Documents for obtaining a drug license
• Documents for forming a corporation and establishing a constitution- If the applicant is a corporation, the certificate of organization, as well as other documents such as the memorandum of association and articles of incorporation, must be given. If the entity is a partnership, the partnership documentation must be given as well. The partnership document will be included in this.
• Proof of the Director's or Shareholder's or Applicant's identity.
• Utility bills, power bills, water bills, and property paperwork are examples of premises documentation.
• The Pharmaceutical Outlet's Site Plan and Architecture Plan
• A copy of the Board Resolution pertaining to the License is attached.
• Proof of Challan and a copy of the Pharmacy Deposit Fee
• Evidence demonstrating the availability of a storage facility as well as cold storage facilities.
• The evidence shows that neither the partner nor the company's director has been convicted.
• The pharmacist's educational qualifications and experience.
Forms for obtaining a drug license are required.
The candidate for a drug license is required to complete out appropriate application forms.
The following are the forms that must be completed and submitted by the applicant:
• This form is used to sell, distribute, and store drugs for distribution. Schedule X medications are required to be displayed or sold in accordance with the Drugs and Cosmetics Act of 1940.
• Form 19A is an application for a restricted license to sell medicines and drugs that is being granted or renewed.
• This type of license would apply to retailers who do not employ the services of a qualified worker.
• Form 19C- This application is for a license to sell, stock, or distribute medicines listed in Schedule X of the Act, or for a renewal of a license to sell, stock, or distribute medicines listed in Schedule X of the Act.
• Form 20B is an application for the wholesale sale or distribution of drugs.
• Form 21C-Application for a specific renewal of a wholesale license for the sale or distribution of pharmaceuticals.
• Form 24- Application for granting or renewing a license for specific medications, or for manufacturing, selling, or distributing drugs other than those listed in Schedule X, Schedule C, or Schedule C1.
• This form would contain an application for a loan license in the form of Form 24A. The purpose of this license is to award or renew a lending license for medicines and pharmaceutical products.
• Form 24B-Application form for repackaging medications and other types of drugs, save those included in Schedule X, Schedule C, or Schedule C1 of the Drugs and Cosmetics Act, 1940.
• Form 24C is a request for a renewal of a license to make and distribute homoeopathic remedies.
• Form 24F-Application for renewal of a license for the sale and manufacture of medications listed in Schedule X, but not for the manufacture and sale of drugs listed in Schedules C and C1.
Frequently asked questions:
1 What kind of establishments will be granted a drug license?
Typically, drug licenses are only issued to a shop or facility in a commercial setting.
2 What are the requirements for a registered pharma firm to keep accounts?
The licensing body may specify the way in which the books of accounts, registers, forms, and other papers must be kept at the time the license is issued. It is the license holder's responsibility to notify the licensing authority of any changes or modifications to its business.
3 Is it true that different licenses are required for each drug-related operation?
Yes, any unit functioning in any area of India requires a drug license. For example, if a pharma company has operations in two states, it must obtain licenses for both of them.
4 What are the different types of licenses available?
The following are the many types of licenses that are available:
Export and Import Licenses, Manufacturing Licenses, Sales Licenses, and Loan Licenses and Licensure for multiple drugs.
5 What is the average time it takes to obtain a drug license?
After the application submits the required information for the drug license, the applicant will receive the license within one month.
6 Is it legal to bring pharmaceuticals into India?
All activities linked to the manufacture, distribution, and sale of medications must be controlled under the Drugs and Cosmetics Act of 1940. Only after obtaining a specific import license is it feasible to bring medicines into the country.
7 Is it feasible to get your drug license renewed?
The drug license can be renewed, and it is possible to do so. To renew a drug license, the applicant must provide the required documentation. These documents must be posted to the website where the shop or location is located. Following this, the authorities will grant a license for a specific time period.
8 What distinguishes a drug license from others?
The following are the characteristics of a drug license:
• A drug license is required for any firm that sells pharmaceuticals, medicines, or cosmetics.
• The license will be issued for a commercial establishment.
• The pharmaceutical and cosmetics industries must adhere to all legal and regulatory requirements and restrictions.
• The license must be displayed in the place of business at all times.
9 What is the purpose of a drug license?
To carry out the process of manufacturing, distributing, and selling pharmaceuticals, the government issues a drug license. This type of license is required by all pharmacies in order to carry out various activities.