18/08/2011 - Central Drugs Standard Control Organization

To, 

Central Drugs Standard Control Organisation 

Directorate General of Health Services 

Ministry of Health & Family Welfare 

/' 

\./the Controlling Cum Licensing Authority, 

Govt. Hospital Building, 1 st Floor, Murungapakkam, 

Kombakkam-Villianur Road, 

Puducherry-605004 

Food and Drug Administration Bhawan 

Kotla Road, New Delhi-110002 

1 8 AUG lOll 

Sub: -Permission for grant of additional list of products to manufacture 

Intraocular Lens in respect of the facility Mis Appasamy Ocular 

Devices Pvt. Ltd., R.S.No.9/1, 2&3, NH 45-A, Villupuram Main Road, 

Vadamangalam, Puducherry 605 102-Regarding. 

Please refer to your fetter ~ DDC/Drugs/U.II/2011/1726 (i) dated 

25/05/2011 vide diary no. FTS 4~~0{1 dated 21/06/2011 on the subject 

matter. 

~\C~ 

~)y 

Two copies of additional list of products duly approved by Central 

Licence Approving Authority (CLAA) are enclosed herewith for necessary 

action. 

The firm may be jointly inspected periodically and the reports may be 

forwarded to this Directorate for information. 

Copy for information and necessary action to:- 

1. The Dy. Drugs ControUer (I) CDSCO (South Zone) 2 nd Floor, Shastri Bhawan 

Annexe, 26, Haddow Road, Chennai-6

GOVERNMENT OF PUDUCHERRY 

DEPARTMENT OF DRUGS CONTROL 

Government Hospital Building 

First Floor, Murungapakkam 

Kombakkam- Villianour 

Puducherry-605 004 

List of additional drugs permitted to be manufactured under the license in form 28 bearing the No: 

0722 2062 dated 10.09.2007 of M/S.Appasamy Ocular Devices (P) Ltd., R.S.No.9/1,2&3,NH-45 A, 

Villupuram Main Road, Vadamangalam, Puducherry-605 102, INDIA. 

Optic 

# Model Chamber diameter 

(mm) 

Location 

holes 

Overall 

length 

(mm) 

Optic design 

A 

constant 

Angulations 

A Brand: SUPRA PHOB (Hydrophobic, Soft Acrylic, Foldable SingjlePiece IOL, Sterile) 

1 SPNT 300 Posterior 5.75 Nil 12.50 Equi-Biconvex 118.0 0 0 

2 SPNT 200 Posterior 6.00 Nil 13.00 Equi-Biconvex 118.0 0 0 

3 SPNT 300-PL Posterior 5.75 Nil 12.50 Equi-Biconvex 118.0 0 0 

4 SPNT 200-PL Posterior 6.00 Nil 13.00 Eql\li-Biconvex 118.0 0 0 

5 SPNT 300-MF Posterior 5.75 Nil 12.50 Equi-Biconvex 118.0 00 

6 SPNT200-MF Posterior 6.00 Nil 13.0!) Equi-Biconvex 118.0 0 0 

7 SPNT 300-MF-PL Posterior 5.75 Nil ~~ Equi-B iconvex 118.0 0 0 

8 SPNT 200-MF-PL Posterior 6.00 Nil ( '.Uloo EqUii-Biconvex 118.0 0 0 

9 HPNT-300 Posterior 5.75 ~1(~ " 12.50 Equj-Biconvex 118.0 00 

10 HPNT-200 Posterior 6.00 ~l~WJ 13.00 Equi-Biconvex 118.0 0 0 

11 

ULTRASMART 

HP 

Posterior 6.0P Nil I] .00 Equi.Biconvex ] 18.0 0 0 

12 

ULTRASMART 

HPM 

Posterior 6.00 Nil ] 1.00 Equi~Biconvex 118.0 0 0 

Central Licence Approving Authority 

Signature 

Licensing 

Signature 

Authority 

!"cl~ __~ ~c>rt~ifj; ..n"fqs ww~.rfrm) 

,"'.IT.wJJ ~::t-nri~f~~ 

Pt· -n Glhi" " 0.)(12

GOVERNMENTOFPUDUCHERRY 




Kombakkam- Villianour 


List of additional drugs permitted to be manufactured under the license in form 28 bearing the No: 07 22 

2062 dated 10.09.2007 of M/S.Appasamy Ocular Devices (P) Ltd., R.S.No.9/1 ,2&3,NH-45A, 

Villupuram Main Road, Vadamangalam, Puducherry-605 102, INDIA. 

Optic Overall 

Optic A Angul 

# Brand Chamber diameter length 

design constant ations 

(mm) (mm) 

A Brand: SUPRAPHOB (Hydrophobic Soft Acrylic, Aspheric Single Piece IOL, Sterile) 

Dioptre 

I 

SUPRAPHOB 

5.75 to 12.50 to -40 to +40 

Posterior 6.50 (with 13.50 (with Biconvex I 18.0 0° (with 0.5 

0.25 0.25 increments) 

increments) increments) 

B 

Brand: SUPRAPHOB BBY (Hydrophobic Soft Acrylic, Aspheric Yellow Single Piece IOL, 

Sterile) 

5.75 to 12.50 to he r,,"< 

-40 to +40 

2 SUPRAPHOB 

6.50 (with 

Posterior 

13.5~'tsh Biconvex 118.0 0° (with 0.5 

BBY 0.25 

increments) 

increments)( )~~~ments) 

! 

l) 

.• 

" 

/, 

C 

3 

Brand: SUPRAPHOB MS (Hydrophobic Soft Acrylic, Aspheric Yellow Single Piece IOL, 

Sterile) 

5.75 to 11.00 to -40 to +40 

SUPRAPHOB Posterior 6.50 (with 13.50 (with Biconvex 118.0 0° (with 0.5 

MS 0.25 0.25 increments) 

increments) increments) 

Central Licence Approvi 

Signature 

Licensing Authority 

Signature 

r,. ;;.~'. oJ 

..~ ..,.'". i ,"",:·r.\r':r,;~ )J'n';,;/Ili~ llrm) 

'~.•n"l~,,1 n en q?pf;'~'l/lT7JTf 

Cnt:~.Gt"n'3(AI Of Hi:~n!th~,A,rv'i('03S 

rOl ..pl";;'»Vfl;"\ ~OT,la p~(t. 

