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Drug & Cosmetic License Registration

Overview

The Drug & Cosmetic License is a mandatory legal requirement for businesses involved in the manufacturing, distribution, and sale of drugs and cosmetics in India. Regulated under the Drugs and Cosmetics Act, 1940, this license ensures that only authorized entities engage in pharmaceutical and cosmetic-related activities, maintaining safety and quality standards.

Types of Drug & Cosmetic Licenses

Manufacturing License
- Required for manufacturers of drugs and cosmetics.
- Issued by the State Drug Control Department.
Loan License
- Issued to manufacturers who do not own manufacturing premises but operate using another licensed manufacturer's facility.
Wholesale Drug License
- Required for businesses engaged in the wholesale distribution of drugs.
- Granted by the Central Drugs Standard Control Organization (CDSCO) or State Licensing Authority.
Retail Drug License
- Needed by pharmacies and chemists selling medicines directly to consumers.
Import License
- Mandatory for businesses involved in the import of drugs or cosmetics.
- Issued by CDSCO.

Eligibility Criteria

For Retail & Wholesale Licenses:

The applicant must be a registered pharmacist or have a competent person with the necessary qualifications.
The establishment must adhere to proper storage conditions (temperature control, ventilation, etc.).

For Manufacturing Licenses:

The manufacturing site must comply with Good Manufacturing Practices (GMP).
The company must appoint technically qualified personnel.

Documents Required

For Wholesale & Retail Drug License
- Application Form as per prescribed format.
- Cover letter with details of the applicant.
- Proof of business premises (rental agreement/ownership proof).
- Blueprint/layout of premises.
- Identity & Address proof (Aadhaar Card, PAN Card) of proprietor/partners/directors.
- Qualification certificates of the competent person/pharmacist.
- Refrigerator purchase bill (for temperature-sensitive drugs).
- Affidavit declaring compliance with regulatory norms.
For Manufacturing License
- Site plan and layout of the manufacturing facility.
- List of equipment and machinery.
- Details of the technical staff, including qualification and experience.
- NOC from Pollution Control Board.
- Quality control procedures and safety measures adopted.
- Proof of GMP compliance.
For Import License
- Application Form in the prescribed format.
- Registration certificate issued by the CDSCO.
- Manufacturing and free sale certificate (for imported goods).
- Product labels and formula compositions.
- Business registration documents.

Registration Process

Step 1: Determine the License Type
Identify whether the business requires a retail, wholesale, manufacturing, or import license.
Step 2: Document Preparation
Gather all necessary documents as per the license type.
Step 3: Application Submission
Apply through the State Drug Control Department or CDSCO portal.
Pay the prescribed fee.
Step 4: Inspection & Verification
Authorities conduct a site inspection to verify the compliance of storage, safety, and technical standards.
Step 5: Grant of License
Upon successful verification, the license is issued within 30-60 days.

Validity & Renewal

The Drug & Cosmetic License is typically valid for 3-5 years.
Renewal should be applied for at least 3 months before the expiry date to avoid penalties or business disruptions.

Why Choose Calzone for Your Drug & Cosmetic License?

Expert Guidance: We simplify the licensing process with end-to-end assistance.
Hassle-Free Documentation: Our professionals handle all necessary paperwork.
Faster Processing: Minimize delays with our streamlined application process.
Regulatory Compliance: Ensure adherence to all legal and regulatory requirements.

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