2023-04-25T05:11:42
SIXTH SCHEDULE
(See rules 21, 22, 33, 34, 45, 47, 52, 53, 60, 67, 68, 75, 76, 80, 81, 86, 91, 97 and 98)
FEE PAYABLE FOR LICENCE, PERMISSION AND REGISTRATION
CERTIFICATE
S.No. Rule Subject In rupees Indian
National Rupee
(INR) except where
specified in dollars
($)
01 21
Application for permission to conduct
clinical trial
(i) Phase I 3, 00, 000
(ii) Phase II 2, 00, 000
(iii)Phase III 2, 00, 000
(iv) Phase IV 2, 00, 000
02 22
Reconsideration of application
for
permission to conduct clinical trial
50, 000
03 33 Application for permission to conduct
bioavailability or bioequivalence study 2, 00, 000
04 34
Reconsideration of application of
permission to conduct bioavailability or
bioequivalence study
50, 000
05 45
Application for registration of
Bioavailability and bioequivalence
study
centre
5, 00, 000
07 47
Reconsideration of application
for
registration of bioavailability and
bio- equivalence study centre
1, 00, 000
08
52 Application for permission to
manufacture new drugs or
investigational new drugs for clinical
trial or bioavailability or bioequivalence
study
5000 per
product
09 53
Reconsideration of application to
manufacture new drugs or
investigational new drugs for clinical
trial or bioavailability or bioequivalence
study
2000 per
product
10 59
Application for permission to
manufacture unapproved active
pharmaceutical ingredient for
development of formulation for test or
analysis or clinical trial or
bioavailability or bioequivalence study
5000 per
product
This is a controlled document. Unauthorized access, copying and replication are prohibited. This document must not
be copied in whole or part by any means, without the written authorization of CDSCO.
11 60
Reconsideration of permission
to manufacture unapproved active
pharmaceutical ingredient for
development of formulation for test or
analysis or clinical trial or
bioavailability or bioequivalence study
2000
12 67
Application for import of new drugs or
investigational new drugs for clinical
trial or bioavailability or bioequivalence
study or for examination, test and
analysis
5000 per
product
13 68
Reconsideration of application for
Import of new drugs or investigational
new drugs for clinical trial or
bioavailability or bioequivalence study
or for examination, test and analysis
1000
14
75
Application for permission to import
new drug (Finished Formulation) for
marketing
5, 00, 000
15
Application for permission to import
new
drug (Finished Formulation)
already
approved in the country for marketing
2, 00, 000
16
Application for permission to import
new drug (Active Pharmaceutical
Ingredient) for marketing
5, 00, 000
17
Application for permission to import
new
drug (Active Pharmaceutical
Ingredient)
already approved in the country for
marketing
2, 00, 000
18
Application for permission to
import
approved new drug for new claims, new
indication or new dosage form or new
route of administration or new strength
for marketing
3, 00, 000
19
Application for permission to import
fixed dose combination having one or
more of the ingredients as unapproved
new molecules for marketing
5, 00, 000
20
Application for permission to import
fixed
dose combination having
approved
ingredients for marketing
4, 00, 000
21
Application for permission to import
fixed
dose combination already approved for
2, 00, 000
This is a controlled document. Unauthorized access, copying and replication are prohibited. This document must not
be copied in whole or part by any means, without the written authorization of CDSCO.
marketing
22
Application for permission to import
fixed dose combination for new claims,
new indication or new dosage form or
new route of administration or new
strength for marketing
3, 00, 000
23
76 Reconsideration of application
for
permission to import new drug for
marketing
50, 000
24
80
Application for permission to
manufacture new drug (Finished
Formulation or Active Pharmaceutical
Ingredient) for sale or distribution
5, 00, 000
25
Application for permission to
manufacture
new drug (Active Pharmaceutical
Ingredient) already approved in the
country for sale or distribution
2, 00, 000
26
Application for permission to
manufacture new drug (Finished
Formulation) for sale or distribution
5, 00, 000
27
Application for permission to
manufacture new drug (Finished
Formulation) already approved in the
country for sale or distribution
2, 00, 000
28
Application for permission to
manufacture
new drug (Active Pharmaceutical
Ingredient) for sale or distribution
5, 00, 000
29
Application for permission to
manufacture
new drug (Active Pharmaceutical
Ingredient) already approved in the
country for sale or distribution
2, 00, 000
30
Application for permission to
manufacture approved new drug for
new claims, new indication or new
dosage form or new route of
administration or new strength for sale
or distribution
3, 00, 000
31
Application for permission to
manufacture fixed dose combination
having one or more of the ingredients as
unapproved new molecules for sale or
distribution
5, 00, 000
This is a controlled document. Unauthorized access, copying and replication are prohibited. This document must not
be copied in whole or part by any means, without the written authorization of CDSCO.
35
80
Application for permission to
manufacture
new drug (Active Pharmaceutical
Ingredient) or to manufacture finished
formulation
5, 00, 000
36
Application for permission to import or
to manufacture phyto-pharmaceutical
drugs
2, 00, 000
37 81 Reconsideration of application for
permission to manufacture new drug for
sale or distribution
50, 000
38 86 Application for Import of unapproved
new
drug by Government hospital and
medical institution
10, 000
39 91 Application for permission to
manufacture unapproved new drug but
under clinical
trial, for treatment of patient of life
threatening disease
5, 000
40 98 Pre-submission meeting 5, 00, 000
41 99 Post-submission meeting 50000
42 -
Any other application which is not
specified above 50000
Note 1: No fee shall be chargeable in respect of application for conduct of clinical trial for
orphan drugs as defined in clause (x) of rule 2.
Note 2: In case of application received from Micro Small Medium Enterprises (MSME) firms
for conduct of clinical trial, approval of new drug and pre and post submission meeting, the
fee payable shall be half of the fee specified above.
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