What Is a Drug License?
An official document authorizing someone or a company to produce, market, store, dispense, or provide medicines, skincare products, and some healthcare equipment falls under what’s called a drug license issued by the state licensing authority known as SLA. Engaging in pharmaceutical activities without a legitimate prescription endorsement constitutes illegal behavior which could lead to sanctions or termination of operations.
Accordingly, based on the type of commercial operations, drugs fall under either primary or secondary licensing classifications:
- Retail Drug License (Form 20 & Form 21)
- Wholesale Drug License (Form 20B & Form 21B)
Every classification fulfills unique functions and mandates particular regulation.
1. Retail Drug License (Form 20 & 21):
To operate as a business selling drugs to individuals requires obtaining an authorization known as a Retail Drug License. The document pertains to:
- Medical stores and chemist shops
- Pharmacies
- Hospital-attached pharmacies
- Online or e-pharmacy retailers
- Applicable License Forms
- Form 20: For the sale of allopathic medicines
- Section 21 pertains to substances categorized in Schedules C and C-1, including medications like injections, vaccines, and insulins.
Eligibility Criteria
An authorized pharmacist certified through an accredited state pharmacy board needs to be selected.
- Minimum shop area of 10 square meters.
- Proper storage and refrigeration facilities must be available.
- Adherence to sanitary, security, and wellbeing regulations must be maintained.
- A licensed pharmaceutical expert is required at all business times.
- Documents Required
- PAN Card and Aadhaar Card
- Pharmacist’s qualification and registration certificate
- Rent agreement or ownership proof of premises
- Electricity bill of business location
- Pharmacist’s affidavit and declaration
- Passport-size photographs
- Layout or site plan of the shop
Application Procedure
- Document Preparation: Collection and verification of required documents.
- E-Application Process: Filing via the State Drugs Board website.
- Verification: A physical examination conducted by a drug inspector is necessary when needed.
- Approval: License issued upon successful verification.
2. Wholesale Drug License (Form 20B & 21B)
An entity engaged in large-scale drug transactions must obtain a wholesale pharmaceutical license if it deals directly with pharmacies, healthcare facilities, or additional distributors. The certification serves as crucially important:
- Drug distributors
- Medical wholesalers
- Stockists and supply chains
- Third-party medicine sellers
- Applicable License Forms
- Form 20B: For wholesale of non-scheduled drugs
- Section B-21 applies specifically for retail sales involving prescription medications such as antibiotics and immunizations.
Eligibility Criteria
A competent person is mandatory, who must have:
- An advanced academic qualification accompanied by not less than a year’s work experience is required.
- An academic qualification in pharmacology coupled with four years of pertinent work experience is required.
- Minimum premises area of 15 square meters.
- Adequate cold storage, air-conditioning, and temperature-controlled facilities.
- Compliance with Good Distribution Practices (GDP) Documents Required
- Applicant’s identity and address proof
- Qualification and experience proof of competent person
- Rent agreement or ownership proof of premises
- Photographs of storage facilities
- Premises blueprint or layout plan
- Partnership deed or incorporation certificate (if applicable)
- GST registration certificate
- Inspection and site photographs
Application Process
- Document Compilation, Prepared with professional assistance.
- E-file submission through the State Drug Control website.
- Inspection: Premises verification by Drug Control officials.
- License Grant: Usually issued within 20–30 working days.
Why Is a Drug License Mandatory?
- Ensures medicines are handled only by qualified and authorized personnel.
- Protects public health and safety.
- Prevents circulation of counterfeit or substandard drugs
- Required for lawful business operations.
- Essential for expansion, government tenders, and online pharmacy platforms.