Document Version- Mfg-02

RUG SALE LICEN

SE
MANUFACTURING LICENCE
STANDARD DOCUMENTS
AND
APPLICATION GUIDELINES

AND
APPLICATION
 Preface

Food and Drug Administration, Maharashtra State is presenting

the guideline Manual for the easy understanding of processing of
various applications through online system. Though the system is in
service since 2015, from 25th January, 2016, it is made completely
paperless. This effort is to bring transparency and uniformity in
processing of various applications. The Manual is available in
Marathi and English. All the stakeholders are requested to read it
properly and follow the online paperless system.
General Instructions to applicants for Licence for manufacturing
of Drugs and Cosmetics through online application software

1. All the documents should be scanned in 150 dpi, gray scale/Black &
White, and then should be uploaded at relevant space provided.
2. Please show all the original documents to the inspector at the time of
inspection.
3. Please be sure that, all the information is filled precisely for respective
application mentioned under standard document and only then e-send the
application. In case of rejection of your application for incomplete
information, the fees once paid will be forfeited.
4. If necessary, the licensing authority may ask for any other relevant
documents.
5. These guidelines are subject to change as and when necessary and will be
updated from time to time.
6. Every application needs to be ‘e-send’, otherwise it will not be forwarded
to the office.
7. In case of Change in Constitution, (Change in partner, proprietor, Pvt.
Ltd. to Ltd, etc.), except in case of death of proprietor, applicant is
required to obtain a fresh Licence.
8. These are only guidelines. For clarity please refer to the provisions of
Drugs and Cosmetic Act 1940 and Rules 1945, whichwill always
prevail.
9. Fees for Licence is as per table given below
 Fees applicable in the State of Maharashtra

Appl Lic Fresh Appl Ren / RetAppl Late Fee Duplicate Addl Prod
Form Form Lic Insp Fee Lic Insp / month Copy fee /
Fee Fee Fee Drug
24 25 3000 750 3000 750 1500 750 750
24A 25A 3000 750 3000 750 1500 300 750
24B 25B 600 300 600 300 300 150 250
24C2 25C 240 60 240 30 90 45 15
24C3 25C 120 30 120 15 90 30 15
24C4 25C 120 30 120 15 45 30 15
24D 25D 400 200 400 200 200 100 100
24E 25E 400 200 400 200 200 100 100
24F 25F 6000 1500 6000 1500 3000 1500 750
27 28 4500 1500 4500 1500 1500 600 1250
275 28 1800 12006 1800 12006 900 300 125 (Max
1500)
27A 28A 4500 1500 4500 1500 1500 600 1250
27B 28B 7500 1500 7500 1500 3600 1200 1250
27C 28C 6000 1500 6000 1500 1000 1000 300
27D 28D 1800 12006 1800 12006 900 600 125 (Max
1500)
27DA 28DA 6000 1500 6000 1500 1000 1000 300
27E 28E 6000 1500 6000 1500 1000 1000 300
27F 28F 6000 1500 6000 1500 1000 1000 300
30 29 150
31 32 3000 1200 3000 1200 1200 600 750
317 32 1200 300 1200 150 600 150 12.50
31A 32A 3000 1200 3000 1200 1200 300 750
36 37 4500 4500 3000 4500 (for
(Sch C & Addl
C1) category )
36 37 (Other 2700 2700 1500 2700 (for
than C & Addl
C1) category)
47 48 6000 6000 1000

