FORM
8
Application for licence to import
drugs (excluding those specified
in Schedule X) to the Drugs and
Cosmetics Rules, 1945.
FORM
8-A
Application for licence to import
drugs specified in Schedule X
to the Drugs and
Cosmetics Rules, 1945.
FORM
9
Form of undertaking to accompany
an application for an import licence
FORM
10
Licence to import drugs (excluding
those specified in Schedule X)
to the Drugs and Cosmetic Rules,
1945
FORM
10-A
Licence to import drugs specified
in Schedule X to the Drugs and
Cosmetic Rules, 1945
FORM
11
Licence to import drugs specified
in Schedule X to the Drugs and
Cosmetic Rules, 1945
FORM
11-A
Licence to import drugs by a Government
Hospital or Autonomous
Medical Institution for the treatment
of patients
FORM
12
[See Rule 34]
Application for licence to import
drugs for
purpose of examination, test or
analysis
FORM
12-A
Application for the issue of a
permit to
import small quantities of drugs
for personal use
FORM
12-AA
Application for licence to import
small quantities of new drugs
by a Government
Hospital or Autonomous Medical
Institution for the treatment
of patients.
FORM
12-B
Permit for the import of small
quantities of drugs for personal
use.
FORM
40
Application for issue of Registration
Certificate for import of drugs
into India
under the Drugs and Cosmetics
Rules, 1945.
FORM
41
Registration Certificate to be
issued for import of drugs into
India
under Drugs and Cosmetics Rules,
1945.
"FORM
8
(See rule 24)
Application for licence to import
drugs (excluding those specified
in Schedule X) to the Drugs and
Cosmetics Rules, 1945.
--------
*
I / we _______________________________________________,
(full address with telephone number,
fax number and e-mail address)
hereby apply for a licence to
import drugs specified below manufactured
by M/s __________________________________
(full address with telephone no,
fax and e-mail no.)
2. Names of the
drugs to be imported:
(1)
(2)
(3)
*
3 I/we _______________________________________________enclose
herewith an undertaking in Form
9 dated ____________ signed by
the manufacturer as required by
rule 24 of the Drugs and Cosmetics
Rules, 1945.
4. I/we _______________________________________________enclose
herewith a copy of Registration
Certificate concerning the drugs
to be imported in India, issued
under Form 41 of the rules, vide
Registration Certificate No __________________________
Dated______________ issued through
M/s_______________________________________________
(name and full address _____________________________________________
valid upto _________________.
5. I/we _______________________________________________
hold a valid wholesale licence
for sale or distribution of drugs
or valid licence to manufacture
drugs, under the provisions of
the Act and rules made thereunder.
A copy of the said licence is
enclosed.
6. A fee of_______________
has been credited to Government
under the Head of Account "0210
- Medical and Public Health, 04-
Public Health,104- Fees and Fines"
under the Drugs and Cosmetics
Rules, 1945 - Central vide Challan
No.____________, dated ____________
(attachedin original ).
Signature ______________________
Name _________________________
Designation _____________________
Seal/Stamp of Manufacturer's agent
in India
Place: ______________
Date: ______________
" delete whichever is not
applicable;'
FORM
8-A
(See rule 24)
Application for licence
to import drugs specified
in Schedule X to the Drugs
and Cosmetics Rules, 1945.
|
*
I / we _______________________________________________,
(full address with telephone number,
fax number and e-mail address)
hereby apply for a licence to
import drugs specified below manufactured
by M/s __________________________________
(full address with telephone no,
fax and e-mail no.)
2. Names of the
drugs to be imported:
(1)
(2)
(3)
3 I/we _______________________________________________enclose
herewith an undertaking in Form
9 dated ____________ signed by
the manufacturer as required by
rule 24 of the Drugs and Cosmetics
Rules, 1945.
*
4. I/we _______________________________________________enclose
herewith a copy of Registration
Certificate concerning the drugs
to be imported in India issued
under Form 41 of the rules, vide
Registration Certificate No _________________________
Dated___________________ issued
through
M/s_______________________________________________
(name and full address _____________________________________________
valid upto _________________.
