Full Judgment Text
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CASE NO.:
Appeal (crl.) 483 of 2008
PETITIONER:
M/s. Medicamen Biotech Ltd. & Anr
RESPONDENT:
Rubina Bose, Drug Inspector
DATE OF JUDGMENT: 13/03/2008
BENCH:
TARUN CHATTERJEE & HARJIT SINGH BEDI
JUDGMENT:
JUDGMENT
CRIMINAL APPEAL NO 483/2008
(arising out of SLP (Crl.) No. 13 of 2007
HARJIT SINGH BEDI,J.
1. Leave granted.
2. This appeal arises out of the following facts.
3. The accused appellant No.1 is a manufacturer of
Enalapril Maleate tablets, a drug which is being manufactured
under licence in its factory premises. The drug was released
for sale only after it quality had been certified by an
independent laboratory. One such batch bearing No. NT 6000
was sold on 29th September 1999 with its shelf life upto
August 2002 and in addition to other organizations some of
the drug from the batch was supplied to the Government
Medical Stores Depot, Kolkata. The Drugs Inspector, Central
Drugs Standard Control Organisation, Kolkata visited the
Government Medical Stores Depot at Belvedere, Kolkata on
14th June 2000 and collected samples of the drug and after
dividing the sample into four equal parts, sent one portion to
the Central Drugs Laboratory, Kolkata under Clause (i) sub-
section(4) of Section 23 of the Drugs and Cosmetics Act, 1940
(hereinafter referred to as the ’Act’) for test/analysis. The
sample portion of the drug was received in the laboratory at
Kolkata on 23rd June 2000. The Drugs Inspector received the
test report from the Drugs Laboratory on 6th July 2001
declaring the drug as not conforming to the prescribed
standards. A show cause notice was issued to the appellants
on 14th August 2001 on which the appellant once again
carried out an in-house test and also obtained an analysis
report from another approved laboratory. Both the reports
opined that the sample satisfied the prescribed norms. The
appellant also received a show-cause notice dated 14th August
2001/17th August 2001 from the Ministry of Health and
Welfare from the Government Medical Stores Depot, Kolkata
informing the appellant that the drug in question had been
declared sub-standard. On 28th August 2001 the appellant
sent a detailed reply to the show-cause notice to the Medical
Stores Department with copies to the Drugs Inspector
disputing the report of the Government Analyst and requesting
for a re-testing of the drug. On 31st August 2001 the appellant
received a letter dated 22nd August 2001 from the Drugs
Inspector once again pointing out that the sample seized was
not of the prescribed standard and also called for the
comments of appellant No.1 within 10 days. The appellant
received yet another letter dated 7th September 2001 from the
Drugs Inspector seeking certain information to which the
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appellant gave a reply on 13th September 2001 giving the
necessary information and also disputing the test report of the
Central Drugs Laboratory, Kolkata and requesting for re-
analysis. On 26th September 2001 the appellant No.1 received
a communication from the Drugs Inspector that the test report
submitted by the Central Drugs Laboratory was conclusive
evidence of the facts stated therein under section 25 of the Act
and declined to consider any other report and on the contrary,
a complaint was filed before the concerned Magistrate under
section 27 of the Act on 2nd July 2002. The Magistrate
summoned the appellant and certain others for appearance on
several dates but the summons were finally served on the
appellant on 9th May 2005. The proceedings initiated on
account of the complaint were challenged before the Calcutta
High Court and a prayer for quashing was made under Section
482 of the Criminal Procedure Code. This petition has been
dismissed by the impugned order dated 19th May 2006. The
learned Judge held that it would be premature to look into the
matter and to take a decision on the basis of affidavits and
documents filed in Court as they were not evidence strictu
sensu. The Court also opined that from the facts of the case,
it appeared that the allegations made in the petition did
indicate the commission of an offence as they did not suffer
from any "inherent absurdity so as to raise controversy in
regard to its maintainability". It also held that one portion of
the sample had been given to the accused and the necessary
formalities had been complied with. It is in this situation the
matter is before us in appeal.
4. The learned counsel for the appellants has raised
several arguments in the course of the hearing. He has
pointed out that section 23(4) of the Act visualized that one
portion of the sample was to be sent to the Government
Analyst for test or analysis, a second to be produced in court,
if proceedings were to be initiated and the third to be sent to
the person, if any, whose name and address have been
disclosed under section 18A. It has also been submitted that
as per sub-section (4) of Section 25 of the Act unless a drug
had been tested in the Central Drugs Laboratory a person was
entitled, within 28 days of the receipt of a copy of the report
from the Government Analyst, to request the Magistrate to
send for analysis the sample, which had to be filed in court, to
the Director, Central Drugs Laboratory and it appeared that
this exercise had not been carried out despite the objections
raised by the appellants to the correctness of the report of the
Government Analyst. It has further been highlighted that in
any event the complaint having been filed on the 2nd July
2002, no request for re-analysis could have been effectively
made as the shelf life expiry date of the drug was August
2002 and there was, thus, paucity of time. The learned
counsel for the respondent has, however, pointed out that as
the appellant had not made any request for sending the
sample to the Central Drugs Laboratory and had not disputed
the accuracy of the report of the Government Analyst and had
not stated that it needed to adduce evidence to controvert the
report, the appellant was precluded from challenging the
report of the Central Drugs Laboratory as provided by sub-
section (4) of Section 25 of the Act. Reliance for this argument
has been placed on State of Haryana vs. Brij Lal Mittal &
Ors. (1998) 5 SCC 343, State of Haryana vs. Unique
Farmaid (P) Ltd. & Ors. (1999) 8 SCC 190 and Amery
Pharmaceuticals & Anr. Vs. State of Rajasthan (2001) 4
SCC 382.