"'1"'" Dell'll-,iOi)02




To, 

Foodand Drl\lgAdministrationBhawan 

Kotla Road,New Delhi-110002 

Dated: 1 8 AUG 2011 

~e Commissioner, 

Food & Drugs Control Administration, 

Gujarat State, Dr. Jivraj Mehta Bhavan, 

Block No.8, 1 st Floor, 

Gandhinagar. 382010 

Sub.: - Permission for grant of additional products permi$sion to manufacture 

Medical Device in respect of the facility MIs. Amigo Surgicare Pvt. Ltd., 

Plot No. 780, Sola-Santej Road, Rakanpur, Tal. Kalol, Distt. Gandhinagar- 

382 721- Reg. 

Please refer to your letter no. AP/Amigo/2011/Hc/44953/B dated 22/06/2011 

received by this office vide diary no FTS 43204/2011 dat¢d 27/06/2011 on the 

subject matter 

Two copies of the additional Product list U~al 50 Products) duly approved by 

Central Licence Approving Authority ~t.eOt'(e \nclosed herewith for necessary 

action. 

X~\Ct. 

The firm may be joQy inspected periodically and the reports may be 


(Dr. Sunnder Singh) 

Drugs Controller General (I) 

The Asst. Drugs Controller (I), Sub-Zonal Office, Central Drug Standards Control 

Organization, Old Terminal BUilding, Air Cargo Complex, Airport, Ahmedabad-380 

003 GUjarat.

Name of the Manufacturer: AMIGO SURGICARE PVT. LTD. 

Plot.No: 780, Sola - Santej Road, Via 

Science City, Rakanpur - 382721. 

Dist: Gandhinagar. 

LIST OF PRODUCTS AS 2 ND BRAND NAME 

1ST BRAND NAME: AMIGO 

( .. ') 

~..../ 

1. 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

9. 

10. 

I.V Cannula (Intravenous Cannula) 

"MAGAW" Brand Sterile Disposable single use Intra Venous Cannula. 

Size:14G- 16G, 18G- 20G, 22G - 24G. 

Catheter Sterile Disposable Single UseRyle'sTube. 

"MAGAW" Brand Sterile Dis osable sin Ie use R Ie's Tube. 

Catheter Sterile Disposable Single Usestomach Tube. 

"MAGAW" Brand Sterile Dis osable sin Ie use stomach Tube. 

Catheter Sterile Disposable Single Usefeeding Tube. 

"MAGAW" Brand Sterile Dis osable sin Ie use feedin Tube. 

Catheter Sterile Disposable Single UseInfant Mucas Extractor. 

"MAGAW" Brand Sterile Dis osable sin Ie use Infant Mucas Extractor. 

Sterile Disposable Single use Scalp Vein Set. 

"MAGAW" Brand Sterile Dis osable sin I se Scal Vein Set. 

Catheter Sterile Disposable Single Use ominal Droinage Kit. 

"MAGAW" Brand Sterile Dis osable e use Abdominal Draina e Kit. 

Catheter Sterile Disposable Singl Nasal Oxygen Catheter. 

"MAGAW" Brand Sterile Dis 0 sin Ie use Nasal Ox en Catheter 

Catheter Sterile Disposable e UseSuction Cathe~er. 

"MAGAW" Brand Sterile Dis sable sin Ie use Suction Catheter. 

Catheter Sterile Disposable Single UseUrethral Catheter. //\oo'V 

"MAGA W" Brand Sterile Dis osable sin Ie use Urethral Cathete '1~' 

~ 

For, Commissioner 

Food & Drugs Control Administration 

GUjarat State 

2 2 JUN 2011

Name of the Manufacturer: 

AMIGO SURGICAREPVT.LTD. 

Plot. No: 780, Sola - Santej Road, Via 

Science City, Rakanpur - 38272'1. 


LIST OF PRODUCTS AS 3 RD BRAND NAME 

1 ST BRAND NAME: AMIGO 

2 nd BRAND NAME: MAGAW 

') 

,-') 

l. 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

9. 

10. 


" SYMON" Brand Sterile Disposable single use Intra Venous Cannula. 



" SYMON" Brand Sterile Dis osable sin Ie use R Ie's Tube. 


II SYMON II Brand Sterile Dis osable sin Ie use stoma h Tube. 


II SYMON" Brand Sterile Dis osable sin Ie use feedin Tube. 


II SYMON II Brand Sterile Dis osable sin Ie use Infant Mucas Extractor. 

Sterile Disposable Single use Scalp Vein Set. 

II SYMON" Brand Sterile Dis osable sin t e Seal Vein Set. 

Catheter Sterile Disposable Single U¥i~ dominal Drainage Kit. 

II SYMON" Brand Sterile Dis osa Q ~ Ie use Abdominal Draina e Kit. 

Catheter Sterile Disposable i~ se Nasal Oxygen Catheter. 

