1. Choose the Right Business Structure
The first step is to decide your business structure—sole proprietorship, partnership firm, LLP, or private limited company. This affects taxation, liability, and ease of operation. Most pharmacies and distributors prefer LLP or Pvt Ltd for credibility and scalability.
2. Secure a Retail or Wholesale Drug License
To operate legally, obtaining a drug license is mandatory under the Drugs and Cosmetics Act, 1940. For retail units, a Retail Drug License is required, while wholesale businesses need a Wholesale Drug License. The license is issued by the State Drug Control Department. You must have a qualified person (pharmacist with a degree/diploma) and a proper premise to be eligible.
3. Register for GST
As you will be trading goods, a GST registration is essential for billing and compliance. It also allows you to claim input tax credit on purchases. Apply online through the GST portal by submitting your PAN, proof of business, and address details.
4. Meet Premise Requirements
The premises should meet specific criteria such as adequate space (minimum 10 sq. meters), clean storage conditions, and refrigeration for temperature-sensitive medicines. Inspection is conducted before the license is granted.
5. Ensure Pharmacist Availability
A qualified pharmacist must be available during business hours in a retail store. For wholesale, a competent person with drug sales experience is required. Their qualification certificates must be submitted during the license application.
6. Get Trade License from Local Authority
Municipal corporations often require a trade license to permit retail or distribution activities within their jurisdiction. This is especially important if you’re operating in an urban or semi-urban setup.
7. Comply with Labeling and Storage Regulations
Drugs must be labeled as per Schedule P and H regulations, depending on the category. Schedule H and X drugs have stricter rules regarding sale, recordkeeping, and storage. Ensure you follow temperature control and segregation norms.
8. Maintain Mandatory Records
Proper records must be maintained for sale and purchase of medicines, especially Schedule H and X drugs. This includes batch numbers, expiry dates, and supplier information. Non-compliance can lead to license suspension or cancellation.
Agile Regulatory – Your Trusted Partner for Drug License Services
Navigating legal processes can be overwhelming for new entrants in the pharma retail or distribution business. Agile Regulatory simplifies this journey by offering expert support for drug license applications, business setup, and regulatory approvals across India. With a team of compliance professionals, we help you prepare documentation, file applications, and coordinate with authorities to ensure timely approvals. Whether you're starting a retail medical store or a distribution unit, we provide end-to-end guidance for a hassle-free setup.
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