*
5. I/we _______________________________________________
hold a valid wholesale licence
for sale or distribution of drugs
or licence to manufacture drugs,
under the provisions of the Act
and rules made thereunder. A copy
of the said licence is enclosed.
6. A fee of_______________ has
been credited to Government under
the Head of Account "0210
- Medical and Public Health, 04-
Public Health, 104- Fees and Fines"
under the Drugs and Cosmetics
Rules, 1945 - Central vide Challan
No.____________, dated ____________
(attached in original).
Signature ______________________
Name _________________________
Designation _____________________
Seal/Stamp of Manufacturer's agent
in India
Place: _____________
Date: _____________
" delete whichever is not
applicable.'
FORM
9
(See Rule 24)
Form of undertaking to accompany
an application for an import licence
Whereas _______________
of ______________ intends to apply
for a licence under the Drugs
& Cosmetics Rules, 1945, for
the import into India, of the
drugs specified below manufactured
by us, we ________________ of
_______________ hereby give the
undertaking that for the duration
of the said licence:
(1) the said applicant shall be
our agent for the import of drugs
into India;
(2) we shall comply
with the conditions imposed on
a licence by Rules 74 and 78 of
the Drugs & Cosmetics Rules,
1945;
(3) we declare that
we are carrying on the manufacture
of the drugs mentioned in this
undertaking at the premises specified
below, and we shall from time
to time report any change of premises
on which manufacture will be carried
on and in cases where manufacture
is carried on in more than one
factory any change in the distribution
of functions between the factories;
(4) we shall comply
with the provisions of Part IX
of the Drugs & Cosmetics Rules,
1945;
(5) every drug,
manufactured by us for import
under licence into India shall
as regards strength, quality and
purity conform with the provisions
of Chapter III of the Drugs &
Cosmetics Act, 1940, and the Drugs
& Cosmetics Rules, 1945;
(6) we shall comply
with such further requirements,
if any, as may be specified by
Rules, by the Central Government
under the Act and of which the
licensing authority has given
to the licensee not less than
four months' notice.
Names of drugs and classes of
drugs
Particulars of premises where
manufacture is carried on.
Date____________
Signed by or on behalf of the
manufacturer
"FORM
10
(See rules 23 and 27)
Licence to import drugs
(excluding those specified
in Schedule X) to the Drugs
and Cosmetic Rules, 1945
|
Licence Number _________________
Date _______________
____________________________
_________________________________
(Name and full address of the
importer) is hereby licensed to
import into India during the period
for which this licence is in force,
the drugs specified below, manufactured
by M/s _____________________________________
(name and full address) and any
other drugs manufactured by the
said manufacturer as may from
time to time be endorsed on this
licence.
2. This licence shall be in force
from _________________ to_______________
unless it is sooner suspended
or cancelled under the said rules.
3. Names of drugs to be imported:
Place:____________ Date :____________
LICENSING AUTHORITY
Seal/Stamp
" delete whichever is not
applicable.
Conditions of Licence
1. A photocopy of licence shall
be displayed in a prominent place
in a part of the premises, and
the original licence shall be
produced, whenever required.
2. Each batch of
drug imported into India shall
be accompanied with a detailed
batch test report and a batch
release certificate, duly signed
and authenticated by the manufacturer
with date of testing, date of
release and date of forwarding
such reports. The imported batch
of each drug shall be subjected
to examination and testing as
the licensing authority deems
fit prior to its marketing.
3. The licensee
shall be responsible for the business
activities of the manufacturer
in India alongwith the registration
holder and his authorised agent.
4. The licencee
shall inform the licensing authority
forthwith in writing in the event
of any change in the constitution
of the firm operating under the
licence. Where any change in the
constitution of the firm takes
place, the current licence shall
be deemed to be valid for a maximum
period of three months from the
date on which the change takes
place unless, in the meantime,
a fresh licence has been taken
from the licensing authority in
the name of the firm with the
changed constitution";
'FORM
10-A
(See rules 23 and 27)
Licence to import drugs specified
in Schedule X to the Drugs and
Cosmetic Rules, 1945
Licence Number ______________
Date ______________
_____________________________________________________________
(Name and full address of the
importer) is hereby licenced to
import into India during the period
for which this licence is in force,
the drugs specified below, manufactured
by M/s _____________________________________
(name and full address) and any
other drugs manufactured by the
said manufacturer as may from
time to time be endorsed on this
licence.
