Central Drugs Standard Control Organisation
Directorate General of Health Services
Ministry of Health & Family Welfare
(Medical Device and Diagnostic Division)
Food and Drug Administration Bhawan
Kotla Road, New Delhi-110002
Dated' • ::
8
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f.J. ~•.•. ,.,
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Mis. Becton Dickinson India Pvt Ltd,
No-34, Assisi N~gar, West Thottam,
Modhavaram, Chennai-51
"
Subject: Import Licence under the Drugs and Cosmetics Act 1940 and Rules 1945
thereunder- regarding.
1. With reference to your application for import Iillence forwarded to this office with
your letter No. BDIURA-IU1 02/11 date~t3rl011
received by this office vide
dj~
no 11203 dated 09/03/2011.1 en
licence(s) NO. MD-825-1276 dated
". f-l,1--';-'
this 1 these Iicence(s)
ave been granted under the Drugs and
Gosmetics Act 1940 and Rules 19
reunder.
2. I am to point out that the ..... ions-of"Orugs andGoslffetics·-A-ct-1@40-·anc}-Rules1945 are in addition to
not derogation of any other law for the time being
in force and as such the licence(s) issued under Drugs and Cosmetics Act and
Rules will be in addition to and distinct from any licence(s) which may be necessary
under the Import Trade Control Regulations made of the Government of India,
Ministry of Commerce.
3. The import licence(s) mentioned in para (1) above will not accordingly to itself 1
themselves be sufficient authority for import of Drugs covered by that 1 those
Iicence(s) if under the Import Trade Control Regulations of the Commerce Ministry
separate Iicense(s) are required for import of such drug(s).
4. I am therefore, to advise you to obtain, where necessary Iicence(s) for import of
drugs in question under the Import Trade Control Regulations.
5. Any literature or packing accompanying the drugs or any matter stated on the label
should not contravene the provisions of the Drugs and Magic Remedies
(Objectionable Advertisement) Act.
6. The Assistant Drugs Controller (India) and Technical Officer of the Central Drugs
Control Organisation at the ports will be Officers authorized to inspect the premises
of importers establishments for the purpose of Rule 26 of the Drugs and Cosmetics
Act and Rules thereunder.
7. Pleaseacknowleldgeneceiptof this letter and its enclosures.
B
20n
4~1I:
(Dr. S. EsWara Reddy)
Asstt. Drugs Controller (I)
Copy forwarded for information to:
1. Asstt. Drugs Controller (India), Ahmedabadl Chennail Cochinl Delhil Hyderabadl
Kandla IKolkatal Mumbail Nhava Sheva.
FORM 10
(See Rules 23 and 27)
Licence to import drugs (excluding those specified in Schedule X) to the Drugs and
Cosmetics Rules, 1945
MIs Becton Dickinson India Pvt Ltd,No-34, Assisi Nagar, West Thottam, Modhavaram,
Chennai-51 is hereby licensed to import into India during the period for which the licence is
in force, the drugs specified below, manufactured by MIs Becton Dickinson and Company,
BD Medical Diabetes Care, 1 Becton Drive, Franklin Lakes, New Jersey 07417 having
factory premises at Mis BD Medical Diabetes Care, 1329 West Highway #6, Holdrege,
Nebraska, 68949, USA and any other drugs manufactured by the said manufacturer as may
from .time to time be endorsed on this licence. ~
v,(§ 8 1-\([1 2011
2. Thislicenceshallbe in forcefrom
unless it is sooner suspended otkcelled
.
.
<;,,\J~
under the said rules.
3. Names of drugs to be i~lled:Oj.\RD
1. Alcohol Swab.
S'\~~
ITEM(S) ONE ONLY·
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8
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Licensing Authority
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1 A photocopyof Iicences~~d~i~PI:;~1n~"~rorrtihe~
Dr.~ESW!~j~P~Y.~h.
;.n.{)
~stt. Drug:::..
.. (!.na;a)
<p)~ceD~tl~~~~~;;ft!~"
premises, and the original Iicenct¥S~lIbe. produced, wh~~t~r required.
2. Each batch of drug imported .into Jrid~hfiPlbr;r~cort\~'riled
with a detailed batch test
report and a batch release certificate, -daly-' ~tgned and authenticated by the
manufacturer with date of testing, date of release and the 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 aJongwiththe- registration -holder and his authorisedagent.
4. The licensee 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
Central Drugs Standard Control Organisation
Directorate General of Health Services
Ministry of Health & Family Welfare
(Medical Device and Diagnostic Division)
Food and Drug Administration Bhawan
Kotla Road, New Delhi-11 0002
Dated:~
To
.
.,/
B ,APR 2,on
/"
MIs Multi Medics,
Plot No.28, HPSIDC,
Phase-III, Baddi, District- Solan (H.P)
Subject: Import Licence under the Drugs and Cosmetics Act 1940 and Rules 1945
thereunder- regarding.
1. ,With reference to your application for im~p:4:ence forwarded to this office with
your letter No. NIL dated 21/0212011 rec· rd'by this offic~~
dj~nq.,~QQ90
dated 03/03/2011.1 enclose licence(s)
D-273-1281 datea (') l\r (, C,'flis 1
these Jicence(s) has 1 have been 9~d
under the Drugs and Cosmetics Act 1940
and Rules 1945 thereunder.
2. I am to point out that the(W~)Visions of Drugs and Cosmetics Act 1940 and
Rules1945 are in addition to 'A"'ndnot derogation of any other law for the time being
in force and as such the Iicence(s) issued under Drugs and Cosmetics Act and
Rules will be in addition to and distinct from any licence(s) which may be necessary
under the Import Trade Control Regulations made of the Government of India,
Ministry of Commerce.
3. The import Iicence(s) mentioned in para (1) above will not accordingly to itself 1
themselves be sufficient authority for import of Drugs covered by that 1 those
licence(s) if under the Import Trade Control RegUlations of the Commerce Ministry
separate Iicense(s) are required for import of such drug(s).
4. I am therefore. to advise you to obtain, where necessary Iicence(s) for import of
drugs in question under the Import Trade Control RegUlations.
5. Any literature or packing accompanying the drugs or any matter stated on the label
should not contravene the provisions of the Drugs and Magic Remedies
(Objectionable Advertisement) Act.
6. The Assistant Drugs Controller (India) and Technical Officer of the Central Drugs
Control Organisation at the ports will be Officers authorized to inspect the premises
of importers establishments for the purpose of Rule 26 of the Drugs and Cosmetics
AttandRules thereunder.
7. Please acknOWledgereceipt of this letter and its enclosures.
N<tI
G'X~
-
- --- - ---
C;;;!OursfailhfuIlY
(Dr. S.~ildY)
Asstt. Drugs Controller (I) .
Copy forwarded for information to:
1. Asstt. Drugs Controller (India), Ahmedabadl Chennail
Kandla IKolkatal Mumbail Nhava Sheva.
Cochin/. Delhil Hyderabadl
FORM 10
(See Rules 23 and 27)
Licence to import drugs (excluding those specified in Schedule X) to the Drugs and
Cosmetics Rules, 1945
MIs Multi Medics, Plot No.28, HPSIDC, Phase-III, Baddi, District- Solan (H.P) is hereby
licensed to import into India during the period for which the licence is in force, the drugs
specified below, manufactured by MIs Natec Medical Ltd., Maeva Centre Building,
Business Park Ebene, Reduit, Mauritius and any other drugs manufactured by the said
manufacturer as may from time to time be endorsed on this licence.
