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Tuesday, 07-Sep-2010
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 Grant of Licence to manufacture drugs for purposes of
   examination, test analysis


Food and Drug Administration M.S. grants Licence to manufacture drugs for purposes of examination,test analysis in Form 29.

Procedure to obtain Licence to manufacture drugs for purposes of examination, test analysis. (Fresh)

Stage 1

Application for grant of Licence to manufacture drugs for purposes of examination, test analysis.

The applicant has to make application in the requisite Form 30 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 -----

210 - 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 layout plan of the area (incase of applicants applying for the first time).

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

  • 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.

  • Details of the product.
    For drug composition of which the drug is not generally recognized a No objection certificate from the Drug Controller General India.

Download

Application Form 30
Details of Fees Appendix A

Stage 2

Scrutiny of application and if required premises inspected.

Stage 3

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

Procedure to Renew Licence to manufacture drugs for purposes of examination, test analysis.

Licences in Forms 29 can be renewed

Stage 1

Application for grant of Licence to manufacture drugs for purposes of examination, test analysis.

The applicant has to make application in the requisite Form 30 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.

Stage 2

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

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