CO

ISSIO ER
0.8, 1ST FLOOR, GAND NAGAR. /G, Dt.

FOOD & DR GS CO TROL ADMINISTRATION,

DR. JIVRAJ MEHTA BHA VAN BLOCK

BY R.P.A.D.
To:

No. TRlNSQ/SCN/ AVK T1S-ELYSIUM/SC.l/2013/

, 5 JUN 2013

M/s. AVENTIS PHARMA LTD., PLOT 0.3501,3503,3513, 6310/B-14, G.I.D.C ESTATE, ANKLESHW AR - 393002 .. Sub: Drugs & Cosmetics Product Batch No. Mfg. Date. Exp. Date. Act, 1940 & Rules thereunder. AVIL INJ. (PHENlRAMINE MALEATE INJ. J.P.) 2111013 DEC.- 2011 JUNE-2014

Drugs reported to be "Not of Standard Quality"

Ref:

Loan with MIs. ELYSIUM PHARMACEUTCALS LTD." AT AND POST: DABHASA,TAL. PADRA,DIST: VADODARA Test Report No., Q.2/604/2013 (D), Dated 14/05/2013 of Government Analyst, VADODARA 2) Tel. Dated. 27/05/2013

/ }"j_ (X 2.
(I) (II) (III)

Dear Sir, I forward herewith a copy of Analytical Report as referred above. You will observe from the test reports that the drug in question is reported as" ot of Standard Quality" in following respect: THE SAMPLE SHOWS THE PRESENCE OF GLASS PARTICLES Stop furthers sale, recall the batch of the drugs in question from the market by Registered A.D. letter and furnish Xerox copy of the acknowledgement receipt thereof. Intimate total stock on hand and details of stock received back from the market and to send a copy of protocol of tests applied to the batch in question. Send sales details showing invoice No., Name and address of the purchaser, date of invoice, quantity of drugs supplied etc. Explain in detail the reasons, if any, for declaring the product as" Government Analyst. ot of Standard Quality" by the said

'~V) (V) (a) (b) (c) (d) (VI) 3. 4.

Send attested true copy of the following documents or information. Purchase invoices and test reports in respect of the raw materials and pharmaceutical aids used III the manufacture of the batch in question. True copies of the manufacturing records. A specimen copy of the label affixed/used for the product in question. In case of the drug being large volume parenteral preparation or liquored preparation, copy of invoices of containers/packing materials used for packing of drugs along with specifications if any. Send the name & address of the parent firm in case of the product manufactured under loan licence. You are also directed to inform the name and address of the technical person responsible for Manufacturing and analysis of the said batch of the said drug along with his explanation if any for the product in question. It is informed that actions deemed fit will be taken against you, if the product of above batch is found in market after 15 days of the receipt of this notice.

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COMMISSIONER
DR. JIVRAJ MEHTA BHA VAN BLOCK NO.8, 1sT FLOOR, GANDHINAAR.

FOOD & DRUGS CONTROL ADMINISTRATION,

5.

You are also directed to submit details of(I) Change of constitution/premises/technical persons, if any. (II) Details of license No., date and validity. (III) Details of product licence for the product in question. By manufacturing and marketing the above stated defective quality of cosmetic, you have contravened the provisions of the section 18(a)(i) of Drugs & Cosmetics Act, 1940 and rules thereunder. You are therefore called upon to take notice under Rule - 85 (2) of the Drugs & Cosmetics Rules 1945 and asked to explain and show cause without prejudice to legal action as to why the marginally mentioned licence should not be suspended for a period d 1eemed fit or even cancelled by me wholly or partly in respect of the product.

6.

I Licence
7.

No.

I G/2129-A

I Form

No. 28-A

You are informed to notify your intention whether you desire to avail an opportunity for personal hearing. Your explanation along with point wise reply should reach to this office within 15 days of the receipt of this notice failing which I shall be constrained to take proceed further in the matter. You are also directed to quote date and complete reference number of this letter in your explanation letter.