5. As would be evident, the matter would turn on an
examination of the legal provisions. Section 23 of the Act
provides the procedure for taking of samples and sub-section
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(4) thereof, as already mentioned above, provides that the
sample shall be divided into four portions and be
kept/disposed of in the manner laid therein including one
sample to be produced before the Magistrate. Section 25 is
reproduced below:
"Section 25. Reports of Government
Analysts.- (1) The Government Analyst to
whom a sample of ay drug [or cosmetic] has
been submitted for test or analysis under sub-
section (4) of Section 23, shall deliver to the
Inspector submitting it a signed report in
triplicate in the prescribed form.
(2) The Inspector on receipt thereof shall
deliver one copy of the report to the person
from whom the sample was taken [and another
copy to the person, if any, whose name,
address and other particulars have been
disclosed under section 18A], and shall retain
the third copy for use in any prosecution in
respect of the sample.
(3) Any document purporting to be a
report signed by a Government Analyst under
this Chapter shall be evidence of the facts
stated therein, and such evidence shall be
conclusive unless the person from whom the
sample was taken [or the person who name,
address and other particulars have been
disclosed under section 18A] has, within
twenty-eight days of the receipt of a copy of the
report, notified in writing the Inspector or the
Court before which any proceedings in respect
of the sample are pending that he intends to
adduce evidence in controversion of the report.
(4) Unless the sample has already been
tested or analysed in the Central Drugs
Laboratory, where a person has under sub-
section(3) notified his intention of adducing
evidence in controversion of a Government
Analyst’s report, the Court may, of its own
motion or in its discretion at the request either
of the complainant or the accused : cause the
sample of the drug [or cosmetic] produced
before the Magistrate under sub-section (4) of
Section 23 to be sent for test or analysis to the
said Laboratory, which shall make the test or
analysis and report in writing signed by or
under the authority of the Director of the
Central Drugs Laboratory the result thereof,
and such report shall be conclusive evidence of
the facts stated therein.
(5) The cost of a test or analysis made by
the Central Drugs Laboratory under sub-
section (4) shall be paid by the complainant or
accused as the Court shall direct.
6. A reading of the aforesaid provisions would reveal
that they lay certain obligations as well as provide safeguards
for a person from whom a drug has been seized for analysis or
testing as Section 25(3) specifies that unless such a person
controverts the correctness of the report submitted by the
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Government Analyst within 28 days in writing that he intends
to adduce evidence to controvert the report of the Analyst, it
would be deemed to be conclusive evidence of the quality of
the drug whereas sub-section (4) of Section 25 obliges the
Magistrate on the request of the complainant or the accused or
on in his own motion to send the fourth sample which has
been disputed for fresh testing to the Director of the Central
Drugs Laboratory. It is the case of the appellant that despite
the fact that the appellant had repeatedly controverted the
accuracy of the report of the Government Analyst the fourth
sample had still not been sent to the Director for re-testing
and analysis. We find that the argument raised by the learned
counsel for the respondent that the appellant had never
expressed a desire to controvert the report of the Drug Analyst
is not correct as is clear from the letter dated 28th August
2001 addressed to the Assistant Director General, Government
Medical Stores Depot in which it was stated as under:
"On receipt of your letter, we have got
the control sample of same batch analysed
from an approved test house, namely
Industrial Testing Laboratory, Delhi. The
test house has reported our control samples
to be of standard quality and conforming to
IP with respect to content of Enalapril
Maleate. Copy of test report No. F- 405/8-
01 dt. 25.8.2001 enclosed.
In the light of above facts, we do not
agree with the Govt. analyst report that the
sample is not of standard quality and
request you to kindly get the sample
retested at your end."
7. Concededly a copy of this letter was addressed to
and received by the Drugs Inspector, Kolkata. The learned
counsel for the appellant has also drawn our attention to the
letter dated 13th September 2001 addressed to the Drugs
Inspector again reiterating:
"We have received the sealed portion of
the subject sample sent by you, but we have
not opened it yet. We sincerely hope that the
Asstt. Director General (MS) will need our
request and get the sample reanalyzed. Until
we receive the result of reanalysis we will
keep your subject sample intact.
As per your directions, we are again
enclosing herewith he manufacturing testing
and distribution details of the batch in
question. We request you to kindly get our
sample re-analyzed at the earliest and oblige,
as we do not agree with the Govt. analyst’s
report."
