IN THE HIGH COURT OF KERALA AT ERNAKULAM
OP No. 14979 of 2001(G)
1. GERMAN REMEDIES LTD.
... Petitioner
Vs
1. STATE OF KERALA
... Respondent
For Petitioner :SRI.B.S.KRISHNAN (SR.)
For Respondent :GOVERNMENT PLEADER
The Hon'ble MR. Justice K.A.ABDUL GAFOOR
Dated :13/12/2006
O R D E R
K.A.ABDUL GAFOOR, J.
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O.P.No.14979 of 2001
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Dated this the 13th day of December, 2006.
JUDGMENT
Abdul Gafoor, J.
The petitioner is a drug manufacturer. In
relation to the drug manufactured by the petitioner
viz. Syntocinon, which contains Oxytocin, the Drug
Inspector detected that labelling was not in conformity
with Rule 96(vii) of the Drugs and Cosmetics Rules,
1945 and entry No.8 under the heading ‘Miscellaneous
Drugs’ in Schedule P to the said Rules. Accordingly,
prosecution was initiated alleging violation of the
relevant provisions, lodging Ext.P7 F.I.R. This is
sought to be quashed in this writ petition.
2. It is submitted that the said medicine is
included as item No.8 under the heading
‘Miscellaneous Drugs’ in Schedule P to the Rules
whereby the storage condition is mentioned as “cold
place”, which is further described in the foot note of
O.P.No.14979 of 2001
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the said schedule as “at a temperature between 2
degree centigrade and 8 degree centigrade” which
shall be available in Kerala, only inside a
‘refrigerator’ other than a ‘freezer’. But the labelling
contained in the item of medicine manufactured by
the petitioner indicated the storage condition as
“store in a cool place and should not be allowed to
freeze”.
3. ‘Cool place’, according to the schedule to
the Rules, is a place where the temperature is
between 10 degree and 25 degree. This was
adopted, according to the petitioner, because of the
storage conditions in the Indian Pharmacopocia,
1996, Ext.P10 as amended by Ext.P4. It is also
submitted that, a learned single Judge has
considered this aspect in respect of the very same
medicine manufactured by another manufacturer and
O.P.No.14979 of 2001
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had found that because of this confusion arising
because of the condition contained in the Rules and
the description in Indian Pharmacopocia, 1996, the
prosecution ought not to have been launched. Thus,
it is submitted that the said view shall be adopted in
this case. Therefore, Ext.P7 shall be quashed.
3. It is submitted by the Government
Pleader, justifying the launching of the prosecution
as per Ext.P7, that the medicine in question is one
mentioned under the heading ‘miscellaneous drugs’
in Schedule P covered by Rule 96(vii) of the Rules.
Necessarily, the manufacturer has, with reference to
the labelling, to conform to the standards mentioned
in Schedule P in relation to the said drug. If the
labelling of the medicine will affect its potency. This
is an important medicine to be administered at the
time of child birth. The administration of the drug,
O.P.No.14979 of 2001
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the potency of which has been reduced because of
the change in the storage condition, may turn fatal
and therefore, the prosecution shall be allowed to
continue the proceedings.
4. It is submitted that the Indian
Pharmacopocia is having statutory recognition as
mentioned in the rules. Therefore, the specifications
in Inidan Pharmacopocia, is also to be followed. The
specification regarding the storage of the medicine
concerned mentioned in the India Pharmacopocia, as
amended by Ext.P4 is, ‘store in cool place and should
not be allowed to freeze’. This will necessarily mean
that the said ‘cool place’ is a place where there is a
chance of freezing. Therefore, it cannot be room
temperature. When this phraseology is used in India
Pharmacopocia, it is not opposed to the storage
conditions mentioned in Schedule P. So, it cannot be
O.P.No.14979 of 2001
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stated that there was commission of any offence to
launch the prosecution.
5. Anyhow, by now, the petitioner is
following strictly the storage conditions mentioned in
Schedule P for the purpose of labelling the drug in
question. Another single Judge has already taken a
view that it was because of the confusion regarding
the storage place as mentioned in Schedule P and
the India Pharmacopocia, this situation had arisen.
In such circumstances, following the said view, which
has not been appealed against with respect to that
aspect, Ext.P7 is quashed.
Writ petition is allowed as above.
Sd/-
(K.A.ABDUL GAFOOR)
JUDGE
sk/
//true copy//
K.A.ABDUL GAFOOR, J.
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O.P.No.14979 of 2001
JUDGMENT
13th December, 2006.
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