learned Senior Counsel for the respondents that the scope of the
interference in an appeal against acquittal is limited. It is
submitted that unless and until the finding recorded by the
Magistrate is found to be either perverse or based on no evidence
or reached on a gross misappreciation of the evidence, no
interference is called for. It is submitted that the view taken by
the Magistrate is a plausible view. It is next submitted that the
prosecution witnesses have admitted that the medicine was
susceptible to changes in temperature, humidity as also light.
Thus, acceptable evidence about the medicine having been stored
in proper storage conditions was necessary. It is submitted that
PW1 has admitted that the medicine was stored at room
temperature and thus, it is not possible to hold that the medicine
was stored under standard conditions. It is submitted that the
Drugs Consultative Committee (DCC) set up under Section 7 of the
Act has prescribed the standard procedure for analysis of the
pharmaceuticals preparations. The learned Magistrate has relied
upon Item No.7 of the guidelines in the minutes of meeting dated
24th and 25th June, 1974, in order to hold that it was necessary to
analyse the sample in relation to the manufacture's standards,
which were registered with the concerned Drug Controller,
Karnataka. That admittedly having not done, the prosecution
cannot rely on the evidence of the analyst. He, therefore,
submitted that the appeal is without any merit.
On hearing the learned Counsel for the parties and on
perusal of the record, I do not find that any case for interference is
made out. In the present case, admittedly, the respondents are
the manufacturers of the drug 'caryrox', which is a patent and
proprietary medicine. It is further an admitted position that
'caryrox' is a suspension of the generic drug 'Roxithromicin'. It is
further undisputed that each 5 ml of the medicine was to contain
50 mg of 'Roxythromicin B.P.' It is also an admitted position that
the said product does not find place in Indian Pharmacopeia, but is
a medicine listed in British Pharmacopeia (BP). The instructions
mentioned as to storage are that the medicine is to be stored in a
'cool place', protected from light. It is further undisputed that the
manufacturing date of the product is July 2002 and the expiry date
was June 2004. A perusal of the Note 1 to Schedule P of the
Rules, would show that the term 'cool place' means a place having
temperature between 10oc and 25oc . Thus, it can be seen that the
standard storage conditions as to temperature for the said product
require that it should be stored at a temperature between 10oc
and 25oc . PW1 Jyoti Sardessai, who is a material witness, has
stated in the cross-examination that at the time of visit to the
premises of M/s. Matrix Pharma, she had not taken any gadget,
instrument or machine for the purpose of taking reading and
measurements pertaining to the temperature, humidity, etc. She
has also admitted that the premises, where the drug was stored,
was not air-conditioned. She could not say what was the
temperature at the premises of M/s Matrix Pharma at the time of
her visit, although she volunteered that it was cool. She then
stated that the average temperature in Goa specially in the month
of June and July ranges from 23 to 32oc and at times goes upto
34oc. She has further admitted that the exposure to heat has a
detrimental effect on the stability of pharmaceutical products and
medicines. It was stated that with every 10 degrees rise in the
temperature, there is possibility of 2 to 3 fold increase in
degradation rates of the drugs. She has stated that in respect of
the drugs, which are sensitive to heat, there is possibility of such
variation.
IN THE HIGH COURT OF BOMBAY AT GOA
CRIMINAL APPEAL NO. 14 of 2014
State of Goa,
At the instance of
Mrs. Jyoti Sardessai (Major)
Director of Food and Drugs
Administration,
V/s
M/s Caryl Pharma
CORAM :- C. V. BHADANG, J.
Date :- 22ndJuly , 2015.
Citation;2016 CRLJ(NOC)54 BOM
By this appeal, the State is challenging the acquittal of
the respondents from an offence punishable under Section 18(a)(I)
read with Section 27(d) of the Drugs and Cosmetics Act,1940 (the
Act, for short).
2. Brief facts are that PW1 Mrs. Jyoti Sardessai, who is
the complainant in this case, and a Drugs Inspector, had visited
the premises of M/s. Matrix Pharma, Ponda, Goa on 14/01/2004
and collected the sample of a medicine 'Caryrox', Batch No.C202,
which is a patent and proprietary medicine. It is a suspension of a
generic drug 'Roxithromycin'. The drug was manufactured by the
respondent no.3 of which the respondent no.4 is a proprietor
under loan license from the respondent no.1, of which the
respondent no.2 is a proprietor. The manufacturing date of
medicine is July, 2002 and the expiry was shown as June 2004.
According to the prosecution, the sample was collected as per the
established procedure. When the sample was sent for analysis by
the State Laboratory in Goa, it was found that it was substandard.
