8.
Reimbursement of expenditure
incurred by exporters on
statutory compliances
i. Registration
charges paid in
case of
pharmaceuticals,
bio-technology,
chemicals/ agro-
chemicals,
agricultural/
animal/marine
products, food
products, etc.;
ii.
Expenses made for
carrying out clinical
trials; data
validation etc., for
pharmaceutical
products,
equipments,
medical
consumables/
disposables, etc.;
iii.
Filing charges for
market access in
specified markets
in respect of Drug
Master File (DM F)
and Abbreviated
New
Drug
Ceiling:
Rs.2
crore
per
exporter per
annum
Sharing
Pattern:
50% : 50%
Application (ANDA)
filing;
iv.
Bio
equivalence
studies in India for
pharmaceutical
exports;
v.
Filing of Patent and
Capacity building /
training related to
patent filing in
respect of
pharmaceutical
products;
VI
.
Testing charges of
Engineering
products (limited to
products indicated
in FTP against EEPC
India) which
require mandatory
testing abroad for
exports;
VII
.
Plant Inspection
Charges for the
Pharmaceutical
products;
Vii .
Charges incurred
by small scale
exporters [below
f.o.b. value of
exports of Rs. 30
crores] on bar-
coding of export.
Expenditure limited
to a maximum of
Rs. 25 lakhs per
exporter;
ÏX . Fees paid for
Quality Certification
required for natural/
Products
(Herbal,
AYUSH
products,
Dietary
Supplement,
Nutraceuticals);
X. Cosmetics products
would also be
eligible for
reimbursement
of
registration
charges;
XÏ. Data generation /
letter of access
cost, including
study cost, data
purchase cost,
research
on
existing data, data
evaluation cost,
consultancy cost,
study monitoring
cost, etc. for
chemicals / agro
chemicals /
cosmetics
products;
Xii . Testing charges in
respect of testing
done in India for
export
of
engineering
products;
Xii
.
Regulatory
requirements for
Services Sector;
XiV . Any other specific
component
approved by the
Empowered
Committee.
Note: The exporter
desirous of getting
reimbursement must
submit evidence of the
payment having made and
claim forms duly filled and
complete in all respect to
the concerned EPC/ FIEO
within 90 days of receipt of
product
certificate.
