drug license
Drug licensing also termed as the pharmaceutical license is needed for kinds of businesses that are involved in distributing medications as well as pharmaceutical supplements. As Drugs & Cosmetics Act, Section 3B introduced in 1940, drugs is the term that encompasses all sorts of medications( for human as well as animal use, both externally & internally ) along with the devices/ substances, everything which is utilized for diagnosis, treating, preventing as well as mitigating or preventing any type of the diseases occurring with the human being or animal.
In the year 1964, there was an amendment introduced in the Drugs & Cosmetics Act that included regulations for ayurvedic & Unani Drugs. Licensing is mandatory for carrying out business in the Drugs & cosmetic industry in the Indian Subcontinent. The provision of this has been made in accordance with the Drugs & Cosmetics Act, 1940 & this is applicable all throughout the country.
In case the business entity has an operating unit in two or more of the states, it is required to seek licensing for each & every state in which the business is opening. The drug license registry is location-specific. So, this entails that whenever the drug products stock is held for sale as well as distribution at more than a single place, then the application is to be made to each & every state & licensing shall be issued about each of such places in exception to the migrant vendors.
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The manufacturers who are involved in the trade of cosmetics, drugs, allopathic or cosmetics, or any other products mentioned under the Drug & Cosmetic Act, 1940 need to seek manufacturing drug licensing.
The manufacturer of the drug who is not owing their own land, however willing to produce drugs through the utilization of their brand name on land upon which the licensing has been granted.
Any dealer who is involved in the import of products to manufacture drugs or working as a drug importer in India is mandated to seek this drug licensing.
All the business entities that are operating in more than one state or owning multiple units need to seek a multi-drug license.
Here are crucial factors that need to be taken into consideration for drug license registration:
There is a need for at least a 10 square meter area in order to establish retail or pharmaceutical units. But under the scenario of the retail cum wholesale drug business, the minimum area which shall be needed for setting up the unit is 15 square meters.
The individual who wants to establish a retail unit must be a qualified pharmacist. However, in the case of doing the wholesale business, the applicant should hold a graduation degree with a single year of experience or even an undergraduate with a minimum of four years of work experience.
There must be the proper storage establishment for the setting up of the refrigerating unit, cold storage facility, or any other type of the same region to facilitate the drug/ medicinal storage as they are required to be restored within the cool area.
The retailer who would like to set up a pharmacy shop must have the requisite experience along with the in-depth knowledge. So, the applicant must be the qualified pharmacist for seeking licensing.
While setting up the retail pharmacy, there must be the employment of proficient as well as technical staff who have thorough knowledge in the pharmaceutical area. A qualification of pharmacist is the mandatory requirement for seeking a drug license.
The drug inspector coming under the jurisdiction will be visiting the establishment for which the application for drug licensing has been filled. The concerned authority will be investing as well as verifying all the particulars which are being furnished within the application. In case required, the individual will also measure the premises and interview the applicant.
Here is the vital of documentation that is required for seeking drug licensing in India:
Here are the steps mentioned below for seeking drug licensing in India:
This is the first & foremost step in which the applicant is required to visit the concerned drug control authority portal. It is dependent upon the nature of the licensing the individual is applying for. As there is a different authoritative portal for issuing varied types of drug licensing.
The applicant needs to file an application for the particular licensing on the portal of the respective authority. This is dependent upon the licensing type based on the applicant applying for.
Once the application form has been filled upon, then the next step is to carry out the uploading of the documentation as well as the form submission along with the applicable fee structure. Along with that, the applicant must be in a condition to keep a record of all original documentation before applying.
Read also this -: How to Apply for New Drug License
Upon receipt of the application, the drug inspector of the area will visit the premises of the company, drug store/shop to verify documentation along with checking the appropriateness of all the facts & figures mentioned.
Once inspection of the area is done and all documentation, as well as applications, have been verified, then the drug controller will be issuing licensing.
Every person must have access to medicines and other pharmaceutical products, living anywhere in the world. However, the drugs as well as the pharmaceutical industry are strictly regulated by Governmental authorities. It is only by obtaining a license, that you can start your operations in India.