2. This licence
shall be in force from _________________
to_______________ unless it is
sooner suspended or cancelled
under the said rules.
3. Names of drugs
to be imported:
Place:____________
Date :____________
LICENSING AUTHORITY
Seal/Stamp
" delete whichever is not
applicable.
Conditions of Licence
1. A photocopy of
licence shall be displayed in
a prominent place in a part of
the premises, and the original
licence produced, whenever required.
2. Each batch of drug imported
into India shall be accompanied
with a detailed batch test report
and a batch release certificate,
duly signed and authenticated
by the manufacturer with date
of testing, date of release and
date of forwarding such reports.
The imported batch of each drug
shall be subjected to examination
and testing as the licensing authority
deems fit prior to its marketing.
3. The licensee shall be responsible
for the business activities of
the manufacturer in India alongwith
the registration holder and his
authorised agent.
4. The licencee shall inform the
licensing authority forthwith
in writing in the event of any
change in the constitution of
the firm operating under the licence.
Where any change in the constitution
of the firm takes place, the current
licence shall be deemed to be
valid for a maximum period of
three months from the date on
which the change takes place unless,
in the meantime, a fresh licence
has been taken from the licensing
authority in the name of the firm
with the changed constitution";
------------------------------------------
Form
11
[See Rule 33]
Licence to import drugs for the
purpose of examination, test or
analysis
I ______________________ of ________________
is hereby licensed to import from
_________________the drugs specified
below for the purposes of examination,
test or analysis at _______________or
in such other places as the licensing
authority may from time to time
authorize.
2. This licence
is subject to the conditions prescribed
in the Rules under the Drugs &
Cosmetics Act, 1940.
3. This licence
shall, unless previously suspended
or revoked, be in force for a
period of one year from the date
specified below:
Names of drugs
Date____________
Quantities which
may be imported
Licensing Authority
'FORM
11- A
(See rule 33-A)
Licence to import drugs by a Government
Hospital or Autonomous
Medical Institution for the treatment
of patients
Licence No.____________________
Date _______________________
Dr______________________________Designation________________
of______________________________________________(Name
of College/ Hospital/
Autonomous Institution)
is hereby licensed
to import from M/s _______________________
(name and full address) the drugs
specified below for the purpose
of treatment of patients for the
disease (name of the disease)
_______________________ at ______________________________
or in such other places as the
licensing authority may from time
to time authorise.
2. This licence
shall, unless previously suspended
or revoked, be in force for a
period of one year from the date
of issue specified above.
3. Names of drugs
to be imported:
Names of drug Quantity which may
be imported
Place: _____________
Date: ______________
LICENSING AUTHORITY
Seal/Stamp
Conditions of Licence
1. The licence shall be displayed
in the Office of the Medical Superintendent
of Government Hospital /Head of
Institution of Autonomous Medical
Institution.
2. The licensee shall store the
drugs imported under this licence
under proper storage conditions.
3. The drugs imported under this
licence shall be exclusively used
for the treatment of patients,
and a record shall be maintained
in this regard, by a registered
pharmacist giving the full name(s)
and address (es) of the patients,
diagnosis, dosage schedule, total
quantity of drugs imported and
issued, and shall be countersigned
by the Medical Superintendent
of the Government Hospital or
Head of the Autonomous Medical
Institution which shall be produced,
on demand by an Inspector appointed
under the Act.
Form
12
[See Rule 34]
Application for licence to import
drugs for
purpose of examination, test or
analysis
I _____________________________resident
of ___________ by occupation __________
hereby apply for a licence to
import the drugs specified below
for the purposes of examination,
test or analysis at _____________
from ___________ and I undertake
to comply with the conditions
applicable to the licence.
