What is the process of Online Retail Drug License?

Retail Drug License is mandatory for all the retailers who want to involve in the business of Drugs and Cosmetics in India. Retail Drug License is defined in the Drugs and Cosmetics Act, 1940. The Government of India had made some changes in the Act, in 1964, the primary purpose behind was to include Unani and Ayurvedic Drugs. The Act covers all the aspects areas of medicine such as homoeopathic, allopathic, ayurvedic, Unani, etc. If any person suffers from the consuming drugs, then the manufacturer or seller and both the parties are chargeable for offence and are hurt under IPC.

If a business person has more than one drug shop in more than two states, then it is compulsory to obtain a drug license in every state in which the business is carried out. It is essential for all the business owner who is dealing with drugs and cosmetics to follow all the rules and regulations of such license. In this blog, we are discussing the process of Retail Drug License in India.

To obtain a drug license in India, it is mandatory for an applicant to provide a shop with enough area, below are the details:

• In Form 21 or Form 20 or both, the size of a region is at least 10 square meters.
• In Form 20-B or Form 21-B or both, the premises are of a region of at the very least 10 square meters.
• In Form 20 or Form 21 or both, and in Form 20-B or Form 21-B or both, the area of a region at least 15 square meters.

Following are the classifications of Drug License in India:

• Manufacturing License: All the manufacturers of cosmetics, ayurvedic products, allopathic, or any other medications or drugs as specified under the Drugs and Cosmetics Act, 1940. This is the state license which is issued by the particular State Government where the manufacturing unit is situated.
• Sale Drug License: This license is acquired by the entity involved in the wholesale or retail business for distribution of drugs in India.

It is divided into two parts:

1. Retail Drug License.
2. Wholesale Drug License.

• Loan Drug License: This license is just like renting a whole plant and its machinery.
• Import Drug License: This license is for those who are importing the products for the manufacturing of drugs or is engaged in the business of importing drugs in India.
• Multi-Drug License: It is acquired by the entity operating more than one state having multiple manufacturing units.

• The applicant’s shop should have an area of at least 10 square meters to start a medical or chemist shop but in case of pharmacy business combines both the wholesale and retail, it requires a minimum of 15 square meters.
• They should be equipped with proper storage facilities for storing or preserving drugs like Sera, vaccines, insulin Injections.
• The applicant must be registered pharmacist with Pharmacy Council.
• Before getting a drug license, the drug inspector visits the place where the retail drug license is required and verify with the application. If required, they will take an interview of the competent person and measure the shops or premises.
• All the medical stores have technical staff with a qualification in the medical field.
• The competent person must be graduated with 1 year of experience in dealing with the drugs or a person who passed SSLC with four years of experience in dealing with drugs.

Following are the list of all the essential documents required at the time for the registration of Retail Drug License:

• Submit Memorandum of Association (MoA) and Article of Association (AoA) of the firm.
• Submit Identity proof of director/partner/proprietor.
• Copy of property paper incases if you are an owner of a property.
• A copy of rent agreement in case of a rented property.
• Site plan and key plan of the premise.
• Invoice details of Refrigerator.
• Affidavit regarding the compliance of MPD 2021.
• Additional documents for Retail Sale Registered Pharmacist.
• Qualification certificate.
• Appointment letter.
• Registration of local pharmacy council.

Documents of Directors/Shareholders:

• If the director owns the property, then the registered GDA/registered Sale Deed/conveyance deed in the name of the owner.
• In case of unregistered GPA/unregistered Sale Deed, make sure to submit electricity or water bill and tax receipt of the property.
• In the case of a village, Khasra Khatauni documents are required.
• Copy of rent agreement in case of the rented property.
• NOC (No Objection Certificate) from the owner of the premises.
• Key plan and site plan of the area.

Documents retailers need at the time of obtaining Drug License:

• Qualification certificate.
• Appointment Letter.
• Registration of local pharmacy council.

You can follow the below steps to obtain Retail Drug License in India:

Step 1: Documentation:

Before filling the application form, the most essential step in the process of retail drug license is to prepare all the documents which include preparation of key plan and site plan and submitting various declaration and affidavits.

Step 2: Application Filling:

After preparing all the documents, then you can fill the drug license application online. Scan and upload all the documents at the time of filling the application.

Step 3: Verification:

After submission of all the documents along with the application, the drug inspector will personally visit the shop to check the authenticity of your documents and information.

Step 4: License Grant:

Once the verification is done by the drug inspector and all the documents provided by you is correct, then the controller of drugs will issue the Drug License.

Drug license is area explicit; if a businessman carried out businesses in multiple states, then it is mandatory to acquire drug license in each state in which business is being continued. All the registers/records/Forms must be kept up in the way specified by the licensing authority and authorities kept educated for all the adjustments or progressions in the business activities.

It is cleared from above, that the drug license is essential who deals with Drugs and Cosmetics in India. It is also necessary for all the business owner who is dealing with drugs and cosmetics to follow all the rules and regulations of such license prescribed by the Drug and Cosmetics Act, 1940.