It may be mentioned that as per the label on the medicine, every 5
ml of the medicine was to contain 50 mg of Roxithromicin. As
against this, the State Analyst's report (Exhibit 25) dated
28/04/2004, found that the sample was containing 39.04% of the
medicine. In this case, admittedly, the sample was also referred at
the instance of the respondents to the Central Drugs Laboratory
(CDL), Calcutta and the report from the CDL, Calcutta dated
05/07/2004 is there on record at Exhibit 39, which shows the
percentage of the medicine as 31.86%. In such circumstances, a
complaint came to be lodged against the respondents for the
offences as aforesaid, before the learned Judicial Magistrate, First
Class at Ponda.
3. At the trial, the prosecution examined in all four
witnesses, namely PW1 Jyoti Sardessai, PW2 Vishwanath, who is
the proprietor of M/s. Matrix Pharma and a chemist, PW3
Mohammad Khalid Ahmed Khan and PW4 Bimol Mandal, who is
from CDL, Calcutta. There was no defence evidence led on behalf
of the respondents, except production of a test certificate dated
09/08/2002, by which the sample was got examined through a
private Lab, namely, Strides Arcolab Ltd. The contents of each 5
ml was found to contain 48.4 mg of Roxithromycin. This was
produced in order to show that in fact the medicine conforms to
the required standard and no offence was made out.
4. The learned Magistrate found that while getting the
sample analysed, the manufacture's standards were not
ascertained and followed. Secondly, it was found that there was
no acceptable evidence that the medicine was stored under
standard conditions as required and thirdly that the sample was
analysed at the fag end of the expiry period, which was June 2004.
In such circumstances, the learned Magistrate found that two
views are possible and the one in favour of the respondents has to
be preferred. In that view of the matter, the learned Magistrate
acquitted the respondents by giving benefit of doubt. Feeling
aggrieved, the State is before this Court.
5. I have heard Shri Rivankar, the learned Public
Prosecutor for the appellant and Shri Lotlikar, the learned Senior
Counsel for the respondents. With the assistance of the learned
Counsel, I have perused the entire evidence and the record as
also, the impugned judgment.
6. It is submitted by Shri Rivankar, the learned Public
Prosecutor that at the instance of the respondents, the sample was
referred to the CDL, Calcutta under Section 25(4) of the Act. It is
submitted that once this is done and the accused opts for sending
the sample to the CDL, Calcutta, the report from the CDL,
Calcutta is conclusive and incontrovertible. Reliance is placed on
the decision of the Hon'ble Supreme Court in the case of Amery
Pharmaceuticals and another Vs. State of Rajasthan,
reported in (2001)4 SCC 382, in order to submit that now the
respondents cannot challenge the contents of the report (Exhibit
39) on the ground that the manufacture's standards were not
ascertained or followed. It is next submitted that as per the
standard storage conditions, mentioned on the carton, the
medicine was to be stored in a 'cool place'. The learned Public
prosecutor has referred to Note I to Schedule P of the Drugs and
Cosmetics Rules, 1945 (the Rules, for short), in order to show that
the term 'cool place' means the place having temperature between
10oc and 25oc. It is submitted that the evidence led by the
prosecution would show that at the time when the sample was
seized i.e. in the month of January, the normal temperature in Goa
does not exceed 25oc and thus, even assuming that the sample was
stored at room temperature, it cannot affect its stability or the
composition. It is next submitted that the mere fact that the
sample was analysed at the fag end of the validity period, cannot
come to the aid of the respondents, in as much as the medicine
has to conform to the requisite composition till the expiry date. It
is submitted that the report of the State Analyst is dated
28/04/2004, which is well before the expiry date, which is June
2004. Even so far as the report of the CDL, Calcutta is concerned
PW4 has stated that the sample was analysed before the expiry
date. It is submitted that thus, the finding recorded by the
Magistrate holding that two views are possible and giving benefit
of doubt to the respondents, is clearly perverse and an impossible
view, which needs interference by this Court.
7. On the contrary, it is submitted by Shri Lotlikar, the
learned Senior Counsel for the respondents that the scope of the
interference in an appeal against acquittal is limited. It is
submitted that unless and until the finding recorded by the
Magistrate is found to be either perverse or based on no evidence
or reached on a gross misappreciation of the evidence, no
interference is called for. It is submitted that the view taken by
the Magistrate is a plausible view. It is next submitted that the
prosecution witnesses have admitted that the medicine was
susceptible to changes in temperature, humidity as also light.
Thus, acceptable evidence about the medicine having been stored
in proper storage conditions was necessary. It is submitted that
PW1 has admitted that the medicine was stored at room
temperature and thus, it is not possible to hold that the medicine
was stored under standard conditions. It is submitted that the
Drugs Consultative Committee (DCC) set up under Section 7 of the
Act has prescribed the standard procedure for analysis of the
pharmaceuticals preparations. The learned Magistrate has relied
upon Item No.7 of the guidelines in the minutes of meeting dated
24th and 25th June, 1974, in order to hold that it was necessary to
analyse the sample in relation to the manufacture's standards,
which were registered with the concerned Drug Controller,
Karnataka. That admittedly having not done, the prosecution
cannot rely on the evidence of the analyst. He, therefore,
submitted that the appeal is without any merit.
