A drug license for a PCD pharma franchise in India isn’t just beneficial but essential. Since commencing a PCD Pharma franchise comes with regulatory requirements due to the laws and rules regarding the distribution and sale of medicines, the drug license helps you run your business legally.
Here, we cover it all step by step: which license to pick, what premises you need, the paperwork, the application, the inspection, and the cost. New to this business? Start with what a PCD Pharma company is.
Key Takeaways:
Why is it important to get a drug license for a PCD Pharma Franchise?
Under the Drugs and Cosmetics Act of 1940, this license authorizes you to store, distribute, and sell pharma products legally in India. Section 18(c) of the Act bars you from stocking, selling or distributing drugs without a valid license. Break that rule, and you could face heavy fines or even jail time.
Check out the importance of having a drug license for a PCD Pharma Franchise in India below:
Demand for PCD pharma keeps growing, and none of it helps if you don’t have a valid license to begin with.
What’s the step-by-step process to get a drug license for a PCD Pharma Franchise in India?
As per the Central Drugs Standard Control Organization (CDSCO), the manufacture, sale, and distribution of drugs are primarily handled by state authorities, whereas new drug approvals and the setting of standards are handled by central authorities. You can read the actual rules on the CDSCO Acts and Rules page.
Step 1: Know the type of drug license you need
While there are two types of drug licenses, to run a PCD pharma franchise, you need to have a wholesale drug license from your state’s State Drug Control Department.
Remember, PCD Pharma Franchises work on selling drugs in bulk to chemists and hospitals, rather than dealing in them at retail. With a wholesale license you can supply retailers, hospitals and other license holders, but not patients directly.
While applying, look for Form 20B (for general drugs) and Form 21B (for specific Schedule C and C(1) drugs). You apply through Form 19, and the license comes in Form 20B, Form 21B or both. Tablets, capsules and syrups usually fall under Form 20B. You only need 21B if you plan to sell Schedule C and C(1) products.
Step 2: Establish the premises for your business
Search for an office space or storage space of about 10 to 15 square metres from where you will start your PCD pharma franchise. The Drugs Rules set the minimum at 10 square metres, and a bit of extra room helps when your stock grows.
While some drugs need to be kept in a properly ventilated environment, and others with special temperature requirements need AC and refrigeration units, you need to ensure that your premises are well equipped with all of these. Keep the space clean, put stock on racks instead of the floor, and have a rent agreement or ownership proof ready.
Step 3: Get expert’s assistance to lock your drug license
When running a PCD Pharma franchise, it is important that you partner with a decent PCD Pharma Franchise Company in your area that can provide you with all-round support you need to excel in the niche.
At Oasis Bio Bloom, we haven’t become a reputed PCD Pharma franchise company by chance; it is our support and cooperation that help our franchise partners with each of their requirements.
A good partner can help with the paperwork and get you ready for the inspection, which saves a lot of back-and-forth.
Step 4: Get the required documents handy
There are certain documents that you need to have beforehand to obtain your drug license for a PCD Pharma franchise in India. It includes:
Carry originals as well as self-attested copies. The checklist differs a little from state to state, so confirm it with your State Drug Control Department first.
Step 5: Submit your application to the appropriate authority
You can file your application in two ways: online or offline through the State Drug Control Department.
You need to pay the officials a fee of INR 3,000 to INR 6,000, depending on the state. Fill in Form 19 with care, attach the documents and save your application number so you can track it. Names or addresses that don’t match across documents often cause delays, so check them once more before you submit.
Step 6: Stay prepared for verification and inspection
After filing the form, you can stay ready for the verification and inspection by the drug inspector. A drug inspector checks whether you’re abiding by all the rules and compliance requirements.
The inspector will usually check if the premises match your layout plan, if the space is big enough, and if storage is proper (racks, ventilation, AC and a fridge). They also want to see the competent person on site and your purchase and sales records. Once they are satisfied, the license is granted, usually within 30 to 60 days overall.
How much does it cost to get a drug license for a PCD Pharma Franchise?
The total cost to obtain a wholesale drug license for a PCD Pharma Franchise typically ranges between INR 5,000 and INR 25,000, depending on the state you belong to.
Here’s the breakdown of the costs involved:
Fees change from time to time, so check the latest charges with your State Drug Control Department. Either way, it is a small one-time cost compared to fines and seized stock.
Bottom Line
A drug license is where a legal and trusted PCD Pharma franchise begins. Follow these six steps, and you should get your license without much delay.
Want to go further? Get in touch with the team at Oasis Bio Bloom today!
Frequently Asked Questions (FAQs)
Q1. Is a drug license mandatory for a PCD Pharma franchise?
Yes. If you stock, sell, or distribute medicines, you need a wholesale drug license under the Drugs and Cosmetics Act, 1940. Without it, you risk fines, seized stock, and legal action, and most PCD companies will ask for it before they onboard you.
Q2. Which forms are required for a wholesale drug license?
You apply in Form 19. The license is issued in Form 20B for general drugs and Form 21B for Schedule C and C(1) drugs. Most franchise partners only need 20B unless their range includes Schedule C and C(1) products.
Q3. Is one drug license valid across different states?
No. The State Licensing Authority issues it for specific premises. If you want to store and distribute from another state, you will generally need a separate license there.
Author’s Bio: Sanjay Garg (MD, Co-Founder, Oasis Bio Bloom LLP)
Sanjay Garg is the Managing Director and Co-Founder of Oasis Bio Bloom LLP, a PCD pharma franchise company in Panchkula, Haryana. He has spent around 30 years serving the pharmaceutical industry. Oasis Bio Bloom offers 500+ WHO-GMP and ISO-certified products and guides its franchise partners from day one.
