Retail or Wholesale Drug business in Andhra Pradesh
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 Andhra-Pradesh, 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 Andhra-Pradesh 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.
What is Retail and Wholesale Drug License?
Drug License in Andhra-Pradesh 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.
Types of Drug Sales License
| 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 |
Which authority issues Retail and Wholesale Drug License in Andhra-Pradesh?
Basic details relating to the application for Retail and Wholesale Drug License in Andhra-Pradesh are as follows:
| Particulars | Details |
| Department | Drugs Control Department, Andhra Pradesh |
| 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 |
Basic Application Details
| 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 | Andhra Pradesh |
| 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 |
Procedure for New Retail or Wholesale Drug License
Step 1 - Application Preparation
The applicant can apply for the grant of Retail Drugs Licence or Wholesale Drugs Licence with the prescribed documents and necessary application fee. The applicant should prepare Form 19, covering letter, self assessed checklist, premises documents, competent person documents, power of attorney and photo identity proof.
Step 2 - Submission to Drug Inspector
The designated drug inspector accepts the application. After acceptance, the application is forwarded for scrutiny.
Step 3 - Scrutiny and Inspection by Drugs Inspector
The Drugs Inspector examines the attached documents. The Drugs Inspector also inspects the premises to verify whether the premises, layout, storage and other details are proper.
Step 4 - Deficiency and Inspection Observation
The Drugs Inspector conveys to the applicant any deficiencies in documents and observations of inspection. The applicant is required to comply with the deficiencies and inspection observations.
Step 5 - Forwarding to Drugs Licensing Authority
After compliance of observations, the Drugs Inspector forwards the application to the Drugs Licensing Authority. The application moves for final decision after the deficiencies, if any, are complied with.
Step 6 - Grant of Licence
After compliance, the Drugs Licensing Authority grants the licence with his / her signature. The licence is issued for the approved premises and approved category of drug business.
Applicable Laws and Regulations
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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