2
Z. This licence shall be in force from '- 8 t\ :~:~!;D 1.1
unless it is sooner suspended or cancelled under the said rules.
3.. Na~:':~:U9sto~I~~~0P,R
1.~~~~~~~~~~~IUe(NOn
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Sterile)
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Place: New Delhi
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o~ ~onditions
of Licenc~~
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Licensing Authority
Seal/StamD
~"'Dr. S. E5WP."R"". REDDY
A...<"N· 1'\0', :r··
~';>D'-.·G~~t~r:
,...
(I/L!'h. Ph.D
(India)
·.-~>)',:.iJil
Kutla Roa(H~sw Delhi
1. A photocopy oflic~nceshall~Ldi~pl~~dJ~~j,rominent
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 the 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
IndiaalQogJlVithJbe.regi§tri3tic)Ilb()JcJ~r al}d .llisaLJthorisedagent.
4. The licensee shall inform the.licensing authoritY forthwifh Illwrifil'lgiri the'eveiifof ~fny
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.
Central Drugs ·Standard .Contro~ 'Organisation
Directorate General of Health Services
Ministry of Health & Family Welfare
(Medical Device and Diagnostic Division)
Food and Drug Administration Bhawan
Kotla Road, New Delhi-110002
Dated:
To
~~
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0
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I)
.t:..'
Evolutis India Pvt.Ltd,
Office No.1, Bldg No.A, First Floor,
MIs S.H Kelkar & Co. P. Ltd., L.B~S Marg,
Mulund (W), Mumbai 400080, Maharashtra
SUbject: Import Licence under the Drugs and Cosmetics Act 1940 and Rules 1945
thereunder- regarding.
1. With reference to your application for import ieMce forwarded to this office with
your letter NO.NiI dated 11/03/2011 receMBly ·this office vici..! c&arx:r'?" 11915
dated 14/03/2011.1 enclose Iice~c~\~.
'1wrQ:282-1273 dated
Q / ....;' , Jtt:ff
bO~a ..
2.
3.
4.
5.
6.
7.
~~e;~~~es~c;J;)t~:~e~.~~~~
under .the Drugs ..~nd co~m~~cs. ~~t~=~~ .
I ·am to· point out ...that the prbvi~r()ns of Drugs and Cosmetics Act 1940 and
Rules1945 are in addition to and not derogation of any other law for the time being
in force and as such the Iicence(s) issued under Drugs and Cosmetics Act and
Rules will be in addition to and distinct from any Iicence(s) which may be necessary
under the Import Trade Control Regulations made of the Government of India,
Ministry of Commerce.
The import Iicence(s) mentioned in para (1) above will not accordingly to itself 1
themselves be sufficient authority for import of Drugs covered by that 1 those
Iicence(s) if under the Import Trade Control RegUlations of the Commerce Ministry
separate Iicense(s) are required for import of such drug(s).
I am therefore, to advise you to obtain, where necessary licence(s) for import of
drugs in question under the Import Trade Control RegUlations.
Any literature or packing accompanying the drugs or any matter stated on the label
should not contravene the provisions of the Drugs and Magic Remedies
(Objectionable Advertisement) Act.
The Assistant Drugs Controller (India) and Technical Officer of the Central Drugs
Control Organisation at the ports will be Officers authorized to inspect the premises
of importers establishments for the purpose of Rule 26 of the Drugs and Cosmetics
Act and Rules thereunder.
Please acknowledge receipt of this letter and its enclosures.
4
~ourn failh:UIIY
(Dr. s. ~ddY)
Asstt. Drugs Controller (I)
Copy forwarded for information to:
1. Asstt. Drugs Controller (India), Ahmedabadl Chennail Cochinl Delhil Hyderabadl
Kandla IKolkatal Mumbail Nhava Sheva.
t'ul
LV I
FORM 10
(See Rules 23 and 27)
Licence to import drugs (excluding those specified in Schedule X) to the Drugs and
Cosmetics Rules, 1945
MIs Evolutis India Pvt.Ltd, Office No.1,Bldg No A, First Floor, Mis S.H Kelkar & Co. P.
Ltd., L.B.S Marg, Mulund (W), Mumbai 400080, Maharashtra is hereby licensed to import
into India during the period for which the licence is in force, the drugs specified below,
manufactured by Mis Evolutis, Avenue De La Liberation- 42720, Briennon, France and
any other drugs manufactured by the said manufacturer as may from time to time be
endorsed on this licence.
8 . '"'~
I!". ••••
/111
- ~ tU"!\ tU h
unless it is sooner suspended or cancelled under the said rules.
2. This licence shall be in force from
3. Names of drugs to beimported:n
ARD
1. HIP JOINTS
S,\~~\J••..
2. KNEE JOUNTS
,. S
::
~~~~
;;:~:e:(
r~i~
5. ANCHOR:-l'i
6. VANQUISH:
7. NAIL 0 F
8. TRAU
ITE
ANTI
IIC)
her
. ·egradab
lasitic radia
'L:J DUCTS: Pia
....
t
) EI.GHTONlY .
CDSC
Place: New Delhi
Date:
If
~
k~~
_--_8_A_"P_R_2011 ~..
'9)-O,<'/i. •.
.~~~
.~-4LTH GO\Jt\\~'
1.
2.
3.
4.
0~~:n:~:~!l~
As;tt.·-D;,~\:~;;'::,~:~-"~
PhD
(India)
Conditions orLlcenc~
D.CHS, ;.~':.;\.~;h:,,"3n
A photocopy of licence shall be displayed in a prominent place inKl4Iii~d-oT2\~lhj
premises, and the original licence shall be produced, whenever required.
Each batch of drug imported into India shall be accompanied with a detailed batch test
report and a batch release certificate, dulysig neda nd authenticated_bytthe_
manufacturer with date of testing, date of release and the 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.
The licensee shall be responsible for the business activities of the manufacturer in
India along with the registration holder and his authorised agent.
The licensee 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
Central Drugs Standard Control Organisation
Directorate General of Health Services
Ministry of Health & Family Welfare
(Medical Device and Diagnostic Division)
Food and Drug Administration Bhawan .
Kotla Road, New Delhi-110002
To
/
/M/s S.R International,
801, Manjusha,57, Nehru
Place, New Delhi-19
Subject: Import Licence under the Drugs and Cosmetics Act 1940 and Rules 1945
thereunder- regarding.
1. With reference to your application for import licence forwarded to this office with
your letter No Nil dated 28/02/2011 received by thi ffice ',ide;;fiar¥..no 9612 dated
28/0212011.1 enclose Iicence(s) NO. FF-425-1
ted - 0 Al"'R t~§nthese
2.
3.
4.
5.
6.
7;
fi~lE~~~:i~~~;~~;~~~lro
~tJ~~:~;~
in force and as such the Iicence(s) issued under Drugs and Cosmetics Act and
Rules will be in addition to and distinct from any licence(s) which may be necessary
under the Import Trade Control Regulations made of the Government of India,
Ministry of Commerce.
