Types of Drug Licenses
- Retail Drug License: For selling drugs to the public (e.g., pharmacies).
- Wholesale Drug License: For selling drugs to retailers or institutions.
- Manufacturing License: For manufacturing drugs.
- Loan License: For manufacturing drugs using another manufacturer's facilities.
- Import License: For importing drugs into India.
Step-by-Step Process
1. Determine the Type of License
Identify the type of license you need based on your business activity (retail, wholesale, manufacturing, etc.).
2. Eligibility Criteria
- Retail/Wholesale License: The applicant must have a degree or diploma in pharmacy (for retail) or adequate experience in drug handling (for wholesale).
- Manufacturing License: The applicant must have a qualified pharmacist or competent technical staff, and the unit must comply with Good Manufacturing Practices (GMP).
3. Prepare Required Documents
- Application Form (Form 19, 20, or 24).
- Proof of Premises (ownership or rental agreement).
- Site Plan (layout of the premises).
- Qualification Proof (degree or diploma in pharmacy).
- Affidavit (compliance with the Drugs and Cosmetics Act).
- Challan (proof of fee payment).
- Key Personnel Details (pharmacist or technical staff).
- No Objection Certificate (NOC) from the local authority (if required).
4. Submit the Application
Submit the application online via the Himachal Pradesh Drugs Control Department website or offline at the nearest Drugs Control Office.
5. Pay the Fees
Pay the required fee based on the type of license:
- Retail License: ₹1,000–₹2,000.
- Wholesale License: ₹2,000–₹5,000.
- Manufacturing License: ₹5,000–₹15,000.
6. Inspection of Premises
The Drugs Control Department will inspect the premises to ensure compliance with the required standards.
7. Grant of License
If the application and premises meet the requirements, the license will be issued. The license is valid for 1 to 5 years and must be renewed before expiry.
Renewal of Drug License
To renew the license, submit an application (Form 20A for retail/wholesale or Form 26 for manufacturing) along with the required documents and fees. Renewal should be done at least 30 days before the expiry date.
Key Authorities
- State Drugs Control Department, Himachal Pradesh: Responsible for issuing retail, wholesale, and manufacturing licenses.
- Central Drugs Standard Control Organization (CDSCO): Responsible for issuing licenses for imported drugs and certain categories of manufacturing.
Contact Information
Himachal Pradesh Drugs Control Department:
CDSCO:
Note: Always consult the State Drugs Control Department or a Professional Consultant for specific guidance.