" SYMON" Brand Sterile D' ~qble sin Ie use Nasal Ox en Catheter 

Catheter Sterile Disposable Single UseSuction Catheter. 

" SYMON" Brand Sterile Dis osable sin Ie use Suction Catheter. 

Catheter Sterile Disposable Single Use Urethral Cathefer. 

" SYMON" Brand Sterile Dis osable sin Ie use Urethral Cathete 

L 

:n. 

~~;rp?t~ 

Dr.~~URI/,:.i::i;S!"ICf1 

;l\r:ll :'~-( f'1il"!.ii[>c"q, 'lo'.tr"'((r (!~l 

';'em::.;n {l"~l 'r(;if:~:f~:~TR'r

Name of the Manufacturer: 

AMIGO SURGICAREPVT.LTD. 




Manufacturing 

License in Form - 28 Mfg. Lic, No.: G/28/1345. 

LIST OF PRODUCTS AS 5 TH BRAND NAME 



3 RD BRAND NAME: SYMON 

4 TH BRAND NAME: Life Safty 

'\ 

! 

) 

l. 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

9. 

10. 


" HARSONS" Brand Sterile Disposable single use Intra Venous Cannula. 

Size: 14G - 16G, 18G - 20G, 22G - 24G. 

Catheter Sterile Disposable Single Use Ryle's Tube. 

" HARSONS" Brand Sterile Dis osable sin Ie use R Ie's Tube. 

Catheter Sterile Disposable Single Use stomach Tube. 

" HARSONS" Brand Sterile Dis osable sin Ie use stomach Tube. 

Catheter Sterile Disposable Single Use feeding Tube. 

" HARSONS" Brand Sterile Dis osable sin Ie use feedin Tube. 

Catheter Sterile Disposable Single Use Infant Mucas Extractor. 

" HARSONS" Brand Sterile Dis osable sin Ie use Infant Mucas Extractor. 

Sterile Disposable Single use Scalp Vein Set., 

" HARSONS" Brand Sterile Dis osable si "'&se Seal Vein Set. 

Catheter Sterile Disposable Single UJ~ tiominal Drainage Kit. 

" HARSONS" Brand Sterile Dis os • sin Ie use Abdominal Draina e Kit. 

Catheter Sterile Disposable S· se Nasal Oxygen Catheter. 

" HARSONS" Brand Sterile sable sin Ie use Nasal Ox en Catheter 

Catheter Sterile Disposable Single Use Suction Catheter. 

" HARSONS" Brand Sterile Dis osable sin Ie use Suction Catheter. 

Catheter Sterile Disposable Single Use Urethral Catheter, /' & DRUGS 

" HARSONS" Brand Sterile Dis osable sin Ie use Urethral Catheter:/~oC)\) ~~ 

I(${ 9-~ 

\~u:.~ ",}h 

'I\IDHINAG;"~* 

For, Commissio,?er 

Food & Drugs Control Administration 

Gujarat State 

2. 2 JUN ZUll


Plot. No: 780, Sola - Santej Road, Via 






3 RD BRAND NAME: SYMON . 


5 TH BRAND NAME: HARSONS 


" B.M.I" Brand Sterile Disposable single use Intra Venous Cannula. 

Size:14G- 16G, 18G - 20G, 22G - 24G. 


" B.M.!" Brand Sterile Dis osable sin Ie use R Ie's Tube. 


" B.M.!" Brand Sterile Dis osable sin Ie use stomach Tube. 


" B.M.I" Brand Sterile Dis osable sin Ie use feedin Tube. 


" B.M.I" Brand Sterile Dis osable sin Ie u e Infant Mucas Extractor. 

Sterile Disposable Single use Scalp v~~t. 

" B.M.!" Brand Sterile Dis osable s· use Seal Vein Set. 

Catheter Sterile Disposable ~ir se Abdominal Drainage Kit. 

" B.M.!" Brand Sterile Dis :M e sin Ie use Abdominal Draina e Kit. 

Catheter Sterile Dispos Single UseNasal Oxygen Catheter. 

" B.M.!" Brand Sterile Dis osable sin Ie use Nasal Ox en Catheter 

Catheter Sterile Disposable Single UseSuction Catheter. 

" B.M.!" Brand Sterile Dis osable sin Ie use Suction Catheter. 

Catheter Sterile Disposable Single UseUrethral Catheter. 

" B.M.I" Brand Sterile Dis osable sin Ie use Urethral Catheter. 

For, C 

missioner 

Food & Drugs Control Ad;ninistrafiofl 

GUjaraf State __ 







1 ST BRAND NAME: AMIGO. 


3 RD BRAND NAME: SYMON 


5 TH BRAND NAME: HARSONS 

1. I.V Cannula (Intravenous Cannula) 

" B.M.I" Brand SterileDisposable single use Intra Venous Cannula. 


2. Catheter Sterile Disposable Single UseRyle'sTube. 

" B.M.I" Brand SterileDis osable sin Ie use R Ie's Tube. 

3. Catheter Sterile Disposable Single Usestomach Tube. 

" B.M.I" Brand SterileDis osable sin Ie use stomach Tube. 

4. Catheter Sterile Disposable Single Usefeeding Tube. 

" B.M.!" Brand SterileDis osable sin Ie use feedin Tube. 

5. Catheter Sterile Disposable Single UseInfant Mucas Extractor. 

" B.M.I" Brand Sterile Dis osable sin Ie use Infant Mucas Extractor. 

6. SterileDisposable Single use Scalp Vein S . 

" B.M.I" Brand SterileDis osable sin I Seal Vein Set. 

