DRUG SALE LICENSE

Drug License is a permission granted by the Government of India to conduct the business to deal with Drugs, Cosmetics, and Medicines. These Licenses are issued by the Competent Authority under Drugs and Cosmetic Act, 1940.

Unless a valid license is obtained, no person can carry on the business of dealing in Drugs/Medicines or Cosmetics. Every entrepreneur who is in the Pharmacy industries has to mandatorily own their Drug licenses to carry on the business.

The valid license permits a businessman to freely sell, advertise, resale, manufacture or trade of Drugs/medicines.

TYPES OF DRUG SALE LICENSE:-

1. Wholesale Drug License
2. Retail Sale drug License

PREREQUISITES FOR DRUG LICENSE

Following are the requirements or prerequisites that have to be mandatorily fulfilled in order to obtain License:

SIZE OF PREMISE: The area of the premise should be a minimum of 10 sq. meter where retail or wholesale outlets have to be established. In the case of combined outlets of retail & wholesale, the minimum area is 15 sq. meter.

VENTILATION OF THE PREMISE: The premise must be properly ventilated along with facilities of refrigerator and air conditioners.

STORAGE FACILITY: Medicines are required to be stored in cool, dry, clean areas. Some Drugs like vaccines are required to be stored in the low-temperature freezing zone.

PRESENCE OF COMPETENT PERSON: There has to be a compulsory presence of a competent person or pharmacist. Medicines are to be handled by a specialist. In the case of a retail outlet, there must be a qualified pharmacist. In the case of wholesale outlet,

1. A graduate with one year experience
2. Undergraduate with four experience

 DOCUMENTATION :-

1. Copy of registry in case the premise is owned.
2. Copy of electricity bill/ water bill/ house tax receipt in case of the sale deed is unregistered
3. Registered Rent agreement in case of the premise is rented
4. Copy of electricity bill/water bill/house tax receipt in case of Unregistered rent agreement
5. In the case of a village, khasra details are required.
6. No objection certificate (NOC) from the owner Plan layout of the premise approved by an architect
7. Partnership deed (for partnership firm or LLP)
8. Photo, Id proof & address proof of partners (for partnership firm or LLP)
9. Certificate of Incorporation (COI), Signed MOA & AOA (For companies)
10. Appointment letter of a competent person
11. Experience certificate of a competent person
12. KYC documents of Proprietor/Partners/Directors and Pharmacist
13. Educational qualification documents
14. Refrigerator and CCTV Invoice.

GOVT FEES:

• Retail Sale Drug License: 1500/- (Biological) + Rs.1500/- (Non-biological) = Rs. 3000/-
• Wholesale Drug License: 1500/- (Biological) + Rs.1500/- (Non-biological) = Rs. 3000/-
• Restricted License: 500/- (Biological) + Rs. 500/- (Non-biological) = Rs. 1000/-

Frequently Asked Questions

What is the area requirement of a premise for obtaining drug License?

The area of the premise should be a minimum of 10 sq. meter where either Retail or Wholesale drug License is required.

For both retail and wholesale drug License minimum of 15 sq. meter area is required. Also the ceiling height should be atleast 9 sq ft. The premise should be in commercial area.

Whether a registered Pharmacist is required to be hired for retail Sale or wholesale Drug License?

For a Retail sale Drug License, registered pharmacist is a mandatory requirement.

For wholesale drug License either a registered pharmacist or a Competent person can be hired.

Who can be a competent person?

1. A graduate with one-year relevant experience
2. Undergraduate with four years of relevant experience

What is expected time frame of getting the Drug License?

After submission of all the requisite documents, a drug License if usually granted within a month.

What is validity of a Drug License?

 A Retail Sale or Wholesale Drug License is valid for 5 Years.