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Form 20- Retail Drug License for retail pharmacies and medical stores Form 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 or apply for renewal / retention of an existing drug sale license in Maharashtra, the application is required to be processed through the online XLN system. Here’s everything you will need to know.
Drug Sale License in Maharashtra is processed through the online system of the Food and Drug Administration, Maharashtra State. The guideline manual has been issued for easy understanding of the online processing of various applications. The system has been in service since 2011 and, from 25th January, 2016, it has been made completely paperless. The objective of the online system is to bring transparency and uniformity in processing of applications.
The applicant is required to apply for user ID and password through the online system, upload the necessary documents, pay the prescribed fees through GRAS, upload the payment receipt and then e-send the application to the department. After submission, the application is received by the concerned area Licensing Authority and Assistant Commissioner, and is then allotted to the Drugs Inspector for inspection.
A Drug Sales License is an approval required for carrying on the business of sale of drugs in Maharashtra. It applies to both retail and wholesale sale of medicines.
Retail Drug License is applicable where drugs are sold directly to consumers. Wholesale Drug License is applicable where drugs are sold to retailers, hospitals or other dealers.
The license is granted only after verification of documents and inspection of premises by the concerned authority.
| Particulars | Details |
| Retail License | Form 20 and Form 21 |
| Wholesale License | Form 20B and Form 21B |
| Household Remedies License | Form 20A and Form 21A |
Basic details relating to application for Retail and Wholesale Drug License in Maharashtra are as follows:
| Particulars | Details |
| Department | Department of Health & Family Welfare, Government of Maharashtra |
| Directorate | Directorate of Drugs Control |
| Competent Authority | Assistant Director of Drug Control of the respective district |
| Processing Time | 90 days after receipt of complete application |
| Fees | As per applicable Act and Rules |
| Payment | To be made through GRIPS before application |
| Particulars | Details |
| License Type | Retail Drug License / Wholesale Drug License / Household Remedies License |
| Applicable Location | Maharashtra |
| Governing Law | Drugs and Cosmetics Act, 1940 |
| Retail License Forms | Form 20 and Form 21 |
| Wholesale License Forms | Form 20B and Form 21B |
| Household Remedies License Forms | Form 20A and Form 21A |
| Statutory Application Form for Retail / Wholesale | Form 19 |
| Statutory Application Form for Household Remedies | Form 19A |
| Key Person Required for Retail License | Registered Pharmacist |
| Key Person Required for Wholesale License | Competent Person / Registered Pharmacist, as applicable |
| Premises Requirement | Plan of premises showing carpet area, length, breadth and area in Sq.m |
| Company Requirement | List of Directors from MCA and affidavit under Section 34, if applicant is a company |
| Inspection Requirement | Original pharmacist certificate is required to be produced before the Drugs Inspector at the time of inspection for endorsement, in case of retail license |
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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Retail Drug License (Form 20 / 20B)
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A Drug Sale License is required under the Drugs and Cosmetics Act, 1940 for any person engaged in the retail sale, wholesale sale, distribution or storage of medicines in Maharashtra.
The license is processed through the online system of the Food and Drug Administration, Maharashtra State. Depending upon the nature of business, separate license forms are applicable for retail sale, wholesale sale, homeopathic drugs, restricted drugs and Schedule X drugs.
At CharteredONE, complete assistance is provided for the entire Drug Sale License process in Maharashtra, including preliminary eligibility review, document preparation, verification of pharmacist or competent person requirements, portal filing, GRAS payment assistance and follow-up with the concerned authority.
You need a Drug License in Maharashtra 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 90 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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