Drug license is a permission granted by the authority under the Drugs and Cosmetic Act in order to carry out a business of drugs/medicines or cosmetics. The Drug license is issued by the State Drugs Standard Control Organization or the Central Drug Standard Control Organization.
The drugs are used in the medicines, in a medically defined ratio to cure our health. Drugs come in use on a need basis, to ensure our well being. However such medicines are manufactured with very restricted and correct amount of the drugs and it does not harm the body.
However, any violation of the medically defined limits may have a very serious effect on the health of the person using it. Therefore it requires to be regulated by the government via imposing stringent law and regulations in the process of manufacturing and distribution of drugs and medicines in India. Once you have Drug License from the government, you can deal with drugs otherwise not.
Drug License registration and everything related to drugs are regulated by the Drugs and Cosmetics Act 1940. The act regulates every step related to the drugs, from the raw material procurement stage during manufacture to sale including distribution, until it reaches the customer/patient. Drug license is required to be taken for all types of drugs or cosmetics business including allopathic, homeopathic, ayurvedic or unani drugs etc. The act even covers the Pharmacist conduct, hospital or a dispensary usage of drugs. The act covers the Ayurvedic and Unani drugs also in it.
The requirement of medicines is a never-ending thing which makes pharmacy business as the most ideal business. It does not get affected by the monetary cycles. In recent years there has been a considerably very high level of developments in the hospitals has also lead to the increasing demand for pharmacies. The pharmacies are set up in hospitals, shopping areas, residential buildings, housing townships; the pharmacies in the residential building are built in form of the firms. E-commerce companies and e-health companies are the main participants due to their market with the easy availability of medicines to customers and by providing same-day delivery, cost saving.
It is Issued to Persons/agencies involved in Standalone/ chemist pharmacy shops
It is issued to Persons/agencies involved in wholesale distribution of drugs
There are mainly two kinds of drug license for drug distribution or sale in India. This license is issued subject to certain conditions attached to premises and competent person who shall be dealing with drugs.
1. Retail license and
2. Wholesale license of
Other types of License are:
1. Manufacturing license
2. Loan License
3. Restricted license for general store basis the type of sale to be made.
Swarit Advisors provides professional assistance in obtaining the drug license in India.
Drugs have varies categories, and for different categories, the different license is required to be obtained, by filing different forms as given below:
In case a retailer is willing to obtain drugs license to sell allopathic drugs, he/she has to apply by filling FORM 20 for drugs license. Note that Form 20 is to be filed for drugs to be sold by retail other than those specified in Schedule C, C(1) and X (Form-19A).
In case a retailer is willing to obtain drugs license to sell restricted allopathic drugs, he/she has to apply by filling FORM 20-A for drugs license. Note that Form 20-A is to be filed for drugs to be sold by retail other than those specified in Schedule C, C(1) and X (Form-19A).
Drug License for wholesale of Allopathic drugs is to be applied in Form 20-B, however not for the categories specified in Sch C, C(1) and X. (Form-19).
Fill in Form 20-C in case you are a retailer of Homoeopathic medicines.
To sell the allopathic drugs first apply for drug license by filing Form 21.
In order to deal in the wholesale business of Allopathic drugs, obtain a license by filing Form 21-B.
Obtain drug license for retail of sale of restricted allopathic drugs, which are specified in Schedule C (I).
For certain drugs as specified in Sch. X of the Act, apply in for drug license in form 20-F.
To establish a wholesale business for drugs specified in Sch. X, apply for drug license in form 20-G.
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The right documents will save you from any kind of rejections, the documents to be submitted is the most important step in obtaining the drug License it includes preparation of key plan and site plan and various affidavits and declaration pursuant to the applicable rules and regulation of the law.
The following documents would be required along with the application
Certain preplanning is required to be done before setting up the business pertaining to the Drugs and for obtaining the grant of drug license
The rules and regulations pertaining to drug license are governed by the Food Safety and Drug Administration Department of the concerned State Government.
Well, the procedure for obtaining the Drug license is quite simple and with proper documentation, it is assured to get the drug license.
Application for the drug License is completely online, along with the payment of government fee. The scanned copy of all documents is uploaded at the time of filing the application.
On receipt of the application, the drug inspector shall personally visit the shop to verify the documents and correctness of information so provided.
On successful completion of the Inspection personal interview for by the inspector or such competent person and upon verification all information and documents furnished is correct the controller of drugs issues the Drug License.
Choose the Form of License as per product, you propose to be manufactured.
Go to http://fsdaup.gov.in and click on online registration for Drugs/Cosmetics Manufacturing icon. Fill online Form, upload required documents and submit.
Submit one hard copy of application form along with complete set of documents in the office of Food Safety and Drug Administration.
The Drugs Control Authorities will carry a joint inspection of proposed premises s as pre-scheduled and intimated to the applicant.
The applicant shall be given an opportunity to rectify the defects in case any discrepancies have been observed.
The license is finally issued by the Licensing Authority on satisfaction and proper submission of documents along with the application.
For cases when you are operating in more than two states following rules are to be adhered and kept in mind:
To obtain the Drugs Import License, one needs to file following Forms at the CDSCO’S SUGAM portal:
No, you are not allowed to start any drug business or sell the drugs without obtaining a license as per the nature of business from the controller of the drugs and cosmetics.
No, in order to obtain the licenses for the sale of drugs commercial premises or other premises independent of residence, also known as mixed land use should be your premise.
Basis the needs of the applicant he/she may apply for following types of license
Yes, for cases where a person is operating in more than two states, it has to obtain a drug license in each state. The Drug license is issued as per the location and hence for, within state application, all site must be included.
It is the responsibility of all persons dealing with drugs to maintain the quality of drugs in the medicines. If any person consuming or using a drug or cosmetic suffers any harm due to the negligence on the part of the manufacturer or seller, it amounts to an offense of grievous hurt under India Penal Code.
No, you need apply, but you need to submit the application copy to the Zonal Office of Central Drugs Standard and Control Organization (CDSCO) also.
Well, Swaritadvisors has set a benchmark for providing all kinds of drug license and related services in India, with its in-house expert team of professionals from different academic excellence.
The main purpose of the Drugs and Cosmetic Act is to ensure the safety, effectiveness, and conformity of the drugs and cosmetics sold in India to the state quality standards for which certain prohibitions have been provided under the Act.