Drug License

Drug License

Every individual has an equal access to pharmaceuticals and drugs in the world. However manufacturing of drugs and pharmaceuticals is strictly regulated by the government in India. Before distributing medicines and pharmaceuticals, it is crucial to obtain a drug license or a pharmaceutical license for a business. With this license, the operations of a pharmacy can commence. Hence it is essential to secure this license for the business as soon as possible.

Package Inclusions for Drug License
  • Procedure for Securing the drug License (Pharmaceutical License)
  • Application Drafting for the Drug License
  • Filing the application with the regulatory authority
  • End-to-End Advise for filing the application
  • Liaising with regulatory authorities for the license
Drug License

Drug License – An Overview

Drug License is crucial for every business that is dealing with drugs and pharmaceuticals. This license would provide the basic requirements for a pharmaceutical business to carry out its operations daily. The government has made specific rules related to manufacturing and selling of drugs and pharmaceuticals. Any pharmaceutical dealing with the distribution of pharmaceuticals has to comply with the provisions of the Drugs and Cosmetics Act, 1940.

There are different forms of drugs and pharmaceuticals governed under the provisions of the above act. These types of drugs include homeopathy drugs, allopathic drugs, ayurveda and Unani Drugs. Any pharmaceutical selling drugs without proper license would be liable under the provisions of the Drugs and Cosmetics Act, 1940. Plus this offence would attract some stringent penalties under the Indian Penal Code, 1860.

Statutory Meaning of Drug License

Drug License is also known as a pharmaceutical license. This license is required for all form of businesses that engage in distribution of medicines and pharmaceutical supplements.

According to section 3(b) the meaning of drug has different interpretations:

Section 3(b)i–

As per this section a drug is a medicine which is used for internal and external use of human beings. It will also include any form of substances used for diagnosis or mitigation or treatment of any form of diseases. Such substances are for human beings and animals.

Section 3(b)ii- 

Any substance which is used for the destruction of insects or vermin that cause problems to the human system. Humans and animals can utilise such substances.

Section 3(b)iii-

Any form of component which is utilised to store drugs which will also include empty gelatine capsules.

Section 3(b)iv-

Any such devices which are used for internal or external treatment of human beings to reduce or prevent or mitigate any form of disease.

The above definition has been amended by the Ayurvedic and Unani Drugs Act, 1964.

Forms of Drugs License

There are different forms of drug license which can be provided based on the requirement of the applicant. The following are the forms of drug license provided:

Forms of Drugs License

Import Drug License-

Such license is usually used for import of drugs from other countries.

Multi Drug License-

Usually this form of license is issued to pharmaceutical businesses that have their pharmacies in different states and cities. A classic example of this form of license is the company Medplus.

Manufacturing License-

This license is usually issued to large industries for manufacture of drugs. In this form of license manufacturing of any form of drugs can occur. Even allopathic and ayurvedic drugs can be manufactured using this form of license.

Sale License-

This license is usually issued for the sale of drugs in pharmaceuticals and other form of stores. Such license is provided to stores for the sale of pharmaceuticals, restricted pharmaceuticals and other stores.

Benefits of Drug License

By securing a drug license the following benefits can be enjoyed by the pharmacy:

Benefits of Drug License

Compliance with Law-

All pharmacies that have the drug license would be compliant with the provisions of the Drugs and Cosmetics Act, 1940. Apart from this, pharmacies would not need to pay penalties for any issues related to non-compliance.

Reputation-

Pharmacies with drug license would have more reputation in the eyes of the public.

Eligibility Criteria for Drug License (Online Drug License)

The applicant has to satisfy the below criteria for the drug license:

Eligibility Criteria for Drug License

Area of Set up-

First and foremost, the applicant must have proper premises to distribute and sell pharmaceutical products. There has to be an independent shop available for the applicant to apply for the drug license. Such an application must be made as a retail or whole sale drug license. If the license made, is under Form 20 or Form 21, then the premises must be not less than 10 Square Meters. If the license applied for is in Form 20-B or Form 21-B then the premises must be not less than 15 Square Meters. Apart from the above pre-requisites the height of the premises must be in accordance to the National Building Code of India. These premises must satisfy the above criteria to be applicable for a drug license in India. An applicant has to apply to the respective state council for securing the drug license in the state. The requirement of the premises and their respective square foot must be adhered by the applicant.

Storage Facilities-

All pharmacies and drug stores must have adequate storage facilities to operate. Such requirements are mandatory as certain drugs and substances are stored at low temperatures. Hence the applicant has to ensure that proper storage facilities are available in the premises.

Technical Staff-

All individuals working in the pharmacy must have special educational and technical requirements. For example all individuals must have the bachelors of pharmacy certification (B.Pharm). Apart from this, any pharmacy must have an individual with at least one to four years experience. Such requirements are different when it comes to owning a retail business and a wholesale business.

Procedure for Securing Drug License in India

The following steps have to be carried out for this form of license in India:

Fill in the application online for the respective state drug license-

The applicant has to first fill the application online for the respective state drug license. The requirements for drug license would be different from one state to another state. Hence, the applicant has to ensure that the requirements for the drug license confirm with the state requirements.

Provide Updated Documents and Upload the Same-

In the second step, the applicant has to provide updated documents and upload the same online. Such documents should be as per the requirements of the authority.

Pay the Fees-

In the next step, the applicant has to pay the fees for the drug license. This has to be carried out online.

Verification-

After applying for the license, verification will occur. The authority will verify the application. An inspector would be assigned to view the premises of the retail or wholesale shop. If all the requirements confirm with the requirements, then the inspector would approve the premises.

