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For any Individual/Corporate/Partnership Firms etc , it is mandatory to obtain a valid Drug Licence from concerned State Authorities (Drugs Control Department). The provisions for this has been made in Drugs and Cosmetic Act 1940 and Rules 1945 applicable in India.
basic pre-requisites for a Drug License
Based on business type, an entity may require different types of drug license. For exact requirement and applicability, consult with our Consultant.
The firm's constitution (MOA & AOA for Company and Partnership Deed for Firm/LLP)
For Retail & Wholesale license - Affidavit from the Regd. pharmacist/competent person
Property Paper ( Registry Deed/Lease Deed/POA in case of owned Property)
Board Resolution, List of Directors, Certificate of Incorporation ( in case of company)
The key plan and the site plan of the premises ( Blue Print).
One Invoice copy of Refrigerator/Air conditioner purchased for use
Copy of Rent agreement ( in case of rented premises)
Covering Letter stating purpose of the Application
ID proof of Directors/Partners/Proprietor
For Manufacturing - Affidavit from employer and or Technical Staff for full time working with the firm
For Manufacturing - List of Technical Staff and their proof of Education Qualification, Experience Certificate, Biodata, Appointment Letter, three photographs.
Incase of Retail License:- Registered Pharmacist's degree certificate, Registration certificate with State Pharmacy Council and Appointment Letter and Bio-data.
Incase of Wholesale License:- Competent person's degree certificate, Experience Certificate in medicine job and Appointment Letter and Bio-data.
For manufacturer - Affidavit of Non Conviction, List of Equipment and Machineries for manufacturing and List of Equipment Provided for Testing