FDA Maharashtra
 
Tuesday, 07-Sep-2010
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 Guidelines for Grant of Licenses as per NDPS Act 1985 and
   Maharashtra NDPS Rules 1985.


Food and Drug Administration M.S. grants Licenses as per NDPS Act 1985 and Maharashtra NDPS Rules 1985 as mentioned below.

Licences

NDPS-I :- Licence for the manufacture ,possession and sale ,otherwise than on prescription of manufactured drugs by dealers.

NDPS-II :- Licence for the possession and sale ,on prescription of manufactured drugs by chemist , and medical practitioners.

Procedure to obtain  NDPS-I & NDPS-II Licence

Stage I

Application for grant of licence NDPS I & II

The applicant has to make application in the prescribed proforma. The applicant has to pay fee of Rs 40/-.

Fee can be paid in cash at Head Office/Division as well as any other District Office. 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 :

  • Receipt for the fees paid or challan.

  • Covering letter.

  • Application in prescribed format.

  • Documents pertaining to legal possession of premises.

  • Documents pertaining to educational qualifications.

  • Documents pertaining to experience.
Stage 2

Scrutiny

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

Down Load
Prescribed Application Form


Procedure to renew Licence

NDPS I & II licence can be renewed.

Stage 1

Application

The applicant has to make application in the prescribed proforma. The applicant has to pay fee of Rs 40/-.The mode of payment of fees is same as fresh approval.

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

  • Receipt for the fees paid or challan.

  • Covering letter.

  • Application in prescribed format.

  • Documents pertaining to legal possession of premises.

  • Documents pertaining to educational qualifications.

  • Documents pertaining to experience.

  • Xerox copy of previous licence .

Stage 2

Scrutiny

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

Down Load
Prescribed Application Form

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