The import Iicence(s) mentioned in para (1) above will not accordingly to itself 1
themselves be sufficient authority for import of Drugs covered by that 1 those
Iicence(s) if under the Import Trade Control Regulations of the Commerce Ministry
separate Iicense(s) are required for import of such drug(s).
I am therefore, to advise you to obtain, where necessary Iicence(s) for import of
drugs in question under the Import Trade Control Regulations.
Any literature or packing accompanying the drugs or any matter stated on the label
should not contravene the provisions of the Drugs and Magic Remedies
(Objectionable Advertisement) Act.
The Assistant Drugs Controller (India) and Technical Officer of the Central Drugs
Control Organisation at the ports will be Officers authorized to inspect the premises
of importers establishments for the purpose of Rule 26 of the Drugs and Cosmetics
Act and Rules thereunder.
Please acknowledge receipt of this letter and its enclosures;
47&-~fuIlY
(Dr. S.Eswara Reddy)
Asstt. Drugs Controller (I)
Copy forwarded for information to:
1. Asstt. Drugs Controller (India), Ahmedabadl Chennail Cochinl Delhil Hyderabadl
Kandla IKolkatal Mumbail Nhava Sheva.
FORM 10
(See Rules 23 and 27)
Licence to import drugs (excluding those specified in Schedule X) to the Drugs and
Cosmetics Rules, 1945
-~ P.
~
J\ i:=~ :~?~~:?'1
;.~
a
\l"
~,_
••.
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~
.;
MIs S.R International, 801, Manjusha, 57, Nehru Place, New Delhi-19 is hereby licensed
to import into India during the period for which the licence is in force, the drugs specified
below, manufactured by MIs Arcadophta Sari, 11, rue Antoine Ricord, 311Q()Toul()se,
France and any other drugs manufactured by the said manufacturer as may from time to
time be endorsed on this licence.
8 APR ZOU
2. This licence shall be in forc~~~
unless it is sooner suspend~~
::
cancelled under the said rules.
o
3. Names of drugs to ~ i~orted:
,
ARD Cr'<
1. Arceole .SL~iDose
I<ll\(rs.~;SFG, t:f2¥6r~oPtraocular Gases)
ITEM(S~
ONLY (:'? ",'
, (*
A'::;
::{"
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o
?
v
"''I'
Date: _-
_8_A_P_R _Z_Ol1
c6r}ditions
of Licence
Jifi~~~Ef1 'e,~~
1. A photocopy of licence shall be
,U:l ~
ent place in a part of the
premises, and the original licence shall be pr(jdrl~a,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 the date of forwarding such
reports.- Theimported-batch-ofeachdrug
shall be subjected to examrnatforrandtestingas the licensing authority deems fit prior to its marketing.
3. The licensee shall be responsible for the business activities of the manufacturer in
India along with the registration holder and his authorised agent.
4. The licensee 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 ctlailgetakes 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.
Centra! Drugs Standard'Control
Organisation
Directorate General of Health Services
Ministry of Health & Family Welfare
(Medical Device and Diagnostic Division)
Food and Drug Administration Bhawan
Kotla Road, New Delhi-110002
File NO.31·719·MD/2009·DC
To
Dated: -_
b..
8 .1\ pf:\' ? flll
f"',
I
il",V
/
\./~!~~
~axter
(India) Pvt. Ltd,
Plot NO-70, A-26, Rama Road,
Industrial Area, New Delhi-110015
Subject: Import Licence under the Drugs and Cosmetics Act 1940 and Rules 1945
thereunder- regarding.
1. With reference to your application for import licence
arded to this office with
your letter No. Nil dated 11/03/2011 received by . 0 Ice vide !ary nE 12047
dated 14/03/2011.1 enclose licence(s} NO. MD- 1 4 dated - li
~f
AP}~
2.
3.
4.
5.
6.
7.
~~m~~F~:~)~~~e~~1~!e~;~~~~~~!~D;
:~~g::::~i:m~~cs1~~
Rules 1945 are in addition to and not derogation of any other law for the time being
in force and as such the Iicence(s) issued under Drugs and Cosmetics Act and
Rules will be in addition to and distinct from any Iicence(s} which may be necessary
under the Import Trade Control Regulations made of the Government of India,
Ministry of Commerce.
The import licence(s} mentioned in para (1) above will not accordingly to itself 1
themselves be sufficient authority for import of Drugs covered by that 1 those
licence(s) if under the Import Trade Control Regulations of the Commerce Ministry
separate Iicense(s} are required for import of such drug(s).
I am therefore, to advise you to obtain, where necessary Iicence(s} for import of
drugs in question under the Import Trade Control Regulations.
Any literature or packing accompanying the drugs or any matter stated on the label
should not contravene the provisions of the Drugs and Magic Remedies
(Objectionable Advertisement) Act.
The Assistant Drugs Controller (India) and Technical Officer of the Central Drugs
Control Organisation at the ports will be Officers authorized to inspect the premises
of importers establishments for the purpose of Rule 26 of the Drugs and Cosmetics
Act and 'Rules thereunder.
PleasEn~ckh(jWleageteCeiptofthis lettetanClits enClosUres.
~:fuIlY
(Dr. S."'ESWaraReddy)
Asstt. Drugs Controller (I)
Copy forwarded for information to:
1. Asstt. Drugs Controller (India), Ahmedabadl Chennail Cochin/ Delhil Hyderabadl
Kandla /Kolkatal Mumbail Nhava Sheva.
FORM 10
(See Rules 23 and 27)
Licence to import drugs (excluding those specified in Schedule X) to the Drugs and
Cosmetics Rules, 1945
M/s Baxter (India) Pvt. Ltd, Plot NO-70, A-26, Rama Road, Industrial Area, New Delhi110015 is hereby licensed to import into India during the period for which the licence is in
force, the drugs specified below, manufactured by M/s Baxter Healthcare Corporation
17511 Armstrong
Avenue Irvine, California,
92614 USA and any other drugs
manufactured by the said manufacturer as may from time to time be endorsed on this
licence.
...
8 ;\rr\
'I1')f'\
~
"pH
LUll
2. This licence shall be in force from
unless it is sooner suspended or cancelled under the said rules.
~
3. Names of drugs to be imJl~d:..
1. Floseal Endosc09tc""plic~~O
ITEM(S) ONE
,~?~
.
&16~"
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(')
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Place: New Delhi
'"
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~
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ZOlfJ.'
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~\
~
censmg Authority
Seal/Stamp
SWP'=!!!,
. " .•.. 17=:1"'>.;->,/
·,..c~..."
':..DruG';
.
1.
~
M .PhI. Ph .0
ITi'd'a)
\..
.•..
I ~.
~~i~~~O~~d
~~~i~~~~~,1t;!;ts~~r6e
..~rOducfcl~h~~:~~u'1E;;~;J~~
2. Each batch of drug imported intet;f'~iashall be accomp~lft~ith
a detailed batch test
report and a batch release certifi~"F
.d{UJ~'\t~lM·; and authenticated by the
manufacturer with date of testing, date of1t~~se
and the 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 ·Iicenseeshall be responsible for the business activities of .themanufactur~eIjn _~.
India along with the registration holder and his authorised agent.
