Overview: Drug & Cosmetic License

The Central Drugs Standard Control Organisation (CDSCO) oversees the import, manufacturing, distribution, and sale of drugs and cosmetics in India. A proper license system ensures all products meet quality standards. CDSCO can also issue special notices under Section 26B of the Drugs and Cosmetics Act to regulate or restrict drug production when needed in the public interest.

Drug and Cosmetic License

A drug license is mandatory for anyone involved in the sale, purchase, or manufacturing of drugs in India—this includes manufacturers, retailers, and traders. It is issued by the Drugs Controller General of India (DCGI) or the CDSCO.

There are two main types:

• Retail Drug License – Needed to run a chemist shop.
• Wholesale Drug License – Needed to sell drugs in bulk to retailers or distributors.

Documents Required

To get a drug license, the applicant must submit a form to DCGI or CDSCO along with required documents. The list may vary by license type, but common documents include:

• ID and address proof
• Proof of ownership or rent agreement of business premises
• Certificate from a registered pharmacist
• Applicable fee

Cosmetic License

Anyone making or importing cosmetics in India must get a cosmetic license from CDSCO. The applicant needs to fill out a form and submit the required documents. The documents may differ based on the type of cosmetic.

Common documents include:

• ID and address proof
• Proof of ownership or rent for the manufacturing/storage space
• List of cosmetic ingredients
• Stability test report
• Required fee

Types of Drug Licenses

1. Manufacturing Drug License

Issued by DCGI/CDSCO, this license is for those who manufacture drugs in India.

Key Requirements:

• Proper space, machinery, and facility setup
• Follow Good Manufacturing Practices (GMP)
• Qualified technical staff (Pharmacy/Pharmaceutical Chemistry graduate with 18+ months’ experience)
• Separate quality testing setup
• Each factory must have its own license

Note: Agents distributing free samples don’t need this license.

2. Import Drug License

Required for anyone importing drugs into India.

Requirements:

• Proper drug storage facility
• Medicines must arrive in labeled retail containers
• Invoices with manufacturer details
• Declaration to be filed with DCGI before importing certain drugs

3. Multi-Drug License

Needed when operating from multiple locations. Each address needs a separate license.

4. Sale Drug License

For wholesalers and retailers selling medicines. Categories include:

• Wholesale License – for bulk sales to retailers
• Retail License – for selling to end customers
• Restricted License – for general stores selling basic medicines

5. Loan Drug License

For those without a manufacturing unit but want to manufacture using another licensed facility.

Key Points:

• Valid for 1 year, renewable
• Must hold a valid manufacturing license
• Must have an agreement with the licensed manufacturer
• Must follow GMP with qualified staff

Documents Required for Drug & Cosmetic License

The list of documents may vary depending on the type of license and regulatory authority, but the commonly needed ones are:

• Company Incorporation Certificate
• KYC of all directors/partners/proprietor
• Proof of Business Premises – rent agreement, electricity bill, or tax receipt
• Site Plan of the premises
• KYC of Technical Person involved
• List of Cosmetics with product sheet and composition
• Brand Ownership Proof – registered or trademark status
• Manufacturing Process Flow and description
• In-House Specifications (if applicable)
• Product Analysis Method
• BIS Certificates (if applicable)

Key Rules Governing Drugs & Cosmetics in India

• Drugs and Cosmetics Rules, 1945
  Regulates the import, manufacture, sale, and storage of drugs and cosmetics. It covers drug classification, licensing, and guidelines for handling.
• Medical Devices Rules, 2017
  Covers the licensing, import, manufacture, and quality standards for medical devices sold in India.
• New Drugs and Clinical Trials Rules, 2019
  Specifies rules for testing new drugs, clinical trial approvals, and ethical standards.
• Cosmetics Rules, 2020
  Regulates the licensing, quality, labeling, and safety standards for cosmetics.
• National Pharmaceutical Pricing Policy, 2012
  Ensures essential medicines are affordable. Sets pricing methods and rules for government procurement.
• Drugs (Prices Control) Order, 2013
  Fixes maximum retail prices (MRP) for essential drugs. MRP must be printed clearly on the label.

Labelling Requirements for Imported Cosmetics in India

To comply with Indian regulations, imported cosmetics must carry the following label details:

• Registration Certificate Number: Issued by CDSCO, must be clearly shown on the label.
• Certificate Holder Details: Name and address of the person or company responsible for the product’s quality and safety.
• Manufacturer Details: Name and address of the manufacturer who produced the cosmetic.
• Product Name: Clearly printed and easy to read.
• Manufacture & Expiry Dates: Must mention both to inform safe usage duration.
• Ingredients List: Listed in order of weight, helps consumers check for allergies.
• Usage Instructions: Clear directions for safe and proper use.
• Warnings or Cautions: Any special instructions or safety notices must be visible.

Why Sperso Filings?

At Sperso Filings, we understand how important it is for businesses in the pharmaceutical and cosmetic industries to get the right licenses. We make the process simple, smooth, and compliant with all legal requirements.

• Specialised Support
  We focus on drug and cosmetic licensing, ensuring your application is handled by experts familiar with CDSCO rules.
• End-to-End Assistance
  From document preparation to final approval, we manage the entire process on your behalf.
• Simple Process
  We simplify complex government procedures, helping you avoid delays and confusion.
• Timely Updates
  You receive regular updates on your application status and quick answers to any queries.
• Affordable and Transparent
  Our fees are straightforward, with no hidden costs—perfect for startups and growing businesses.
• Trusted by Many
  Sperso Filings has successfully helped many clients in the health and beauty sector get licensed and stay compliant.