Overview of Retail Drug License

Obtaining Drug License is mandatory for all the retailers who want to indulge in the business of Drugs and Cosmetics in India. Provisions related to obtaining Retail Drug License are defined in the Drugs and Cosmetics Act, 1940. These provisions are applicable in every state and region of India. In 1964, the government of India had made several changes in the Act, the purpose behind the amendment was to include Ayurvedic and Unani drugs.

In layman term, you can say it is not legally possible to step into a business dealing with drugs or cosmetics unless you have not obtained the license under Drugs and Cosmetics Act, 1940. The Act covers all the areas of medicine such as allopathic, homeopathic, ayurvedic or unani.  In case any person suffers any harm while consuming drugs then negligence falls into the lap of the manufacturer or seller and both parties are chargeable for offence and are hurt under IPC.

If a business man has more than one drug retail shop in more than two states then it is mandatory for the businessman to obtain the drug license in every state in which the business is being carried on.

It is necessary for the businessman who is dealing in the business of drugs and cosmetics to comply with all the rules and regulations of such license at all the time during the course of their business. It is obligatory to maintain all the records/registers/forms in the specified manner and authorities shall be informed of all the changes made in the business activity.

Things to keep in mind:

It is necessary for all the pharmacies to obtain drug license. State Drug Control Organization is responsible to issue the license to the wholesale pharmacies as well as to the retail pharmacies. Though, rate of approval for retail license is quite low in comparison to wholesale license.

• Competent Pharmacist

Usually a specialist manages the medicines and for that matter a need of qualified pharmacist arises in case of retail drug license.

• Area of Pharmacy Shop

For opening a drug retail business, the floor covering region of the drug store must be at least 10 square meters, and if the application is for both retail and wholesale drug store the base zone recommended in 15 square meters. The premises must be enough ventilated.

• Storage Facility of Drugs

It is necessary to keep medicines at low-temperature freezing zone because it is the requirement of all the medicines to be stored at a clean, ventilated and cool storage facility, particularly vaccines since they cannot survive the wrath of high-temperature. Hence, make sure that you have a refrigerator or air-conditioner before you apply for drug license in India.

• Inspection by Drug Inspector

Before receiving drug license, the inspector having ward of the territory visits the premises where drug license is required and confirm the points of interest outfitted with the application and whenever required take measurement of the premises and furthermore meet the able individual.

Documents Required to Obtain Retail Drug License

• Constitution of the firm (MOA/AOA)
• Identity proof of partner/ proprietor/director
• If you own a property then a copy of property paper
• In case of rented property a copy of rent agreement
• Site plan and key plan of the premises
• Refrigerator invoice details
• Affidavit regarding compliance of MPD 2021 (if premise are situated on DDA residential flat/plot/building)
• Additional Documents for Retail Sale Registered Pharmacist
• Proof of qualification
• Registration of local pharmacy council
• Appointment letter

Documents of Shareholders/Directors

• If director owns the property then the registered Sale Deed/registered GPA/conveyance deed in the name of the owner.
• In case of unregistered Sale Deed/unregistered GPA make sure to submit electricity bill/water bill/property tax receipt.
• In case of village, Khasra Khatauni documents are accepted
• Rent agreement in case of rented property along with the rent receipt
• No objection certificate from the owner of the premises
• Key plan and site plan of the area duly attested by the mapmaker of the municipality

List of documents retailer need at the time of obtaining Drug License

• Proof of qualification
• Registration of local pharmacy council
• Appointment letter

Classification of Drug License

• Manufacturing License

All the manufacturers of allopathic, cosmetics, ayurvedic products or any other medications or drugs as specified under the Drugs and Cosmetics Act 1940. This is the state license that is issued by the particular state government where the unit is situated.

• Loan Drug License

The manufacturer of drugs who don't possess land on his own rather willing to manufacture using his brand name on the land to which license is already issued.

• Sale Drug License

Sale drug license is acquired by the entity engaged in whether wholesale or retail business for distribution of drugs in India.

It is further divided into two parts:

• Multi-Drug License

Multi-Drug license is acquired by the entity operating in more than one state having multiple units.

• Import Drug License

Any dealer importing the products for the manufacturing of drugs or is engaged in the business of importing drugs in India shall obtain this license.

Registration Procedure for Obtaining Drug License

• Documentation

This is the first and most important step in the process of obtaining drug license. As an applicant all you have to do is prepare all the documents which include preparation of key plan, and site plan and submitting various affidavits and declaration. 

• Application Filling

You can fill the drug license application online. All you have to do is scan and upload all the documents at the time of filling the application. However, later on, inspector will verify your documents.

• Inspector Visit

After the application for issue of drug license is recorded, the equivalent is set apart for inspection and from that point the drug inspector will personally visit the shop to check the authenticity of your documents and information.

• Grant of License

Once the inspection is done and all the information and documents provided by you is furnished to be correct then the controller of drugs issues the Drug License.

Infrastructure Requirement

In order to obtain a drug license, it is necessary for the applicant to provide an independent shop with enough area, the details are mentioned below:

• For award of permit in Form 20 or Form 21 or both, the premises are of a region of at the very least 10 square meters;
• For award of permit in Form 20-B or Form 21-B or both, the premises are of a region of at the very least 10 square meters; and
• For award of permit (I) In Form 20 or Form 21 or both, and (ii) In Form 20-B or Form 21-B or both the premises are of a region of at the very least 15 square meters

Multi-State Operation

If a business is working in multiple states, it needs to acquire drug license in each state in which business is being continued. Drug License is area explicit. In the event that medications are sold or loaded available to be purchased at more than one spot, application ought to be made, and permit ought to be given, in regard of each such spot aside from transient merchants. When the permit is conceded to the business, all such Licensee must guarantee that all the condition in the drug license is consented at constantly over the span of the business. All the records/registers/Forms must be kept up in the way specified by the licensing authority and authorities ought to be kept educated for all the progressions or adjustment in the business activities.

Frequently Asked Questions