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Illustration of an online pharmacy platform in India showing a doctor, laptop screen with medical icons, prescription drugs, and digital license approval
Online Pharmacy License

Wed, Jul 30 2025

Shubham Bansal

Online Pharmacy License in India – Legal Requirements & CDSCO Process (2025)

The healthcare sector in India is rapidly going digital, and online pharmacies are at the center of this revolution. With increased demand for doorstep medicine delivery, launching an e-pharmacy can be highly profitable — but only if done legally and compliantly.

In this blog, we’ll walk you through everything you need to know about getting an online pharmacy license in India, including regulatory authorities, eligibility, documentation, CDSCO compliance, and key legal requirements as per 2025 rules.

What is an Online Pharmacy?

An online pharmacy, also known as an e-pharmacy, is a digital platform that allows users to purchase medicines, healthcare products, and devices online through websites or apps. These businesses must follow strict regulatory norms to ensure public health and safety.

Who Regulates Online Pharmacies in India?

Online pharmacies are regulated under:

Despite pending legislation, all online pharmacies must comply with existing offline drug rules, and obtain necessary licenses to operate legally.

Licenses Required for an Online Pharmacy

To legally start an online pharmacy in India, you must obtain:

1. Wholesale Drug License (Form 20 & 21)

For businesses that store and dispatch medicines

2. GST Registration

Mandatory for sale of goods and filing returns

3. Company Registration (Private Ltd / LLP / OPC)

Legal business structure with PAN, TAN, and incorporation certificate

4. Pharmacist Appointment

A registered pharmacist must verify and dispense all prescriptions

5. FSSAI License (if dealing in nutraceuticals or supplements)

6. CDSCO Registration

For listing on national e-pharmacy platforms and approval for online medicine sales.

Step-by-Step Process to Register an Online Pharmacy in India

Step 1: Register Your Business Entity

Step 2: Secure Premises and Storage

  • Set up a compliant warehouse with cold storage if needed

  • Install refrigeration for temperature-sensitive medicines

Step 3: Appoint a Registered Pharmacist

  • He/she will verify e-prescriptions before dispatch

Step 4: Apply for Drug License (Wholesale)

  • Submit application (Form 20/21) to State Drug Control Dept

  • Include pharmacist details, premises layout, and rent/ownership proof

Step 5: Apply for CDSCO Registration

  • Register as a distributor/seller with CDSCO portal

  • Mention APIs, drugs sold, and pharmacist-in-charge

Step 6: Launch Website/App

  • Secure HTTPS domain

  • Integrate prescription upload and order tracking

  • Ensure pharmacist verification before delivery

  • Follow data privacy under IT Act & Rules

Step 7: Add Privacy Policy & Terms of Use

  • Clearly mention prescription requirements, return policy, and helpline

Note: CDSCO may inspect your premises before approval.

Documents Required for Online Pharmacy License

Document Type Required Documents
Business Company incorporation, PAN, GST Certificate
Premises Rent agreement/ownership proof, layout plan, cold storage bill
Drug License Application form (Form 20/21), fees, pharmacist affidavit
Pharmacist Qualification certificate, registration with State Pharmacy Council
IT Compliance Website/app screenshots, privacy policy, customer T&C

Legal Requirements for Online Pharmacies in India (2025 Update)

  1. Medicines must not be sold without prescription

  2. Prescription must be verified by a licensed pharmacist

  3. Narcotic and Schedule X drugs cannot be sold online

  4. All sales and invoices must be stored digitally

  5. Helpline number must be available for customer support

  6. Pharmacy name and license number must be displayed on the website

  7. Packaging must follow Drugs & Cosmetics Rules

  8. Customer data must be protected as per IT Act & Data Privacy Rules

Role of CDSCO in Online Pharmacy Approval

The Central Drugs Standard Control Organization (CDSCO) ensures compliance, inspections, and drug safety for online players. As of 2025, online pharmacy platforms are expected to:

  • Register with CDSCO

  • Maintain traceability of each drug sold

  • Follow all guidelines under the proposed E-Pharmacy Rules

  • Report adverse reactions or recalls if needed

Penalties for Operating Without License

Operating without a valid Drug License can result in:

  • Imprisonment (up to 3 years)

  • Fines (₹50,000 or more)

  • Seizure of stock and website shutdown

  • Blacklisting from CDSCO and State Drug Departments

How PSR Compliance Can Help

Setting up an online pharmacy requires expert coordination with CDSCO, State Drug Departments, and technical setup. PSR Compliance offers:

  • Expert consultation

  • License application filing

  • Pharmacist onboarding support

  • Documentation assistance

  • Website/app compliance review

Ready to launch your online pharmacy? Contact PSR Compliance for a FREE consultation.

FAQs – Online Pharmacy License in India

Q1. Can I run an online pharmacy without a physical store?

🅰️ No, you need a registered premise with a Drug License for storage.

Q2. Is pharmacist verification compulsory?

🅰️ Yes, every order must be approved by a registered pharmacist.

Q3. Do I need CDSCO approval to sell online?

🅰️ Yes, CDSCO registration is mandatory under current norms.

Q4. Can I sell Ayurvedic medicines through my online pharmacy?

🅰️ Yes, but you’ll need Ayush License separately.

Q5. How long does it take to get a license?

🅰️ On average, 30–60 days, depending on the state and application quality.

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