A fee of rupees
of fifteen has been credited to
the Government under the Head
of Account “0210-
Medical & Public Health, 04-Public
Health, 104-Fees & Fines�
under the Drugs & Cosmetics
Rules, 1945-Central vide treasury
receipt attached.
Names of drugs and
classes of drugs Quantities
Date: __________________
Signature: ______________
Form
12-A
[See Rule 36, Second Proviso]
Application for the issue of a
permit to
import small quantities of drugs
for personal use
I _____________________________
resident of _____________ by occupation
_______________ hereby apply for
a permit to import the drugs specified
below for personal use from ___________________
I attach a prescription
from a registered medical practitioner
in regard to the need for the
said drugs.
Names of drugs Quantities
Date_______________
Signature_____________
FORM
12-AA
(See rule 34A)
Application for licence to import
small quantities of new drugs
by a Government Hospital or Autonomous
Medical Institution for
the treatment of patients.
--------------------------
I, ___________(name
and designation) ____________________________of
___________________________________________________
(name of the Hospital/Autonomous
Medical Institution)hereby apply
for a licence to import small
quantities of new drugs specified
below for the purpose of treatment
of patients for the disease __________________(name
of the disease) at _____________________________________________
(name and place of the hospital)
and I undertake to comply with
the conditions applicable to the
licence and other provisions of
the Drugs and Cosmetics Act ,
1940 and the rules made thereunder,
from time to time.
1. A fee of rupees_________________
has been credited to Government
under the Head of Account “0210-
Medical and Public Health, 04-
Medical and Public Health, 104-
Fees and Fines� under
the Drugs and Cosmetics Rules,
1945 – Central
vide Challan No.________, dated
________, (attached in original).
2. Name of new drug
to be imported: - Names of drug
Quantity which may be imported
Place: __________________
Date: __________________
Signature ____________________________
Name_______________________________
Seal/Stamp___________________________
CERTIFICATE
Certified that
the drugs specified above for
import are urgently required for
the treatment of patients suffering
from________________________________and
that the said drug(s) is /are
not available in India.
SIGNATURE ______________________
Medical Superintendent
of the Government Hospital/Head
of
Autonomous Medical
Institution
Seal/Stamp;
Place: _____________
Date: _____________
Form
12-B
[See Rule 36, Second Proviso]
Permit for the import of
small quantities of drugs
for personal use. |
__________________________________
of ______________________ is hereby
permitted to import from ______________the
drugs specified below for personal
use.
This permit is subject to the
conditions prescribed in the Rules
under the Drugs & Cosmetics
Act, 1940.
This permit shall, unless previously
suspended or revoked, be in force
for a period of six months from
the date specified below.
Names of drugs Quantities
which may be imported
Date________________
Licensing Authority.
Form
40
(See rule 24-A)
Application for issue of Registration
Certificate for import of drugs
into India
under the Drugs and Cosmetics
Rules, 1945.
*I/We_____________________________________________________
Name and full address) hereby
apply for the grant of Registration
Certificate to the manufacturer,
M/s ______________________________________
(full address with telephone,
fax and E-mail address of the
foreign manufacturer) for his
premises, and manufactured drugs
meant for import into India.
1. Names of drugs
for registration.
(1)
(2)
(3)
2. I/We enclose
herewith the information and undertakings
specified in Schedule D (1) and
Schedule D (II) duly signed by
the manufacturer for grant of
Registration Certificate for the
premises stated below.
3. <![endif]>.A
fee of _________________ for registration
of premises, the particulars of
which are given below, of the
manufacturer has been credited
to the Government under the Head
of Account “0210-Medical
and Public Health, 04-Public Health,
104-Fees and Fines�
under the Drugs and cosmetics
Rules, 1945 –
Central vide Challan No._________,
dated _________, (attached in
original).
4. A fee of _________________
for registration of the drugs
for import as specified at Serial
No.2 above has been credited to
the Government under the Head
of Account “0210-Medical
and Public Health, 04-Public Health,
104-Fees and Fines�
under the Drugs and cosmetics
Rules, 1945 –
Central vide Challan No._________,
dated ________, (attached in original).