4. The licensee 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.
Central Drugs Standard Control Org~nisation
Directorate General of Health Services
Ministry of Health & Family Welfare
(Medical Device and Diagnostic Division)
Food and Drug Administration Bhawan
Kotla Road, New Delhi-110002
To
/
/
~/s Boston Scientific International
BV
(C & FM/s Parekh Distributors),
C-40, Okhla Industrial Area,
Phase-II, New Delhi- 20.
Subject: Import Licence under the Drugs and Cosmetics Act 1940 and Rules 1945
thereunder- regarding.
1. With reference to your application for import licence forwarded to this office with
your letter No Nil date~ 01/03/2011 received by this office _vid~diat.Wno9~57 dated
01/03/2011.1 enclose hcence(s) NO. MD-166-190 dated ~
these
~t,tt
~~~~~~~5ht~~:e~~~:r~een g~anted under the Dru~s
~G~~tlCS
_~~~~=~an~____
2. lam to point out that the provisions of Dr~~~
Cosmetics Act 1940 and
RUles1945 are in addition to and not derogatio~fany
other law for the time being
in force and as such the Iicence(s) issued under Drugs and Cosmetics Act and
Rules will be in addition to and distinct from any Iicence(s) which may be necessary
under the Import Trade Control RegUlations made of the Government of India,
Ministry of Commerce.
3. The import Iicence(s) mentioned in para (1) above will not accordingly to itself 1
themselves be sufficient authority for import of Drugs covered by that 1 those
Iicence(s) if under the Import Trade Control Regulations of the Commerce Ministry
separate Iicense(s) are required for import of such drug(s).
4. I am therefore, to advise you to obtain, where necessary licence(s) for import of
drugs in question under the Import Trade Control RegUlations.
5. Any literature or packing accompanying the drugs or any matter stated on the label
should not contravene the provisions of the Drugs and Magic Remedies
(Objectionable Advertisement) Act.
6. The Assistant Drugs Controller (India) and Technical Officer of the Central Drugs
Control Organisation at the ports will be Officers authorized to inspect the premises
of importers establishments for the purpose of Rule 26 of the Drugs and Cosmetics
Act-andRulesthe[ellnc:f~r.
7. Please acknowledge receipt of this letter and its enClosures.
(Dr. S.
ra Reddy)
Asstt. Drugs Controller (I)
Copy forwarded for information to:
~,
2. Asstt. Drugs Controller (India), Ahmedabadl Chennail Cochinl De"1,1 Hyderabadl
Kandla IKolkatal Mumbail Nhava Sheva.
.
FORM 10
(See Rules 23 and 27)
Licence to import drugs (excluding those specified in Schedule X) to the Drugs and
Cosmetics Rules, 1945
MIs Boston Scientific
International BV, (C & F MIs Parekh Distributors), C-40, Okhla
Industrial Area, Phase-ll, New Delhi- 20 is hereby licensed to import into India during the
period for which the licence is in force, the drugs specified below, manufactured by MIs.
Boston Scientific Corporation, Boston Scientific Place, Natick, Massachusetts
01760-1537, USA having factory premises at MIs. Availmed S.A. de C.V. Av. Pasaeo
Reforrna No. 8950 Int. GIByG1 H, Col. Fraccionamiento Rubio, C.P. 22116, Le Mesa,
Tijuana, Baja, California, Mexico 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
unless it is sooner suspended or cancelled under the said rules.
~
3. Names of drugs to be irn-Aed:
1. Wiseguide Cathete(,V·.<~Nvr.,"-
~: =~,~eGAM!!nlg,O
n 1\ R D
-.=;.~~.~J"'e\er__
c-••
·-.·
.•.
ITEM(S)
EONty'
~".
N
Place: New Delhi
Date:
- 8
-
..?1J~._~
__
:.r~
(j
~
J...::.
~
$
..••
!\DR
111
1
I.
i:., ~ : U
E'd
rr~~. .:>
L\LICensmg
D
Authority
Seal/Stamp
%
Dr~
~
~~.
\J"'..>:
~"
-1Gonditionjl-~m~t-1\:e'1i8i
.
0
.~
Eswr.?Jl.,P7=.DD:( ..
j'i.1;P~.•~~D
D:U!?::,:d:r;_,:,~~,;,!~,;'-;""1
D.G.H.,,).,, ,.,.,". ;.c, ,,,,,un
Kotla Road-Nevv Delhi
1. A photocopy of licence shall. ~14~layed
in a pro~eJ1f place in a part of the
premises, and the original licence shal~~]w:,oQUCref~ftenever required.
2. Each batch of drug imported into India sharlbe-%dcompanied 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 the date of forwarding such
reports. The imported batch of each drug shall be sUbjected to examination and testing
as thelicensing·authority deems fit prior·to its marketing.
3. The licensee shall be responsible for the business activities of the manufacturer in
India along with the registration holder and his authorised agent.
4. The licensee 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.
Centrai Drugs Standard·Contro! Organisation
Directorate General of Health Services
Ministry of Health & Family Welfare
(Medical Device and Diagnostic Division)
Food and Drug Administration Bhawan
Kotla Road, New Delhi-110002
•. 8
T~
.
.. ~.~
.~
.~
;-- oj
:;
.... ,'.
i; ~ '.~
.
MIs Veritas Bioventions Pvt.Ltd,
G-8, Plot No.5305, Phase-IV, G.I.D.C,
Vapi, Tal: Pardi (Valsad), Pin-396195
SUbject: Import Licence under the Drugs and Cosmetics Act 1940 and Rules 1945
thereunder- regar~ing.
1. With reference to your application for import licence forwarded to this office with
-8~~i:l~~~~~1~:;~~fgz~
~~ffJ11re~;!~N~g~;;~
2. I am to point out that the provisions of Dru~,,~
Cosmetics Act 1940 and
Rules1945 are in addition to and not derogati~~rany
other law for the time being
in force and as such the Iicence(s) issued ulfder Drugs and Cosmetics Act and
Rules will be in addition to and distinct from any licence(s) which may be necessary
under the Import Trade Control Regulations made of the Government of India,
Ministry of Commerce.
.
3. The import Iicence(s) mentioned in para (1) above will not accordingiy to itself I
themselves be sufficient authority for import of Drugs covered by that I those
Iicence(s)'if under the Import Trade Control RegUlations of the Commerce Ministry
separate license(s) are reqUired for import of such drug(s).
4. I am therefore, to advise you to obtain, where necessary Iicence(s) for import of
drugs in question under the Import Trade Control Regulations.
5. Any literature or packing accompanying the drugs or any matter stated on the label
should not contravene the provisions of the Drugs and Magic Remedies
(Objectionable Advertisement) Act.
6. The Assistant Drugs Controller (India) and Technical Officer of the Central Drugs
Control Organisation at the ports will be Officers authorized to inspect the premises
of importers establishments for the purpose of Rule 26 of the Drugs and Cosmetics
Act and -RUles-thereunder.
7. Please acknowledge receipt of this letter and its enclosures.
(Dr. S. Es
dy)
Asstt. Drugs Controller (I)
Copy forwarded for information to:
1. Asstt. Drugs Controller (India), Ahmedabadl Chen nail Cochinl Delhil Hyderabadl
Kandla IKolkatal Mumbail Nhava Sheva.
