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 PCD Pharma Franchise 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 PCD Pharma Franchise 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.
