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| Grant of Drug and Manufacturing License in Loan Premises. |
| Food and Drug Administration M.S. Grants Manufacturing Licences for Drugs (
Allopathy, Ayurvedic, Siddha, Unani ) and Cosmetics to be carried out in
Loan premises in Forms 25,A 28A, 25E and 32 A
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| Procedure to obtain Drug Manufacturing licence(Fresh) in Loan Premises |
Stage 1
| Application
for grant of Loan Manufacturing Licence |
| The applicant has to make application in the requisite
application form in Form 24A , 27A, 24E respectively and pay Necessary fees as given in fee chart 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 of payment of Fees.
- Documents such as partnership-deed, Memorandum and Articles of Association.
- List of Drugs/Cosmetics to be manufactured in duplicate.
- Copy of the letter written to the manufacturer whose premises, machinery equipments are to be taken on loan.
- Copy of consent letter of the manufacturer who gives his premises, Machinery and
equipments on loan. Labels and cartons of the Drugs to be manufactured.
- In case, the application is for the products covered under C and C (1) category,
then the details of stability data are required.
- If the products are covered under ‘Patent and Proprietary’ definition,
then the two Copies of methods of Analysis of the products be supplied.
- Additional Information in Appendix (F) .
Stage2
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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| Procedure to Renew Drug Manufacturing
licence in loan premises |
| Licenses in Forms 25A, 28A, 25E can be renewed. |
Stage 1
| Application for renewal of Loan Manufacturing Licence |
The applicant has to make application in the requisite
form( 24A,27A,24E) 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
- Copy of the letter written to the own licence whose manufacturing capacity is
decided to be utilised on loan.
- Copy of the consent letter of the own licencee who has agreed to give his
manufacturing capacity to be utilised on loan.
- Label, cartons of all the drugs to be manufactured.
- Additional Information in Appendix (F).
Stage 2
Inspection
| The application is scrutinized and premises inspected . |
Stage 3
| If all conditions as prescribed by the act are complied license is granted |
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