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Dear Mr.

Mehta,
Thanks for your mail dated 28th May 2009. As explained, your case would fall under
the domain of Patents Act. I would therefore suggest you to take appropriate action
accordingly. In case, however, you feel there is any action that is required to be taken
under practice with Cosmetics Act, you should approach the Drugs Commissioner
with specific details.
Best wishes
Sincerely
Jay Narayan Vyas
From: jayesh mehta
To: min-health@gujarat.gov.in
Cc: ronakksale ; ronakksales
Sent: Thursday, May 28, 2009 6:25 PM
Subject: Re: REQUEST FOR APPOINTMENT WITH YOU.

JAI JINANDRA,

Sir,
This is to confirm our partner[sleeping] MR. Vimalbhai on 26th may 2009 and had small discussion
about ,

''Such Look-a-Like CLOBET-GM,ENAC GEL/FUNGDID-B. Samples identified,as per discussion, it


was decided to have meeting with Mr, H.G.KOSHIA NEXT DAY ON 27TH MAY 2009 In the
afternoon along with him.

Due to your permeating with visitors we can seek your meeting on that day but we had brief discussion
with MR.H..KOSHIA and Mr. Shileshbhai vays in this matter for half an hour on the issue about
granting product permission to M/S Gmbell healthcare [india] pvt.ltd after cancellation order has been
issued by office for CLOBET-GM RF/CLOBET-GM RC.

With due respect all the depts. of FOOD AND DRUG ADMINISTRATION in this matter,it seems that
drug depts. is helpings out of the THE DRUG AND COSMETICS ACT AND RULES THER UNDER
1940.

the observation of Mr. H.G.KOSHIA AND AGAIN AND AGAIN ASKING US TO GO TO COURT
WHICH I without any justification given.

Only we wanted to bring it to your office kind attention that :-

1. Fda office has acted only after Bombay High Court order dt.6/07/2007 and this office
orde dt.12/08/2008 .
2. ACTION WAS TAKEN ON SAME AND SIMILAR PRODUCTS AND AS PER DRUG ACT
THAT SHOULD NOT AVAILABLE IN MARKET
3.ONE OF THE MOST IMPORTANT QUESTION IS FDA ACTION ON 12/08/2008 WAS
RIGHT OR NOW ALLOWING the same firm to manufactured under same name,design,get-
colour etc. by just adding two prefix after the same name ,for dept.s has taken action?
4. This move of FDA can not justifies on what basia they are help which is called ''BIG
BROTHER'S OR JUST IGNORING ALL THE LAWS OF FOOD AND DRUG ACT,BY JUST
ASKING US TO GO TO COURT AGAIN,THE MATTER WAS IN COURT AND AFTER
COURT ORDER CLOBET-GM PRODUCT PERMISSION WAS CANCEL
NOW
AGAIN ASKING US TO GO TO COURT,WITH ALL RESPECT ,CAN WE KNOW HOW
MANY TIMES DO WE HAVE TO GO TO COURT?
AND HOE MANY TIMES FDA WILL ALLOW GMBELL BY GIVING SAME CLOBET-GM
PRODUCT PERMISSION BY JUST GMBELL WILL TAKE PRODUCT PERMISSION LIKE
ADDING PREFIX WORD OF ENTIRE ALPHABETS OF ABCD TO XYZ?
IN THIS CASE ITS SHOWS OUR OF THE WAY GMBELL HAS BEEN FAVOURED
BY THE COMMISSIONERS,S OFFICE.
5. DO GUJARAT FDA ONLY WILL CANCEL GMBELL PRODUCT PERMISSION OF
CLOBET-GM RF/RC AND HOW MANY TIMES DO WE HAVE TO GO TO COURT?

6. DO GUJARAT FDA HAS DIFFERENT ACT/RULES THAN MAHRASTRA FDA ?

7. DO INDIAN DRUGS AND COSMETICS ACT AND RULES IF DIFFERENT IN


MAHARASHTRA AND GUJARAT?
8. DO THE COMMISSIONERS OFFICE HA ACTED IN CASE OF ANY COMPANY
LIKE TORRANT/CADILA/PARAS ETC.?
9. WE HAVE FORWARDED TO YOUR OFFICE BY REG.AD. ALL THE DOCUMENTS
TO-DAY

ONCE AGAIN WE MAKING HUMBLE REQUEST TO YOUR OFFICE TO GRANT US TIME,OR


CAN WE COME ON NEXT TUSEDAY 2/6/09.

WE OBLIGE YOUR OFFICE FOR CO-OPERATION.

RGDS,
JAYESH K.MEHTA
VIMALBHAI LAKHANI

CLOBET-GM :-

UNIVERSAL IMPEX HAS FDA PERMISSION 1997.


