What is the difference between a drug license and a medical device license?

A drug license allows businesses to sell or manufacture medicines, while a medical device license is required for products like diagnostic kits, surgical tools, etc. Both are governed by different sets of rules.

Who issues medical device licenses in India?

Medical device licenses in India are issued by CDSCO, with State Licensing Authorities handling Class A and B, and CDSCO handling Class C and D.

Do I need both licenses for a health-related business?

It depends on the nature of your product. If you sell both drugs and devices, you may need both licenses to comply with Indian regulatory laws.

Drug License vs Medical Device License in India: What’s the Difference?

CDSCO License

Sat, Jan 03 2026

Raju Karn

Drug License vs Medical Device License in India: What’s the Difference?

In India, navigating the regulatory landscape of pharmaceuticals and medical equipment can be overwhelming. Whether you're a startup in the healthcare sector, an established manufacturer, or an importer, understanding the difference between a Medical Device License and a Drug License is not just a legal necessity — it’s a strategic advantage.

In this blog, we break down the core differences between the two licenses, their legal framework, applicability, and why choosing the correct license is crucial for compliance and market success.

What is a Drug License?

A Drug License is a legal document issued under the Drugs and Cosmetics Act, 1940, which allows entities to manufacture, distribute, or sell drugs and pharmaceutical products in India. It applies to:

Allopathic medicines

Homeopathic medicines

Ayurvedic/Unani/Siddha drugs

Cosmetics and blood-related products

Types of Drug Licenses

Types of Drug Licenses are:

License Type	Purpose
Retail Drug License (RDL)	For chemists or pharmacies selling directly to consumers
Wholesale Drug License (WDL)	For businesses involved in the bulk sale of drugs
Manufacturing License	For manufacturers producing pharmaceutical drugs
Loan License	For those using third-party manufacturing facilities
Import License	For importers of drugs from outside India

What is a Medical Device License?

A Medical Device License is issued under the Medical Device Rules, 2017 (framed under the same Drugs and Cosmetics Act) but deals specifically with medical devices, not drugs. These include:

Surgical instruments

Diagnostic kits

Glucometers

Implants

MRI/CT machines

Ventilators, etc.

Classification of Medical Devices

Devices are classified into four risk-based classes:

Class	Risk Level	Example
Class A	Low Risk	Thermometers, surgical gloves
Class B	Low-Moderate Risk	Nebulizers, BP monitors
Class C	Moderate-High Risk	Dialysis machines
Class D	High Risk	Heart valves, implantable defibrillators

Each class has different regulatory and licensing requirements.

Key Differences Between Medical Device License and Drug License

Parameter	Drug License	Medical Device License
Governing Rule	Drugs and Cosmetics Act, 1940	Medical Device Rules, 2017
Applicable To	Medicines, blood products, cosmetics	Diagnostic and therapeutic devices
Licensing Body	CDSCO & State Drug Controller	CDSCO for Class C & D, State for A & B
Risk-Based Classification	Not applicable	Classes A, B, C, D
Import Requirements	Import License under Form 10	Import License under MD Form 15
Labelling Norms	As per Schedule P, H, etc.	UDI (Unique Device Identification) for traceability
Audit/Inspection	Drug Inspectors	Notified Bodies (for Class C & D devices)

Why Choosing the Right License Matters

Compliance: Avoid legal penalties, product seizures, or business shutdowns.

Market Trust: Licensed entities are trusted more by healthcare providers and consumers.

Global Trade: Licenses streamline the import/export process and help in international partnerships.

Investment & Funding: Regulatory compliance boosts investor confidence in healthcare startups and manufacturers.

Expert Insight

Many businesses wrongly assume that a medical device like a digital thermometer or a glucometer falls under drug regulation — a costly mistake. The classification system under the Medical Device Rules is based on risk management, which is not considered in standard drug licensing.

For example, if you’re launching a wearable health monitor, you don’t need a Drug License, but you may need a Class B Medical Device Registration from CDSCO.

Quick Checklist: Which License Do You Need?

Product Type	License Required
Paracetamol Tablets	Drug License (Retail/Wholesale)
Digital Blood Pressure Monitor	Medical Device License (Class B)
Face Cream	Drug License (Cosmetics)
Pacemaker	Medical Device License (Class D)
Cough Syrup	Drug License
Glucometer	Medical Device License (Class B)

Final Thoughts

Both Drug Licenses and Medical Device Licenses play a vital role in ensuring public health and product quality in India. Choosing the right license depends on what you manufacture, distribute, or import, and misunderstanding these requirements could risk your entire business operation.

Whether you're just starting or scaling up, consult a licensed compliance expert to ensure your paperwork aligns with Indian regulatory norms.

Need Help With Licensing?

PSR Compliance helps startups, SMEs, and multinational companies in India get their Drug and Medical Device Licenses smoothly and legally. Contact us for end-to-end support — from documentation to approval.

👉 Visit PSRCompliance.com for more details.