7. Catheter Sterile Disposable Singl ~e bdominal Dminage Kit. 

" B.M.!" Brand Sterile Dis osa . Ie use Abdominal Draina e Kit. 

8. Catheter Sterile DisposablEQ gle UseNasal Oxygen Catheter. 

II B.M.I" Brand SterileDis osable sin Ie use Nasal Ox en Catheter 

9. Catheter Sterile Disposable Single UseSuction Catheter. 

II B.M.!" Brand SterileDis osable sin Ie use Suction Catheter. 

10. Catheter Sterile Disposable Single UseUrethral Catheter. 

II B.M./" Brand Sterile Dis osable sin Ie use Urethral Catheter. 

For, C 

Food & Drugs 

missioner 

Control Aiministrafiofl 

GUjara! State- 





To, / 

JThe Drugs Controller, 

Dte. General of Health Services, 

Civil Dispensary, Sector 20, 

Panchkula (HARYANA). 



i1 8 AUG 2011 

Sub.: - Approval of additional products viz. I.V. Cannula with brand name 

VARDHMAN in respect of. Mis. iUfe Medical Devices Pvt Ltd, # 86, 

Sector 56, Phase-IV, I.E. Kundli, Sonepat 131(1)28Haryana - Reg. 

Please refer to your letter no. 12/67-4Drugs-I-2011/4928 dated 

13/06/2011 vide diary no. FTS 41503/2011 dated 22/06/2011 on the SUbject 

matter. 

Two copies of product list I.V. Cannula with brand name VARDHMAN 

amended by inserting the word "For E~se Only" and validity period, duly 

approved by Central Licence ...f\~~g Authority (eLM) are enclosed 

herewith for necessary a~~ 

C"- 

o . 

The firm may be jointly inspected periodically and the reports may be 


(Dr. S rin· er Singh) 

Drugs Contro ler General (I) 

Copy for Information and necessary action to:- 

The Dy. Drugs Controller (I), casco (North Zone), Segment Wing 'A', 1 st 

Floor, Central Govt. Office Building, Kamla Nehru (Central Govt. Enclave), 

Hapur Road Ghaziabad

iLife 

i·X ••• 

" F6 R. G~PaIZT ONi-)''' 

LIST OF ADDITIONAL ITEMS UNDER MFG. Lie No. 673-8 un VA, Li P lJPTo P+~Sfp 

. _u___ 1 

Sterile Intravenous 

Cannula 

14G,16G,17G,18G,2OG,22G,~4G,25G 

26G 

& 

.•... 

-_., ,"'''' pliT ITD 0', 

F ILt 'Fl: "'FDli':.: 'i ' .!,iJ I ~ • ' 

or r 

r~,.' 

\'[1_ 1"li.' 1'" '. - • 'Y 

~ \v

iLife 






.1 8 AUG lOll 

To, 

~ Drugs Controller, 



Panchkula (Haryana). 

Sub.: - Approval of additional products of Medical Devices viz. Sterile I.V.Cannula 

viz. CANUVEIN Safety (Duplicate Copy) in respect of Mis. Harsoria 

Healthcare Pvt. Ltd., 110-111, Phase-IV, Udyog Vihar, Gurgaon Haryana 

(India) - Reg. 

Please refer to your letter no. 2817-3 Drugs-1-2011/5503 dated 07/07/2011 

received by this office vide diary no. FTS 47034/2011 dated 12/07/2011 on the subject 

matter. 

< 

'\ 

Two copies of additional products of M~Q~Devices viz. Sterile I.V. Cannula viz. 

CANUVEIN Safety (Duplicate COPY~.d. .~pproved by Central Licence Approving 

Authority (CLAA) are enclosed herewit.. ecessary action. 

~ 

() 

The firm may be jointly inspected periodically and the rreportsmay be forwarded 

to this Directorate for information. 

(Dr. Surinder Singh) 

Drugs Controller General (I) 

The Dy. Drugs Controller (I), CDSCO (North Zone), Segment Wing 'A', 1 st Floor, Central 

Govt. Office Building, Kamla Nehru (Central Govt. Enclave), Hapur Road, Ghaziabad

list of Medical Devices (notified as drug) to be manufactured by M Is Harsoria 

Health care (P) Ltd, 

110-111 phase-lV Udyog Vihar, Gurgaon (Hr) Under Drug Manufacturing Ucense no: 637-B(H) on 

FORM -28 for export sale. V~ tA.f~ '8'~.'}A)' I 

Item NO description Gauges Brand Name 

24G&~t, 

I '1 . 

C/' 

"sterile Disposable Safety IV Cannula with 

12G, 13G, 1-G, 100, 11G, 100, 2OG, 22G, 

1. Catheter and with injection valve for Single CANUVEIN Safety 

use Only" 

Appmod hem ••. t2:!::!::.::.~:c-.. 

Except Sr. No..• _-_.~_ 

JI ~\\r. \.. 

•.••....•..••..•__ •....••... 

....,"" 1A' J1 

(R.M. Sharma} 

State Drugs ControUer 

(Controllin & licensing AuthoritV) 

Foo rug ministration Haryani.l.

Ust of Medical Devices (notified as drug) to be manufactured by MIs Harsoria Health Care (P) ltd, 

110-111 pha~V Udyog Vihar, Gurgaon (Hr) Under Drug Manufacturing Li.cense no: 637-8(H) on 

FORM -28 for export sale. V'~ ~ , s' 4 ' ~ " 

"Sterile Disposable Safety IV Cannula with 

1. Catheter and with injection valve for Single 

use Only" 

12G, 13G, 14G, 100, 17






.1 8 AUG 2011 

To, 

~e Drugs Controller, 




Sub.: - Approval of additional products of Medical Devices viz. Scalp Vein Set in 

respect of MIS Hindustan Syringes & Medical Devices Ltd., 174, Sector 25, 

Ballabgharh (Faridabad) 121004-Reg. 