1. In case of itinerant vendor or applicant who desires to establish a shop in town or village
having population 10000 or less.
2. Fees for manufacture of homoeopathic mother tinctures and potentised preparations.
3. Fees for manufacture of homoeopathic potentised preparations only.
4. Fees for manufacture of homoeopathic potentised preparations from back potencies by
Pharmacies.
5. For Allergens only.
6. For first inspection and fee of Rs 600/- for subsequent inspection.
7. For odoriferous substances (Aromatic products).
NDPS Transport permit 10
Licence I / II (grant or 20
renewal) per year
Poisons Licence 500
Blood Storage Centre Approval 2000 (for WHB) + 200 (per product)
Competent Person Interview 1000
Approval
Individual Certificate 500
Upto 1 cr 1 to 5 cr More than
5 cr
Plan Approval One Section Fresh 1000 2000 5000
Modification 500 1000 2500
More than 1 section Fresh 2000 5000 10000
Modification 1000 2500 5000
Blood Storage Centre 1000
General GMP 500 + 2500 1000 + 2500 (Insp fee)
(Insp fee)
Capacity certificate 500 + 2500 1000 + 2500 (Insp fee)
(Insp fee)
Performance 2000 (for 10 prod) 1000 for additional 10
certificate products
Free sale certificate 1000 (for 10 prod) 500 for additional 10
products
No conviction 1000
Any other certificate (Validity, Neutral Code) 1000
WHO GMP Fresh WHO-GMP 5000/- for each section
Certificate – Inspection fee
(Own)
Fresh WHO-GMP 2000/- for each section
Certificate – Inspection fee
(Loan)
Unit WHO-GMP Certificate 1000 for every 10 products
First time COPP with 1500/-
Annexure (with Validation
& Stability)
First time COPP (with 1000/-
Validation & Stability)
COPP with any type of 1000/-
Annexure
COPP (if WHO – GMP 500/-
Cert. or COPP already
granted)
Statement of Licensing 1000 for every 10 products
status
 STEPS FOR GRANT OF MANUFACTURING LICENCE BY
APPLICANT

APPLICANT APPLY FOR PASSWORD AND USER ID

THROUGH ONLINE SYSTEM

AFTER RECEIPT OF PASSWORD AND USER ID, APPLICANT

UPLOAD NECESSARY DOCUMENTS.

PAY PRESCRIBE FEES THROUGH GRAS SYSTEM

(GOVERENMENT RECEIPT ACCOUNTING SYSTEM)

AFTER PAYMENT OF FEES, THROUGH GRAS SYSTEM,

PRINT PAYMENT RECEIPT AND UPLOAD THE SAME IN
SYSTEM.

APPLICATION IS RECEIVED BY CONCERNED ASSISTANT

COMMISSIONER.
 ALLOTMENT OF APPLICATION.

AFTER RECEIPT OF APPLICATION, ASSISTANT

COMMISSIONER ALLOCATES IT TO THE CONCERN DRUGS
INSPECTOR.

INSPECTION STAGE.
AFTER RECEIPT OF APPLICATION AREA INSPECTOR
ALONG WITH CDSCO DRUGS INSPECTOR, JOINT
INSPECTION CARRIED OUT RELATED TO THE PREMISES
AND FACILITY.

VERIFICATION OF UPLOADED DOCUMENTS BY

INSPECTORS
 INSPECTOR MAKE ENTRIES RELATED TO INSPECTION
REPORT

INSPECTOR WILL FORWARD REPORT TO ASSISTANT

COMMISSIONER WITH RECOMMENDATION. ASSISTANT
COMMISSIONER WITH HIS REMARK AND
RECOMMENDATION FORWARD TO LICENSING
AUTHORITY FOR FURTHER ORDERS.

LICENSING AUTHORITY WILL VERIFY ENTRIES,

UPLOADED DOCUMENTS AND INSPECTION REPORT OF
INSPECTOR.

LICENSING AUTHORITY WILL MAKE NECESSARY

REMARKS REGARDING GRANT OR REJECTION OF
APPLICATION.

DRAFT COPIES OF LICENCES VERIFIED BY LICENSING

AUTHORITY BEFORE FINAL ORDER OF GRANT OR
REJECTION OF APPLICATION.
FINAL ORDER OF GRANT OR REJECTION OF APPLICATION
BY LICENSING AUTHORITY.

SYSTEM GENERATED SMS WILL FORWARD TO APPLIACNT

FINAL PRINT OUT OF LICENCES CAN TAKE OUT BY

APPLICANT WITH IN THREE DAYS FROM THE GRANT OF
LICENCES/ PERMISSION
Step 1. HOW TO OBTAIN LOGIN ID AND PASSWORD

Steps Action

1. Visit https://fda.maharashtra.gov.in/Home.aspx web site. Use Google Chrome OR

Mozilla Browser.

2. Click on XLN Manufacturing Website link on home page

3. Popup tab will take yu the site or alternatively you can visit
https://xlnindia.gov.in/login.aspx?ST=6j4eq4PwS%2fg%3d&XLNMFG=MFGweb site.

