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Form 20- Retail Drug License for retail pharmacies and medical storesForm 21- Wholesale Drug License for wholesale dealers and distributorsForm 20B- Retail Drug License (Restricted Categories) for retail sale of scheduled/restricted medicinesForm 21B- Wholesale Drug License (Restricted Categories) for wholesale of scheduled or restricted medicines
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If you are planning to start a retail medical store, wholesale drug business, sell Schedule X drugs, apply for restricted drug license or sell drugs from a motor vehicle in Karnataka, the application is required to be made online to the Drugs Control Department. Here’s everything you will need to know.
Drug Sales Licences in Karnataka are granted by the Drugs Control Department through the respective jurisdictional delegated Licensing Authorities. The licences are granted depending on the type of sale activity proposed by the applicant, such as retail sale, wholesale sale, sale of Schedule X drugs, restricted sale and sale of drugs from a motor vehicle.
The applicants are required to submit the online application for grant of fresh licence as per the applicable checklist. After submission of application, verification of documents, scrutiny, inspection and final processing, the licence is granted by the Licensing Authority.
Drug License in Karnataka is an approval granted by the Drugs Control Department for sale of drugs through retail, wholesale, restricted sale, Schedule X sale or sale from motor vehicle.
The licence is granted by the respective jurisdictional delegated Licensing Authority after the applicant submits the online application, uploads scanned copies of the prescribed documents, pays the applicable fee and completes the process required for grant of licence.
The application is required to be made as per the type of licence required by the applicant.
| Particulars | Details |
| Retail License | Form 20 and Form 21 |
| Wholesale License | Form 20B and Form 21B |
| Licence to sell drugs under Schedule X | Form 20F for Retail and Form 21G for Wholesale |
| Restricted Licence | Form 20A and Form 21A |
| Licence to sell drugs from motor vehicle | Form 20BB |
Basic details relating to the application for Retail and Wholesale Drug License in Karnataka are as follows:
| Particulars | Details |
| Department | Drugs Control Department, Karnataka |
| Directorate | Directorate of Drugs Control |
| Competent Authority | Respective jurisdictional delegated Licensing Authority / Assistant Drugs Controller |
| Processing Time | Maximum 30 working days |
| Fees | As per applicable Act and Rules |
| Payment | To be made through online before application |
| Particulars | Details |
| License Type | Retail Drug License / Wholesale Drug License / Schedule X Drug License / Restricted Drug License / License to sell drugs from motor vehicle |
| Applicable Location | Karnataka |
| Governing Law | Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945 |
| Retail License Forms | Form 20 and Form 21 |
| Wholesale License Forms | Form 20B and Form 21B |
| Schedule X License Forms | Form 20F for Retail and Form 20G for Wholesale |
| Restricted License Forms | Form 20A and Form 21A |
| Motor Vehicle License Form | Motor Vehicle License Form |
| Statutory Application Form for Retail / Wholesale | Form 19 |
| Statutory Application Form for Schedule X | Form 19C |
| Statutory Application Form for Restricted License | Form 19A |
| Statutory Application Form for Motor Vehicle License | Form 19AA |
| Key Person Required for Retail License | Registered Pharmacist |
| Key Person Required for Wholesale License | Competent Person / Registered Pharmacist, as applicable |
| Premises Requirement | Minimum floor area of 10 sq. meters for retail or wholesale license, and 15 sq. meters where application is made for both retail and wholesale licenses. |
| Retention Requirement | Retention fee is required to be deposited before expiry of every succeeding five years from the date of issue |
| Inspection Requirement | Application is scrutinised and the proposed premises is inspected before grant of license |
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The applicants are required to submit online application for grant of fresh licence as per the checklist given for each type of licence.
In case of Change of Premises or Change of Constitution, fresh licences are required to be obtained. The licensees are expected to make their online applications well in advance by surrendering the existing licences.
In case of retention of licences, the applicants are required to apply online and deposit the retention fees before expiry of the licences.
If the application is made on Letter of Authority or Power of Attorney, the original LA or POA should be signed by the Director, Company Secretary, Owner or Partner of the firm, as the case may be.
Where the LA or POA is issued by a company, it should be supported with board resolution.
The LA or POA holder is also required to upload his photo and residential address proof along with the application.
The Drugs Control Directorate works as a public health measure through enforcement of the applicable drug laws.
The Directorate is entrusted with grant or retention of manufacturing and selling licences relating to allopathic drugs, homoeopathic medicines, cosmetics manufacturing licences, Blood Bank, surgical and medical device units.
It also carries out inspection of manufacturing process of sera or vaccines units, monitors and issues GMP and GLP certificates, including MSC, NVC, COPP and Free Sales Certificate, and approves quality control laboratory of medicines and cosmetics.
After submission, the application is processed by the department.
The form and submitted documents are verified. Inspection is conducted by the Senior Inspector or Inspector of Drug Control. The inspection report is submitted to the Assistant Director of Drug Control.
After completion of the departmental process, the competent authority communicates the decision to the applicant. If approved, the applicant can download or take print out of the license or approval.
The following laws and regulations are applicable:
| Sl. No. | Regulation |
| 1 | Drugs and Cosmetics Act, 1940 and rules formed thereunder |
| 2 | Drug Price Control Order, 2013 |
| 3 | Narcotic Drugs and Psychotropic Substances Act, 1985 |
| 4 | Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954 |
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A Drug License is required under the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945 for any person who is engaged in the sale, distribution or storage of medicines in Karnataka.
At CharteredONE, complete assistance is provided for the Drug License application process, starting from initial assessment of eligibility and premises requirements to preparation, review and verification of documents, filing of the application and follow-up with the concerned authority.
The objective is to ensure that the application is filed correctly, the required documents are complete in all respects, and the licensing process is completed in a smooth and proper manner without avoidable delays or unnecessary queries.
You need a Drug License in Karnataka if:
CharteredONE assists in preparing and filing the drug license application accurately. It ensures proper selection of license type, correct filling of online form, and complete documentation as per requirements to avoid delays or rejection.
CharteredONE helps in organizing and verifying all required documents including premises proof, pharmacist details, and affidavits. It also supports in responding to queries raised by the competent authority during the application process.
CharteredONE provides end-to-end support from application to approval. It assists in tracking status, coordinating during inspection, and ensuring smooth completion of the process, including guidance after approval for compliance and record maintenance.
Here are some common questions we receive from our customers. If you have any additional questions, please don’t hesitate to contact us.
The license is issued by the Assistant Director of Drug Control of the respective district under the Directorate of Drugs Control, Department of Health & Family Welfare.
The application is required to be filed online through the Drug License portal by registering, filling the form and uploading prescribed documents.
The processing time is 30 days after receipt of complete application in all respect.
Yes, the application, document submission and tracking are done through the online portal.
Documents include trade license, premises proof, pharmacist details, affidavits and other prescribed documents in PDF format.
The application is forwarded to the competent authority, verified by the Inspector and inspected before decision is taken.
Yes, the competent authority may ask for additional information or clarification if required.
The applicant can track the application online and receives updates through email or SMS alerts.
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If you notice anything that isn’t right, you can report the issue to us, and we’ll address it promptly.
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