Legal Requirements

COMMUNITY PHARMACY MANAGEMENT

C) LEGAL REQUIREMENTS

1. Legal Basis

• Community pharmacies in India are governed by the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945.
• No person can sell, stock, exhibit, or distribute drugs without a valid license issued by the State Licensing Authority (Drugs Control Department).

2. Who Must Obtain a License?

A license is required for:

• Retail sale of drugs
• Wholesale sale of drugs
• Sale under restricted license (without a qualified person)
• Sale of drugs from a motor vehicle
• Wholesale or retail sale of Homeopathic medicines
• Sale of Schedule X drugs

3. Application Forms for Drug Sale Licenses

S. No	Application Form No.	Category of Drug Sale	Qualified Person Required
1	Form 19	Wholesale / Retail sale of drugs (excluding Schedule X)	Yes
2	Form 19A	Restricted license	No
3	Form 19AA	Sale of drugs from motor vehicle	Yes
4	Form 19B	Wholesale / Retail sale of Homeopathic medicines	Yes
5	Form 19C	Wholesale / Retail sale of Schedule X drugs	Yes

4. License Forms Issued (After Approval)

For Retail Sale

• Form 20 – Retail sale of drugs (other than Schedule C, C1 & X)
• Form 21 – Retail sale of Schedule C & C1 drugs
• Form 20F – Retail sale of Schedule X drugs

For Wholesale Sale

• Form 20B – Wholesale sale of drugs (other than Schedule C, C1 & X)
• Form 21B – Wholesale sale of Schedule C & C1 drugs
• Form 20G – Wholesale sale of Schedule X drugs

Renewal

• Form 21C – Renewal of retail / wholesale licenses

5. Minimum Requirements to Start a Community Pharmacy

A. Premises

• Minimum area required:
• Retail pharmacy: 120 sq. ft.
• Retail + Wholesale: 150 sq. ft.
• Must be:
• Clean
• Well-ventilated
• Properly lighted

B. Qualified Person

• Must be a Registered Pharmacist
• Registration with State Pharmacy Council
• Mandatory for all licenses except restricted license (Form 19A)

C. Storage Facilities

• Refrigerator mandatory for:
• Schedule C & C1 drugs (vaccines, insulin, sera, etc.)
• Proper storage conditions as per labeling requirements

6. Documents Required for License Application

1. Duly filled application form with prescribed fee
2. Layout plan of the pharmacy premises
3. Ownership proof / Rental agreement
4. Refrigerator purchase invoice
5. Appointment letter of registered pharmacist
6. Pharmacist registration certificate
7. Identity and address proof of applicant

7. Procedure to Obtain License

1. Submit application to Drugs Control Department
2. Attach all required documents
3. Payment of prescribed fee
4. Inspection of premises by Drug Inspector
5. Verification of:
• Premises
• Storage conditions
• Qualified person
6. License granted if all requirements are satisfied

8. Key Exam Points (⭐ Important)

• Governing Act: Drugs & Cosmetics Act, 1940
• Minimum area for retail pharmacy: 120 sq. ft.
• Registered pharmacist is mandatory
• Schedule X drugs require separate license
• Refrigerator compulsory for Schedule C & C1 drugs