https://fda.maharashtra.gov.in/guidelinesown.

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Grant of Drug and Cosmetic Manufacturing Licence in Own Premises

 Food and Drug Administration M.S. Grants Own Manufacturing Licences for Drugs (Allopathy,
Homoepathy, Ayurvedic, Siddha,Unani ) and Cosmetics in Forms 25, 28, 25B, 25C,25D and 32
 The Administration also grants Licences for Blood & Blood products Vaccines & Sera in Form 28C &
28D. However the said Licences have also to be approved by Central Licensing Approving Authority
i.e. Drug Controller General of India.

Procedure to obtain Drug Manufacturing Licence (Fresh)

Stage 1

Approval of Layout Plan

 For Approval of Lay out Plan the Applicant has to submit 3 Blueprint copies of plan to the concerned
Licensing Authority.(in case of Licenses for Blood Products and Vaccines Sera 4 Blue print copies of
plan to be submitted)
 The plan should be as per the requirements prescribed for manufacturing premises in the Drugs and
Cosmetics Act 1940.
 The prescribed requirements as per the Act for Layout plan are given in the checklist.
 The plan is scrutinized by panel of officers as per the requirements of the Drugs and Cosmetics Act
1940.
 If necessary the premises is inspected by the concerned Inspector before plan Approval.
 Finally after scrutiny and compliance as per requirements of the Act the layout plan is approved and
two copies are given to the Applicant.

Down Load

Check List for Layout of Plan Approval Allopathic Drugs

Check List for Layout of Plan Approval Medical Devices

Check List for Layout of Plan Approval Ayurvedic Drugs

Check List for Layout of Plan Approval Cosmetics

Stage 2

Application for grant of Own Manufacturing Licence

The applicant has to make application in the requisite Form (24,24B,24C,27,27C,27D) and pay Necessary
fees as given in Appendix A.

Fee can be paid in cash at Head Office/Division as well as any other District Officer.The fee can also be paid
through challan at Government Treasury, Reserve bank of India, State Bank of India and State Bank of
Hyderabad for Maratha Wada Region under Head Account-----

0210 - Medical and Public Health.

04 - Public Health
04 - Fees and Fines, etc.

Documents to be attached along with the application form:

 Receipt for the fees paid or challan, (the fees are as given in Appendix A) as the case may be or
their attested copies.

 Copy of Approved layout plan of the manufacturing area.

 Documents viz. Rent receipt, purchase documents or its attested copies showing lawful possession
of the premises

 List of machinery and equipments.

 Documents relating to the constitution of the firm viz. Partnership-deed, memorandum and article
of association etc.

 Full particulars of the competent technical staff employed for manufacturing and testing of drugs
and cosmetics along with copies of their educational qualifications and experience certificates
approval letter as competent staff. The competent technical staff is required to furnish consent
letter for full time employment with the applicant firm.

 List of Drugs Cosmetics in triplicate along-with undertaking to be submitted.

 In case, the application is for the products covered under Schedule C and C (I) category, then the
details of stability data is required.

 If the products are covered under ‘Patent and Proprietary’ definition, then the two copies of
methods of Analysis of the products be supplied.

 Full name of the proprietor or the partners, as the case may be shall be provided in the application.
In case of private or public limited concerns, full name of the Directors who sign the application and
the authorized signatory, if any, shall be provided in the application .

Stage3

Inspection

The application is scrutinized and premises inspected.

 Stage 4

Grant of Licence

If all conditions as prescribed by the act are complied licence is granted

Down Load

Application Forms 24 , 24B , 24C , 24D, 27 , 27C , 27D ,31

Details of Fees Appendix A

Procedure to Renew Drug Manufacturing Licence

Licences in Forms 25, 25B, 25C,25D, 25F, 28, 28B,28C,28 D can be renewed.

Stage 1

Application for grant of Own Manufacturing Licence

The applicant has to make application in the requisite Form ( 24, 24B, 24C, 27, 27C, 27D)and pay necessary
fees as given in fee chart in Appendix A .

The mode of payment of fees is same as fresh licence.

Documents to be enclosed along with application of renewal of licence :-

 Copy of cash receipt or challan for payment of fees.

 Xerox copy of Licence /Previous renewal certificate.

 Xerox copy of the list of Drugs previously approved.

 List of Drugs along with names of proprietary medicines and dates of its approval (two copies).

 Full particulars of the competent technical staff appointed for

 manufacturing and testing along with their educational qualification and experience certificates.

Stage 2

Inspection

The application is scrutinized and premises inspected.

Stage 3

Grant of Licence

If all conditions as prescribed by the act are complied licence is granted