Drug License Registration
Drug License Registration in India
Drug License in India at a glance
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. |
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)
- 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
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.
Preparing Application
Once your documents is prepared, we starts preparing your application along.
Application Submission
Once your application is completed in all respect, we proceed to file with state Drug Control Authority.
Inspection assistance
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.
Registration Copy
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. |
| 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. |
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