Sir, 

Please refer to your letter no. 3/43-4 DrUgS-1-1J/~i1d 05/07/2011 received 

by this office vide diary no. FTS 46676/201 O~f\(J'Je7/2011 

on the subject matter. 

Two copies of additional product duly approved by Central Licence Approving 

Authority (CLAA) are enclosed herewith for necessary action. 

The firm may be jointly inspected periodically and the reports may be forwarded 

to this Directorate for information. 

Copy for Information and necessary action to:- 

The Dy. Drugs Controller (I), CDSCO (North Zone), Segment Wing 'A', 1 st Floor, Central 

Govt. Office Building, Kamla Nehru (Central Govt. Enclave), Hapur Road, Ghaziabad

HINDUSTAN SYRINGES 

& MEDICAL DEVICES lTD. 

MANUFACTURERS OF CE MARKED 

STERILE MEDICAL DISPOSABLES 

Brand Name 

f • 

Q•... , Size 

,. Scalp Vein Infusion Set 

'1. ..Scalp Vein Infusion Set 

(with additional function 

Narindra Nath 

Managing Director 

ks 

of safety) 

SELECT 1~ ~~, 2OG, 21G, 22G, 23G, 24G, 25G & 26G 

(" 

SELECTPREVENTX'~)':tEG, 19G, 2OG, 21G, 22G, 23G, 24G, 25G & 26G 

HINDUSTAN SYRINGES 

& MEDICAL DEVICES lTD. 

MANUFACTURERS OF CE MARKED 

STERILE MEDICAL DISPOSABLES 

L'L~(:~~~_.~3_~-g(H) V"Jii{ Ur ~.Qjl~\').ol( 

="'~"="'--=-~c_=-~_ 

.._.._.._~~_ .._.__~=._=__ 

~_-=-===~.= __ =~~ 

Brand : SELEet & SELECT PREVENT 

Brand Name ~ 

I. Scalp Vein Infusion Set 

SELECT 

le(jl;"\OO, 21G, 22G, 23G, 24G, 25G & 26G 

1 

Scalp Vein Infusion Set 

(with additional function of safety) 

. 

for Hindustan Syringes & Medical Devices Ltd. 

Narindra Nath 

Managing Director 

ks 

SELECT PREVE~{\c,~8G, 

;:gr. ~\ ~ ""?:', tf'h? 

Dr. SURINDER SINGH 

0ft>f;!j ~7f~ C~\?fl!Drugs contrOller (Ino'ia) 

:r~1~;:.71'~~Jr ~~ 

Ole. Gar'ira! of Health Servioa" 

I':'E)AflhcW/M, K(jM ~~~, 

I:-Jpw G~lhHlf:1~f)2 

0






,i1 8 AUG 2011 

The State Drugs Controller, 




Sub.: - Approval of additional products viz. tV. Cannula (PROMED,WINNER 

USA, TPK) in respect of MIs. Mediplus (India) Limited 1261-1262 MIE 

Bahadurgarh Haryana 124507 (India) - Reg. 

Please refer to your letter no. 10/100-2 Drugs-I-201115061 dated 17/06/2011 

• 

received by this office vide diary no. FTS 43374/2fl dated 28/06/2011 on the 

subject matter. 

~ 

Two copies of list of product ~a(

~Ci'J§ 

MEDIPLUS 

An ISO 9001 : 2008 COMPANY 

MEDIPLUS (INDIA) LIMITED 

1261-1262 MIE PART B 

BAHADURGARH HARY ANA-124507 

{ 

IV Cannula With 

Injection port 

, 

14G, 16G, 17G, 18G, 20~'\ PROMED 

22G, 24G, 26G CO 

14G, 1§,,~\fO~G, 20G, WINNER USA 

22~~2()G 

. I ~ 

Approved IterR No••..•.•.••••..._ .•.•..tG •••••••••., , •••• 

Except Sr. No. -_._ •••••••••_•..••~ •••••_ ••. 

~~IL 

(n.M. Sharma) 

5ista ONos Cont,~ 

IControKing & Licensing Authority) 

Food & Drug Administration, Haryana 

~ 

, ;Ji'~f'}jFL.u:1' U"j';""" 

'~'~. ,"urAl . 