4. Click for Mfg ID & password.

5. Enter your firm’s details precisely & upload Company or Proprietor’s Pan
Card in JPEG File Format within file Size – 75 KB.
SELECT OWN OR LOAN AS APPLICABLE
6. Wait for 24 hrs to receive ID and password on the mobile number provided.

Approval of plan For Own Manufacturer.

(All documents which are to be uploaded should be in PDF format)

Hard copy is required to be submitted to office only once at initial stage. (Due to
logistic constraint for approved plan, Article of Association and Memorandum of
Association, Agreements, etc.)

S. No Document type Format Copy

1 Covering letter (with brief of Hard copy 01
company, categories of products, Soft copy 01
dosage forms proposed to
manufacture)
2 GRN generated by payment of fees Hard copy 01
through Soft copy 01
https://gras.mahakosh.gov.in/echallan/
Upload in MFW module.
3 Site Plan and layout of the building Hard copy 03
with name, address, scale, Soft copy 01
measurements of the Area as per (A4 size PDF)
Schedule- T requirement (For
Ayurvedic, Siddha, and Unani)& as
per Schedule- M requirement
(Allopathic Medicines)& as per
Schedule- M - II requirement (For
 Cosmetics)
4 Self attested copies of documents Hard copy 01
pertaining to the possession of Soft copy 01
premises such as, Register ownership
/rent / lease/ allotment letter/
Possession Letter, Tax
Receipt,(Documents should be
Registered with appropriate
Authority)
5 Consent to establish from Hard copy 01
Maharashtra Pollution Control Board. Soft copy 01
6 List of Directors, Partners, Trustees, Soft copy
along with AOA and MOA submitted
to ROC, LLP, HUF, Registered
Partnership deed, Trust deed, etc. (As
applicable)

Information of Directors, Partners, Trustees, proprietor should be in

Format as follows.
Sr Name Educational Designation PAN Residential Mob. Email Date
No. Qualification No. Address No. ID OF
&Adhar & Ph. Joining
No. No.

This format should be signed by responsible person and then it should be uploaded

DOCUMENTS FOR GRANT OF LICENCE

(All documents should be in PDF format)

S. No Document type Format

1 A) APPLICATION IN FORM 24 & 27 (FOR Soft copy
ALLOPATHIC MEDICINE)
B) APPLICATION IN FORM 24-B (FOR LICENCE TO Soft copy
REPACK)
APPLICATION IN FORM 24D (FOR AYUVERDIC Soft copy
MEDICINE)
APPLICATION IN FORM 31 (FOR COSMETICS) Soft copy
Application In Form 24c (For Homoeopathic Medicine) Soft copy
2 Challan Of Fees Paid To Be Upload In MFW Module Soft copy
3 Specific Power Of Attorney In FavorAuthorized Signatory Soft copy
For Submitting Application On Behalf Of The Company
4 List Of Competent Technical Staff, With Their Soft copy
Qualification, Registration, Experience, Previous FDA
Approvals, Etc. TO BE UPLOADED AT MFT MODULE
5 Appointment/Acceptance Letter Of Competent Technical Soft copy
Staff Of Manufacturing Section. TO BE UPLOADED AT
MFT MODULE

6 Appointment/Acceptance Letter Of Competent Technical Soft copy

Staff Of Testing Section. TO BE UPLOADED AT MFT
MODULE
7 Section Wise List Of Plant And Machineries Soft copy
8 Plan Layout Of The Premises Approved By The Licensing Soft copy
Authority
9 Consent To Establish & Consent To Operate From Soft copy
Maharashtra State Pollution Control Board.
10 Noc of Department Of Industrial Safety & Health Soft copy
11 Details Of Manufacturing Process, Process Flow Chart Soft copy
(For Bulk Drug)
12 AHU Installation And Validation Certificate (Wherever Soft copy
Necessary)
13 Water System Installation And Validation Certificate Soft copy
(Wherever Necessary)

DOCUMENTS FOR GRANT OF LICENCE FOR THE DRUGS

TO BE CERTIFIED BY CENTRAL LICENSING APPROVING
AUTHORITY
(FOR LVP/SERA & VACCINES/rDNA derived drugs)

