DOCUMENTS / INFORMATION REQUIRED FOR GRANT OF DRUG

MANUFACTURING LICENSE.
i). Properly filled in application on prescribed Form-1 along-with pro-forma and all
other required documents as per schedule A of the Drugs (Licensing, egistering
! Ad"ertising) ules #$%&. 'he prescribed FORM-1 see Drugs (Licensing,
egistering ! Ad"ertising) ules #$%& is reproduced as below(-
FORM-1
#. )*we +++++ of +++++++hereby apply for the grant of a license to
manufacture Drugs by way of++++++.on the premises situated at
+++++++++.
,. 'he drug (s) or class (es) of drugs intended to be manufactured( -
()) -lass (es) of drugs
())) Dosage form(s) of drugs.
()))) .ame of drug (s).
/. ) enclose( -
i. Particulars regarding legal status of the applicant (i.e. in case of
Proprietorship the name(s) of proprietors and their address(es), in case of
firm the name and names and addresses of its partners and in the case of
company the name and address of the company and its directors).
ii. Details of the premises including layout plan of the factory.
iii. Details of the section-wise equipment and machinery for manufacture and
quality control.
iv. .ames and qualifications of the Production )n-charge and 0uality -ontrol
)n-charge for super"ising manufacturing processes and 0uality -ontrol
Department, and other technical staff wor1ing in these departments.
2. 'he premises and plant will be ready for inspection on ++++++.. or are
ready for inspection.
Dated+++++++++ 3igned++++++++++++
Place +++++++++ .ame, Designation ! Address++..
ii). Pro-forma as per abo"e referred 3chedule A.
iii). -opy of -hallan of 4ee in original duly retained by 3tatistical 5fficer DAP as
per following schedule to be deposited under the following head of account
A/C No. 0010008!"-100018 A##i$% &a'( Limi)$%
i. 4ee of s. #66,666*- for 7rant of D8L by way of 4ormulation.
ii. 4ee of s. /6,666*- for 7rant of D8L by way of 9asic and 3emi 9asic
4ormulation.
iii. 4ee of s. &6,666*- for 7rant of D8L by way of epac1ing.
i". 4ee of s. :,666*- per Drugs specified in 3chedule D for repac1ing.
i"). All documents submitted should be duly attested.