YOURS F AITHFULL

Y,

~JI'(DR. H.G.KOSHIA ) COMMISSIONER AND LICENSING AUTHORITY FOOD & DRUGS CONTROL ADMINISTRA TIO

No. TRlNSQ/SCN/AVENTlS-ELYSIUM/SC.l/2013

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Copy

forwarded

with complim

ents for information

to the:

,.1 Copy to Assistant Commissioner ADIAD CIRCLE, ADIAD, for information with reference to The Telegram confirmation endorsement letter. o. TRffEL/NSQ/AYENTIS-ELYSIUM//SC. 1/2013/43987-91/G. Dated. 27/05/2013, for information. Copy of Test Report is enclosed herewith. He is asked to investigate the matter at the manufacturer's end and submit the Inspection Report within 2 weeks. 2 'G' Branch in this office for data compilation for T.R. No. Q.2/604/2013 (D), Dated 14/05/2013 of Government Analyst, V ADODARA. 3

Copy to The Drugs Inspector, Jamnagar, , , or information

IU

(DR. H.G.KOSHIA ) COMMISSIONER AND LICENSING AUTHORITY FOOD & DRUGS CONTROL ADMINISTRATION.

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BY R.P.A.D.

COMMISSIO ER FOOD & DR GS CO, TROL ADMINISTRATION, DR. JIVRAJ MEHTA BHAV BLOCK 0.8, 1ST FLOOR, GANDHINAGAR. o. TRlNSQ/SC I lAVE T1S-ELYSI M/SC.1I2Gl31 ~ IG, Dt.

5 JUN 2013

~;.EL YSIUM PHARMACEUTICALS LTD.,

AT A D POST: DABHASA, DIST: V ADODARA Sub: TAL. PADRA,

c;o

Drugs & Cosmetics Act, 1940 & Rules thereunder. Drugs reported to be "Not of Standard Qual ity Product A VIL INJ. (PHENIRAMINE MALEATE INJ. I.P.) Batch o. 2111013 Mfg. ate. DEC.- 2011 Exp. Date. JUNE - 2014 Mfg. for M/s. A VENTIS PHARMA LTD.,. PLOT NO. 3501, 3503, 3513, 6310/B,14, EST A TE,ANKLESHW AR - 393002 .. Report No. 0.2/604/2013 (D) Date. Dated 14/05/2013

G.I.D.C

.-/

f.ea~ ~~;ward herewith a copy of Analytical Analyst, V ADODARA 2.

issued by Government Quality" in following

You will observe from the test report that the drug in question is reported as "Not of Standard respect: THE SAMPLE SHOWS THE PRESENCE OF GLASS PARTICLES

You are also asked to inform the name and address of the technical person responsible for Manufacturing the said batch of the said drug along with the explanation ifany for the product in question. 4. In this connection, You are further asked to submit detai Is if any for (I) Change of constitution/premises/technical persons. 2'Details of products of permission for the product in question. Details of license No., date and validity. 5. By manufacturing above stated quality drugs, for M/s.AVENTIS 63101B,14, G.I.D.C ESTATE,ANKLESHWAR - 393002.,You have of Drugs & Cosmetics Act, 1940, you are therefore called upon to Cosmetics Rules 1945 and asked to explain and show cause without mentioned manufacturing licence should not be suspended for a period Licence No. G/I002

and analysis of

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PHARMA LTD.,. PLOT NO. 3501, 3503, 3513, contravened the provisions of the section 18 (a) (i) take notice under C Rule - 85 (2) of the Drugs & prejudice to legal action as to why the marginally deemed fit or even cancelled by me. Form No. 28

6.

Further, you are asked to notify your intention whether you desire to avail of the opportunity for personal hearing. Your explanation along with point wise reply should reach this office within 15 days of the receipt of this notice failing v"hich I shall be constrained to proceed further in the matter. You are asked to quote date and complete reference o. of this letter in your explanation letter.

YOURS FAITHFULLY,

sift ,(DR. H.G.KOSHIA ) COMMISSIONER AND LICE SING AUTHORITY FOOD & DRUGS CO TROL ADMI ISTRA TION.
G,Dt. o.T O/SC /AVE TIS-ELYSIUMlSC.1I2013/ COPy forwarded with compliments for information to the: 1. Cop to Assistant Commissioner VADODARA CIRCLE, VADODARA), for information the matter and submit the Inspection Report within two weeks.

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1 5 JU 2013

2013.

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Copy to 'G' Branch in this office for data compilation.

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and asked to investigatt

(DR. H.G.KOSHIA ) COMMISSIONER AND LICENSING AUTHORITY FOOD & DRUGS CONTROL ADMINISTRATIO .

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