.,'tt;~horised S/;gl" "fO' ~ 

.lea i¥ 

:51. t=rr~ 

Df. ~·_·\..;~

~~~- 

MEDIPLUS 

An ISO 9001 : 2008 COMPANY 

LIST OF PRODUCT 

MEDIPLUS (INDIA) LIMITED 

1261-1262 MIE PART B 

BAHADURGARlI HARYANA-124507 

Drug Manufacturing Licence No. 646 B (H) Valid up to 31-05-2012 

• 

~ ~ 

S.NO. Description GAUGE .~ 

IV Cannula With Injection Valve with CO; 

14G, 16G, !~ 1§G, 

20G 

, 

wings 

22G,24G,(5t1f 

X~ 

O~ 

. AppIovedherA N•• -.L_.Ci ~_.9~ J 

&Cept Sr. No..••••••••.••._ •.•.•_---- ..•.•....-...•.•....... 

(R.M. Sharma) 

Stat. Drugs ContrQller 

(Controlling & licensing Authority) 

Food & lkug Administration, Harvana 

/1r 

Regd.Office: 

37/5 

Punjabi Bagh (East). 

New Delhi-110026 

(INDIA) 

Marketing Office: 405-406, 4th Floor, R.G. Trade Tower, Netaji Subhash Place, 

Pitampura, New Delhi -110034 

Tel.: +91-11-27353189/47047481, Fax: +91-11-47082818 

E-mail: info@mediplusdisposillbles.com.export@mediplusdisposables.com 

Works: 1261-1262, M.I.E., Bahadurgarh - 124507, Haryana (INDIA) 

Tel. : +91-1276-267269/267629, Fax: +91-1276-268843, 

E-mail: plant@mediplusdispo$ables.com 

Website: www.mediplusdispo~ables.com

To, . 




~ Controlling Cum Licensing Authority, 

Govt. Hospital Building, 1 st Floor, Murungapakkam, 

Kombakkam-Villianur Road, 


Food and Drug: Administration Bhawan 


1 8 AUG 2011 

Sub: -Grant of permission to manufacture medical devices i.e. IOL (list 

attached) in form 28 to MIs Eye Photonics India Pvt. Ltd., R.S. No. 

9/3, 4 & 5, NH 45-A, Villupuram Main Road, Vadamangalam, 

Puducherry - Reg. 

Please refer to your letter no. DDC/Drugs/U.II/2011/1792 dated 02/06/2011, 

received by this office vide diary no. FTS 37974/2011 dated 11/06/2010 on the 

CO~'i 

subject matter. 

~f\Ct. 

Two copies of the licences al~~ with list of products duly approved by 

Central Licence Approving Authority (CLAA) with product list are enclosed 

herewith for necessary action. 

You are requested to direct the firm to submit a complete set of 

application as per guidelines issued by this directorate to this office, for record 

purposes 

The firm may be jointly inspected periodically and the reports may be \ 

forwarded to this Directorate for information. \ 

Copy for information and necessary action to:- 

1. The Dy. Drugs Controller (I) CDSeO (South Zone) 2 nd Floor, Shastri Bhawan 

Annexe, 26, Haddow Road, Chennai-6

wm'PA 



FORM 28 

[See Rule 76J 

Licence to manufacture for sale [or for distribution of) drugs specified in 

Schedules C, C (1) [excluding those specified in Schedule XJ 

1. Mrs. R.V.A. Rajeswari, Managing Director of, MIs Eye Photonics (India) 

Pvt. Ltd., is hereby licensed to manufacture at the premises situated at R.S. No.9/3, 

4 & 5, NH-45A, Villupuram Main Road, Vadamangalam, Puducherry - 605 102 

the following categories of drugs, being drugs specified in Schedules C, C (1), 

[excluding those specified in Schedule XJ to the Drugs and Cosmetics Rules, 1945. 

2. Names of approved [competent technical staff) 

1. Mr. R. Thirumalaikumar, RE., (Mechanical) for ManUfacturing 

2. Mr. A. Kanniappan, D.M.E (Mechanical), for Manufacturing 

3. Mr. V. Dineshkaran D.E.E.E for Testing 

4. Mr. V. Ashok Kumar, M.Sc., (Microbiology) for Testing 

. 

3. The licence authorizes the ~ale by w "hofesale dealing and storage 

for sale by the licensee of the drugs manufa8u ~ under the licence, subject to the 

conditions applicable to licence for sale.x.~'~ 

4. The licence shall be in forcO(,m 01.06.2011 to 31.05.2016 

5. The licence is subject to the conditions stated below and to such other 

conditions as may be specified in the rules for the time being in force under the 

Drugs and Cosmetics Act, 1940. 

Conditions o(Licence ,~,'~', ";0~,~;~ -'~.i"~H 

I. This licence and any certificate 

r ,.•: t .• ", ' .Ii t,r'j'J~ L,."H '•• ., :lntfit!!l 

of renewal in force shall be kcpt '¥J ',~I1'e'~ifi?C~d~",~~ shall be 

produced at the request of an Inspector appointed under the Drugs and Cosmetics Act, .I~~~;,~ of Q8'th $lolrviC6! 

2. If the Licensee wishes to undertake during the currency of the licence the mal~~!f,~.~JiYfitt8g:specified in 