FORM 10
(See Rules 23 and 27)
Licence to import drugs (excluding those specified in Schedule X) to the Drugs and
Cosmetics Rules, 1945
'Date:
~ /s. :~'.~jr": :~.f, ,:.~
~
'
..•
MIs Veritas Bioventions Pvt. Ltd, G-B, Plot No.5305, Phase-IV, G.I.D.C, Vapi, Tal: Pardi
(Valsad), Pin-396195 is hereby licensed to import into India during the period for which the
licence is in force, the drugs specified below, manufactured by MIs Natec Medical Ltd.,
Maeva Centre Building, Business Park Ebene, Reduit, Mauritius and any other drugs
manufactured by the said manufacturer as may from time to time be endorsed on this
licence.
8
!\r;:~2ull
2. This licence shall be in force from
:..
unless it is sooner suspe~ed or c~nceBed under the said rules.
to 31-12-2013
3. Names of drugs to ~ported:
. 'OARD rn .
'
Catheter
.c.,.,\~~
.. . '-UN,I?,
1. PTCAca~:
Tamarl~jue (Non Sted..le....
)
O( ()
ITEM(~
ONLY
J1Jr,
<).'
v~
v. ..
iP-~:"
0«'
_."----.-.- ·-···'-~:------··V;.;;:·--·-·--
v'
~,\
"6
Place: New Delhi
Date:~·
- 8 fiffi.
t:,
1'1n
c.~
..7'7-A
• 0--0
,",,!"l1l1
L{Jh
~
~-=-
Licensi;;g---A-ut-h-o-ri-ty
~
~..
....,-E}
;;::;
Seal/Stamp
S. ES\Nt:~C'l.':':::D~Y
. d·t·~•.....
~Assti:.<:=~
..":,' M.pn. Ph.D
~onl
Ion 'Htl!IG\?l
_
~
D.G.i-i r:' ;"::' ',:-: '-Her (India)
1. A ph~tocopy of Iic~n~es,hitf~~diSPlayea
ina promine'\t<..~ac~ inK&bj>~ltd:J~qt~aw~n
premises, and the orrglnalllcence";§Qa1lbe produced, wh~I1~ffi"reqUired.
New DeIhl
~"'I'
2. ~~~rt b~~~ o~d~;t~~Pie~:~si~toc~~~~~~Il{W5~~m~~:it:U~h~~~~~~t~~a~yh
t~~
manufacturer with date of testing, date of release and the 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 along with the registration holder and his authorised agent.
4. The licen$ee~shall inform the-licensing-authority-forthwithin writing in the ~eventof-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
Central Drugs Standard Control Organisation
Directorate General of Heaith Services'
Ministry of Health & Family Welfare
(Medical Device and Diagnostic Division)
Food and Drug Administration Bhawan
Kotla Road, New Delhi·110002
Dated' .
TO~S
1
~ .~,..'? '!IH
u!' '. '.~ t..,L ~
Smith & Nephew Healthcare Pvt. Ltd.
(C & F Elian Trading Co.) Bldg No. 2-3 & 15-17,
Rajlaxmi Complex, Opp. Hanuman Bus Stop Kalher,
Thane Bhiwandi Road, Dist- Thane 421302 Maharashtra
Subject: Import Licence under the Drugs and Cosmetics Act 1940 and Rules 1945
thereunder- regarding.
1. With reference to your apPlication~o import licence forwarded to this office with
your letter No. Nil dated 25/02/201
eived by this office vide diary no 9387.dated
28/02/2011.1 enclose Iicence(s)~
0-779-1279 dated-=:
p.:"'\ r.:
1 these
Iic~I}c:~(~Lh~s 1 have been oca~d_ under the Drugs and C "'!etics _Ad ~Ig~~_a!1_~
Rules1945 thereunder.
~~
2. I am to point outih ~'l provisions of Drugs and Cosmetics Act 1940 and
Rules1945 are in a
n to and not derogation of any other law for the time being
in force and as suc the Iicence(s) issued under Drugs and Cosmetics Act and
Rules will be in addition to and distinct from any licence(s) which may be necessary
under the Import Trade Control Regulations made of the Government of India,
Ministry of Commerce.
3. The import Iicence(s) mentioned in para (1) above will not accordingly to itself 1
themselves be sufficient authority for import of Drugs covered by that 1 those
licence(s) if under the Import Trade Control Regulations of the Commerce Ministry
separate Iicense(s) are required for import of such drug(s).
4. I am therefore, to advise you to obtain, where necessary licence(s) for import of
drugs in question under the Import Trade Control Regulations.
5. Any literature or packing accompanying the drugs or any matter stated on the label
should not contravene the provisions of the Drugs and Magic Remedies
(Objectionable Advertisement) Act.
6. The Assistant Drugs Controller (India) and Technical Officer of the Central Drugs
Control Organisation at the ports will be Officers authorized to inspect the premises
of importers establishments for the purpose of Rule 26 of the Drugs and Cosmetics
Act and .Rtlles thereunder.
7. Please acknowledge receipt of this letter and its enclosures.
At
"#1'
~fuilY
(Dr.s.ES~)
Asstt. Drugs Controller (I)
Copy forwarded for information to:
1. Asstt. Drugs Controller (India), Ahmedabadl Chennail Cochinl Delhil Hyderabadl
Kandla IKolkatal Mumbail Nhava Sheva.
FORM 10
(See Rules 23 and 27)
Licence to import drugs (excluding those specified in Schedule X) to the Drugs and
Cosmetics Rules, 1945
MIs. Smith & Nephew Healthcare Pvt. Ltd.(C & F Elian Trading Co.), Bldg No. 2-3 & 1517, Rajlaxmi Complex, Opp. Hanuman Bus Stop Kalher, Thane Bhiwandi Road, DistThane 421302 Maharashtra is hereby licensed to import into India during the period for
which the licence is in force, the drugs specified below, manufactured by MIs. Smith &
Nephew Inc., Orthopaedic Division, 1450 Brooks Road, Memphis, TN 38116, USA 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
unless it is sooner suspended or cancelled under the said rules.
3. Names of drugs to be imported:
n
~~
!i~~~~~~~?;~:~~V
5.
6.
7.
8.
9.
VersaBond_and
Journey Kne
Legion Kne
~m
Tandem Hi
y~~m
R3 Acetabular S~tem
ITEM(S) NINE ONt'C
Place: New Delhi
Date: -
mL
DSC0
::r:
~
8 APR 2011 %1>,
~tcr
r0
o~
...~~ Licensin~rity
t,:~" 0
. Seal/Stamp
{~'4!
-"
. , <,-t"~\\'4
r. s. ES\Jlj,I.\t:;;;'\ n1"'""DV ~
, ",I H [0\1\;:'1""
Ac-tt <,.'.: : '-:';.' ,·i.Ph. Ph.D
'/:'lir-
Conditions of li~ence
"'=
~. ~~.·:'j:,:<·r;~(oJ!c:.r (India)
D~ti~~~i;,,~~~~n
1. A photocopy of licence shall be displayed in a prominent place
premises, and the original licence shall be produced, whenever required.
I
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
rnanyfaqturer witl}.g~!e9t tE3$til1g,d~JE3
of JE3leClseandthedClte of forwarg.iD9-.§_U(~I}
..
