Document Version- Mfg-01

General Instructions to applicants for Licence for manufacturing

of Drugs and Cosmetics through xlnindia.gov.in

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. The licensing authority may ask for any other specific documents if
required.
5. These guidelines are subject to change as and when required and will be
updated from time to time .
6. Every application needs to be ‘e-send’, or it will not be forwarded to the
office.
7. Except in case of death of proprietor, If there is change in proprietor, it
will not be treated as ‘change in constitution’. Applicant will have to
obtain a fresh license.
8. These are only guidelines. The provisions of Drugs and Cosmetic Act
1940 and Rules 1945 will always prevail.
9. Fees for Licence is as per table given below
 Fees applicable in the State of Maharashtra

Appl Lic Fresh Appl Renewal Appl 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
Step 1. HOW TO OBTAIN LOGIN ID AND PASSWORD.

Steps Action

1 Visit www.xlnindia.gov.in web site. Use Google Crome OR Mozilla Browser.

2 Click on MFG Login . Then Click for Mfg ID & password.

3 Enter your firm’s details precisely & upload Company Pan Card or
Authorized Person Pan Card in JPEG File Format Size – 75 KB.
SELECT OWN OR LOAN AS APPLICABLE
4 Wait for 24 hrs.

5 If you do not receive User ID & password contact area local office or officer .

Approval of plan For Own Manufacturer.

(All documents should be in PDF format)

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 ROC Copy Registered
Partnership deed, Trust deed (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 Favor Authorized 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 Favor Authorized 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 & 27A Proforma-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 Favor Authorized 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 License 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
Adhar Ph. Joining
No. No.

This format should be signed by responsible person and then it should be uploaded
HOW TO MAKE PAYMENT IN GRAS

1ST STEP

https://gras.mahakosh.gov.in

2ND STEP
3RD STEP

4TH STEP
5TH STEP

6TH STEP
HOW TO CREATE USER ID

http://xlnindia.gov.in/

1ST STEP

2ND STEP
3RD STEP

HOW TO ADD CHALLAN IN E-WALLET MODULE

1ST STEP

Visit to http://xlnindia.gov.in
2ND STEP

(USER ID & PASSWORD ENTER WITH CAPITAL)

3RD STEP
4TH STEP

5TH STEP
6TH STEP