Retail Drug license registration is a type of drug license required to those enterprises who intends to sell medicines including OTC products directly to customers in India. The objective of issuing a drug license to the retailer aims at regulating the sale of generic and non-generic medicines in India and also to enhance trust of consumers in the market. Drug License Registration also permits the retail sale of medicines as well as for other traditional businesses relating to drugs in India.

Obtaining a retail drug license in India is an important step taken to save the public health from fake/expired medicines, and ensure legality under the Drugs & Cosmetics Act, 1940. Professional Utilities team brings structured regulatory expertise in managing Retail Drug License registrations across India. We ensure that all procedural requirements are met enabling retail drug operations to run with confidence while we handle the retail drug licensing procedure with professionalism.

Retailer Drug License Certificate Sample

Form-20B
Form-21B

Details of Applicant
Proof of Business
Affidavit from the Registered Pharmacist or Competent Person
Proof of Qualification is Required
Address Proof and Identity Proof of Applicant
Key Plan and Site Plan of the Premises

Affidavit of Non-Conviction Regarding Proprietor or Director
FSSAI License (if required)
Registration with Respective Pharmacy Council is Required
Appointment Letter or Bio Data of Pharmacist
Proof of Premises, such as Sale Deed, Utility Bills, or Rent Agreement if Rented

Retail drug license registration is essential for businesses engaged in the sale of pharmaceutical products in India. As the sector is strictly regulated to protect public health, obtaining the license from the State Licensing Authority ensures lawful operations and regulatory compliance.

Timely retail drug license registration helps maintain business continuity, avoid penalties, and build customer trust. Professional Utilities offers comprehensive support throughout the registration process to ensure smooth documentation and approval.

FAQ’s on Retail Drug Licesne Registration

What is a retail drug license?

A retail drug license is a legal authorization granted by the State Drug Control Department to sell drugs and pharmaceutical products directly to end users through a pharmacy or medical store.

Which licence is required for retail pharmacy?

A retail pharmacy in India is required to have a Retail Drug License, which is issued by the State Drugs Control Department, in the form of Form 20 for general drugs and Form 21 for drugs specified in Schedule C and C(1) of the Drugs and Cosmetics Rules, 1945.

What is Form 19 in Retail Drug License?

Form 19 is the prescribed form of application as provided in the Drugs and Cosmetics Rules, 1945 (Rule 59(2)), which is used for the grant or renewal of a retail/wholesale license for dealing in drugs. It is used to seek permission to sell, stock, or distribute drugs except those included in Schedule X

What is Form 20 and Form 21 drug license?

Form 20 and Form 21 are the compulsory licenses required under the Drugs and Cosmetics Act, 1940, for running a retail outlet in India. While Form 20 is required for the retail sale of general medicines or allopathic medicines, Form 21 is required for the retail sale of drugs covered under Schedule C and C(1) such as biological drugs and vaccines.

How to apply for retail drug license online?

To apply for a retail drug license online, the applicants are required to register on the portal of the respective State Drugs Control Department, fill in Form 19, and upload the necessary documents and pay the necessary fees. Upon the submission of the application and inspection by the authorities, the license is issued within 30-60 days.

Is a pharmacist mandatory for a retail drug license?

Yes, a registered pharmacist is mandatory for obtaining a retail drug license for a pharmacy store in India.

What is the minimum area required for a retail drug license?

The minimum area required to obtain a retail drug license is 10 square meters whereas to obtain a drug license for both wholesale and retail operations is 15 square meters.

What equipment is required for a retail pharmacy?

A retail pharmacy needs to have dispensing equipment, storage facilities such as refrigerators and shelves, and basic technology such as computers and pharmacy software to keep records. The retail pharmacy also needs basic safety equipment such as fire extinguishers, waste disposal containers, and security devices.