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 along with the registration holder and his authorised agent.
4. The licensee 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
Central Drugs Standard Control Organisat~on
Directorate General of Health Services
Ministry of Health & Family Welfare
(Medical Device and Diagnostic Division)
Food and Drug Administration Bhawan
Kotla Road, New Delhi-110002
T/f
MIs KMSMedisurgi Pvt. Ltd, .
44, Mangladas Road, Bulakhidas Bldg,
Shop No.7, MUl11bai400002, Maharashtra.
.
Subject: Import Licence under the Drugs and Cosmetics Act 1940 and Rules 1945
thereunder- regarding.
1. With reference to your application for i~
licence forwarded to this office with
ff:;~~:~li{~ii~~g~
~E~~l:~b1::
i~U~d~:~n~:~~~~~:;~~:~~g:f:
....
2. ~~~1~~~~
3.
4.
5.
6.
7.
in force and as such the licence(s) issued under Drugs and Cosmetics Act and
Rules will be in addition to and distinct from any licence(s) which may be necessary
under the Import Trade Control Regulations made of the Government of India,
Ministry of Commerce.
The import Iicence(s) mentioned in para (1) above will not accordingly to itself!
themselves be sufficient authority for import of Drugs covered by that I those
licence(s) if under the Import Trade Control Regulations of the Commerce Ministry
separate Iicense(s) are required for import of such drug(s).
I am therefore, to advise you to obtain, where necessary licence(s) for import of
drugs in question under the Import Trade Control Regulations.
Any literature or packing accompanying the drugs or any matter stated on the label
should not contravene the provisions of the Drugs and Magic Remedies
(Objectionable Advertisement) Act.
The Assistant Drugs Controller (India) and Technical Officer of the Central Drugs
Control Organisation at the ports will be Officers authorized to inspect the premises
of importers establishments for the purpose of Rule 26 of the Drugs and Cosmetics
Act and Rules thereunder.
Please acknowledge receipt of this letter~anditsenclosures.
~fuilY
(Dr. S.E""swara Reddy)
Asstt. Drugs Controller (I)
Copy forwarded for information to:
1. Asstt. Drugs Controller (India), Ahmedabad! Chennai! Cochin! Delhil Hyderabad!
Kandla !Kolkatal Mumbai! Nhava Sheva.
FORM 10
(See Rules 23 and 27)
Licence to import drugs (excluding those specified in Schedule X) to the Drugs and
Cosmetics Rules, 1945
Mis KMS Medisurgi Pvt. Ltd, 44, Mangladas Road, Bulakhidas Bldg, Shop No.7,
Murnbai, 400002, Maharashtra is hereby licensed to import into India during the period for
which the licence is in force, the drugs specified below, manufactured by Mis MASCIA
BRUNELLI s.p.a Vie. Monza, 272, 20128 Milano -Italy and any other drugs manufactured
by the said manufacturer as may from time to time be endorsed on this licence.
~"~l to 31-01·2014
8
2. This licence shall be in force ~~
A DR
unless it is sooner suspende(1"Cancelled under the salcfH.Ies.
3 Names of drugs to b~.rted:
..
.RD ..
1. Haem ostati c_G~
SPDnge'(~lfttFOlVlf?O
ITEM(S) ON~LY
GS~
.%, 0
C'k'J
r~
()'-
v
~~
:;.--'"
V
--
Date :::'
8
a!=l
litH
..
o
DSCO~
20n
~
~
Licensing Authority
Seal/Starnp
;:s
i?s.
...
V'.ACOnditiO. •. ... ..
•
1. A photocopy of IiCenCeSh~f-~.diSPI~~4'n~rOmine~,
2.
~
.. ---~-, .. _._--~
<c"'Asstt.
ESWl.,PJ:.. REDCW
DrU~;s..
~U>h.Ph.D
. '_.(India}
f?T~~~#~~i9.tJfl5~i~n
<p1~ce
~~;~~~~~~!
~~~~~~~1:~~~~~~J
manufacturer with date of testing, date of release and the 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 along with the registration holder and his authorised agent.
4. The licensee 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
'Centra! Drugs Standard Control Organisation
Directorate General of Health Services
Ministry of Health & Family Welfare
(Medical Device and Diagnostic Division)
Food and Drug Administration Bhawan
Kotla Road, New Delhi-11 0002
- 8 hif\i'"}Dn
Dated:
To
?;111
:.,tn
/'
~~
Alpha and Omega Diagnostics (I) Ltd.
Room No.1, 1st Floor, 13- Rajmahal,
Bhuleshwar Road, Mumbai- 400002, Maharashtra.
Subject: Import Licence under the Drugs and Cosmetics Act 1940 and Rules 1945
thereunder- regarding.
1. With reference to your' application for import Ii erlce forwarded to this office with
your letter No. Nil dated 24/02/2011 receiv
his office \lidecfiarx no 9195 dated
25/02/2011.1 enclose Iicence(s) NO. M
- 83 dated ••.• u t~ ~~1~these
t·-';'
~~~~~~~~§~b~:~~;~:r~een~r&\~
the Drugs and Cosmetics' Act 1'940 and
2. 1 am to point out -that th~~rSions
of DrugsanaC()smetics,A;cr-lg-40~amt----Rules1945 are in addition to and not derogation of any other law for the time being
in force and as such the Iicence(s) issued under Drugs and Cosmetics Act and
Rules will be in addition to and distinct from any Iicence(s) which may be necessary
under the Import Trade Control Regulations made of the Government of India,
Ministry of Commerce.
3. The import Iicence(s) mentioned in para (1) above will not accordingly to itself 1
themselves be sufficient authority for import of Drugs covered by that 1 those
licence(s) if under the Import Trade Control RegUlations of the Commerce Ministry
separate Iicense(s) are required for import of such drug(s).
4. I am therefore, to advise you to obtain, where necessary licence(s) for import of
drugs in question under the Import Trade Control Regulations.
5. Any literature or packing accompanying the drugs or any matter stated on the label
should not contravene the provisions of the Drugs and Magic Remedies
(Objectionable Advertisement) Act.
.
6. The Assistant Drugs Controller (India) and Technical Officer of the Central Drugs
Control Organisation at the ports will be Officers authorized to inspect the premises
of importers establishments for the purpose of Rule 26 of the Drugs and Cosmetics
Act and Rules thereunder.
7. Please acknowledge receipt of this letter and its enclosures.
~IIY
(Dr. S. EsWanr"Reddy)
Asstt. Drugs Controller (I)
Copy forwarded for information to:
.
1. Asstt. Drugs Controller (India), Ahmedabadl Chennail
Kandla IKolkatal Mumbail Nhava Sheva.
Cochinl Delhil Hyderabadl
--'
FORM 10
(See Rules 23 and 27)
Licence to import drugs (excluding those specified in Schedule X) to the Drugs and
Cosmetics Rules, 1945
MIs Alpha and Omega Diagnostics
(I) Ltd. Room No.1, 1st Floor, 13- Rajmahal,
Bhuleshwar Road, Mumbai- 400002, Maharashtra is· hereby licensed to import into India
during the period for which the licence is in force, the drugs specified below, manufactured by
MIs Labotect GmbH, .Labour- Technik- Gottingen Wille- Eicher Str. 25, 0-37079
Gottingen Germany and any other drugs manufactured by the said manufacturer as may
from time to time be endorsed on this licence.
i\ ;:;)
ry n'11
i"\l I'. L';J ~
2. This licence shall be in force fro'll\.
_
. unless it is sooner suspende~Cbncelled
under the said rules.
