general instructions to applicants for licence for manufacturing...
TRANSCRIPT
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 Form
Lic Form
Fresh Appl Renewal Appl Late Fee / month
Duplicate Copy fee
Addl Prod /
Drug Lic Fee
Insp Fee Lic Fee
Insp Fee
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 (Sch C &
C1)
4500 4500 3000 4500 (for Addl
category ) 36
37 (Other than C &
C1)
2700 2700 1500 2700 (for Addl
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
renewal) per year 20
Poisons Licence 500 Blood Storage Centre Approval 2000 (for WHB) + 200 (per product) Competent Person Approval
Interview 1000
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
(Insp fee) 1000 + 2500 (Insp fee)
Capacity certificate 500 + 2500 (Insp fee)
1000 + 2500 (Insp fee)
Performance certificate
2000 (for 10 prod) 1000 for additional 10 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
Certificate – Inspection fee (Own)
5000/- for each section
Fresh WHO-GMP Certificate – Inspection fee (Loan)
2000/- for each section
Unit WHO-GMP Certificate 1000 for every 10 products First time COPP with
Annexure (with Validation & Stability)
1500/-
First time COPP (with Validation & Stability)
1000/-
COPP with any type of Annexure
1000/-
COPP (if WHO – GMP Cert. or COPP already granted)
500/-
Statement of Licensing status
1000 for every 10 products
Step 1. HOW TO OBTAIN LOGIN ID AND PASSWORD.
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
company, categories of products, dosage forms proposed to manufacture)
Hard copy Soft copy
01 01
2 GRN generated by payment of fees through https://gras.mahakosh.gov.in/echallan/ Upload in MFW module.
Hard copy Soft copy
01 01
3 Site Plan and layout of the building with name, address, scale, measurements of the Area as per Schedule- T requirement (For Ayurvedic, Siddha, and Unani) & as per Schedule- M requirement (Allopathic Medicines) & as per Schedule- M - II requirement (For Cosmetics)
Hard copy Soft copy (A4 size PDF)
03 01
4 Self attested copies of documents pertaining to the possession of premises such as, Register ownership / rent / lease / allotment letter / Possession Letter, Tax Receipt, (Documents should be Registered
Hard copy Soft copy
01 01
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 .
with appropriate Authority) 5 Consent to establish from
Maharashtra Pollution Control Board. Hard copy Soft copy
01 01
6 List of Directors, Partners, Trustees ,along with ROC Copy Registered Partnership deed, Trust deed (As applicable)
Soft copy
Information of Directors, Partners, Trustees, proprietor should be in Format as follows.
Sr No.
Name Educational Qualification
Designation PAN No. & Adhar No.
Residential Address
Mob. No. & Ph. No.
Email ID
Date OF Joining
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
ALLOPATHIC MEDICINE) Soft copy
B) APPLICATION IN FORM 24-B (FOR LICENCE TO REPACK)
Soft copy
APPLICATION IN FORM 24D (FOR AYUVERDIC MEDICINE)
Soft copy
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 For Submitting Application On Behalf Of The Company
Soft copy
4
List Of Competent Technical Staff, With Their Qualification, Registration, Experience, Previous FDA Approvals, Etc. TO BE UPLOADED AT MFT MODULE
Soft copy
5 Appointment/Acceptance Letter Of Competent Technical Staff Of Manufacturing Section. TO BE UPLOADED AT MFT MODULE
Soft copy
6 Appointment/Acceptance Letter Of Competent Technical Staff Of Testing Section. TO BE UPLOADED AT MFT MODULE
Soft copy
7 Section Wise List Of Plant And Machineries Soft copy
8 Plan Layout Of The Premises Approved By The Licensing Authority
Soft copy
9 Consent To Establish & Consent To Operate From Maharashtra State Pollution Control Board.
Soft copy
10 Noc Of Department Of Industrial Safety & Health Soft copy 11 Details Of Manufacturing Process, Process Flow Chart
(For Bulk Drug) Soft copy
12 AHU Installation And Validation Certificate (Wherever Necessary)
Soft copy
13 Water System Installation And Validation Certificate (Wherever Necessary)
Soft copy
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
Compliance Soft copy
4 Specific Power Of Attorney In Favor Authorized Signatory For Submitting Application On Behalf Of The Company
Soft copy
5 List Of Competent Technical Staff, With Their Qualification, Registration, Experience, Previous Fda Approvals, Etc. To Be Uploaded At MFT Module
Soft copy
6 Appointment/acceptance letter of Competent Technical Staff of manufacturing section. TO BE Uploaded At MFT Module
Soft copy
7 Appointment/acceptance letter of Competent Technical Staff of testing section. To Be Uploaded At MFT Module
Soft copy
11 Section wise list of Plant and machineries Soft copy 12 Plan layout of the premises Approved by the Licensing
Authority Soft copy
13 Consent to establish & consent to operate from Maharashtra State Pollution Control Board.
Soft copy
14 NOC of Department Of Industrial Safety & Health Soft copy 15 Details Of Manufacturing Process, Process Flow Chart &
Stability Data Soft copy
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
Allopathic Medicine) Soft copy
2 Application In Form 24E, Proforma- 1/2/3/4/D (For Ayuverdic Medicine)
Soft copy (A4 size PDF)
3 Application In Form 31A, Proforma- 1/2/3/4/D (For Cosmetics)
Soft copy
4 Challlan Of Fees Paid To Be Upload In MFW Module Soft copy 5 Specific Power Of Attorney In Favor Authorized Signatory
For Submitting Application On Behalf Of The Company Soft copy
6 Details Of Manufacturing Process, Process Flow Chart (For Bulk Drug)
Soft copy
7 List Of Directors, Partners, Trustees ,Along With ROC Copy Registered Partnership Deed, Trust Deed (As Applicable)
Soft copy
8 Proof Of Establishment (For Allopathic License Copy In 20B & 21B)
Soft copy
Information of Directors, Partners, Trustees, proprietor should be in Format as follows.
Sr No.
Name Educational Qualification
Designation PAN No. & Adhar No.
Residential Address
Mob. No. & Ph. No.
Email ID
Date OF Joining
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
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