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Drug License Registration
A Drug license is a document/certificate issued under the Drugs and Cosmetic Act of 1940 that gives the permission to the applicant for carrying out businesses related to drug, medicines and cosmetics. It is mandatory to obtain Drug License before launching a drug business.
As per Drugs and Cosmetic Act of 1940, the term drug includes:
– All medicines and devices/ substances used for or in the treatment, diagnosis, prevention or mitigation of any disorder or disease in human beings or animals internally or externally, including preparations applied on the human body to repel insects like mosquitoes.
– All substances used for destruction of insects and all components of the drug like empty gelatine capsules
– Medical devices
ComplianceIndia can help you obtain your Drug license Registration quickly and hassle-free.
Types of Drug License Registration
Manufacturing License: License issued to a business that manufactures drugs inclusive of allopathic/ homeopathy medicines.
Sale License: License issued for the sale of drugs. It has the following bifurcations: – Wholesale Drug License – Retail Drug License – Restricted Drugs
Loan License: License issued to a business that does not own the manufacturing unit but uses the manufacturing facilities of another licensee.
Import License: License issued for the import of drugs.
Multi-Drug License: License issued to businesses that own pharmacies in multiple states with the same name.
Advantages of Drug license Registration
Avert unfair Pricing Policy
Compliance with legal regulators
Increase Goodwill and reputation in the Public
Ensure Quality in vaccination
Eliminates Prohibited Drugs
Discourages Adulteration
Eligibility for Drug License Registration
The first requirement for a pharmaceutical business is to have a competent person or a qualified and registered pharmacist. The qualification or eligibility of a Competent Person for Retail and Wholesale Drug License is as under:
For Retail Drug License | For Wholesale License |
B Pharma/D-Pharma Degree holder Registration with State Pharmacy Council No Prior Experience Required | B Pharma/D-Pharma Degree holder Registered with State Pharmacy Council or A graduate with one year of experience of dealing in drugs or An undergraduate having four years experience of dealing in drugs |
The Second requirement is related to space within which the Pharmacy Unit will operate. It must be as prescribed under the Guidelines issued and the other requirement is Storage Facility since some drugs requires to be kept in low temperatures.
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Packages
Consultation Charges
Nil
Complete assistance by Experts or Professionals indicating Process, Documents required, Benefits, Tax compliance, Legal Compliance, etc.
Basic Plan
Rs. 4,499/- only
– Drug License Registration for Fresh Pharmacy
– Expert advice from Experts/ Legal Professionals
Advance Plan-I
Rs. 5,499/- only
– Drug License Registration for Manufacturing Cosmetics
– Legal Drafting of documents
– Expert advice from Experts/ Legal Professionals
Advance Plan-II
Rs. 8,499/- only
– Drug License Registration for Manufacturing Drugs
– Legal Drafting of documents
– Expert advice from Experts/ Legal Professionals
Documents required for Drug License Registration
A. Company/LLP
B. Directors/Partners/Proprietor
C. Premises Related
D. Technical person documents
D. Technical person documents
Frequently Asked Questions
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