S. No Document type Format

1 Application In Form 27 Soft copy
2 Challlan Of Fees Paid To Be Upload In MFW Module Soft copy
3 Copy Of Joint Inspection Report Along With Its Soft copy
Compliance
4 Specific Power Of Attorney In FavorAuthorized Signatory Soft copy
For Submitting Application On Behalf Of The Company
5 List Of Competent Technical Staff, With Their Soft copy
Qualification, Registration, Experience, Previous Fda
Approvals, Etc. To Be Uploaded At MFT Module
6 Appointment/acceptance letter of Competent Technical Soft copy
Staff of manufacturing section. TO BE Uploaded At MFT
Module
7 Appointment/acceptance letter of Competent Technical Soft copy
 Staff of testing section. To Be Uploaded At MFT Module
11 Section wise list of Plant and machineries Soft copy
12 Plan layout of the premises Approved by the Licensing Soft copy
Authority
13 Consent to establish & consent to operate from Soft copy
Maharashtra State Pollution Control Board.
14 NOC of Department Of Industrial Safety & Health Soft copy
15 Details Of Manufacturing Process, Process Flow Chart & Soft copy
Stability Data
16 Copy Of New Drug Permission In Form 46/46a Soft copy
17 AHU Installation And Validation Certificate Soft copy
18 Validated Water System Installation Certificate Soft copy

DOCUMENTS FOR GRANT OF LOAN LICENCE

S. No Document type Format
1 Application In Form 24A& 27AProforma-1/2/3/4/D (For Soft copy
Allopathic Medicine)
2 Application In Form 24E, Proforma- 1/2/3/4/D (For Soft copy
Ayuverdic Medicine) (A4 size PDF)
3 Application In Form 31A,Proforma- 1/2/3/4/D (For Soft copy
Cosmetics)
4 Challlan Of Fees Paid To Be Upload In MFW Module Soft copy
5 Specific Power Of Attorney In FavorAuthorized Signatory Soft copy
For Submitting Application On Behalf Of The Company
6 Details Of Manufacturing Process, Process Flow Chart Soft copy
(For Bulk Drug)
7 List Of Directors, Partners, Trustees, Along With ROC Soft copy
Copy Registered Partnership Deed, Trust Deed (As
Applicable)
8 Proof Of Establishment (For Allopathic Licence Copy In Soft copy
20B& 21B)

Information of Directors, Partners, Trustees, proprietor should

be in Format as follows.
Sr Name Educational Designation PAN Residential Mob. Email Date
No. Qualification No. & Address No. ID OF
Aadhar & Ph. Joining
No. No.

This format should be signed by responsible person and then it should be

uploaded
HOW TO GET USER ID & PASSWORD
Go to website Visit https://fda.maharashtra.gov.in/Home.aspx
preferably in Google chrome / Mozilla Firefox or internet explorer
version 8 and above. Popup blocker should be allowed.

Click on XLN Manufacturing Website link on home page

Popup tab will take yu the site or alternatively you can visit
https://xlnindia.gov.in/login.aspx?ST=6j4eq4PwS%2fg%3d&XLNM
FG=MFGweb site.

Click for Mfg ID & password.

Enter your firm’s details precisely & upload Company or Proprietor’s
Pan Card in JPEG File Format within file Size – 75 KB. SELECT
OWN OR LOAN AS APPLICABLE
Wait for 24 hrs to receive ID and password on the mobile number
provided.
HOW TO MAKE PAYMENT IN GRAS
1ST STEP
https://gras.mahakosh.gov.in

2ND STEP
Payment of fees - After every inward application wherever fees are
applicable, ‘make payment’ tab will appear after inward application is
completed. Click on this option. Then new window will appear click on
‘make a new payment’ tab. It will redirect to ‘Gras’ site of Government
of Maharashtra.

All the payments must be paid through GRAS SYSTEM ONLY

After paying the fees through GRAS, please fill all the details in the
following screen. The GRN number, amount paid should be very
accurately filled otherwise the payment will not be certified.
Then select as follows –
Department: Food & Drugs Administration
Payment Type: select menu e.g. Drugs sale Licence etc.
Scheme name: will come automatically
District: select district where Licence premises is existing
Office name: Select from drop down
Period (Year): current financial year and select – one time / adhoc
payment.
Form ID: write Licence Form No.
Then select the payment option from three radio buttons – i) e-payment,
ii) payment across the bank counter, iii) SBI payment gateway.