- 8
3.~~~:b~~~~~~~
•.....
~::\I'-~OiXRO
• ·Gc,?
ITEM(S) ON~~(
o
.Q~
O.r;)
'G'
-----~---
:cr
.~.
Date:~
~
DS C (ilicensing
~.
/}IrS.
~C()l1diti
~Ji·
AtrffiOiity
Seal/Stamp
ES\;~It.\R.l\,
Rf'::-"v
".,Ph Ph 0
.?f.s.stt. D;~~~';;C(;~~':;~i;::;
(l~dia)
8~~
1. A ph~tocopy of Iic~n~e
be displ
~wominent
i"o~t:R~:~)~:n
premIses, and the onglnal"ce~shall
be pro uced, whenev~ f~qUlred.
2. Each batch of drug imported·int&~i~shall
be accomp~~~ith
a detailed batch test
report and a batch .release· certlfi(al~l;{dHIY)~m1\e\i and authenticated by the
manufacturer with date of testing, date oftePe"ase and the date of forwarding such
reports. The imported batch of each drug shall be SUbjectedto 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 along with the registration holder and his authorised agent.
4. The licensee shall inform thE3licensing authority f()rthvvith in writing in theeventof any
change!n 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.
Central Drugs Standard Control Organisation
Directorate General of Health Services
Ministry of Health & Family Welfare
(Medical Device and Diagnostic Division)
Food and Drug Administration Bhawan
Kotla Road, New Delhi-11 0002
Dated:
- 8 APR 2011
To
/
J~!.s
Depuy Medical P.Ltd,
Plot No.4, Survey No. 277/4, Demni Road,
Village- Dadra-Dadra & Nagar Haveli (U.T.)
Subject: Import Licence under the Drugs and Cosmetics Act 1940 and Rules 1945
thereunde~- regarding.
1. With reference to your application for import Ucence forwarded to this office with
your letter No. No. DepUY/RAl2011/Fe~ru ~-01 dated 28/02/2011 received by
this office vide diary no 9808 dated 0
11.1 enclose licence(s) NO. MD-8521278 dated-._Dni~r:'~~ ~
1 th
Ii
ce(s) has 1 have been granted under the
Dr.ugs.andCo_.eJf(:;_~
'.~¢t.~j~_~O
les1945 thereunder. .
ri~f.
2. ~~~S1t~4~~~~ i~u~d~:~nt~nd v~~~~:~o~~~~~g;f:~:~~~~~:~~~~~~-tJ~:~~~~------in force and as such the Iicence(s) issued under Drugs and Cosmetics Act and
Rules will be in addition to and distinct from any licence(s) which may be necessary
under the Import Trade Control Regulations made of the Government of India,
Ministry of Commerce.
3. The import Iicence(s) mentioned in para (1) above will not accordingly to itself 1
themselves be sufficient authority for import of Drugs covered by that 1 those
licence(s) if under the Import Trade Control RegUlations of the Commerce Ministry
separate Iicense(s) are required for import of such drug(s).
4. I am therefore, to advise you to obtain, where necessary licence(s) for import of
drugs in question under the Import Trade Control Regulations.
5. Any literature or packing accompanying the drugs or any matter stated on the label
should not contravene the provisions of the Drugs and Magic Remedies
(Objectionable Advertisement) Act.
6. The Assistant Drugs Controller (India) and Technical Officer of the Central Drugs
Control Organisation at the ports will be Officers authorized to inspect the premises
of importers establishments for the purpose of Rule 26 of the Drugs and Cosmetics
Act and Rules thereunder.
7. Please acknowledge receipt of this letter and its enclosures.
~UIIY
(Dr. S. Eswara Redd"y)
Asstt. Drugs Controller (I)
Copy forwarded for information to:
1. Asstt. Drugs Controller (India), Ahmedabadl Chennail Cochinl Delhil Hyderabadl
Kandla IKolkatal Mumbail Nhava Sheva.
FORM 10
(See Rules 23 and 27)
Licence to import drugs (excluding those specified in Schedule X) to the Drugs and
Cosmetics Rules, 1945
MIs Depuy Medical P.Ltd, Plot No.4, Survey No. 277/4, Demni Road, Village- Dadra-
Dadra & Nagar Haveli (U.T.) is hereby licensed to import into India during the period for
which the licence is in force, the drugs specified below, manufactured by MIs Depuy
Orthopaedics Inc. PO BOX 988, 700 Orthopaedics Drive, Warsaw, Indiana 46581- 0988,
USA having factory premises at MIs Johnson and Johnson Medical (Suzhou) Ltd,
No.299, Chang Yang Street, Suzhou Industrial Park, Suzhou Jiangsu215126 China and
any other drugs manufactured by the said manufacturer as may from time to time be
endorsed on this licence.
8 APR l011
2. This licence shall be in force from
~
unless it is sooner suspended or cancelled under the said rules.
to 31-01-2014
3. Names of drugs to be.imported:
.•...• ~BD
1. PFC Tibial Tray~.-§.ta.
n.dltP~~b'dolar'
2... APe..x.. H.ole...E
...um.·.,nato
..~9~
~:.~W~~~!i~::~.i"·
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Date: -
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Place: New Delhi
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Dr. S. ,-...,vIU-I,'?.:..•. "..':Li0 (
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Con6i~9t~of Licen~~~ ~I\ \~.
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A photocopy of licence shall be dispfay~
~rominent place in Ie:>tlWbcdNtM Delhi
premises, and the original licence shall be produced, whenever required.
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 the 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.
The licensee shall be responsible for the business activities of the manufacturer in
India along with the registration holder and his authorised agent.
The licensee 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.
GP~
Centrai Drugs Standard Control Organisation
Directorate General of Health Services
Ministry of Health & Family Welfare
(Medical Device and Diagnostic Division)
Food and Drug Administration Bhawan
Kotla Road, New Delhi-110002
Dated'.'-To
8 !~p,R: ?11'11I
1 ,.:
a.
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/
~~s
Leading Health Technologies Pvt Ltd,
Shop No.A-24, Local Shopping Centre,
A-Block, Naraina Vihar, New Delhi-110028
Subject: Import Licence under the Drugs and Cosmetics Act 1940 and Rules 1945
thereunder- regarding.
1. With reference to your application for import licence forwarded to this office with
your letter No. Nil dated 11/03/2011 received by this office vi
diary no 11589
dated 11/03/2011.1 enclose licence(s) NO. MD-292-1275 da
DR tj1')~ 1
these Iicence(s) has 1 have been granted under the Drug
osmeties' Acrr~40
al'ldRules1945 thereunder.
,.~
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2.
3.
4.
5.
6.
7.
~~:;E:~~:~~~~~~~~~E~
---Rules will be in addition to and distinct from any licence(s) which may be necessary
under the Import Trade Control Regulations made of the Government of India,
Ministry of Commerce.