Issue of Drug License-

In the last step, the license would be issued by the authority.

Application Forms required for Drug License

There are specific application forms required to be filled by the applicant for the drug license. The following are the application forms which have to be submitted by the applicant:

  • Form 19- This form is for the sale, distribution and storage of medicines for distribution. Some drugs which are present in Schedule X are supposed to be displayed or sold as per the requirements of the Drugs and Cosmetics Act, 1940.
  • Form 19A- Such form is the application for grant of license of renewal for a restricted license to sell medicines and drugs. Retailers who do not engage the services of a qualified individual would come under the purview of this form of license.
  • Form 19B- If an applicant wants to sell, stock, distribute any form of Homeopathy medicines then such application must be utilised.
  • Form 19C- This form of application is used for license to grant certifate or renewal for selling, stocking or distributing medicines which are mentioned under Schedule X of the Act.
  • Form 20B- Application for Sale or Distribution of Drugs at Wholesale.
  • Form 21C-Application for Wholesale license for the sale or distribution of drugs for specific renewal.
  • Form 24- Application for granting of license or renewal of license for specific medicines or to manufacture for sale or distribution of drugs other than the drugs which are mentioned under Schedule X , Schedule C and Schedule C1.
  • Form 24A- Application for the form of Loan License would be present under this form. Such license is for the grant of the loan license or the renewal of loan license for medicines and pharmaceutical products.
  • Form 24B-Application form for repacking of medicines and other forms of drugs but not the drugs which are mentioned under Schedule X, Schedule C or Schedule C1 of the Drugs and Cosmetics Act, 1940.
  • Form 24C- Application form for grant of the renewal of license to manufacture and distribution of homeopathy medications.
  • Form 24F- Application from for renewal of license for sale and manufacturing of drugs which are mentioned under Schedule X but not the manufacture and sale of drugs mentioned under Schedule C and C1.

Documents for Drug License

  • Incorporation Documents and Constitution Documents- If the applicant is a company, then certificate of incorporation must be provided along with other documents such as the memorandum of association and articles of association. In case the entity is a partnership then respective partnership documents must be provided. This will include the partnership deed.
  • Identification Proof of the Director or Shareholder or the Applicant.
  • Premises Documentation- Such as utility bills, electricity bills, water bills and property documents.
  • Site Plan and the Architecture Plan Of the Pharmaceutical Outlet.
  • Copy of the Board Resolution related to the License.
  • Proof of Challan and Copy of the Deposit Fee for the Pharmacy.
  • Evidence showing proof of availability of storage place and cold storage facilities.
  • Evidence showing no form of conviction is against the partner or the director of the company.
  • Educational Qualifications and Experience of the Pharmacist.

How to reach Enterslice for  Drug License Registration

Fill The Form

Get a Callback

Submit Document

Track Progress

Get Deliverables

Frequently Asked Questions

A drug license is issued by the government to carry out the process of manufacturing drugs, distributing and selling of drugs. All pharmacies require this form of license to carry out different processes.

Some of the basic requirements for securing a drug license are:

  • Sufficient Storage Space
  • Sufficient Refrigeration Facilities for Storing Medicines
  • Premises
  • Technical Staff.

Yes drug license is a mandatory requirement if the business carried out is dealing with pharmaceutical materials and other forms of drugs. If a drug license is not taken out by the business then there can be penalties levied under the Indian Penal Code, 1860 and the Drugs and Cosmetics Act, 1940.

Yes it is possible to renew the drug license. The applicant has to provide requisite documents for renewing the drug license. Such documents have to be uploaded on the website where the shop or premises is established. After this step, the authority will issue the license for a particular period of time.

Once the applicant provides the particulars for the drug license, the same will be provided within a period of one month to the applicant.

As per the Drugs and Cosmetics Act, 1940 all the works related to manufacturing drugs, distributing and selling of drugs have to be regulated. It is possible to import drugs into the country only after securing the specific import license.

The following are the types of licenses provided:

  • Export License
  • Import License
  • Manufacturing License
  • Sale License
  • Loan License
  • Multi Drug License.

Usually drug licenses would only be granted for a shop or establishment in commercial premises.

Related Articles

Related Articles
11 Mar, 2020
Drug License, Government Registration

How to start a Pharmacy Business in India

To start a Pharmacy business, the entrepreneur needs to choose or create a business idea, as this is a crucial step for those who want to go ahead with the...

Read More
09 Aug, 2018
Drug License

Licenses Required Opening a Drugstore in India

A drugstore or a pharmacy is a shop that sells medicines and drugs as per doctor prescriptions, over-the-counter, cosmetics, toiletries and other such prod...

Read More
25 Mar, 2018
Drug License

Drug License Brochure

Drug License Brochure in India, you cannot start any type of pharmaceutical business without getting a valid license from authority as per law. Drug Licens...

Read More
30 Oct, 2017
Drug License

Do You Want to Start a Pharmacy Business in India? Obtain Drug License!

To start a Pharmacy business you will need to choose or create a business idea. While this is an obvious step many people who want their own business don't...

Read More

Why Enterslice?

Top 100 Most Innovative Companies in Asia

Top 100 Most Innovative Companies in Asia - Red Herring

Forbes 30 Under 30 in American business

Forbes 30 Under 30 in American business and industry figures Lists.

Services delivered by 300+ Qualified CA and CS

Services delivered by 300+ Qualified CA and CS

Top 100 Most Innovative Companies in Asia - Red Herring

Top 100 Most Innovative Companies in Asia - Red Herring

Trusted Partner

Hey I'm Suman. Let's Talk!