Who Needs a Drug License in India? (Doctors, Pharmacies, Hospitals, Distributors)

CDSCO License

Mon, Dec 29 2025

Raju Karn

Who Needs a Drug License in India? (Doctors, Pharmacies, Hospitals, Distributors)

Q: Can I start an online pharmacy without a drug license?

No. Online pharmacies must have a Retail Drug License and a registered pharmacist.

Q: Do doctors need a drug license to give medicines to patients?

Only if they are selling medicines separately or operating like a pharmacy.

Q: Is a wholesale license valid across India?

No. Drug licenses are state-specific unless CDSCO issues them for central licensing purposes.

Q: What’s the difference between a competent person and a pharmacist?

Pharmacists are needed for retail pharmacies, while competent persons handle wholesale licensing based on qualification or experience.

Q: How long is the drug license valid?

It is usually valid for 5 years and must be renewed before expiry.

If you're planning to sell, distribute, stock, or manufacture drugs in India, obtaining a Drug License is not just recommended—it’s legally required. Under the Drugs and Cosmetics Act, 1940, this license ensures that medicines are handled safely, responsibly, and under regulated conditions.
But the big question is:
Who exactly needs a drug license in India?

In this blog, we’ll explain—clearly and simply—which businesses and professionals are required to have a drug license and why it matters in 2025.

What Is a Drug License?

A Drug License is an official permit issued by a State Drug Control Department or the Central Drugs Standard Control Organization(CDSCO). It authorizes a person or company to engage in activities such as:
- Sale of medicines (retail or wholesale)

- Storage and distribution of drugs

- Manufacturing of drugs

- Online pharmacy operations

- Drug import or export

No person can legally operate any drug-related business without a valid license.

Who Needs a Drug License in India?

1. Pharmacies & Chemist Shops

Any medical store or pharmacy selling medicines to the general public must obtain a Retail Drug License.
🔹 Must appoint a registered pharmacist

🔹 Must meet space and storage criteria (minimum 10 sq.m area)

2. Wholesale Distributors & Stockists

If you’re supplying medicines to other pharmacies or hospitals, you need a Wholesale Drug License
🔹 Requires a competent person (science graduate or experienced pharma professional)

🔹 Cold storage may be necessary for temperature-sensitive drugs

3. Hospitals with In-House Pharmacies

Many hospitals operate internal pharmacies for patient use. These must have a Retail Drug License too, especially if drugs are sold to walk-in patients.

🔹 Hospitals dispensing to only admitted patients may be exempt, but if they operate like a pharmacy, a license is needed.

4. Doctors & Clinics Stocking Medicines

While registered doctors are allowed to stock and dispense medicines to their own patients, they cannot sell drugs for commercial purposes without a license.
🔹 If a doctor’s clinic acts like a pharmacy—charging separately for medicines—a drug license is mandatory.

5. Online Pharmacies

Digital health platforms and apps that deliver medicines to homes must have:

- Retail Drug License (based on location of dispatch)
- GST Registration

- Registered pharmacist to handle orders

6. Importers & Exporters of Medicines

Companies importing drugs or APIs (Active Pharmaceutical Ingredients) must obtain:

- Import Drug License from CDSCO

- Manufacturing or Wholesale License (based on operations)
- FSSAI License(for nutraceuticals or supplements)

7. Drug Manufacturers & Third-Party Manufacturers

If you’re manufacturing any kind of pharmaceutical product—tablets, syrups, ointments, etc.—you need a:

- Drug Manufacturing License

- Loan License (if using third-party facilities)
Manufacturers must comply with GMP (Good Manufacturing Practices) and maintain strict hygiene and record standards.

Who Doesn't Need a Drug License?

- Patients buying medicines

- Doctors dispensing to their own patients only (without separate billing)

- Companies selling non-drug health products (unless covered under AYUSH, CDSCO, or FSSAI)

If there is any sale, storage, or supply of medicines—a license is mandatory.

Drug License Types Based on Activity

Business Type	Required License Type
Retail Pharmacy	Retail Drug License
Wholesale Distributor	Wholesale Drug License
Online Pharmacy	Retail + GST + Pharmacist
Drug Manufacturer	Manufacturing/Loan License
Import/Export Company	Import License from CDSCO
Ayurvedic Product Seller	AYUSH License
Nutraceutical Product Seller	FSSAI License

Why It’s Important to Get the Right License

Not having a valid drug license can result in:

- Legal action, fines, or jail

- Cancellation of business operations

- Reputational damage

- Seizure of goods

A valid license ensures:

- Legal operations

- Access to supply chains

- Trust with consumers and regulators

- Business continuity

How PSR Compliance Can Help

At PSR Compliance, we assist:
- Pharmacies, hospitals, and wholesalers
- Doctors setting up clinics
- Online startups
- Distributors and exporters
- Manufacturers and third-party plants

Our services include:

- Document preparation

- Portal application

- Drug Inspector coordination

- Fast-track approvals

- Post-approval compliance

FAQs – Drug License Requirement in India

Q1. Can I start an online pharmacy without a drug license?
🅰️ No. Online pharmacies must have a Retail Drug License and registered pharmacist.

Q2. Do doctors need a drug license to give medicines to patients?
🅰️ Only if they’re charging separately or acting like a pharmacy.

Q3. Is a wholesale license valid across India?
🅰️ It’s state-issued. For multi-state operations, apply separately or through CDSCO for certain categories.

Q4. What’s the difference between a competent person and a pharmacist?
🅰️ Pharmacists are required for retail, while wholesale businesses need a competent person (with science background or experience).

Q5. How long is the drug license valid?
🅰️ Usually 5 years; it can be renewed before expiry.