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REGISTRATIONS & LICENCES
Drug License Registration in India at glance - Process, Documents Required
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.
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PRACTICAL SERVICE GUIDE
Understand the requirement before you file
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.
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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.
- Conditions for obtaining Drug License
- Documents required for Drug License registration
- Drug License Registration Process
- Our Pricing
- Our service package inclusion
- FAQs
Drug License Certificate Sample
- Form-20B
- Form-21B
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.
Storage Facility
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.
Commercial Premises
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)
- For Retail & Wholesale license - Affidavit from the Regd. pharmacist/competent person
- Property Paper ( Registry Deed/Lease Deed/POA in case of owned Property)
- Board Resolution, List of Directors, Certificate of Incorporation ( in case of company)
- The key plan and the site plan of the premises ( Blue Print).
- One Invoice copy of Refrigerator/Air conditioner purchased for use
- Copy of Rent agreement ( in case of rented premises)
- Covering Letter stating purpose of the Application
- ID proof of Directors/Partners/Proprietor
- For Manufacturing - Affidavit from employer and or Technical Staff for full time working with the firm
- For Manufacturing - List of Technical Staff and their proof of Education Qualification, Experience Certificate, Biodata, Appointment Letter, three photographs.
- 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
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.
Online Application
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.
Upload Documents
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.
Physical Inspection
Show all the original documents to the inspector at the time of inspection. Inspector may ask you any further documents relevant to your application.
Approval/Rejection
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.
Our Service Package Inclusion in Drug License Registration
Consultation
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.
Documentations
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.
LIQUETAX DELIVERY WORKFLOW
One accountable path from review to completion
- 01
Requirement review
We confirm the applicant, objective, jurisdiction and correct service scope.
- 02
Secure document collection
A practical checklist keeps the required records and missing information visible.
- 03
Validation and preparation
Records are checked for completeness and consistency before the filing pack is prepared.
- 04
Professional review
A LIQUETAX professional reviews the prepared information and flags facts needing confirmation.
- 05
Authorised submission
Only after your approval is the applicable matter submitted to the relevant portal or authority.
- 06
Tracking and handover
Acknowledgements, follow-ups and the next known compliance action are coordinated.
SCOPE BOUNDARIES
Dependencies are confirmed before work starts
- Government, portal and third-party charges are separated unless the quote specifically says otherwise.
- Approval and authority processing times are outside LIQUETAX control.
- Notices, objections or additional submissions are included only when stated in the agreed scope.
- Changing eligibility, fees and rules require current professional verification.
EXPERTISE & CONTROL
A reviewed workflow, without outcome promises
Prepared information is reviewed before authorised submission.
Changing requirements are checked against the relevant authority.
Acknowledgements and known next actions stay connected.
Final approval and processing remain with the government authority.
FREQUENTLY ASKED QUESTIONS
Before you get started
What is included in Drug License Registration in India at glance - Process, Documents Required?
LIQUETAX first reviews your facts and records, then confirms the exact preparation, filing, follow-up and completion documents included in your engagement.
How are fees and timelines confirmed?
Professional fees, statutory charges and a realistic preparation timeline are confirmed after the initial document review. Authority processing time can vary.
Can I track the work after I engage LIQUETAX?
Yes. Active clients can use the client portal for assigned work, document status, due dates, filing progress and acknowledgements.