For any Individual/Corporate/Partnership Firms etc , it is mandatory to obtain a valid Drug Licence from concerned State Authorities (Drugs Control Department). The provisions for this has been made in Drugs and Cosmetic Act 1940 and Rules 1945 applicable in India.
basic pre-requisites for a Drug License
Minimum area of the Office/Shop.
Granted in the commercial premises or other premises independent of residence.
Refrigerator or Air Conditioner on the premises.
Needs to comply with the conditions of licence of the issuing Authority.
Displayed at premises of business.
A technical staff :- A registered pharmacist or competent person with same line experienced as approved by the Department if Drug Control.
Based on business type, an entity may require different types of drug license. For exact requirement and applicability, consult with our Consultant.
Conditions for obtaining Drug License in India
Minimum Area & Height of Premises
The minimum area of 10 square meter is required to start a medical shop or pharmacy or wholesale outlet. In case, the pharmacy business combines retail and wholesale, a minimum of 15 square meter is required.
The clear height of the premises should be in accordance with the National Building Code of India, 2005 as amended from Time to Time.
Must have refrigerator & air conditioner in the premises. According to the labeling specifications certain drugs like vaccines, Sera, Insulin Injections etc., are required to be stored in the refrigerator.
Phamacist / Competent / Technical Staffs
Manufacturing :- for an Drug manufacturing unit there must be Technical Staff at manufacturing and Technical Staff for testing as well.
Wholesale :– The sale of drug by wholesale shall be made either in the presence of registered pharmacist or in the presence of a competent person who shall be a graduate with 1 yr experience in dealing in drugs or a person who has passed S.S.L.C with 4 years experience in dealing in drugs, specially approved by the department of drug control for the purpose.
Retail :– The sale of drug by retail must be made in the presence of registered pharmacist approved by the department, Registered pharmacist is required throughout the working hours.
Licences for the sale of drugs can be granted only at premises that is commercial premises or premises independent of residence. For this purpose state drug office issues guidance which may be referred to.
Location Based License
If drugs are sold or stocked for sale at more than one place, a separate license is needed in respect of each such place. Similarly, in case of manufacturer, a separate license is required to manufacture same or different drugs but at different location
License for Each State
In case a business is operating in more than two states, it has to obtain drug licence 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.
Importer of Drugs or Cosmetics
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
Documents requirement for Drug License in India
The firm's constitution (MOA & AOA for Company and Partnership Deed for Firm/LLP)
ID proof of Directors/Partners/Proprietor
Property Paper ( Registry Deed/Lease Deed/POA in case of owned Property)
Copy of Rent agreement ( in case of rented premises)
The key plan and the site plan of the premises ( Blue Print).
One Invoice copy of Refrigerator/Air conditioner purchased for use
Board Resolution, List of Directors, Certificate of Incorporation ( in case of company)
Covering Letter stating purpose of the Application
For Retail & Wholesale license - Affidavit from the Regd. pharmacist/competent person
For Manufacturing - List of Technical Staff and their proof of Education Qualification, Experience Certificate, Biodata, Appointment Letter, three photographs.
For Manufacturing - Affidavit from employer and or Technical Staff for full time working with the firm
Incase of Retail License:- Registered Pharmacist's degree certificate, Registration certificate with State Pharmacy Council and Appointment Letter and Bio-data.
Incase of Wholesale License:- Competent person's degree certificate, Experience Certificate in medicine job and Appointment Letter and Bio-data.
For manufacturer - Affidavit of Non Conviction, List of Equipment and Machineries for manufacturing and List of Equipment Provided for Testing
For Medicine Retailers
Retail Drug License ( for one premises)
For Medicine Wholesalers and Stockist
Wholesale Drug License ( for one premises)
For Medicine Manufacturers
Pharmaceutical Manufacturing Drug License
For Cosmetic Manufacturers
Cosmetic Manufacturing Drug License
Apply Additional Drug license
Application of additional Retail/Wholesale license
Drug License Amendment
Changes of Pharmacist/Competent Person in Existing License
Drug License Amendment
Addition or Reduction of premises
The above fee is our professional Fee for Consultation, Documentation and Filing. Govt. Fees, Departmental Expenses, etc payable as per actual basis and not included on above fees
Our Service Package Inclusion in Drug License Registration
First, Get Consultation from our Drug License Consultant to know the Drug License Rule, Documents Requirements, License Expenses, Renewal , Types of License applicability as per your business nature, etc.
