What is Form 20 and 21 Drug License?
Have you thought about how medicines get to your nearest pharmacy? It’s through a drug license In India. Two important types of drug licenses are Form 20 and Form 21. They are permitted to sell medicines to retail stores and to customers. We will explore more about this license in the rest of the article but for now, let us focus on what form 20 and form 21 is all about.
If you want to know how exactly medicine sales are done or have plans to venture into setting up a pharmacy business, this article will take you through the drug license in India.
What is a Drug License?
Before we even get to Form 20 and Form 21, it is, important to understand what it is. In India, a drug license is a legal document issued by the Government of India for the purposes of manufacturing, selling, and distributing medicine.
Form 20: Retail Drug License
Now, let's talk about Form 20. It is a class of drug licenses in India which covers the whole aspect of practising medicine by selling drugs to the general populace.
Form 20 is for retail sales and this Form is use for sales in commerce. This is for medicine cabinets or stores. If a shop has a Form 20 license, it can sell medicines directly to customers.
People who want to run a pharmacy or a medical store in India should get this license. Scale does not matter for such a licensing, be it miniscule medicine shops or gargantuan pharmaceutical chains.
Process of Form 20 Retail Drug License
Obtaining a Form 20 retail drug license in India involves the following steps:
- You must check with the licensing authority of your state for online of physical application submission.
- Pay the challan amount of Rs. 3000.
- After application submission and fee payment, drug inspection will go through all of the submitted documents.
- If all seems to be in order, the drug retail license will be issued to you.
Form 21: Wholesale Drug License
Form 21 is related to the trade of medicines in bulk. It is not for selling to the end consumers who will be using the medicines. Rather it is meant for selling them to other companies like pharmacy chains, hospitals, etc. People who want to sell medicines to shops or hospitals will need a Drug License in India. These are usually referred to as wholesalers or distributors.
Process of Form 21 Wholesale Drug License
Here is how to get a Form 21 License:
- Apply with your state’s licensing authority commonly known as drug deparmtent.
- Submit all neccessary documents, pay the challan.
- Prepare the premises of per compliance during the site inspection.
- Get a Wholesale license post complete application verification.
Differences between Form 20 and Form 21
- Form 20 is for selling to ordinary citizens who require drugs. In structure, Form 21 is meant for a customer base that institutions sell to the people.
- Form 20 permits the sale of smaller quantities of medicines, such as those needed by individual persons. But, Form 21 is for the selling of large quantities, more like what an entire store would require.
- For Form 20 outlets, the space requirement of a typical community pharmacy will suffice. Businesses in Form 21 will require much more space to accommodate many drugs than pharmaceuticals.
Why Form 20 and 21 drug licenses matter?
In every country, there are a number of drug licenses. In India too you can find Form 20, Form 21, etc., which are adjudged of utmost importance. The reasons are:
- These licenses are to ensure that only competent individuals administer medications. It benefits all participants.
- By issuing licenses, the state ensures that the distribution of drugs is done in an appropriate manner.
- A license means that the regulations are being observed. As a result, both buyers and sellers are protected.
What is the process of Form 20 and 21 Drug License?
- Step 1: Apply to State Licensing Authority: This is the fist step of getting a form 20 & 21 drug license.
- Step 2: Prepare Your Documents: Details like interior photos of your business or shop, docukments of company registraton, KYC of authorized signatory, address proof, detail of comeptent person etc.
Step 3: Pay the Fees: There is a fees of Rs. 3000 that you need to pay to get a license.- 3. Get an Inspection: A Drug inspector from the concerned licensing authority will come to inspect your store, shop or business.
Conclusion
Form 20 and Form 21 drug licenses play a crucial role in setting up your drug business in India. If you are considering beginning a small chain of pharmacy or looking forward to starting a wholesale distribution business, then knowing about these licenses is essential. Keep in mind that a drug license in India is much more than a mere formality. it is a responsibility. Take the help of experts like Agile Regulatory and get your drug license today.
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