Drug and Cosmetic license in India?

Drug and Cosmetic license in India?

The healthcare world is very complex. It is full of strict rules. Every company that makes or sells medicines must follow the law. In India, the Drug and Cosmetic Act, 1940, controls this space. Getting a Drug and Cosmetic License is the first step. Without this license, it is illegal to sell drugs and cosmetics. 

Many people think the process is hard. Some fear the paperwork. Others worry about approvals. The truth is simple. With the right help, you can get your license easily. You only need to know what steps you must follow.

This guide will explain everything clearly. Let’s dive deep into the process 

What is a Drug and Cosmetic License?

A Drug and Cosmetic License is a legal permit. It allows you to manufacture, distribute, or sell medicines and cosmetics in India.

The license ensures that your products are safe. This license checks that your goods meet quality standards. It also confirms that all the laws are followed. Without a license, you cannot run a pharmacy, wholesale store, cosmetic brand, or manufacturing unit

Who Issues the Drug and Cosmetic License?

Two main bodies control drug licenses in India:

• Central Drugs Standard Control Organization (CDSCO): Handles large cases, such as manufacturing bulk drugs or importing foreign medicines.
• State Drug Standard Control Organizations: Manage retail shops, small manufacturers, and cosmetic sellers within states.

Depending on your business type, you may need approval from either or both.

Types of Drug and Cosmetic Licenses

You cannot use one license for all activities. Different businesses need different licenses. Here are the main types:

• Retail Drug License (RDL): It is for pharmacies that sell drugs to customers directly.
• Wholesale Drug License (WDL): For businesses that sell drugs in bulk to retailers or hospitals.
• Manufacturing License: For factories that make medicines or cosmetics.
• Loan License: For those who use another company’s factory to make their own brand.
• Import License: For companies that bring foreign drugs or cosmetics into India.

Knowing the right license type is key before you apply.

Eligibility for Drug and Cosmetic License

Not everyone can apply for a license. You must meet strict conditions:

• Premises: You must have a proper shop or office with enough space (minimum 10 square meters for retail).
• Storage: You must have refrigerators and air conditioners for drugs that need cold storage.
• Qualification: A qualified person (like a registered pharmacist) must be present for retail licenses. For wholesale, a graduate with one year of experience or a diploma holder with four years of experience is needed.

You must meet these basic standards before applying.

Documents Required for Drug and Cosmetic License

Paperwork is the heart of the license process. Missing even one document can cause rejection. Here’s the complete list:

• Identity proof (Aadhar, PAN card)
• Address proof of premises (Electricity bill, Rent agreement)
• Ownership proof (if premises owned)
• Affidavit of non-conviction under Drug and Cosmetic Act
• Qualification certificates of the pharmacist or expert
• Appointment letter of the pharmacist (for retail shops)
• Site plan and layout of premises
• Refrigerator purchase bill
• Registration certificate of the company (for companies)

Prepare these papers carefully to avoid delay.

Step-by-Step Process to Apply for the License

The process may seem long. But if you follow it step-by-step, it becomes easy:

Step 1: Decide the License Type

Think carefully about your business needs. Choose the correct license type first.

Step 2: Arrange Premises and Staff

Set up a clean, legal shop or office. Appoint the right qualified person.

Step 3: Gather Documents

Collect all papers as per the list above. Make clear copies.

Step 4: Apply Online

Visit the State Drug Authority website. Fill the online form. Upload documents. Pay the required fees.

Step 5: Inspection of Premises

After submission, a drug inspector will visit your site. They will check cleanliness, storage, and documents.

Step 6: License Grant

If all is well, you will get your license in about 30–60 days.

How Long Does It Take?

Normally, it takes between 30 to 60 days after application submission. If the drug inspector finds issues, it can take longer. If your documents are perfect and premises are ready, approval can be faster.

Penalties for Running a Business Without a License

Running a drug or cosmetic business without a license is a serious crime. You could face:

• Heavy fines
• Seizure of your products
• Business closure
• Court cases and even imprisonment

Conclusion

Getting a Drug and Cosmetic License is not just a legal duty.  It is your commitment to quality, safety, and trust. Every successful pharmacy, cosmetic brand, and healthcare startup began with this first correct step.

If you want expert support in your license journey, you can reach out to Agile Regulatory. We are committed to healthcare excellence. Our experts guide businesses with clarity, speed, and full compliance. Trust us to help you meet every licensing standard confidently and professionally. Begin your journey today with the right partner by your side.