Schedules C and C (I) lexcluding those specified in Schedule XI not induded above. he sho"ld'#;p~lb the Licensing 

Authorit)' for the necessary endorsement as providcd in Rule 75(3). This licence will be deemed to extend to the items so 

endorsed. 

3. Any change in the (competent technical staff! named in the licence shall be forthwith reported to the Licensing 

Authority. 

4·1* * *1 

5. The licensce shall inform the Licensing Authol'ity in writing in the evcnt of any change in the constitution of the 

firm opcrating under the licence. Where any change in the constitution of the firm takes place. the current liceuce shall be 

deemed to be valid for a maximum period of three months from the date on which the chang4 takes place unless. in the 

meantime, a fresh licence has been taken from the Licensing Authorit)' in the name of t~e firm with the changcd 

constitution. t.





Kombakkam - Villianour Road 


List of drugs permitted to be manufactured under the license in form 28 bearing the No: 11 22 3059 

Dated: 01.06.2011 of MIS. Eye Photonics (INDIA) Pvt. Ltd., R. S. No. 9/3,4 & 5, NH-45 A, 

Villupuram Main Road, Vadamangalam, Puducherry-605 102, INDIA for the following products 

# Model Chamber Optic Location Overall Optic A Angulations 

diameter holes length design Constant 

(mm) 

A Brand: APPALENS (PMMA, Single Piece IOL) 

I. 100 Posterior 5.00 Nil 12.00 Biconvex 118.4 100 

2. 101 Posterior 5.25 Nil 12.00 Biconvex 118.4 100 



. 

5. 105 Posterior 6.00 /Nil 13.00 Biconvex 118.2 100 


7. 107 Posterior 6.00 Nil 12.50 13iconvex 118.2 100 

8. 108 Posterior 6.50 Nil 12.5~(; "Siconvex 118.2 100 

9. 109 Posterior 6.50 Nil 1~ Biconvex 118.2 100 

10. 110 Posterior 6.50 Nil t~~·50 Biconvex 118.2 100 

II. 205 Posterior 6.00












(mm) 

(mm) 

B Brand: LIBERTY LENS (PMMA, Single Piece IOL) 

18. 100L Posterior 5.00 Nil 12.00 Biconvex 118.4 10° 

19. 101 L Posterior 5.25 Nil 12.00 Biconvex 118.4 10° 

20. 102L Posterior 5.50 Nil 12.00 Biconvex 118.4 10° 





25. 108L Posterior 6.50 Nil 12.50 Biconvex 118.2 10° 

26. 109L Posterior 6.50 Nil 13.00 Biconvex ~2 10° 

27. 1l0L Posterior 6.50 Nil 13.50 Biconvex ..Q1'18.2 10° 

28. 205L Posterior 6.00 0.35x2 13.00 Biconv.ex J 118.2 10° 

29. 206L Posterior 6.00 0.35x2 13.50 B' 

I 

":.c 

v 

x 118.2 10° 

.c "- 

30. 207L Posterior 6.00 0.35x2 12.50 I ,~ioonvex 118.2 10° 

31. 208L Posterior 6.50 0.35x2 12.50 "Biconvex 118.2 10° 

" 

32. 209L Posterior 6.50 0.35x2 13.00 Biconvex 118.2 10° 

33. 210L Posterior .6.50 0.35x2 13.50 Biconvex 118.2 10° 

34. 302L Anterior 6.00 Nil 12.50 Biconvex 115.3 10° 

Central Licence Approving 

A 

Licensing 

Authority 

Signature 

Signature 

Name 

Designation 

(ft r. 

Controlling 'A







List of drugs permitted to be manufactured under the license in form 28 bearing the No: 11 223059 

Dated: 01.06.2011 of MIS. Eye Photonics (INDIA) Pvt. Ltd., R. S. No. 9/3, 4 & 5, NH-45 A, 




(mm) 

(mm) 

C Brand: HEERA LENS (PMMA, Single Piece IOL) 

35. 100H Posterior 5.00 Nil 12.00 Biconvex 118.4 J0 0 

36. 10lH Posterior 5.25 Nil 12.00 Biconvex 118.4 10° 

37. 102H Posterior 5.50 Nil 12.00 Biconvex 118.4 10° 



40. 106H Posterior 6.00 /Nil 13.50 Biconvex 118.2 10° 

41. 107H Posterior 6.00 Nil 12.50 Bi~~ex 118.2 10° 

42. 108H Posterior 6.50 Nil 12.50 c 

ft~nvex 118.2 10° 

'::I~ 

43. 109H Posterior 6.50 Nil ..•.,rf't1P ~ Biconvex 118.2 10° 

44. 110H Posterior 6.50 N(!\r












(mm) 

(mm) 

D Brand: APPALENS PLUS (PMMA, Single Piece IOL) 

52. SQIOO Posterior 5.00 Nil 12.00 Biconvex 118.4 10° 

53. SQIOI Posterior 5.25 Nil 12.00 Biconvex 118.4 10° 

/ 

54. SQI02 Posterior 5.50 Nil 12.00 A~T1ttex 118.4 10° 

. 

- 

55. SQI03 Posterior 5.50 Nil .•I.l~ \, Jfficonvex 118.4 10° 

56. SQ207 Posterior 6.00












(mm) 

E Brand: SWISS LENS (pMMA, Single Piece IOL) 

59. SQ50120 Posterior 5.00 Nil 12.00 Biconvex 118.4 10° 

60. SQ52120 Posterior 5.25 Nil 12.00 Biconvex 118.4 10° 

. 

61. SQ55120 Posterior 5.50 Nil 12.00 ~onvex J 18.4 10° 

62. SQ55125 Posterior 5.50 / Nil ~~.~\. Biconvex 118.4 10° 

