Starting a pharma franchise in India can be a good way for entrepreneurs to enter the drug business. Still, you have to follow the rules to run things legally. The most vital thing is getting a drug license. This article gives you a rundown of what you need to get one to start a Top 10 PCD Pharma Franchise Companies in India.
🔹What is a Drug License?
What is the definition of a drug license and what is the procedure of applying for a drug license? In India, it is extended by Central Drugs Standard Control Organization (CDSCO) /concerned State Drug Control Department under Drugs and Cosmetics Act, 1940.
Manufacturing, sale and distribution of medicines in India is strictly governed by the provisions of the drug licence.
🔹Why is a Drug License Required for Pharma Franchise?
A PCD Pharma Franchise business involves the distribution and sale of medicines under the name of a parent pharmaceutical company. Since it deals directly with the marketing and supply of drugs, having a drug license is mandatory. It ensures:
- Legal authorization to sell or distribute medicines.
- Ensurement of quality and safety in drug handling.
- Conformity with health policies and industry norms.
- Seamless operations in case of inspections and audits.
🔹Types of Drug Licenses Necessary for Pharma Franchise
Based on the type of your business, the following kinds of drug licenses might be necessary:
1. Retail Drug License (RDL):
This is granted to those engaged in the sale of medicines directly to consumers. If you are going to establish a pharmacy or work as a medical store under the franchise system, you’ll require this.
- Issued by: State Drug Control Department.
- Eligibility: Pharmacist with degree or diploma in pharmacy.
2. Wholesale Drug License (WDL):
This license is required for those who are dealing in bulk drug distribution, i.e., PCD Pharma Franchise partners. It enables the sale of drugs to retailers, clinics, and hospitals.
- Issued by: State Drug Control Department.
- Qualification: Generally requires a graduate with pharmaceutical experience or a registered pharmacist.
3. Manufacturing Drug License:
If you intend to make drugs, this license is mandatory. Yet, in a standard PCD Pharma Franchise business, the master company already possesses this license.
🔹Most Important Requirements to Obtain a Drug License
In order to obtain a drug license for your pharma franchise business, you must fulfill a number of conditions:
1. Premises Requirements:
- Area: In the case of a retail or wholesale license, at least 10 square meters.
- Storage: enough space for refrigeration and cold storage of medicines which are sensitive to temperature.
2. Qualification of Staff:
- For Retail License: Qualified registered pharmacist is required.
- For Wholesale License: Graduate with 1-year experience or SSLC with 4 years’ experience in dealing in drugs.
3. Checklist of Documents:
- Identity & address proof of applicant.
- Proof of premises (lease agreement or ownership documents).
- Blueprint/layout of premises.
- Qualification and experience certificates.
- Affidavit for non-conviction of applicant under the Drugs & Cosmetics Act.
- GST registration (in few states).
- Fee receipt or challan for license application.
🔹Application Process for Drug License
Here’s how you can apply:
- Draw up all the documents as per the checklist.
- Submit the application through the respective state drug department’s online or offline portal.
- Inspection of the premises by the Drug Inspector.
- Documents and eligibility verification.
- Drug license issuance (about 30–60 days).
- Go to your local drug control or knowledgeable advisors as each state may have different procedures.
🔹Validity & Renewal
- The drug license is usually valid for 5 years.
- Renewal application needs to be made prior to expiry to prevent penalties or cancellation.
- Any address, ownership, or technical staff changes needs to be updated.
🔹Consequences of Not Having a Drug License
There are several serious legal consequences for operating a vehicle without a current drug license:
- High penalties and punishments.
- Seizure of inventory or business shutdown.
- Legal proceeding under the Drugs & Cosmetics Act.
- Loss of trust and business reputation.
🔹Last Words
Obtaining a drug license is not merely a legal requirement but a duty. It guarantees the safe supply of medicines and establishes reputation in the pharma industry. Be it a small Top 10 PCD Pharma Franchise Companies in India or a big pharma distribution network, obtaining the correct category of drug license is the initial and most significant step.
To make the process hassle-free, you may also seek assistance from drug license consultants or hire pharma companies like Symlek Healthcare that assist you at each step in setting up the franchise.
