Drug License

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In India, the business entity who works in the health care sector such as medicines, drugs or cosmetics shall obtain the Drug License from the appropriate authority. As per the Drugs and Cosmetics Act, a License is issued by the State/Central Drug Standard Control Organization.

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Introduction

What is Drug License

In India, the business entity who works in the health care sector such as medicines, drugs or cosmetics shall obtain the Drug License from the appropriate authority. As per the Drugs and Cosmetics Act, License is issued by State/Central Drug Standard Control Organization.

Drugs are used in the formation of medicines in a medically defined ratio. Drugs are used in medicines that cure disease and are used as per the needs to ensure the well-being of human beings. Therefore the preparation and use of such drugs in medicines is restrictive, and the standards are set for using the correct amount of drugs that don’t harm the body by its overdose.

Key-Requirement to Obtain Drug License in India

Benefits

Benefits of Drug License

Process

Process For Drug License

Types of Drug Licenses Issued in India

Manufacturing Drug License

License issued to a business that manufactures drugs inclusive of allopathic/homoeopathy medicines.

Sale License

License issued for the sale of drugs. It has the following bifurcations: – Wholesale Drug License – Retail Drug License

Loan License

License issued to a business that does not own the manufacturing unit but uses the manufacturing facilities of another licensee.

Document Checklist

Documents Required for Drug License Online

Identification Proof of the Director

Identification Proof of the Director or Shareholder or the Applicant.

Copy of the Board Resolution

Copy of the Board Resolution related to the License.

Educational Qualifications

Educational Qualifications and Experience of the Pharmacist.

Proof of Challan

Proof of Challan and Copy of the Deposit Fee for the Pharmacy.

Incorporation Documents

Incorporation Documents and Constitution Documents

Site Plan and the Architecture Plan

Site Plan and the Architecture Plan Of the Pharmaceutical Outlet.

Faq

Frequently Asked Questions (FAQ)

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