Drug License registration need various documents in support of application filing. Documents varies Region wise as well as business to business and type of Drug License. We prepare all required documents first.
Once your documents is prepared, we starts preparing your application along.
Once your application is completed in all respect, we proceed to file with state Drug Control Authority.
We Assist client at the time of Inspection of premises by the Drug Inspector appointed by the Authority to check the Documents in Original and inspection of premises to ensure the particulars as mentioned in the applications is correct and premises fit for the drug business as per guidelines.
Update and Followup
We follow up with the Authority for an updated status of the application and we update client time to time.
The whole process of approval shall take upto 45 to 60 days by the Authority.
Drug License Registration process in India ( General Instruction)
Login ID and Password
Applicant has to obtain user ID and Password by giving request letter in person with the details of the firm.
Please be sure that, all the information is filled precisely for respective application mentioned below and only then e-send the application. In case of rejection of your application for incomplete information, the fees once paid will be forfeited.
All the documents should be scanned in 100 dpi & black and white, and then should be uploaded using the said ID and Password at space provided for the purpose.
The licensing authority may ask for any other specific documents if required.
Show all the original documents to the inspector at the time of inspection.
Inspector may ask you any further documents relevant to your application.
After grant or rejection of your application, you will receive an SMS about the same.
Take a print out of the approval/rejection from ‘Print License’ option for fresh license and renewal and click ‘MISC approvals’ for other approvals within 3 days. You will receive licenses/approvals with the valid e-signature and official seal.
Change in constitution
If the proprietor/ partner are changed, it will be treated as ‘change in constitution’ and applicant will have to obtain a fresh license.
Separate Password for Pharmacists
Registered Pharmacists are also required to update their details by obtaining separate password.
Why do you need FinTax Corporate Professional's service for Drug License issue?
Our Consultants possess deep exposure in Drug License Rules and Regulations in India. FinTax Consultant’s service is hassle free. Starts from documents preparation, application filing to get the license issued smoothly from the Authority, FinTax Consultants serve you till further any amendment in license if required and guide you as and when required.
Is FinTax Corporate Professional works in pan India for Drug License?
What is a Loan License?
It is the license issued to an applicant who does not have his own arrangement for manufacture but who intends to avail of the manufacturing facilities owned by another licensee.
What are the basic requirements for obtaining Retail Drug Licences for the Chemist shop?
The applicant should have premises of an area of not less than 10 sq. mtrs., equipped with proper storage facilities for preserving the properties of drugs and must have one Registered pharmacist.
What are the basic requirements for obtaining wholesale Drugs Licences?
The Applicant should have premises of an area of not less than 10 sq. mtrs and are in charge of a Competent Person who is a Registered Pharmacist/who has passed Matriculation or its equivalent with four year’s experience in dealing with Drugs or who holds a degree of a recognised university with one year’s experience in dealing with Drugs.
What is the minimum area of the premises required for retain cum wholesale licences?
The premises should be of an area of not less than 15 sq. mtrs.
Where licences to manufacture Cosmetics can be granted?
Licence to manufacture Cosmetics can be granted only in Industrial areas
Where licences to manufacture Drugs can be granted?
The licences to manufacture Allopathic Drugs/Homoeopathic medicines and also to repack Drugs can be granted only in the recognised Industrial Areas.
Which licence is required for sale of household medicine?
Licences in Form 20-A/21-A are required for the sale of restricted Drugs commonly used as household Remedies. For sale of such drugs, services of registered pharmacist and prescription of Doctor (RMP) are not required.
How long it takes to get License?
in normal course takes upto 45 t0 60 days.
The Drug Regulatory Body has made it mandatory for its officials to attend as well as grant all the licenses, whether retail or wholesale, in the time frame of 30 days, if they fulfill all the required eligibility criteria. The intention is to make the whole process of drug license transparent and user-friendly.
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