Drug License for PCD Pharma Franchise

You need to obtain a Wholesale Drug License (Form 20B/21B) from your State Drugs Control Department to secure a drug licence for the PCD Pharma Franchise business in India. This licence is essential for everyone who wants to do marketing, distribution, and sale of pharmaceutical products on a wholesale basis. The Drugs and Cosmetics Act of 1940 and its rules govern the application process and specific documentation.

Key requirements for a Wholesale Drug License

To obtain a Wholesale Drug License, you need to meet several requirements. Listed below are the key requirements that you require:

1. Premises

• Minimum Area: The minimum storage and office space must be at least 15 square meters.
• Property Documents: You need to provide proof of ownership (e.g., a sale deed) or a rent agreement and a No Objection Certificate (NOC) from the landlord if the property is rented.
• Layout Plan: A detailed blueprint of the premises is required, which may need to be attested by an architect.
• Storage Facilities: You must have proper storage facilities, including refrigerators or air conditioners. These are required to maintain the required temperature for certain medicines. 

2. Competent Person (Qualified Staff)

The person responsible for the business must meet specific qualifications: 

• Registered Pharmacist: A person needs to get registered under the State Pharmacy Council.
• Experienced Graduate: A Person must be a graduate and have a minimum of one year of experience in drug sales and marketing.
• Experienced Undergraduate: An undergraduate who has at least four years of experience in the pharmaceutical field.
• Documents: You will need to provide the following documents from the competent person, which include an affidavit, qualification, experience certificates, and an appointment letter. 

3. Business Registration Documents

The required documents will depend on your business structure:

• For a company: You need to get the Memorandum of Association (MoA) and Articles of Association (AoA).
• For a partnership firm: The Partnership Deed.
• Identity and Address Proof: Pan Card, Aadhaar Card, and proof of address for the proprietor, partners, or directors are required.

4. Financial and Tax Documents

• Goods and Services Tax (GST) Registration: It is mandatory for all businesses that deal in goods.
• Bank Account Details: A cancelled check and bank statements are required for the company’s account. 

5. Other documents

• Application Form: The specific application form (e.g., Form 19 for general wholesale) is required, which varies depending on the type of drugs you will distribute.
• Fee Deposit Challan: Proof of payment is required for the licensing fee.
• Affidavit of non-conviction: An affidavit is required stating that the business owner or partners have no prior conviction under the Drugs and Cosmetics Act.
• Franchise Agreement: The legal agreement between you and the parent pharma company you are franchising with is essential. 

Step-by-Step Application Process

Read to complete the step-by-step process to get your Wholesale Drug Licence. Here are the steps: 

• Preparation: Get all the necessary documents, including business registration, premise details, and information on the competent person.
• Online Application: Apply for the license on the website of your respective State Drugs Control Department. You have to pay the fee online.
• Submission: Upload all scanned copies of the required documents along with the application form.
• Inspection: A Drug Inspector will visit and inspect your business premises to verify the documents and ensure all conditions are met.
• License Issuance: After the inspection report is sent to the licensing authority and all requirements are met, you will get the Wholesale Drug License. 

Important Considerations

Here are some of the important considerations that you need to read before applying for the drug licence. Read below:

• State-specific rules: The application fees and some specific requirements can vary from state to state.
• Location-specific: A drug license is location-specific, so if you operate in multiple states, you need a separate license for each one.
• Validity and Renewal: A drug license is typically valid for five years and must be renewed before its expiration date.

Read More:

• How to Choose a PCD Pharma Franchise Product List
• Pharma Companies to Start PCD Pharma Franchise Business

Frequently Asked Questions (FAQs)

Why is a drug license required for a PCD Pharma Franchise?
It is mandatory to legally sell, distribute, and market pharmaceutical products in India.

Which type of drug license is needed for PCD Pharma Franchise?
Usually, a Wholesale Drug License or Retail Drug License is required, depending on your business model.

Who issues the drug license for PCD Pharma Franchise?
The State Drug Control Authority issues the license under the Drugs and Cosmetics Act.

What documents are needed for obtaining a drug license?
You need business registration, premises proof, a pharmacist qualification, and other KYC documents.

How long does it take to get a drug license for a PCD Pharma Franchise?
It usually takes 30–45 days, depending on state regulations and document verification.