8. On hearing the learned Counsel for the parties and on
perusal of the record, I do not find that any case for interference is
made out. In the present case, admittedly, the respondents are
the manufacturers of the drug 'caryrox', which is a patent and
proprietary medicine. It is further an admitted position that
'caryrox' is a suspension of the generic drug 'Roxithromicin'. It is
further undisputed that each 5 ml of the medicine was to contain
50 mg of 'Roxythromicin B.P.' It is also an admitted position that
the said product does not find place in Indian Pharmacopeia, but is
a medicine listed in British Pharmacopeia (BP). The instructions
mentioned as to storage are that the medicine is to be stored in a
'cool place', protected from light. It is further undisputed that the
manufacturing date of the product is July 2002 and the expiry date
was June 2004. A perusal of the Note 1 to Schedule P of the
Rules, would show that the term 'cool place' means a place having
temperature between 10oc and 25oc . Thus, it can be seen that the
standard storage conditions as to temperature for the said product
require that it should be stored at a temperature between 10oc
and 25oc . PW1 Jyoti Sardessai, who is a material witness, has
stated in the cross-examination that at the time of visit to the
premises of M/s. Matrix Pharma, she had not taken any gadget,
instrument or machine for the purpose of taking reading and
measurements pertaining to the temperature, humidity, etc. She
has also admitted that the premises, where the drug was stored,
was not air-conditioned. She could not say what was the
temperature at the premises of M/s Matrix Pharma at the time of
her visit, although she volunteered that it was cool. She then
stated that the average temperature in Goa specially in the month
of June and July ranges from 23 to 32oc and at times goes upto
34oc. She has further admitted that the exposure to heat has a
detrimental effect on the stability of pharmaceutical products and
medicines. It was stated that with every 10 degrees rise in the
temperature, there is possibility of 2 to 3 fold increase in
degradation rates of the drugs. She has stated that in respect of
the drugs, which are sensitive to heat, there is possibility of such
variation.
It can, thus, be seen that it has sufficiently come on
record that the drug was sensitive to temperature variations and
as per the standard conditions, it was supposed to be stored at a
temperature between 10oc and 25oc . It is not possible to take a
judicial notice of the temperature, which prevails at a particular
place and that too, at the time when the sample was collected.
That apart, it is not only the time when the sample was collected
which would be relevant, as the medicine has to conform to the
required standard and, therefore, during the entire validity period,
is required to be stored in standard condition as to the humidity,
light and temperature, during the period of its validity i.e. till the
expiry date. For this reason, it is not possible to accept that at the
time when the sample was taken PW1 says that it was 'cool'.
There has to be acceptable evidence on record to show that indeed
the medicine was stored under standard conditions. The
prosecution had examined PW2 Vishwanath, who is a proprietor of
M/s. Matrix Pharma from where the sample was collected. He was
the best witness, who could have deposed that the medicine was
stored under standard conditions as required. However, that
evidence is not forthcoming. This witness was cross-examined at
length and he has admitted that the said drug was to be stored at
a cool place, protected from light. He admitted that only certain
drugs can be stored at room temperature. If that be so, certainly
the drug, in the present case, could not have been stored at room
temperature. As has been admitted by PW1, the composition of
the drug is susceptible to variation and change with the variation
of the temperature.
9. It is true that under Section 25(4) of the Act, once the
accused opts for sending sample to the CDL, Calcutta,
conclusiveness would attach to the report of the CDL, Calcutta
However, the question is whether such deterioration, as has been
noticed either by the State Anaylist or the CDL, Calcutta, was on
account of a defect at the stage of manufacture or was as a result
of drug being stored under improper storage conditions.
Certainly, on that count, there is no acceptable and satisfactory
evidence forthcoming from the prosecution that the drug was
stored under standard conditions, as required. There is one more
aspect. Admittedly, the manufacture's standards were not
ascertained or followed at the time of analysis in this case. PW4
has stated in his cross-examination that the manufacture's
procedure of testing the sample was asked for, however, for want
of sufficient time, as the expiry date was approaching, he could
not wait till the procedure was received. The learned Magistrate
has considered this as one of the reasons for extending the benefit
of doubt.
10. I have given my anxious consideration to the reasons
articulated by the learned Magistrate in holding that the
respondents are entitled to a benefit of doubt in this case, as two
views are possible. I do not find that the view taken can either be
said to be perverse or an impossible view. The appeal is,
therefore, without merit and is accordingly, dismissed.
C. V. BHADANG, J.
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