Procedure for obtaining Retail (medical store) Drug Licences


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Procedure for obtaining Retail (medical store) Drug Licences / Wholesale Drug Licences
Any person who wants to start a medical store or wants to deal in drugs by way of wholesale should obtain license from this Directorate under the Drugs & Cosmetics act & Rules thereof by following the procedure given below. Grant of retail/wholesale drug licences is done online by the Department
1. To obtain license in Form 20/20B & 21/21B (for Allopathic drugs), 20C/20D (for Homoeopathic drugs) and 20F/20G (for Schedule X drugs) applicant should fill form 19,19B and19C respectively, form for Additional information data, Self-declaration form. The Forms and the list of all the documents that needs to be submitted may be obtained from the Directorate of Food & Drugs Administration or it can also be downloaded from link below.
List of documents to be submitted for Grant of Retail/wholesale Licence Drug Forms
2. Once all the documents are ready the applicant should verify the documents from area Drugs Inspector or any Drugs Inspector of Food & Drugs Administration.
3. After documents are verified and found ok, applicant may pay the necessary fees vide Echallan. The fee of Rs. 3000/- with additional fee of Rs 250/- for Homoeopathic Licence and Rs. 500/- for Schedule X licence needs to be paid to Head of accounts, Demand No. 53; 201 Medical and Public Health, 04 Public Health, 104 Fees and Fines, 01 Fines. Fee structure can also be downloaded from link below:
Fee Structure
4. For generation of E- challan applicant needs to fill the challan form available with the department for requisite fees and get it verified from Drugs Inspector and submit it to accounts section where E-challan will be generated and issued to the applicant. Generated E-challan to be paid in the Treasury branch of State Bank of India.
5. Applicant may then apply for ID and password on XLN INDIA website. For application of ID and password applicant may either fill a form available with the department and submit it to entry section of the department or follow the instructions from the link of Xlnindia website and submit it online.
Application of New Login ID & Password on XLN INDIA
6. With the ID and Password provided, applicant can login to http://www.xlnindia.gov.in using only google chrome browser (allow pop-up) and create new application by clicking on “New Inward” and upload the required documents as per the instructions in the sales guidelines; which will be available once the applicant logs in to xlnindia web application.
7. After generating full application, take print out of software generated applications i.e Form 19/19B/19C, Self-Declaration and Undertaking and then e-send to Department. For future reference; note down the inward ID that is generated on the system which will be generated

only when full application is completed. The Inward ID generated is required to be mentioned on the covering letter while submitting hard copies of the application.
8. Submit hard copy of all documents and Software generated application forms duly signed along with original copy of e-challan paid towards the fees in a file to the entry clerk in the inward Section within 72 hours of e-send of application.
File movement once it is submitted in entry section is as under:
1. Hard copy of application received in the inward Entry section.
2. Entry clerk forwards the file to Accounts section of the Department for verification of amount paid through challan.
3. The Accounts Section after verification of amount forwards the file to concerned dealing hand.
4. The dealing hand registers the application, generates the file number and scrutinises all the documents and puts up to the Director for allotting to the Drugs Inspector/ADC.
5. The Director peruses the application and marks it to any Drugs Inspector/Asst. Drugs Controller for further processes.
6. Drugs Inspector/ADC scrutinises the application and calls for rectification of deficiencies in the document if any and once documents are found satisfactory, inspects the premises. After inspection of the premises forwards the inspection report along with observations and recommendation to the ADC/Dy. Director online.
7. The ADC/Dy. Director peruses the report and forwards the file to Director with their comments and recommendations, same is also recorded online.
8. The Director agrees/rejects to grant the licences as the case may be and if agreed licence is issued by the Director online. The e-signed licence is printed and forwarded to Dispatch clerk.
9. Licensee shall collect the licences from Technical Section of Directorate of Food & Drugs Administration.
Note: 1) Validity of licence - valid upto 5 years from issue of licence subject to the conditions specified in the licence & to the provisions of the Drugs & Cosmetics Act, 1940 and the Rules thereunder.
2) Click on the link below for timelines: Citizen charter

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Procedure for obtaining Retail (medical store) Drug Licences