How to Apply for a Drug License for PCD Pharma Franchise – Starting a PCD pharma franchise business in India is one of the most profitable opportunities in today’s healthcare market. But before you start, there is one important step that every pharma entrepreneur must take, which is getting a drug license. Without it, you cannot legally sell, market, or distribute medicines in India.
To start a PCD Pharma Franchise business in India, you need a Wholesale Drug License (Form 20B/21B) from your State Drugs Control Department. This license is required for anyone who wants to market, distribute, or sell pharmaceutical products on a wholesale basis. The application process and necessary documents are outlined in the Drugs and Cosmetics Act of 1940 and its rules.
If you are new to this industry and wondering how to apply for a drug licence for your PCD pharma franchise, this blog will guide you through the entire process in simple, easy-to-understand steps.
What is a Drug License?
A drug license is an official permission issued by the State Drugs Standard Control Organisation (SDCO) or the Central Drugs Standard Control Organisation (CDSCO) in India. It allows individuals or businesses to legally deal in pharmaceuticals – whether it is manufacturing, selling, marketing, or distributing medicines.
For a PCD pharma franchise business, you mainly need a wholesale drug license or sometimes a retail drug license, depending on your business model. It is a legal requirement that ensures safety, quality, and proper distribution of medicines.
Step-by-Step Process to Apply for a Drug License in India
Now, let’s understand how to apply for a drug licence in India in simple steps:
Step 1 – Decide the Type of License You Need
For a PCD pharma franchise, apply for a wholesale drug license. If you are also running a pharmacy, you may need a retail license too.
Step 2 – Arrange Business Premises
You must have a suitable office or shop space to apply. The minimum area requirement is:
- 10 square meters for a retail or wholesale license.
- 15 square meters if you are applying for both retail and wholesale.
Step 3 – Hire a Qualified Person
To get a wholesale drug license, you must appoint a qualified person with either:
- A degree or diploma in pharmacy, OR
- At least one year of experience in pharma distribution.
This is a mandatory rule under the Drugs and Cosmetics Act.
Step 4 – Prepare the Documents
Collect all required documents (as listed below). Ensure everything is clear and valid.
Step 5 – Apply Online or Offline
Most states in India have an online portal for drug license applications. Fill the form, upload documents, and pay the required government fee. In some states, you may also need to submit documents physically to the State Drug Control Department.
Step 6 – Inspection by Drug Inspector
Once your application is submitted, a drug inspector will visit your premises. They will check:
- Storage conditions (refrigerator, racks, ventilation)
- Authenticity of documents
- Qualification of the responsible person
Step 7 – Approval and License Issuance
If everything is correct, the department will issue your drug license certificate. The time may vary, but it usually takes 30 to 60 days.
Also Read: How to Start PCD Pharma Franchise on Monopoly Basis
Documents Required to Apply for a Drug License
To complete the process to apply for a drug licence, you need to submit certain documents. While requirements may slightly vary by state, here is the general list:
- Application form in the prescribed format
- Covering letter with the purpose of the application
- Identity proof (Aadhar Card, PAN Card)
- Address proof of business premises (rental agreement/ownership papers)
- Proof of qualification of a registered pharmacist or competent person
- Appointment letter of the pharmacist or employee (if applicable)
- Blueprint or layout of the premises
- Proof of refrigeration facility (since some medicines require cold storage)
- Affidavit of non-conviction of the proprietor/partners/directors
- Copy of GST registration certificate
- Photographs of the applicant
Having these documents ready makes the process of getting a drug licence smoother and faster.
Why Do You Need a Drug License for PCD Pharma Franchise Business?
You cannot run a pharma franchise business without a drug license. Here’s why it is important:
- It gives legal approval to sell and distribute medicines
- Builds trust with customers and doctors
- Prevents legal troubles in the future
- Makes your business eligible to partner with top pharma companies
- Ensures that you follow the rules set by the Indian Drugs and Cosmetics Act, 1940
So, before you invest in stock or start promoting your business, you must complete the process to get a drug licence.
Also Read: How to Become a Pharmaceutical Distributor in India- A Simple Step-By-Step Guide
Validity and Renewal of Drug License
- A drug license is generally valid for 5 years.
- You must apply for renewal before expiry to avoid penalties.
- Renewal also requires document submission and sometimes re-inspection.
Frequently Asked Questions
Do I need a drug license for a PCD pharma franchise business?
Yes, it is mandatory to have a drug licence. Without a drug license, you can not legally sell or distribute medicines.
Which type of drug license is needed for a PCD pharma franchise?
Most franchise owners need a wholesale drug license. If you also want to run a medical store, you may need a retail license.
How long does it take to get a drug license in India?
The process usually takes 30-60 days, depending on your state and document verification.
Can I apply for a drug license online?
Yes, many states in India allow you to apply online through their drug control department portals.
What is the cost of applying for a drug license in India?
The cost ranges from Rs. 3,000 to Rs. 6,000 depending on the type of license and state.
