Drug License Registration
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
- Minimum area of the Office/Shop.
- Granted in the commercial premises or other premises independent of residence.
- Refrigerator or Air Conditioner on the premises.
- Needs to comply with the conditions of licence of the issuing Authority.
- Displayed at premises of business.
- A technical staff :- A registered pharmacist or competent person with same line experienced as approved by the Department if Drug Control.
Based on business type, an entity may require different types of drug license. For exact requirement and applicability, consult with our Consultant.
Compulsory Drug License for Pharmaceutical Business in India
- Retail Drug License
- Wholesale Drug License
- Pharmaceutical Manufacturing Drug License
- Cosmetic Manufacturing Drug License
Documents requirement for Drug License in India
The firm’s constitution (MOA & AOA for Company and Partnership Deed for Firm/LLP)
ID proof of Directors/Partners/Proprietor
Property Paper ( Registry Deed/Lease Deed/POA in case of owned Property)
Copy of Rent agreement ( in case of rented premises)
The key plan and the site plan of the premises ( Blue Print).
One Invoice copy of Refrigerator/Air conditioner purchased for use
Board Resolution, List of Directors, Certificate of Incorporation ( in case of company)
Covering Letter stating purpose of the Application
For Retail & Wholesale license – Affidavit from the Regd. pharmacist/competent person
For Manufacturing – List of Technical Staff and their proof of Education Qualification, Experience Certificate, Biodata, Appointment Letter, three photographs.
For Manufacturing – Affidavit from employer and or Technical Staff for full time working with the firm
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