63. SQ60125 Posterior 6.00 0.35~, ~50 Biconvex 118.2 10° 

64. SQ60130 Posterior 6.00 0~' 13.00 Biconvex 118.2 10° 

65. SQ65130 Posterior 6.50 0.35x2 13.00 Biconvex 118.2 10° 

(mm) 

- 


Signature 

Licensing 

Signature 

Authority












(mm) 

F Brand: APPALENS(PMMA, Multi Piece IOL) 

66. BMC520 Posterior 5.25 Nil 12.00 Biconvex 118.4 10° 

- 

67. BMC602 Posterior 6.00 0.35x2 12.52c ~iG\>nvex 118.2 10° 

/ 

68. BMC652 Posterior 6.50 0.35x2 Biconvex 118.2 10° 

-~~ , .. 

69. BMJ652 Posterior 6.50 0~~~' 

- 

'-13.00 Biconvex 118.2 10° 

(mm) 


Signature 

Licensing 

Signature 

Authority 

:,~n. 't!:f~;;:"" ft::hr 

f)r. ~::)J,;; ;~~c ...~c.,~~/..;H 

,~ 0.:: :-",1: . 1i'7~~ Jr~. ,,_ ~~. ",'.,';. 

~"fJF:l ~~,:1q,:"rr~':lrr'71'~ 

Gf~n~:Al ()f Hvaftt\ S~rv'r;9fJ. 

-T)II !:'''!'l''''i'lr'. I












(mm) 

(mm) 

G Brand: ACRYFOLD (HEMA, Hydrophilic, Foldable Single Piece IOL) 

70. 701 Posterior 6.00 Nil 11.00 Biconvex 118.0 0° 

. 

71. 601 Posterior 6.00 Nil 12.00 B~~vex 118.0 0° 

72. 502 Posterior 6.00 Nil 123°( 0Yonvex 118.0 0° 

73. MF 605 Posterior 6.00 Nil.G~ \G~ Biconvex 118.0 0° 

1- 

74. MF 705 Posterior 6.00 N\L) , 11.00 Biconvex 118.0 0° 

75. RL 700 Posterior 6.00 Nil 11.00 Biconvex 118.0 0° 

.' 


Signature 

.f:;.~~ .•~:~ 

~...,.. "':.: '~'. ~,t? 

r,c ~3dRl"r~fjERSIN(;H . 

!~r.~\ /:~'?~Prl:~~: ;~M) 

ljl~~f~ .~np,,'~l (!f HA~lt~1 ~~r'\l\t)tU} 

~D/\ ~~?v·:V·'. K",,:q ~t;)~QI 

r•."" tNllli.ll ij0J~: 


Signature 

(P. 

,iii












(mm) 

(mm) 

H Brand: HEERAFOLD (HEMA, Hydrophilic, Foldable Single Piece IOL) 

76. 70lH Posterior 6.00 Nil 11.00 Biconvex 118.0 0° 

77. 60lH Posterior 6.00 Nil 12.00 Biconvex 118,0 0° 

.-c. Ii> '" 

78. 502H Posterior 6.00 Nil 12.0~ 

118.0 0° 

I' 

u~··vex 

79. MF 605H Posterior 6.00 Nil 

'(~~~ 

Biconvex 118.0 0° 

80. MF 705H Posterior 6.00 Nil \)' 11.00 Biconvex 118.0 0° 

81. RL 700H Posterior 6.00 Nil 11.00 Biconvex 118.0 0° 



Signature 

·~"'l-.~·rfnL~ 

t}r. ~uRTr~DERSt",l(.~ti 

~t!>:- fr-r.;;·1;tqr~~~{\ 11::tuOI.: eOf, f'l 'f>T rtn '. \ 

'!-n('''~ ~r'Tj l:n"~t~:rr 

L;l~_ 'l~~l~.):,,-:j01' Hl?nlt~·, S~F'i~~ 

I

GOVERNMENT 

DEPARTMENT 

~~;iS! 

fPfil~~I~ 

OF PUDUCHERRY 

OF DRUGS CONTROL 







V"II I upuram M' am Roa· d, V adiP amanga am, uduc herry- 605 102, INDIA fIor the fI0 II' owmg pro ducts 

I 

Assorted Brands (Single Piece IOL) 

# Brand Material Model Optic Location Overall Optic A Angul 

. 

dia. holes length design Constant ations 

(mm) (mm) 

82. 

Liberty Lens 

Plus 

PMMA MF207 6.00 0.35x2 12.50 Biconvex 118.4 10° 

83. 

Liberty - 

BBY 

PMMA YE207 6.00 0.35x2 12.50 Biconvex 118.4 10° 

84. 

Acryfold - 

BBY 

HEMA BB502 6.00 Nil 12.00 Biconvex 118.0 0° 

85. 

Acryfold - 

HEMA BB601 6.00 

BBY / 

Nil 12.00 Biconvex 118.0 0° 

86. 

Hydro 

HEMA HS700 6.00 Nil 

Smart ; 

".oto'i 

Biconvex 118.0 0° 

87. Naspro HEMA NAS207 6.00 .•••\1Q~ 12.00 Biconvex 118.0 0° 

88. 

Naspro - 

BBY 

HEMA NASY207 6.0P \ • Nil 12.00 Biconvex 118.0 0° 

89. Ultrasmart HEMA US700 6.00 Nil 11.00 Biconvex 118.0 0° 

90. 

Liberty Hydro HY 

Hydrophob phobic NTJOO 

5.75 Nil 12.50 Biconvex 118.0 0° 

I 

91. 

Liberty 

Hydro HY 

Hydrophob - 

phobic BB300 

BBY 

5.75 Nil 12.50 Biconvex 118.0 0° 

92. Supraphob 

Hydro 

phobic 

SPNTJOO 5.75 Nil 12.50 Biconvex 118.0 0° 


Signature 

Licensing 

Signature 

Authority 

.i},' .'.~. " 

rl!. ~.\JR!tt-.::; ''''r-;;ct (%'7f\/o,,,g, (A>·tnJll!o; (ie"".) 

. :..~..-..,--.. ~-~+ ..~...- 

\ ..: ; ~"\ ..• - i', " 

f~·'h? '-;UorH:H·~'.1 (,f •...• f,~lt•.l S'~('VV~d6i 

Ff;l\ B ..•. 

1.\1." :,.J~li;l'11oue·;> 

~\,,"·~f" KI)t:~ ~(.,;'AC.







List of drugs permitted to be manufactured under the license in form 28 bearing the No:ll 223059 



Intra ocular rings (Endocapsular rings) 

Brand: Liberty Rings (PMMA) 

# Model Dimensions (mm) Position Thilckness Material 

With Without Holes (mm) 

Compression Compression (No.) 

93. ER 125 10.5 12.5 2 0.18 PMMA-Clear 

94. ERB 125 10.5 12.5 2

18/08/2011 - Central Drugs Standard Control Organization

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