Drug Licence Form 20 & 21 PDF Download: What You Need to Know
If you are planning to start or run a business related to drugs or cosmetics in India, you need to obtain a drug licence from the competent authority under the Drugs and Cosmetics Act, 1940. A drug licence is a legal document that grants permission to engage in activities such as manufacturing, selling, distributing, importing, or exporting drugs or cosmetics. Obtaining a drug licence is not only mandatory but also beneficial for ensuring the quality, safety, and efficacy of the products you deal with.
However, obtaining a drug licence is not an easy task. It involves various types of licences, forms, documents, fees, and procedures that can be confusing and time-consuming. In this article, we will focus on one of the most common types of drug licences in India: the retail sale drug licence in form 20 and 21. We will explain what they are, who needs them, how to download and fill them online, and what are the benefits and challenges of obtaining them.
drug licence form 20 amp; 21 pdf download
Drug Licence Form 20 & 21: What are they and who needs them?
A retail sale drug licence is a type of sale licence that allows a person or an entity to sell drugs or medicines to consumers through a retail outlet such as a pharmacy, chemist shop, or medical store. A retail sale drug licence is issued by the State Licensing Authority (SLA) under the Drugs and Cosmetics Rules, 1945.
There are two types of retail sale drug licences in India: form 20 and form 21. Form 20 is for non-biological drugs, such as allopathic, ayurvedic, homeopathic, or unani drugs. Form 21 is for biological drugs, such as vaccines, sera, toxins, antitoxins, etc.
To apply for a retail sale drug licence in form 20 or 21, you need to meet certain requirements such as:
Having a minimum area of 10 square meters for your premises
Having a registered pharmacist or a competent person with adequate qualification and experience
Having adequate facilities for storage and refrigeration of drugs
Having proof of ownership or possession of premises
Having educational certificates and identity proofs of the applicant and the qualified person
Having an affidavit or declaration from the applicant and the qualified person
You need to apply for both form 20 and form 21 if you want to sell both non-biological and biological drugs. You also need to apply separately for each retail outlet if you have more than one.
How to download and fill drug licence form 20 & 21 online?
The process of applying for a retail sale drug licence in form 20 or 21 varies from state to state. Some states have online portals where you can download and fill the forms online, while others require you to submit the forms offline. You can check the website of your state's drug control department or contact the SLA for more details.
However, here is a general procedure that you can follow to download and fill drug licence form 20 & 21 online:
Visit the website of your state's drug control department and look for the online application portal for drug licences.
Register yourself as a new user by providing your name, email, mobile number, and password.
Login to your account and select the type of licence you want to apply for (retail sale in form 20 or 21).
Download the drug licence form 20 or 21 pdf from the portal or from the links given below:
Type of LicenceForm NumberPDF Link
Retail sale of non-biological drugsForm 20
Retail sale of biological drugsForm 21
Fill the drug licence form 20 or 21 online by providing the required information such as:
Name and address of the applicant and the qualified person
Name and address of the premises where the drugs will be sold
List of drugs or classes of drugs that will be sold
Details of storage and refrigeration facilities
Details of previous licences, if any
Declaration and signature of the applicant and the qualified person
Upload the scanned copies of the documents required to submit along with the drug licence form 20 or 21 online such as:
Proof of ownership or possession of premises (rent agreement, lease deed, etc.)
Educational certificates and identity proofs of the applicant and the qualified person (degree, diploma, registration certificate, Aadhaar card, PAN card, etc.)
Affidavit or declaration from the applicant and the qualified person (format available on the portal)
Fee receipt or challan for payment of licence fee (online or offline)
Any other document as specified by the SLA
Submit the application online and take a printout of the acknowledgement slip.
Wait for the verification and inspection of your premises by the SLA officials.
If your application is approved, you will receive your drug licence in form 20 or 21 by post or email.
Conclusion
A retail sale drug licence in form 20 or 21 is a legal requirement for selling drugs or medicines to consumers in India. It ensures that you comply with the rules and regulations of the Drugs and Cosmetics Act, 1940 and that you provide quality, safe, and effective products to your customers. Obtaining a retail sale drug licence in form 20 or 21 can be a challenging process, but it can be made easier by following the steps given above. You can download and fill drug licence form 20 & 21 online from the website of your state's drug control department or from the links provided in this article. You need to submit the forms along with the required documents and fee to the SLA and wait for their approval. Once you get your drug licence in form 20 or 21, you can start selling drugs or medicines legally in India.
FAQs
How much is the fee for obtaining a drug licence in India?
The fee for obtaining a drug licence in India varies from state to state and depends on the type and number of licences you apply for. However, as per the Drugs and Cosmetics Rules, 1945, the maximum fee for obtaining a retail sale drug licence in form 20 or 21 is Rs. 3000 per licence per premises. You can pay the fee online through net banking, debit card, credit card, etc. or offline through challan, demand draft, etc.
How long does it take to get a drug licence in India?
The time taken to get a drug licence in India depends on various factors such as the completeness and correctness of your application, the availability and efficiency of the SLA officials, the workload and backlog of the SLA, etc. However, as per the Drugs and Cosmetics Rules, 1945, the SLA should grant or refuse a drug licence within 30 days of receiving the application. If you do not receive any communication from the SLA within 30 days, you can assume that your licence has been granted.
What are the penalties for violating the drug licence rules in India?
Violating the drug licence rules in India can result in serious consequences such as cancellation or suspension of licence, seizure or confiscation of drugs, imposition of fine, imprisonment, or prosecution. The penalties depend on the nature and extent of the violation and are decided by the SLA or the court of law. Some of the common violations and their penalties are:
Selling drugs without a valid licence: Fine up to Rs. 5000 or imprisonment up to 3 years or both
Selling drugs that are not of standard quality: Fine up to Rs. 10000 or imprisonment up to 2 years or both
Selling drugs that are misbranded, adulterated, or spurious: Fine up to Rs. 20000 or imprisonment up to 3 years or both
Selling drugs that are prohibited or restricted: Fine up to Rs. 50000 or imprisonment up to 5 years or both
How to renew a drug licence in India?
A drug licence in India is valid for a period of 5 years from the date of issue. You need to renew your licence before it expires by applying to the SLA in the same manner as you applied for the original licence. You need to submit the same forms, documents, and fee as you did for the original licence. You also need to submit a copy of your existing licence along with your renewal application. You should apply for renewal at least 3 months before the expiry of your licence to avoid any delay or interruption in your business.
How to check the status of a drug licence application in India?
You can check the status of your drug licence application in India by visiting the website of your state's drug control department and logging into your account. You can also contact the SLA office or visit their website for more information. You can track your application status by using your application number, acknowledgement number, or registration number. You can also get updates on your application status through email or SMS notifications.
I hope this article has helped you understand what a drug licence form 20 & 21 is, who needs it, how to download and fill it online, and what are the benefits and challenges of obtaining it. If you have any questions or doubts regarding this topic, feel free to ask me in the comments section below. I will be happy to answer them. 44f88ac181
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