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Date:- 18/06/2009

To,
Shree Ravi S. Saxena
Principal Secretary,
( Health & Family Welfare Depts.)
Block No.: 1,8th Floor,
Sachivalaya,
Gandhinagar – 382 010.

Ref.:- Our Personal Meeting on 16/06/2009.

Sub.:- Drugs and Cosmetic Act.1940 and Rules there under.


To stop Manufacturing & Sale of Clobet GM skin cream and other
Products Manufactured by M/s. Gmbell Healthcare (India) Pvt. Ltd.
Under License No. G/25/1713 & G/28/1203 of Product Clobet-gm RF
Dt.:- 04/01/2008 and Clobet-gm RC Dt.:-07/01/2008.

Dear Sir,

As this Product “Clobet-gm” Permission was Cancelled by Food & Drug Control
Administration, Gujarat on 12/08/2008 on the basis of “Drug and Cosmetics Act. 1940 and
Rules there under To Stop Manufacturing and Sale of Clobet-gm Skin Cream.”

“To Stop Manufacture / Sale and Distribution of ‘Clobet-gm’ skin cream as


Same brand of product Clobet-gm skin cream Manufactured by different
Manufacturer is Available in the market till further Order.”

With Reference to above we are please to send herewith following documents in support of
this:-
1. Office of State Assistant Commissioner (Maharashtra State) letter Dt:- 21/11/2007
(To us and M/s. Gmbell Healthcare (India)Pvt. Ltd.)

“Both the above Products have the same Pack, Design and Colour With Composition
and Both are identical of Looking a like. It is difficult to identify the genuine Product
from those two.”
(Annex No. 1.)

After checking all necessary details and our application to Trade Mark Office
Dt.:- 03/01/1997 729866 in Class 5 in the name of Jayesh K. Mehta.
(Annex No. 2.)

2. M/s. Gmbell Healthcare (India) Pvt. Ltd. letter Dt:- 12/05/2008 to Commissioner
Office (Maharashtra State) (Annex No. 3.)
3. Product Permission “Clobet-gm” was cancelled vide order No. Mfg./G.M.Bell/J-
2/52503/B Gandhinagar Dt.:- 12/08/2008 to M/s. Gmbell Healthcare (India) Pvt. Ltd.
(Annex No. 4.)

4. Letter Dt.05/12/2008 from Joint Commissioner (Maharashtra State) to Joint


Commissioner (Gujarat) under Drugs and Cosmetics Act. 1940 for same brand of
Clobet-gm in reply to Gujarat Food And Drugs Control Administration Office vide
Ref. no. Mfg/gmbell/j-2/08/73277/B Dt.:- 15/11/2008 (With copy of Document of
more than 100 Pages) (Annex No. 5.)

5. Letter from Joint Commissioner (Maharashtra State) to Joint Commissioner (Gujarat)


for ‘Clobet-gm RF’:-
“ Has introduced the product ‘Clobet – gm RF’ in the place of product ‘Clobet-gm’
for which action was taken by us and after cancellation of product permission by your
Office.” (Annex No. 6.)

6. With reference to our meeting with Shri H. G. Koshia about our Compliant vide letter
Dt:- 11/05/2009 and after fully convinced by the said office has issued us a letter
Dt:-15/05/2009 under ref. 29942 Received by us on 21/05/2009
In response to this we have submitted all documents to Food & Drugs Control
Administration office on 26/05/2009. and informed us that action will be taken in due
of time. (Annex No. 7)
But we have been taken by totally surprise when we have received one more letter
from Food & Drug Control Administration Office Gandhinagar, Dt.:-16/05/2009
received by us on 01/06/2009 which was Totally Against to the Letter
Dt.:- 15/05/2009 (Annex No. 8)

7. Universal Pharma has got the Product Permission of the Clobet-gm on 18/07/2007
from Drug Controller – Cum. Licensing authority Simla (H.P.)
And M/s. Gmbell Healthcare (India)Pvt. Ltd. has got Product Approval on
04/01/2008 and Clobet – gm RC on 07/01/2008 from Gujarat Food and Drugs
Administration (Annex No. 9)

We have got Product Approval Prior to M/s. Gmbell and hence it is established
and M/s. Gmbell Product Permission has to be cancelled on this ground itself.