8. It is, therefore, evident that the appellant had not
once but on at least two occasions and within 28 days of the
receipt of the show cause notice clarified that it intended to
adduce evidence to show that the test report of the
Government Analyst was not correct. The judgments cited by
the learned counsel for the respondent, therefore, do not apply
to the facts of the case as they were given in the context where
the dealer/manufacturer had not expressed its desire to
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challenge the veracity of the report of the Drugs Analyst. In
Brij Lal Mittal’s case (supra) this Court held that a person
could not claim that the fourth sample should be sent to the
Central Drugs Laboratory unless the requirements of sub-
section (3) of Section 25 was complied with. In that case,
despite the service of the copies of the Analyst report the
manufacturer had not informed the Inspector within the
prescribed period that he intended to adduce evidence to
controvert the report. It was held in Brij Lal Mittal’s case
(supra) :
"From a bare perusal of sub-section(3) it is
manifest that the report of the Government
Analyst shall be evidence of the facts stated
therein and such evidence shall be conclusive
unless the person from whom the sample was
taken or the person whose name, address or
other particulars have been disclosed under
Section 18-A (in this case the manufacturers)
has within 28 days of the receipt of the report
notified in writing the Inspector or the court
before which any proceedings in respect of the
sample are pending that he intends to adduce
evidence in controversion of the report. Sub-
section (4) also makes it abundantly clear that
the right to get the sample tested by the
Central Government Laboratory (so as to make
its report override the report of the Analyst)
through the court accrues to a person accused
in the case only if he had earlier notified in
accordance with sub-section (3) his intention
of adducing evidence in controversion of the
report of the Government Analyst. To put it
differently, unless requirement of sub-section
(3) is complied with by the person concerned
he cannot avail of his right under sub-section
(4)."
9. In Unique Farmaids’s case (supra) which was a
case under the Insecticides Act which has provisions
analogous to Section 25(4) of the Act, the court found that the
accused had indeed made a request to the Inspector for
sending the sample for re-testing within the prescribed time
limit and as this request had not been accepted an important
right given to an accused had been rendered ineffective on
which the proceedings could be quashed. This is what the
Court had to say:
"It cannot be gainsaid,
therefore, that the respondents in these
appeals have been deprived of their
valuable right to have the sample tested
from the Central Insecticides Laboratory
under sub-section (4) of Section 24 of the
Act. Under sub-section (3) of Section 24
report signed by the Insecticides Analyst
shall be evidence of the facts stated therein
and shall be conclusive evidence against
the accused only if the accused do not,
within 28 days of the receipt of the report,
notify in writing to the Insecticide
Inspector or the court before which
proceedings are pending that they intend
to adduce evidence to controvert the
report. In the present cases the
Insecticides Inspector was notified that
the accused intended to adduce evidence
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to controvert the report. By the time the
matter reached the Court, the shelf life of
the sample had already expired and no
purpose would have been served informing
the Court of such an intention. The report
of the Insecticide Analyst was, therefore,
not conclusive. A valuable right had been
conferred on the accused to have the
sample tested from the Central Insecticides
Laboratory and in the circumstances of the
case the accused have been deprived of
that right, thus, prejudicing them in their
defence.
In these circumstances, the
High Court was right in concluding that if
will be an abuse of the process of the court
if the prosecution is continued against the
respondents, the accused persons. The
High Court rightly quashed the criminal
complaint. We uphold the order of the
High Court and would dismiss the
appeals."
10. We find that this judgment helps the case of the
appellant rather than that of the respondent because in spite
of two communications from the appellant that it intended to
adduce evidence to controvert the facts given in the report of
the Government Analyst, the fourth sample with the
Magistrate had not been sent for re-analysis. The
observations in Amery Pharmaceuticals’s case (supra) are
also to the same effect. We find that the aforesaid
interpretation supports the case of the appellants inasmuch
they had been deprived of the right to have the fourth sample
tested from the Central Drugs Laboratory. It is also clear that
the complaint had been filed on the 2nd July 2002 which is
about a month short of the expiry date of the drug and as
such had the accused appellant appeared before the
Magistrate even on 2nd July 2002 it would have been well nigh
impossible to get the sample tested before its expiry. In the
affidavit filed to the petition by Dr. D. Rao, Deputy Drugs
Controller, and in arguments before us, it has been repeatedly
stressed that the delay in sending of the sample to the Central
Drugs Laboratory had occurred as the appellant had avoided
service of summons on it till 9th May 2005. This is begging the
question. We find that there is no explanation as to why the
complaint itself had been filed about a month before the expiry
of the shelf life of the drug and concededly the filing of the
complaint had nothing to do with the appearance of the
accused in response to the notices which were to be issued by
the Court after the complaint had been filed. Likewise, we
observe that the requests for retesting of the drug had been
made by the appellant in August/September 2001 as would be
clear from the facts already given above and there is absolutely
no reason as to why the complaint could not have been filed
earlier and the fourth sample sent for retesting well within
time. We are, therefore, of the opinion that the facts of the
case suggest that the appellants have been deprived of a
valuable right under Section 25(3) and 25(4) of the Act which
must necessitate the quashing of the proceedings against
them.
11. The appeal is allowed accordingly and the
proceedings against the appellants are quashed.