Complete Guide to Form 20 and Form 21 Drug License Registration
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Overview of Drug License Form 20B 21B
Have you ever wondered how medicines make their way to your local pharmacy? In India, this process is governed by a drug license. Two critical licenses in this process are Drug Licence Form 20B 21B, which authorize the wholesale sale of medicines to retail stores and other eligible buyers. In this article, we will break down what these licenses entail and how they impact the pharmaceutical industry in India.
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 diving into Form 20 and Form 21, it’s important to first understand what a drug license is. In India, a drug license is an official document issued by the Government of India, allowing the manufacturing, distribution, and sale of medicinal products.
Form 20 and 21 Drug License Certificate
Form 20: Retail Drug License
Let’s begin with Form 20, which is primarily concerned with retail sales of medicines. This license applies to stores that sell medicines directly to consumers. Form 20 is for retail sales, and this form is used 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.
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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 or 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 for those who intend to trade medicines in bulk, selling to pharmacies, hospitals, or other institutions, rather than directly to consumers. This is the license for 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 the drug department.
- Submit all necessary documents and pay the challan.
- Prepare the premises for compliance during the site inspection.
- Get a wholesale license post-complete application verification.
Differences Between Drug Licence Form 20B 21B
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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.
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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.
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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.
Documents Required for Drug Licence Form 20B 21B
- A duly signed application form
- Covering letter addressed to licensing authority
- Identity and address proof like aadhar, pan
- Business premises ownership proof: rent agreement, lease deed, sale deed
- Site plan showing proper storage facilities like racks, refrigeration, etc.
- Qualification certificate of Pharmacist
- Registration certificate from state pharmacy council
- Appoint and acceptance letter from pharmacist
- Competent person qualification certificate
- Letter of appointment and experience of competent person
- Duly signed copy of Declaration and undertaking
- Attach a partnership deed in case of a partnership firm
- Copy of COI, MOA, AOA in case of MCA registered firm
- Copy of refrigerator bill to show the proper cold storage facilities
- Copy of electricity bill as address proof of premises.
Who Needs to Apply for Form 20 and 21 Drug License?
Form 20 Retail Drug License and 21 Wholesale Drug License are compulsory for a person or business entity engaged in business activities like import, sale, stock, or distribution of allopathic medicine in India.
Form 20: Retail Drug License is mandatory for business activities like
- Medical Shops
- Pharmacy Stores
- Hospitals Pharmacy stores
- Clinics dispensaries
Form 21: Wholesale Drug License is mandatory for business activities like
- Medicine Distributor or stockist
- Pharmaceutical Products Wholesaler
- Suppliers to Hospital, Clinics, Medical Stores
- Online pharma logistics firms: B2B
- Companies supplying medicines in bulk
Why Drug Licence Form 20B 21B Matters?
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.
How can we apply for form 20 and 21 Drug Licenses online?
Step 1: Apply to State Licensing Authority: This is the first step of getting a Form 20 & 21 drug license.
Step 2: Prepare Your Relevant Documents: You’ll need to submit various documents, including photos of your business or store’s interior, company registration, KYC of the authorised signatory, address proof, and the credentials of the competent person managing the license.
Step 3: Pay the Applicable Govt. Fees: There is a fee of Rs. 3000 that you need to pay to get a license.
Step 4: Be Ready for an Inspection: A drug inspector from the concerned licensing authority will come to inspect your store, shop, or business.
Step 5: Grant of Form 20 or 21 Drug License: After successful verification of the application, fee, and premises, you will be rewarded with the grant of a certificate.
What is the validity of Form 20 and 21 Drug License?
As per the latest guidelines, both Form 20 and 21 drug licenses are valid for five years from the date of grant of certificate.
Renewal of Form 20 and 21 Drug License
A drug license holder must start the renewal process of the application before the expiry of Form 20 and 21 drug licenses. Renewal is done online through the Drug Control Department portal of the ONDLS portal.
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Conclusion
Form 20 and Form 21 drug licenses play a crucial role in setting up your drug business in India. If you are considering starting a small chain of pharmacies or planning to begin a wholesale distribution business, understanding these licenses is essential. A drug license in India is much more than a mere formality; it is a responsibility that ensures compliance with applicable drug laws and regulations. Therefore, it is important to understand the eligibility criteria, documentation, and application process before starting your business.
Agile Regulatory helps businesses navigate the drug license registration process with professional guidance and end-to-end support. From understanding the requirements for Form 20 and Form 21 to preparing the necessary documents and assisting with the application process, our team helps simplify regulatory compliance. Whether you plan to open a retail pharmacy or establish a wholesale drug business, connect with Agile Regulatory for assistance in obtaining your drug license and meeting the applicable regulatory requirements.
Frequently Asked Questions (FAQs)
1. What is drug licence form 20b 21b?
Drug Licence Form 20B 21B allows eligible businesses to wholesale general allopathic medicines and specified Schedule C and C(1) drugs.
2. How can I apply for drug licence form 20b 21b?
You can apply through your State Drug Control Department by submitting the required documents and paying the applicable government fees.
3. What is the difference between Form 20 and Form 21?
Form 20 covers retail sales of certain allopathic medicines, while Form 21 covers retail sales of specified Schedule C and C(1) drugs.
4. What documents are required for a Form 20 and Form 21 drug license?
Common documents include identity proof, premises proof, a site plan, pharmacist qualifications, and other applicable declarations.
5. How long is a Form 20 and Form 21 drug license valid?
The license is subject to applicable validity and retention requirements. Check with your State Drug Control Department for current rules.
About the Author
View ProfileNishi Chawla
Content Writer & Compliance Specialist
Nishi is an expert content writer with expertise in Business Legal Compliances, Certifications, and Registrations — BIS, EPR, Medical Devices, Cosmetics, Drugs, and Import Export. She holds a B.Com from the University of Delhi and has been writing industry content since 2019.
