible to take the license from both states mandatorily. Registration for Drug license is location specific. It means if the drugs are stocked or sold for sale and distribution at more than one place, then the application shall be made to every state, and license shall be issued, regarding each such place except for migrant vendors.
Different category of Drug Licenses in India
Manufacturing Drug License:
Manufactures deal with allopathic / homeopathic / cosmetics or any other medicines or drugs, as mentioned under the Drugs and cosmetics Act, 1940 are mandatorily obtain the Manufacturing Drug License.
Loan Drug license:
The Drug Manufacturer who do not have any land on his own but is ready to manufacture drugs by using his brand name on the land to which license is already granted.
Import Drug License:
Any dealer who is importing the products include in the Drugs and Cosmetics Act, for manufacturing drugs or is involved in the business of importing drugs in India shall mandatorily obtain this specific license.
Sale license is issued for sale of the drugs. There are 2 types of sale licenses:
Wholesale License: Wholesalers who are engaged in the business of pharmaceuticals shall mandatorily acquire wholesale drug license from the department.
Retail Drug License: Retailers who are engaged in the business of pharmaceuticals shall mandatorily acquire retail drug license from the department.
Basic requirements to obtain Drug License:
As per the Act, a minimum area of 10sqm is required for setting up a wholesale or retail drug license business. However, in the case of both that means Wholesale cum Retail business, the minimum area should be 15sqm.
The storage facility is optional for getting drug licenses. It depends upon the drugs we deal with. If some drugs require to be stores in low temperatures. For this instances refrigerators and air conditioners are must.
Pharmacist / Competent Person:
Sale of a drug can be carried out in the presence of a registered pharmacist/competent person approved by the department who will be required to make his/her presence in the retail shop throughout the working hours. Drugs sold in a wholesale store has to be carried out in the presence of a registered pharmacist, by a person who is a graduate with one year experience or by a person who has completed SSLC with an experience of four years approved by the drug control department and it is called competent person.
Procedure for obtaining the Drug license in India:
The Applicant has to make the application form and update the details in prescribed form such as Form 19, 19A, 19AA, 19B.
Attach the documents:
The next step is to attach the necessary documents in the prescribed format and submit to the office
The officer will conduct the inspection process to examine our premises and infra.
Issue of License:
The officer will be satisfying with all the documents what we submitted, and inspection process is successfully completed. Then they will grant the license. We can download it from the website / collect it from the office.
Aadhar, Pan, Photo, email and contact number of the Applicant
PAN, Certificate of Incorporation, MoA and AoA of the firm / partnership deed
Board Resolution Letter / Authorization Letter (Appointment of the Applicant)
Ownership Certificate of the premises in Original
Rent Agreement (Self Attested) and Latest building tax receipt
Declaration of Registered Pharmacist / Competent Person
Registration Certificate of Pharmacist / Certificate of the Competent Person
Aadhar Card of Pharmacist (Self Attested) / competent person
Receipt of refrigerator if required
Location Plan of the premises
Validity of License:
The Validity of the license will be 5 years from the license issued