[FORM
27D
(See
rule
75)
Application
for grant or renewal of a licence to manufacture for sale
or
for distribution of Large Volume Parenterals/Sera and Vaccines
excluding
those specified
in Schedule X
1. I/We of
hereby apply for grant/renewal of a
licence to manufacture for sale or
distribution on the premises situated
at
..
the under-mentioned Large Volume Parenterals/Sera and
Vaccines, specified in Schedules C and C(1) to the Drugs and Cosmetics Rules,
1945.
2. Name(s) of
drug(s)
(each item to be separately
specified).
3. The name(s), qualifications and
experience of the competent technical staff responsible for
the manufacture of the above mentioned drugs.
(a) Name(s) of staff responsible for testing......
(b) Name(s) of staff responsible for manufacturing.....................
4. The premises and
plant are ready for inspection/will be ready for inspection
on
5. A fee of
rupees and
an inspection fee of rupees
has been credited to the Government under the Head of
Account.........
Date:
.......... .................... Signature......
Designation.
*Delete
whichever is not applicable.
Notes:
1. The
application is to be accompanied by a plan of the premises, list of machinery
and
equipment to be employed for manufacture and testing, memorandum of
association/constitution
of the firm, copies of qualification
and experience of competent
technical staff and documents relating to ownership or tenancy of the
premises.
2.
A
copy of the application together with the relevant enclosures shall also be sent
each
to the Central Licence Approving Authority and concerned Zonal/Sub-Zonal Officers
of Central Drugs Standard Control Organization].
_______________________________________________________________
1.
Ins. by. G.S.R.119(E), dt. 11-3-1996.