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
- Premise Area
- Storage
- Technical and expert staff
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)
Yes drug license is a mandatory requirement if the business carried out is dealing with pharmaceutical materials and other forms of drugs. If a drug license is not taken out by the business then there can be penalties levied under the Indian Penal Code, 1860 and the Drugs and Cosmetics Act, 1940.
Once the applicant provides the particulars for the drug license, the same will be provided within a period of one month to the applicant.
Usually drug licenses would only be granted for a shop or establishment in commercial premises.
Various provisions dealing with Drug licenses are given under the Drugs & Cosmetics Act, 1940 & rules thereunder. Information can also be sought in person from the drug inspectors seated in Drugs Control Department.
The books of accounts, registers, forms and other documents shall be maintained in such manner as may be specified by the licensing authority at the time of issue of such license. It is the responsibility of the license holder to intimate every change and modification that occurred in its business.
Yes, drug license is necessary for every unit operating in any part of India. For instance, in case the drug business has its unit in two separate states, it shall get the license for both such an operational unit.
A drug license is issued by the government to carry out the process of manufacturing drugs, distributing and selling of drugs. All pharmacies require this form of license to carry out different processes.
