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| Grant of Drug and Cosmetic Manufacturing License 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.
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| Procedure to obtain Drug Manufacturing licence (Fresh) |
Stage 1
- 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 a copy is given to
the Applicant.
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Down Load
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 |
| 104 - 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 .
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Stage3
| Inspection |
| The application is scrutinized and premises inspected. |
Stage 4
| Grant of Licence |
| If all conditions as prescribed by the act are complied license
is granted |
| Procedure to Renew Drug Manufacturing licence |
| Licenses 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.
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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 license
is granted |
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