The import licence(s) mentioned in para (1) above will not accordingly to itself 1
themselves be sufficient authority for import of Drugs covered by that 1 those
Iicence(s) if under the Import Trade Control Regulations of the Commerce Ministry
separate license(s) are required for import of such drug(s).
I am therefore, to advise you to obtain, where necessary licence(s) for import of
drugs in question under the Import Trade Control Regulations.
Any literature or packing accompanying the drugs or any matter stated on the label
should not contravene the provisions of the Drugs and Magic Remedies
(Objectionable Advertisement) Act.
The Assistant Drugs Controller (India) and Technical Officer of the Central Drugs
Control Organisation at the ports will be Officers authorized to inspect the premises
of importers establishments for the purpose of Rule 26 of the Drugs and Cosmetics
Act and Rules thereunder.
Please acknowledge receipt of this letter and its enclosures.
~ithfullY
(Dr. S. Eswara Reddy)
Asstt. Drugs Controller (I)
Copy forwarded for information to:
1. Asstt. Drugs Controller (India), Ahmedabadl Chennail Cochinl Delhil Hyderabadl
Kandla IKolkatal Mumbail Nhava Sheva.
FORM 10
(See Rules 23 and 27)
Licence to import drugs (excluding those specified in Schedule X) to the Drugs and
Cosmetics Rules, 1945
Mis Leading Health Technologies
Pvt Ltd, Shop No.A-24, Local Shopping Centre, ABlock, Naraina Vihar, New Delhi-110028 is hereby licensed to import into India during the
period for which the licence is in force, the drugs specified below, manufactured by Mis
InterVascular, Zone Industrielle Athelia I, 13705 La Ciotat Cedex France 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
?O
unless it is sooner suspended or cancelled urider the sal rules.
to 14-09-2013
3.. Names of drugs to be impoil.rte . ~''''"'' 1\ Q rr;.
1. Collagen Coated wove' ." .1fij1ttda'v!dscuIkWPl~theses and Patches
.
of different Size~an
·e ers-lnterGard, Hema~C)r.otidand HemaPatch
i""
2. Collagen Coated.. . '.. parin B.O
.....
n
..dEt~Qitt.e ..d
....VasC~prostheses
and
Patch!s of diff'1
.. zesand ,~ja. I>
I ..~~~ard, He~rin and HemaCarotid
Heparm.
('\~
3. Antimicrobiaf't0Ll1gen
Coate"
ed vascul~Prostheses
and
Patchesofdiffet!nt·s,izes-and.
ard,-SilY.eOibd
HemaPatch SilV~l'"
~
4. Inter Flow™ Ult~a Thin, EPTFE v
-"y
/
~
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~
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t-
Licensi~ority
Dr. 5 C...
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Asstt. C;:-t':'~;:3
1.
2.
3.
4.
, c', .,: Q!'''
1,' ..1
(Ind~a)
Conditions of Licence
D.G.H.:':., F.D.":-" Ehawan
A photocopy of licence shall be displayed in a prominent place iri<q\laPiiMdrlfe'ffl~ethi
premises, and the original licence shall be produced, whenever required.
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 the 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.
.,
The licensee shall be responsible for the business activities of the manufacturer iil
India along with the registration holder and his authorised agent.
The licensee 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.
Centra) Dr~lgsStandard Control Organisatioh
D;rectorata'Ganerai of Health Services
Ministry of Health & Family Welfare
(Medical Device and Diagnostic
Division)
Food and Drug Administration Bhawan
Kotla Road, New Delhi-110002
- 8 f:.
Dated:
To
J
nl')
,-~..;
I".j Ii",
"011
L
~~s Allergan India Pvt.Ltd.
KSEF Bldg. Opp Kims Hospital,
Kondojji Basappa Road, Kalasipalyam,
Bangalore- 560002
Subject: Import Licence under the Drugs and Cosmetics
thereunder- regarding.
Act 1940 and Rules 1945
1. With reference to your application for import licence forwarded to~
office with
your letter No Nil dated 25/02/2011
received by this office vi o:'iary no 107~ 1
dated 07/03/2011.1 enclose licence(s) NO. MD-483-1282 dat
nnfts
1
~~el~~~~n1~~~\~~fe'u~a~f-~~(3n- g_rCl~!~9
.ynder the
[)rY~\!_G9_!!~~_~
~Q
2. I am to point out that the provisions of Drugs ~
Cosmetics Act 1940 and
Rules 1945 are in addition to and not derogation of any other law for the time being
in force and as such the Iicence(s) issued under Drugs and Cosmetics Act and
Rules will be in addition to and distinct from any Iicence(s) which may be necessary
under the Import Trade Control Regulations made of the Government of India,
Ministry of Commerce.
3. The import licence(s) mentioned in para (1) above will not accordingly to itself /
themselves be sufficient authority for import of Drugs covered by that 1 those
Iicence(s) if under the Import Trade Control Regulations of the Commerce Ministry
separate license(s) are required for import of such drug(s).
4. I am therefore, to advise you to obtain, where necessary Iicence(s) for import of
drugs in question under the Import Trade Control Regulations.
5. Any literature or packing accompanying the drugs or any matter stated on the label
should not contravene the provisions of the Drugs and Magic Remedies
(Objectionable Advertisement) Act.
6. The Assistant Drugs Controller (India) and Technical Officer of the Central Drugs
Control Organisation at the ports will be Officers authorized to inspect the premises
of importers establishments for the purpose of Rule 26 of the Drugs and CosmeticsAct and Rules thereunder.
7. Please acknowledge receipt of this letter and its enclosures.
(Dr. S. s
eddy)
Asstt. Drugs Controller (I)
Copy forwarded for information to:
1. Asstt. Drugs Controller (India), Ahmedabadl
Kandla IKolkatal Mumbail Nhava Sheva.
Chen nail Cochinl
Delhil Hyderabadl
_
FORM 10
(See Rules 23 and 27)
Licence to import drugs (excluding those specified in Schedule X) to the Drugs and
Cosmetics Rules, 1945
MIs Allergan India Pvt. Ltd., KSEF Bldg. Opp Kims Hospital, Kondojji Basappa Road,
Kalasipalyam, Bangalore- 560002 is hereby licensed to import into India during the period
for which the licence is in force, the drugs specified below, manufactured by MIs Allergan,
31, rue des Colonnes du Trone, 75012, Paris, France having factory premises at MIs
Allergan, Route de Promery, Zone Artisanale de pre- Mairy, 74370 Pringy, France 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
unless it is Sooner suspended or cancelled under the said rules'.
3.
Names of drugs to be imported:
"r: ARD (nil.
.
1. Hyaluronic Acid with Li40~I,
".
CtjVl~)
(2*0.8 ml, 30G1/,,21il~CifI\' ••,.'BOX-JUVede~tE.tra
XC, also Known as
-;;S'-'u
erm
ith Lidoc
(2*0;& mt,27~''lec4A
.. ~.,e"r~lnt
•.~tus-XG-also-KnoWn-af-~
Lldocam\"
. .~«.
ee:t.""
:?
Li1
u
Place: New Delhi
Date: ':;
8 ~,?~to
::::.
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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 the 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 along with the registration holder and his authorised agent.
4. The licensee shall inform the licensing authority forthwith in writing i,"!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 rponths from the date on which the change takes place