From all above documents one thing proves that product permission was cancelled by
Food and Drugs Administration Gujarat after considering all the facts and as per the
“Drugs and Cosmetics Act.1940 & Rules There Under”
1. Than Question arises How can the Commissioner Office can issued license of
Clobet-gm RF/RC. On 04/01/2008. ?
2. Even Clobet –gm RF has been Discontinue or cancelled after Maharashtra State
Food And Drugs Administration letter Dt.:-23/01/2009 and M/s. Gmbell
Healthcare (India) Pvt. Ltd. Started new name Clobet-gm RC in same colour
Design, get-up and same name for which
- action was taken
- permission was cancelled by dept. on Dt.:-12/08/2008
Common man (C.M.) will be not able to understand the stand taken by
Commissioner Office Gujarat, after given Assured Assurance to us on
Dt.:- 26/05/2009

M/s. Universal Pharma Loan License with M/s.Gmbell Healthcare (India) Pvt. Ltd. Bearing
the License No. G/25A/3746-A Dt.:-24 Oct. 2007. along with list of products. Some of the
subject products are granted permission under the name of M/s. Universal Pharma. The copy
of the said loan license is enclosed. While referring above mention documents we are of the
opinion that:- Submission of No Objection Certificate from, GMBELL. M/s. Universal
Pharma has Obtain loan License with M/s. Gmbell Healthcare (India) Pvt. Ltd. After
submitting necessary documents, declaration and consent by Either party. Therefore, we
request you to kindly verify the facts and consider submitted documents, please give us the
chance to appear in person before you. Once again we request you to consider above mention
facts and decide in the interest of justice.

The loan license was granted by Food And Drugs Administration Department These have
been unprecedented as well “This is the only state where the principal and the actual
manufacturer should personally attend a formal interview conducted by the actual before the
grant of a contract manufacturing license,” says the Commissioner (Ex. Of Food & Drug
Commissioner, Gujarat, Mr. Subodh P. Adeshara has granted loan license to us for above
stated products)

Thanking You,

Yours Faithfully,
M/s. Universal Pharma

(Mr. Jayesh K. Mehta)

* Note:- This Surprise us and can raised so many question about action and Actual
functioning of Office and Food And Drugs Control Administration as both the letter Dt.:-
16/05/2009. Ref 30358 and Dt:- 15/05/2009 Ref 29942 both being dispatch to us by register
A.D. on 16/05/2009 Does this can happen ?
“This two letter from the “Commissioner” Office to us proves the Activities taken behind
closed door to give out and out favour to M/s. Gmbell Healthcare (India) Pvt. Ltd. and this
demand the stand taken by Mr. H. G. Koshia for M/s. Gmbell Healthcare (India) Pvt. Ltd.”?
Annex

Sr. No. Particulars Pages

01. Order No. DCA/JRM/568-07/Z-1 form Maharashtra State 01


Food & Drugs Administration
02. Trade Mark Registry of Clobet-gm Letter 01
03. Letter Dt.:-12th MAY 2008 M/s.Gmbell Healthcare (India) 01
Pvt. Ltd. to Food & Drug Control Administration
04. To Stop Manufacturing & Sale of Clobet – gm
(Commissioner Office Food & Drug Control 01
Administration to M/s.Gmbell Healthcare (India) Pvt. Ltd.)
05. Letter Dt. 05/12/2008 from Joint Commissioner FDA 01
(Maharashtra State) To Joint Commissioner FDA (Gujarat)
06. Letter Dt. 23/01/2009 from Joint Commissioner FDA 01
(Maharashtra State) To Joint Commissioner FDA (Gujarat)
07. Letter Dt:- 15th MAY 2009 Commissioner (Food & Drug 01
Control Administration) Gandhinagar To M/s. Universal
Pharma
08 Letter Dt:- 16th MAY 2009 Commissioner (Food & Drug 01
Control Administration) Gandhinagar To M/s. Universal
Pharma
09. Product Permission of Clobet – gm(M/s.Universal Pharma)
Product Permission of Clobet –gm RF Dt.:-04/01/2008 02
(M/s. Gmbell Healthcare (India) Pvt. Ltd.)
10. Letter Dt. :- 09/03/2009 to Shree Ravi S. Saxena 01 to 04

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