How to Apply for New Drug License?

What is drug licensing?

Every individual should have the equivalent as well as fair access to the drugs as well as the medications. And this should be the prime concern of each & every Government of the country. However the right to produce as well as sell the medications needs to be assigned cautiously by the Governmental authorities. Thus the Government needs to come up with the most stringent of rules & regulations for granting licensing for the production as well as the sales of the drugs as well as the medications. The regulation that governs the end-to-end procedure from the manufacturing to the sales of medications in the country is the Drug & Cosmetics Act introduced in the year 1940s.

Each & every business individual working within the pharma industry is required to possess their drug licensing for conducting the day-to-day business work. So, as per the Drugs & Cosmetics Act in the year 1940, it is compulsory for pharmaceutical individuals to obtain drug licensing.

Whenever you are searching for ways to seek drug licensing in the country or you intend to ascertain the process of seeking drug licensing, then the trade as well as the business of the medications plays a crucial aspect with regard to the Government as it involves the lives of the public. Also, the rules as well as the regulations about the drugs are quite strict. This involves the ownership of the drug licensing. So, in this post, you can ascertain the steps on how to seek drug licensing in India.

What all is included in the drug?

The Drug & Cosmetics Act, 1940 under section 3B illustrates the term drug which includes the medications as well as the equipment for the utilization of humans or animals either internally or even externally. And all the material that has been utilized for the diagnosis, mitigation, therapy, or prevention of diseases in animals or human beings. This also includes the preparations which is having its applicability to the human body for the process of repelling insects for example mosquitoes. Also, it includes the material that is meant for the destruction of the insects as well as all the drug components, for example empty gelatin capsules. The definition was changed in 1964 and since then it has also included the Ayurvedic as well as the Unani Drugs.

What is the need of drug license?

There must be restrictions on the access to the medications as well as the drugs and also completely regulated and this is ensuring that such types of the goods are not at all abused/misused by the people. Thus, whether it is pharmacists, wholesalers, retailers, manufacturers, sellers, importers, dealers, cosmetics companies, Ayurvedic, Unani, or any other type of drug manufacturers, it is mandatory to seek a drug license as per the Drugs & Cosmetics Act, introduced in the year 1940.

What is goal of drug licensing?

The main objective of drug licensing is granting permission to facilitate companies or individuals to engage in businesses with regard to drugs as well as cosmetics. So, no company or individual is allowed to start and run a business in drugs, medications, or cosmetics, without seeking drug licensing in the country.

Thus, this Drugs & Cosmetics Act introduced in the year 1940 as well as the regulations that were put forward in 1945 is assisting the Government in regulating as well as monitoring the quality of the drugs as well as the medications that are being sold in the country. The Government exercises control over the drugs made from the raw material stage during the production, sales, distribution and till the step it is sold to the patient/ consumer through the pharmacist in the retail store/ hospital or dispensary.

What are prerequisites for seeking drug license?

Pharmacist

The pharmacist professional must have the requisite of qualifications in case of setting up the retail business. Also, under the condition of the wholesale business, the person must hold a graduation degree with a minimum of 1 year of experience or be an undergraduate with a minimum of 4 years of experience.

Facility needs

This is another crucial aspect with regard to the facility's needs. So, there must be a specific minimum area of the pharmacy unit. In terms of both wholesale as well as retail licensing, the space of the pharmacy unit is 15 square meters. Also, in the condition of the retail/ medicine store, the minimum area should be 10 meters square. Also, there are clear indications about the height of the sales premises and this has been laid down according to the National Building Code, India in the year 2005.

Storage Area

This is another crucial need with regard to the storage facility as some of the drugs will need to be stored towards low temperatures, as well as the refrigerators as well as air conditions are important.

Technical professionals

Retail pharmacy professionals must have the requisite experience as well as in-depth knowledge. The employees of the wholesale pharmacy store must hold a graduation degree with a minimum of 1 year of experience or an undergraduate with 4 years of experience.

What is the procedure of drug licensing registration?

For the assembly of Ayurvedic, allopathic as a cosmetics drug, the assembling license is needed as per the Drugs & Cosmetic Act, 1940. The state permitting authority will be providing the details about how to apply drug license online. There are varied capacities that are completed by the workplace while conducting ordinary business premises reviews.

The drug licensing certification is extended to the applicant after going through the following procedure.

The steps involved in the procedure for obtaining a Drug License in India are as follows:

Here are the steps for the online apply a drug license:

During the initial step, the applicant is required to submit the request letter along with the details of the company for seeking the User ID as well as the password.

During the next step, the applicant needs to conduct the preparation of the documentation, which includes the site plan, key plan as well as several of the other declarations along with the affidavits that are prescribed through the law.

Also, the applicant is required to carry out the filing of the online application for seeking Drug licensing along with the fee which is being prescribed by the Governmental authorities. Furthermore, the documentation needs to be scanned within 100 DPI, black, and white, and needs to be uploaded during the application filing of the drug licensing.

After the online application is issued for the filing of the drug licensing, the same will be having the marking for the inspection process. The inspection will denote that the drug inspector will be visiting the concerned store to verify the documentation filed and will ascertain the correctness of the details that are being submitted.

Once the procedure of the inspection as well as verification is completed, the controller of the drugs will be issuing the drug licensing to the applicant.

Once the procedure of inspection as well as the verification is completed, the controller of the drugs will be issuing the drug licensing to the applicant.