The Food and Drug Administration (FDA), Maharashtra on August 13, 2026, issued the FDA Guidelines for Online Drug Sale Licence Applications.
The following has been stated:
• The department has issued guidelines for the online, paperless processing of applications for retail and wholesale drug sale licences under the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945. The system is operated through the Aaple Sarkar/XLNIndia online platform and was made completely paperless from January 25, 2016, with the objective of ensuring transparency and uniformity in processing applications.
• Applicants shall ensure certain prerequisites before applying. A retail or wholesale drug licence requires premises of at least 10 sq. metres carpet area, while combined retail and wholesale operations require at least 15 sq. metres, with a separate and exclusive entrance. Retail establishments shall have a Registered Pharmacist, whereas wholesale establishments require a competent person or Registered Pharmacist. A refrigerator is mandatory for retail licences, while wholesale applicants shall maintain storage facilities appropriate to the drugs being handled.
• The application process involves registration on Aaple Sarkar, selection of the Medical Education and Drug Department and FDA service, completion of the online application, and subsequent processing through XLNIndia. Applicants shall pay the prescribed fees through the Government Receipt Accounting System (GRAS), upload the payment receipt and required documents, and e-send the application to the department. The concerned Licensing Authority then allocates the application for inspection; the Drugs Inspector verifies the premises, facilities and documents and submits an inspection report, after which the Licensing Authority takes the final decision to grant or reject the application.
• The prescribed fees vary according to the licence category. For example, the booklet specifies ₹1,500 for fresh/renewal of retail licences in Forms 20 and 21 and wholesale licences in Forms 20B and 21B; ₹250 for Homeopathic licences; ₹600 for retail Schedule X licences (Form 20F); and ₹1,200 for wholesale Schedule X licences (Form 20G). Separate fees apply to restricted and vehicle licences. The guidelines also provide for late fees and duplicate-copy charges.
• For fresh retail/wholesale applications, applicants are required to upload the applicable statutory application forms, firm constitution documents and other supporting documents. Documents shall generally be scanned at 150 dpi in grayscale/black and white, while originals shall be produced before the Inspector during inspection. The guidelines caution that incomplete or incorrect information may result in rejection, with fees already paid being forfeited. The guidelines are subject to periodic revision, and the provisions of the Drugs and Cosmetics Act, 1940 and Rules, 1945 prevail in case of any inconsistency.