Fill all the details and take a printout of Challan. Use this Challan for
your Inward Application.
HOW TO ADD CHALLAN IN E-WALLET MODULE
Enter your login credentials

After logging in go to MFW tab

Click on Make a Payment

Click on button “new”, add details and save

AFTER E WALLET PAYMENT, APPLICATION CAN BE MADE
EITHER FOR NEW LICENCE OR ADDITIONAL PRODUCTS
OR FOR RETENSION OF LICENCES.
AFTER LOG IN,CLICK ON MFA, PLACE ON MENU BAR
CLICK ON PREPARE/EDIT ONLINE APPLICATION.

CLICK ON ADD NEW APPLICATION.

COMPLETE THE APPLICATION BY FILLING NECESSARY
INFORMATION ON CATEOGRY, INWARD TYPE, LICENCE
TYPE, APPLICATION REMARKS

SAVE THE INFORMATION.

CONFIRMATION OF APPLICATION.

UNDERTAKING/ CHECK LIST

UNDERTAKING

ESIGN
GO TO APPLICATION AGAIN

ENTER THE PRODUCT / CATEGORIES DETAILS

 SAVE THE INFORMATION.

ENTER COMPOSITIONS AND UPLOAD METHOD OF ANALYSIS

CHECK THE FEES AND ENTER RELEVANT REMARKS
ESEND THE APPLICATION
APPLICATION IS RECEIVED BY CONCERNED AREA
ASSISTANT COMMISSIONER.

Note. Query is raised by Inspector or / and Licensing

Authority/ Assistant Commissioner in case of incomplete /
inadequate information. Applicant receives the application
back along with an SMS. Application should be resubmitted
by taking corrective actions by the Applicant.
ALLOTMENT OF APPLICATION.
AFTER RECEIPT OF APPLICATION, ASSISTANT
COMMISSIONER ALLOCATES IT FOR INSPECTION TO THE
DRUGS INSPECTOR.
INSPECTION STAGE

AFTER RECEIPT OF APPLICATION, AREA INSPECTOR

CARRIES OUT INSPECTION / JOINT INSPECTION FOR
GRANT OF NEW LICENCE OR ADDITIONAL PRODUCT
FOR VERIFICATION OF THE REQUIREMENTS AS PER
PROVISIONS OF RULES SUCH AS INFRASTRUCTURE,
STAFF, FACILITY, DOCUMENTATION, ETC. IN CASE OF
NON COMPLIANCES QUERY IS RAISED TO
MANUFACTURER FOR CORRECTIVE ACTION AND
SUBMISSION OF COMPLIANCE REPORT.

PROCESSING BY DRUGS INSPECTOR

SELECT APPLICATION IN CHRONOLOGICAL ORDER (RED
MARK APPLICATION TO BE DISPOSED OFF ON PRIORITY
BASIS)
INSPECTOR SCRUTINISES APPLICATION FOR APPLIED
PRODUCTS, LICENCE DETAILS, STAFF,
MANUFACTURING FACILITY, ETC.
SUBMMISSION OF APPLICATION WITH REMARKS AND
RECOMMENDATION TO ASSISTANT COMMISSIONER.

BEFORE SENDING APPLICATION TO ASSISTANT

COMMISSIONER, INSPECTOR HAS TO e-sign THE
APPLICATION
AFTER RECEIPT OF APPLICATION FROM ASSISTANT
COMMISSIONER, LICENSING AUTHORITY MAKES FINAL
DECISION ON THE SAID APPLICATION
 PRODUCT PERMISSION / APPLICANT DETAILS,
UPLOADED DOCUMENTS CAN BE VERIFIED, BEFORE
GRANT

REMARKS OF LICENSING AUTHORITY

FINAL ORDER OF LICENSING AUTHORITY REGARDING
GRANT OR REJECTION OF APPLICATION.
PRINTING OF LICENCE/ PERMISSION/
CERTIFICATES BY APPLICANT
---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

After grant or rejection of application, applicant will receive an SMS

about the same.Take a print out of the approval / rejection from MFR
and ‘certificate / permit printing’ option for new Licence and retention,
product permission, certificates within three days. Applicant will
receive Licences /approvals with the valid e-signature and official seal.
COVERING LETTER AND LICENCE WITH AADHAAR
AUTHENTICATED eSIGNATURE OF LICENSING
AUTHORITY HAVING THIRD PARTY APPROVAL
VERIFICATION (TPAV) NUMBER.