How to Sell Medicines Online in India Legally – Licensing & Compliance Guide (2025)

In today’s digital-first world, the demand for online medicine delivery services is skyrocketing. From independent pharmacies to startups and e-commerce platforms, everyone is exploring the opportunity to sell medicines online. However, before diving into this market, it’s essential to understand the legal framework and mandatory licenses involved.

This guide walks you through how to legally sell medicines online in India, ensuring your business remains compliant and thrives in the competitive pharmaceutical space.

Understanding the Legal Landscape

Selling medicines online in India falls under the jurisdiction of the Drugs and Cosmetics Act, 1940, and its associated rules. Even though the Act doesn’t explicitly mention “online pharmacies,” all drug sale regulations apply regardless of the medium—offline or online.

So, whether you’re running a digital pharmacy, a medicine delivery app, or an e-commerce platform listing drugs, compliance is non-negotiable.

Do You Need a Drug License to Sell Medicines Online?

Yes, absolutely. Anyone selling, stocking, exhibiting, or distributing drugs must have a valid Drug License under the law. This applies to both traditional chemist shops and online players.

To run an online pharmacy legally in India, you need the following:

• Retail Drug License (Form 20 and Form 21) if you’re selling general and prescription medicines.

• Wholesale Drug License (Form 20B and 21B) if you intend to distribute drugs to other sellers or institutions.

• GST Registration for taxation compliance.

• Registered Pharmacist present at the place of business to supervise the sale and dispensing.

These licenses must be obtained from the State Drug Control Department.

Eligibility Criteria for Getting a Drug License

Before applying, ensure you meet the following basic requirements:

• A minimum area (10 sq. meters for retail; 15 sq. meters for wholesale) for your establishment.

• Adequate storage facilities, including refrigerators for temperature-sensitive medicines.

• Qualified pharmacist with a degree/diploma in pharmacy (for retail license).

• Business registration such as proprietorship, partnership, or private limited company.

• Adequate documentation including identity proof, address proof, premises proof, and educational certificates of the pharmacist.

Steps to Start an Online Medicine Selling Business in India

1. Register your business entity: Choose your business structure—sole proprietorship, partnership, or private limited company—and register it officially.

2. Secure a Drug License: Apply for Retail and/or Wholesale Drug License through your State Drug Authority.

3. Hire a registered pharmacist: A qualified pharmacist must be employed to oversee operations and ensure ethical sales.

4. Build a compliant platform: Your website or app must allow uploading prescriptions for Schedule H and X drugs. Ensure secure data handling and clear disclaimers.

5. Integrate logistics and cold storage: Partner with licensed logistic providers capable of handling pharmaceutical-grade transport and temperature-sensitive medicines.

6. Follow prescription validation: You can only dispense Schedule H or X drugs upon receipt of a valid prescription from a registered medical practitioner.

7. Maintain records: Keep proper records of all purchases, sales, prescriptions received, and stock movements, as required under the Drugs and Cosmetics Rules.

Prohibited Practices for Online Pharmacies

To stay compliant and avoid penalties, avoid:

• Selling prescription drugs without a prescription.

• Advertising Schedule H, H1, or X drugs online.

• Selling drugs through unregistered platforms or social media channels.

• Delivering expired or spurious medicines.

• Using unqualified staff to handle pharmacy operations.

Non-compliance can lead to license cancellation, penalties, or even criminal charges.

Challenges in the Online Pharmacy Sector

While the sector is booming, it faces several regulatory and operational challenges:

• Lack of centralized regulation: India currently does not have dedicated e-pharmacy guidelines, creating ambiguity.

• Compliance monitoring: Many players operate in gray areas due to enforcement gaps.

• Consumer safety: Unregulated platforms may compromise patient safety by selling unverified medicines.

However, if done legally and ethically, this sector offers immense potential for scalable growth.

Role of PSR Compliance in Drug License Consultation

Navigating the licensing process can be complex and time-consuming. That’s where expert support comes in. At PSR Compliance, we help businesses:

• Understand licensing requirements based on their business model.

• Prepare and submit complete documentation.

• Coordinate with Drug Control Authorities for license issuance.

• Ensure ongoing compliance with the Drugs and Cosmetics Rules.

Whether you’re starting a new venture or expanding an existing one into the digital medicine space, our consultants ensure a smooth and hassle-free experience.

Final Thoughts

Selling medicines online is not just about logistics and technology—it’s about trust, safety, and compliance. Before going live, it is vital to get your legal foundation in place. A valid Drug License is not just a regulatory formality—it’s the backbone of a legitimate and sustainable online pharmacy business.

As the industry matures and regulatory clarity increases, compliant businesses will emerge as leaders in this space.

Need help with getting a Drug License for your online pharmacy?
Contact PSR Compliance today for expert assistance and end-to-end support: www.psrcompliance.com