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THINGS TO KNOW BEFORE YOU REGISTER-DRUG LICENSE PHARMACY BUSINESS

A drug licence is permission from the drug’s controller to handle the medications. This drug licence is provided subject to certain conditions linked to the premises and the competent person, whether for wholesale or retail operation. We help pharmacies and pharmaceutical enterprises get medication licences.

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INTRODUCTION

Drug license by the competent authority under Drugs and Cosmetic Act, 1940 is mandatory to carry out a business concerning drugs/medicines or cosmetics.Drug Control Department is a regulatory authority which regulates the manufacture of medicines & cosmetics, storage, distribution and sale of medicines.With the purpose of including Ayurvedic& Unani drugs, The act was later amended in the year 1964. There are three kinds of license, the retail license, wholesale license for drug distribution or sale in India and Restricted license for Gen.Store.

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DOCUMENTS REQUIRED

Procedure of Drug License Registration in India

Step - 1 : Documentation

The most important step in obtaining the drug License is the preparation of documents which includes, preparation of key plan and site plan and various affidavits and declaration as prescribed under law.

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Step - 2 : Filling of Application

The drug License applications are filed online, these days including the payment of government fee. All documents are scanned and uploaded at the time of filing the application. However, filed documents are verified by the inspector.

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Step - 3 : Inspector Visit

After filing of the application for grant of drug license, the same is marked for inspection and thereafter the drug inspector personally visits the shop to verify the documents and correctness of information.

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Step - 4 : Grant of License

After the Inspection is complete and in case personal interview is called for is cleared by the competent person and upon verification all information and documents furnished is correct the controller of drugs issues the Drug License.

FAQ

Most frequent questions and answers
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Yes, it is necessary to obtain drug license prior to commencement of the drug business, whether it is Allopathic Drugs, Ayurvedic Medicine, Homeopathy or Unani, to manufacture, distribute or sell the drugs It is mandatory to obtain a license as per the nature of business by applying to the controller of the drugs and cosmetics

As per Section 3(aaa) of the Drugs and Cosmetics Act 1940 and Rules 1945,Cosmetic means any article intended to be rubbed,poured,sprinkled or sprayed on, or introduced into, or otherwise applied to, the human body or any part thereof for cleansing,beautifying,promoting attractiveness, or altering the appearance, and includes any article intended for use as a
component of cosmetic.

Based on the requirement of the pharmaceutical business, an applicant must apply for issue of specific drug license. There are various licenses, for example,

1.Drug Manufacturing License.

2.Wholesale Drug License. 

3.Retail Drug License.

4.Import of Drugs or Cosmetics.

5.Import of Medical Equipment.

6.Export of Medicines etc.

Licenses for the sale of drugs can be granted only at premises which is commercial premises or other premises independent of residence, also known as mixed land use.

Yes, In case a business is operating in more than one state, it has to obtain drug license in every state in which business is being carried on. Drug licence is location specific, and hence within state application, all site must be included.

Drugs and Cosmetic Act aims at ensuring safety, effectiveness and conformity of the drugs and cosmetics sold in India to the state quality standards. Drugs or cosmetics of schedule X can be imported into India only after obtaining a License

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