TRADE MARK APPLICATION ON 03/01/1997
UNIVERSAL IMPEX HAS LOAN LICENCE WITH M/S TIME PHARMA & M/S
GOPALDAS & CO. BOTH IN MAHARASHTRA STATE.
UNIVERSAL IMPEX LOAN LICENCE VALID UP TO 31/12/2007
UNIVERSAL IMPEX HAS THIRED PARTY MANUFACTURING WITH M/S
GMBELL HEALTHCARE [INDIA] PVT.LTD.
GMBELL HAS SUPPLY TO UNIVERSAL IMPEX AND SUPPLY TO UNIVERSAL
IMPEX AGENTS.
GMBELL HEALTHCARE [INDIA] PVT.LTD 'S DEED OF ASSIGNMENT HAS
BEEN CANCELLED ON 06/07/2007
GMBELL HAS FILLED AFFIDAVIT ON 22/08/2007 WHRE GMBELL HAS
CONFIRMED ORIGINAL OWNERSHIP BELONGS TO UNIVERSAL IMPEX
ONLY.
GMBELL HAS FILLED AFFIDAVIT IN COURT OF CONTEMPT AND GIVEN
APOLOGY TO COURT.
GMBELL HAS GIVEN LETTER TO ''COMMISSIONER'' M.S. ON 12/05/2008 IN
REPLAY TO 21/11/2007 FOR SAME AND SIMILAR PRODUCTS AVAILABLE IN
MARKET
JT.COMMISSIONER'S LETTER DT. 2/7/2008 TO GUJ.JT.FDA [ DCA/JRM/569-
07/Z-1 DT.21.11.2007
REMINDER LT. DT. NO. DCA/JRM/30-08/Z-1 DT.5/1/2008
D.O. LT. NO. DO/CLOBET/103-08/Z-1 DT. 5/2/2008
THIS OFFICE LT. NO. JVY/356-08/Z-6 DT. 23/05/2008
LT.& DOCUMENTS RECD. FROM M/S UNIVERSAL IMPEX & JAYESH
MEHTA]
GUJARAT FDA HAS CANCELLED CLOBET-GM ON 12/08/2008 '' FOR SAME
AND SMILIER PRODUCTS AVAILABLE IN MARKET.
GUJ.FDA HAS CANCELLED AS PER SEC. 66 OF INDIAN DRUGS AND
COSMETICS ACT 1940 ACT
AND AS ACT GUJ.FDA HAS ISSUE ''SHOW CAUSE NOTICE'' TO GMBELL
FOR ''CLOBET-GM
AS PER ACT WITHIN 3 MONTHS GMBELL CAN APPLY TO SATE FOR
CANCELLATION ''CLOBET-GM''[ GUJ.JT. LT.15/11/2008 MFG/GMBELL/J-
2/08/73277/B.
TO REPLY TO THIS JT. COMM. HAS WRITTEN LT. DT.5/12/2008 WITH 102
PAGE TO PROVE THAT GMBELL ALL PRODUCT PERMISSION HAS BEEN
ACQUIRED BY GMBELL AS PER DEED OF ASSIGNMENT HAS BEEN
TERMINATED ON 29/09/2006 BY UNIVERSAL AND CANCELLED BY
BOMBAY HIGH COURT ETC.]
JT.COMM.LT.DT.23/01/2009 FOR ''CLOBET-GM RF'' GMBELL HAS
MANUFACTURED AFTER ALL THIS LEGAL AND FDA GUJ. CANCELLATION
12/08/2008.

JAYESH MEHTA NUMBERS LTETTERS TO GUJ.FAD AND PERSONAL


MEETING WITH MS. MONA KHANDHAR ON 29/05/2008/26/7/2008
&31/072008 ETC.

JUST FOR MORE INFORMATION SHOW CAUSE NOTICE TO M/S GREEN


PHARMACEUTICALS AP/GMLAB/GREEN/J2/30984/B AND REPLY FROM
THEM ON 19/05/2008 AND
JAYESH MEHTA & ATRISH TREVADI HAD PERSONAL HEARINGS IN JT.
COMM MR. H.G. KOSHIAJI OFFICE N 04/08/2008 ALONG WITH
DY.COMM.MR. VASHIA.
[ UNIVERSAL PH ARM HAS MANUFACTURED ON TH IRED PARTY BASIS ''
ENAC GEL/ENAC EXCEL GEL/FUNGDID-B/CLOBET-S ETC]
POINT TO BE NOTE TED THAT MR. KOSHIA HAS GIVEN 100% ASSURANCE
THAT ALL THIS PRODUCT OF GMBELL WILL BE CANCELLED AS PER THIS
OUR PERSONAL HEARING AND ALL THE DOCUMENTS HAS BEEN GIVEN
AND RECORDED IN JT. COMM.OFFICE OF MR. H.G.KOSHIA]