5. <![endif]>Particulars
of premises to be registered where
manufacture is carried on:
Address (es) ___________________________________
Telephone: _______________________
Fax: ____________________________
E- mail: _________________________
I/we undertake to
comply with all the terms and
conditions required to obtain
Registration Certificate and to
keep it valid during its validity
period.
PLACE:
DATE:
Signature ________________________
Name ______________
Designation ________________
Seal/Stamp of manufacturer
or his authorised agent in India.
(Note:- In case the applicant
is an authorized agent of the
manufacturer in India, the Power
of Attorney is to be enclosed).
whichever is not applicable.
Form
41
(See rule 27-A)
Registration Certificate
to be issued for import
of drugs into India
under Drugs and Cosmetics
Rules, 1945.
|
Registration Certificate No.________
Date ________
M/s ___________________________(Name
and full Address of registered
office) ___________________ _______________________________________having
factory premises at____________________________
(full address) has been registered
under rule 27-A as a manufacturer
and is hereby issued this Registration
Certificate.
2. Name (s) of drugs,
which may be imported under this
Registration Certificate.
(1)
(2)
(3)
3. This Registration
Certificate shall be in force
from ___________ to
_______________unless
it is sooner suspended or cancelled
under the rules.
4. This Registration
Certificate is issued through
the office of the manufacturer
or his authorised agent in India
M/s (name and full address) ____________________________________________________________
who will be responsible for the
business activities of the manufacturer,
in India in all respects.
5. This Registration
Certificate is subject to the
conditions, stated below and to
such other conditions as may be
specified in the Act and the rules,
from time to time.
Place _______________
Date: _____________
LICENSING AUTHORITY
Seal/Stamp
Conditions of the Registration
Certificate
1. The Registration
Certificate shall be displayed
at a prominent place by the authorised
agent.
2. No drug shall
be registered unless it has a
free sale approval in the country
of origin, and/or in other major
countries.
3. The manufacturer
or his authorised agent in India
shall comply with the conditions
of the import licence issued under
the Drugs and Cosmetics Rules,
1945.
4. The manufacturer
or his authorised agent in India
shall inform the licensing authority
forthwith in the event of any
administrative action taken due
to adverse reaction, viz. market
withdrawal, regulatory restrictions,
or cancellation of authorisation,
and/or not of standard quality
report of any drug pertaining
to this Registration Certificate
declared by the Regulatory Authority
of the country of origin or by
any Regulatory Authority of any
other country, where the drug
is marketed/sold or distributed.
The despatch and
marketing of the drug in such
cases shall be stopped immediately,
and the licensing authority shall
be informed immediately. Further
action in respect of such stopped
marketing of drug shall be followed
as per the direction of the licensing
authority. In such cases, action
equivalent to that taken with
reference to the concerned drug
in the country of origin or in
the country of marketing shall
be followed in India also, in
consultation with the licensing
authority. The licensing authority
may, however, direct any further
modification to this course of
action, including the withdrawal
of the drug from Indian market
within 48 hours time period.
5. The manufacturer
or his authorised agent in India
shall inform the licensing authority
within 30 days in writing in the
event of any change in manufacturing
process, or in packaging, or in
labelling or in testing, or in
documentation of any of the drug
pertaining to this Registration
Certificate.
In such cases, where
there shall be any major change/modification
in manufacturing, or in processing
or in testing, or in documentation
as the case may be, at the discretion
of the licensing authority, the
manufacturer or his authorised
agent in India shall obtain necessary
approval within 30 days by submitting
a separate application along with
the registration fee, as specified
in clause (ii) of sub rule (3)
of rule 24-A.
6. The manufacturer
or his authorised agent in India
shall inform the licensing authority
immediately in writing in the
event of any change in the constitution
of the firm and /or address of
the registered office/ factory
premises operating under this
Registration Certificate. Where
any such change in the constitution
of the firm and/or address takes
place, the current Registration
Certificate shall be deemed to
be valid for a maximum period
of three months from the date
on which the change has taken
place unless, in the meantime,
a fresh Registration Certificate
has been taken from the licensing
authority in the name of the firm
with the changed constitution
of the firm and/or changed address
of the registered office or factory
premises�.
