Overview

Obtaining a drug license is mandatory for all retailers who wish to get involved in the drugs and cosmetics business in India. The provisions relating to obtaining retail drug licenses are defined in the Drugs and Cosmetics Act, 1940. These provisions are applicable in every state and territory of India. In 1964, the Government of India made several changes to the Act, the purpose behind the amendment was to include Ayurvedic and Unani medicines.

In the term of the common man, you can say that it is not possible to enter into a business related to drugs or cosmetics unless you are licensed under the Drugs and Cosmetics Act, 1940. The Act covers all areas of medicine. Allopathic, Homeopathic, Ayurvedic or Unani. & If any person incurs any kind of harm while consuming drugs, then the manufacturer or seller gets negligence in the lap and both the parties are responsible for the crime and are hurt under IPC.

If a practitioner has more than one drug retail outlet in more than two states, it is mandatory for the practitioner to obtain a drug license in each state in which the business is being conducted.

It is essential for the businessman who is working in the drugs and cosmetics business and follows all the rules and regulations of such license in the course of his business. It is mandatory to maintain all records / registers / forms in the specified manner and the authorities will be informed about all the changes made in the business activity.

Things to keep in mind:

Obtaining a drug license is required by all pharmacies. The State Drug Control Organization is responsible for issuing licenses to wholesale pharmacies as well as retail pharmacies. However, approval rates are much lower for retail licenses than for wholesale licenses.

• Competent Pharmacist

A specialist usually administers drugs and a qualified pharmacist is required in the case of a retail drug license for that matter.

• Pharmacy Shop Area

To open a pharmaceutical retail business, the area to cover the drugstore must be at least 10 square meters, and if the application is for both retail and wholesale pharmaceuticals, the base area is recommended in 15 square meters. The premises should be adequately ventilated.

• Drug storage facility

It is necessary to keep the drugs in a low temperature ice zone because it requires all the drugs to be stored in a clean, ventilated and cold storage facility, especially since they do not survive high-temperature outbreaks. . . Therefore, make sure that you have a refrigerator or air-conditioner before applying for a drug license in India.

• Inspection by Drug Inspector

Before obtaining a drug license, inspectors from area wards visit the premises, where a drug license is required and confirm the points of interest set forth with the application and, whenever necessary, measure the premises. And then meet a competent person.

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

Required Documents

• Constitution of the firm (MOA / AOA)
• Identity proof of partner / proprietor / director
• If you have any property then a copy of the property paper
• In the case of rented property, there is a copy of the rent agreement
• Site plan and main plan of the campus
• Refrigerator Invoice Details
• Affidavit regarding compliance with MPD 2021 (if the base is located on DDA residential flat / plot / building)
• Additional documents for retail sales Registered Pharmacist
• Proof of Qualification
• Local Pharmacy Council Registration
• Appointment letter

Shareholders / Directors Documents

• If the director is the owner of the property, the registered sale deed / registered GPA / communication deed is in the owner's name.
• In case of unregistered sales deed / unregistered GPA, be 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 with rent receipt
• NOC from the owner of the premises
• Key plan and site plan of the area duly attested by the Municipal Cartographer

List of documents of retailers at the time of obtaining drug license

is required

• Proof of Qualification
• Local Pharmacy Council Registration
• Appointment letter

Registration process

This is the first and most important step in the process of obtaining a drug license. As an applicant all you have to do is to prepare all the documents including preparing the main plan, and submitting the site plan and various affidavits and declaration forms.

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, the inspector will verify your documents.

After an application for the issuance of a drug license is filed, the equivalence is set aside for inspection and from that point on the drug inspector will personally visit the shop to check the authenticity of your documents and information.

Once the inspection is done and all the information and documents provided by you are equipped to be correct, the Drug License Controller of Drugs.

• Documentation
• Filling the application
• Go to Inspector
• Grant of license

Required Infrastructure

In order to obtain a drug license, the applicant is required to provide an independent shop with sufficient area, the details are given below:

• For award of permits in Form 20 or Form 21 or both, the premises is of an area of ​​not less than 10 square meters;
• For the award of permits in Form 20-B or Form 21-B or both, the premises is of an area of ​​not less than 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 the area of ​​not less than 15 square meters.

Multi-state Operational

If a business is operating in multiple states, it must obtain a drug license in each state in which the business is being continued. Drug license is clear. In the event that the drugs are sold or made available for purchase at more than one location, the application must be made, and permission must be given in respect of each location separately from the transit merchants. When the permit is accepted for business, all such licensees must guarantee that all stipulations in the drug license continue continuously during the business period. All records / registers / forms should be kept in the manner specified by the licensing authority and the authorities should be educated for all progress or adjustments in business activities.