UNIVERSAL PHARMA HAS LOAN LICENCE WITH M/S GMBELL


HEALTHCARE[INDIA] PVT.LTD
NO. G/25A/3746 DT. 24/10/2007 VALID UP TO 23/10/2012
THE OFFICE OF THE FOOD AND DRUG CONTROL ADMIN.GRANT
PRODUCT PERMISSION FOR THE PRODUCT TO BE MANUFACTURED ON
THIRD PARTY OR ON MANUFACTURED BY -MARKETED BY UPON
SUBMISSION OF EITHER AGREEMENT BETWEEN TWO PARTIES OR ON
SUBMISSION OF NO OBJECTION CERTIFICATE FROM MARKETING
FIRM.IN THIS CASE GMBELL SHOULD HAVE SURRENDERED ALL
PRODUCT OF UNIVERSAL IMPEX SOON AFTER REVIVING THE LT. OF
TERMINATION OF AGREEMENT AND ALSO AFTER HIGH COURT ORDER.
M/S UNIVERSAL PHARMA HAS OBTAIN LOAN LICENSE WITH GMBELL
AFTER SUBMITTING NECESSARY DOCUMENTS DECLARATION AND
CONSENT BY EITHER PARTY.

UNIVERSAL PHARMA HAS APPLY AND GOT APPROVAL FROM DRUG


OFFICE ON 18/07/2007 FROM H.P
WHIT GMBELL HAS GOT CLOBET-GMRF ON 04/01/2008 AND CLOBET-
GMRC ON 07/01/2008]
## THIS ONLY THE BEST DOCUMENTARY PROOF ON THIS BASIS
GUJARAT FDA SHOULD IMMEDIATELY CANCEL PRODUCT PERMISION OF
M/S GMBELL HEALTHCARE [INDIA] PVT.LTD

IN THIS CASE GUJARAT DRUG OFFICE SPECIALLY ''COMMISSIONER'S''


HAS ACTED AND BEND THE RULES AND REGULATION AND FAVOUR M/S
GMBELL HEALTHCARE [INDIA] PVT.LTD
AS IF THE ENTIRE DRUG OFFICE HAS BEEN DOING AND FAVOURING TO
ONLY AND ONLY GMBELL .
AND
ITS SO SURPRISE THAT COMMISSIONER OFFICE ASKING US TO
APPROACH COURT OF LAWS AND STILL OUT ALL THE WAY FAVOURED
TO GMBELL FOR CLOBET-GMRF/CLOBET-GMRC
DOES NOT THIS PROVE WITH ALL THIS MALPRACTICES AND
BENDING/BY PASSING ACT AND RULES FOR GMBELL AND ASKING
OTHER PARTY TO GO TO COURT,
DOES FDA GUJARAT HAS REPLY FOR THIS QUESTION:-
1.WHY FDA HAS CANCELLED GMBELL CLOBET-GM PRODUCT
PERMISSION ON 12/08/2008?
2. DO WE HAVE DRUHS AND COSMETICS ACT 1940 IS ONLY APPLICABLE
TO MAHARASHTRA AND NOT TO GUJARAT FDA?
3. JT.COMM/COMMISSIONER OFFICE ACTED FOR AND ONLY FAVOURING
GMBELL AND UNIVERSAL PHARMA TO GO TO COURT WHY ?
4. IF GMBELL HAS RIGHT FOR THIS PRODUCT CLOBET -GM THAN WHY
FDA HAS CANCELLED ON 12/08/2008?
5. WHY FDA HAS WRITTEN LT. TO M.S. ON 15/11/2008?
6. GUJ.ORDER DT. 12/08/2008 MENTIONED THAT SAME AND SIMILAR OF
DIFFERENT MANUFACTURER IN MARKET[ THAT IS UNIVERSAL PHARMA
'S CLOBET-GM''?
7. UNIVERSAL PHARMA LOAN LICENCE WITH GMBELL ON 24/10/2007?
8. UNIVERSAL PHARMA CLOBET-GM PERMISSION ON 18/07/2007 ?
9. GMBELL PRODUCT PERMISSION APPROVAL ON 04/01/2008 & 07/01/2008 ?

ALL THIS POINT SHOULD BE TAKEN IN TO A/C WHILE WHY GMBELL IS


STILL MANUFACTURING ONLY BECAUSE OF MR. KOSHIA OUT OF THE
WAY FAVOUR?

JAYESH MEHTA

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