REPORTABLE
IN THE SUPREME COURT OF INDIA
CRIMINAL APPELLATE JURISDICTION
CRIMINAL APPEAL NO. 1489 of 2011
(Arising out of SLP(Crl.) No. 3 of 2011)
GlaxoSmithKline Pharmaceuticals Ltd. & Anr. …Appellants
Versus
State of Madhya Pradesh …Respondent
J U D G M E N T
Dr. B.S. CHAUHAN, J.
1. Leave granted.
2. This appeal has been preferred against the judgment and order
dated 14.9.2010 passed by the High Court of Madhya Pradesh at
Jabalpur in Misc. Criminal Case No. 6315 of 2008 which rejected the
application of the appellants for quashing the complaint under theprovisions of The Drugs and Cosmetics Act, 1940 (hereinafter called
`the Act 1940’).
3. Facts and circumstances giving rise to this appeal are that:
A. The Drug Inspector under the Act 1940 had taken a sample of
Betnesol tablets (Batch No. NC 160 Mfg. October 1996, expiry March
1998), manufactured by the appellant-company from the shop of one
Mahesh Agarwal at Chattarpur on 9.12.1996. The statutory authority
sent the medicine for chemical analysis to the laboratory i.e.
Government Analyst, Madhya Pradesh (Bhopal) on 10.12.1996.
B. The said Government Analyst vide certificate dated 27.8.1997
declared that the sample was not of “standard quality” as defined under
the Act 1940. The sample led to “analytical difficulties” for the purpose
of determining compliance with the official standards as stated under
uniformity of content.
C. In view thereof, a show cause notice was issued to the appellantcompany by the statutory authority on 29.9.1997 as to why proceedings
should not be initiated against the appellants and others. The appellant
submitted its reply on 3.11.1997, submitting that sample of the
aforesaid medicine ought to have been examined/analysed under Indian
2Pharmacopoeia (hereinafter called ‘I.P.’) 1996 and it had wrongly
been analysed under I.P. 1985. Subsequent thereto, the department
filed a complaint against the appellants on 3.7.2001 impleading the
company as well as its Managing Director and Officers under the
provisions of the Act 1940. A prayer was made that the appellants and
other accused be punished under Section 35 of the Act 1940 and
information of the said punishment be published in the newspapers at
the cost of the accused.
D. The Chief Judicial Magistrate, Chattarpur, took cognizance and
issued summons to all accused persons including the appellants. The
appellants filed an application under Section 25(3) of the Act 1940
before the Chief Judicial Magistrate, Chattarpur, with a prayer that
sample of Betnesol tablets be sent for chemical analysis to the Director,
Central Drugs Laboratory for being tested as per I.P.1996 on
1.10.2007. The said application stood rejected vide order dated
5.5.2008. The appellants approached the High Court by filing Misc.
Criminal Case No. 6315 of 2008 for quashing the proceedings in
Criminal Case No. 982 of 2001 (State of Madhya Pradesh v. M/s
Aggarwal Medical Stores and Ors.). The said application stood
3rejected by the impugned judgment and order dated 14.9.2010. Hence,
this appeal.
4. Shri R. Ramachandran, learned senior counsel appearing for the
appellants, submitted that the Drugs Inspector issued show cause notice
dated 29.9.1997 which was duly replied by the appellants on
3.11.1997. Therefore, there was no occasion for the respondentauthorities to file a complaint, that is too after the expiry of more than 3
years and 9 months of the expiry date of the medicine itself. The
appellants could not avail their remedy under Section 25(3) of the Act
1940 which can be exercised within 28 days from the date of service of
show cause notice. The chemical analyst’s report was not clear at all.
The certificate declared that the medicine “was not of the standard
quality”. The analyst had analytical difficulties in determining the
compliance with the official standards as stated “Under uniformity of
Contents”. The purpose of exercising his right under Section 25(3) of
Act 1940 is to ask the statutory authority to send the medicine to some
other laboratory for chemical analysis in case the report was not
acceptable to the accused. In the instant case, it was the technical
problem as the fault had been found in view of analytical defects, and
thus, there was no violation of substantive character. There could be no
4justification for the State to file the complaint at such a belated stage.
Thus, the High Court erred in rejecting the application for quashing the
complaint.
5. On the other hand, Ms. Vibha Datta Makhija, learned counsel
appearing for the respondent-State, has vehemently opposed the appeal
contending that the applicants are the manufacturer of drugs and under
Section 18(a)(i) of the Act 1940, they could not manufacture drugs of
sub-standard quality. They could have expressed their option to
adduce evidence in contravention of the analytical report within the
period of limitation i.e. 28 days which they did not do. Unless the
accused has given option that it would adduce evidence in
contravention of the analytical report, it cannot ask the court to send
the medicine for chemical analysis to the Central Government
Laboratory. As no such option had been made by the appellants, they
are not entitled to challenge the report. More so, the onus of proof was
on the appellants to tell as on what date the company had received the
show cause notice dated 29.9.1997. The appellants have not disclosed
the date of receipt of the show cause notice till date. The issue of
launching criminal prosecution at a much belated stage has not been
raised before the High Court in the gravity in which it is being agitated
5before this Court. Appeal lacks merit and thus, is liable to be
dismissed.
6. We have heard the learned counsel for the parties and perused
the records.
7. The issue involving herein is no more res integra matter. The
issues have been examined time and again. It is a settled legal
proposition that report of the analyst is conclusive. It means that no
reasons are needed in support of conclusion given in the report, nor it is
required that the report should contain the mode or particulars of the
analysis. (See: Dhian Singh v. Municipal Board, Saharanpur &
Anr., AIR 1970 SC 318.)
However, law permits the drug manufacturer to controvert the
report expressing his intention to adduce evidence to controvert the
report within the prescribed limitation of 28 days as provided under
Section 25(3) of the Act 1940. In the instant case, the report dated
27.8.1997 was received by the statutory authorities who sent the show
cause notice to the appellants on 29.9.1997 and the appellants replied
to that notice on 3.11.1997. The case of the statutory authorities is that
option/willingness to adduce evidence to controvert the analyst’s report
6was not filed within the period of 28 days i.e. limitation prescribed for
it. The appellants are the persons who knew the date on which the
show cause notice was received. For the reasons best known to them,
they have not disclosed the said date. It is a company which must be
having Receipt and Issue department and should have an office which
may inform on what date it has received the notice, and thus, should
have made the willingness to controvert the report. In fact, such
application had only been made on the technique adopted for analysis.
It has been the case that instead of testing the medicine under the I.P.
1985, it could have been done under I.P. 1996 because the I.P.1996 had
come into force prior to the date of taking the sample on 9.12.1996.
8. In view of the fact that the appellants did not express an intention
to adduce evidence to controvert the analyst report within the statutory
limitation period of 28 days, further delay in filing the complaint
becomes immaterial. Even otherwise, expiry date of the medicine was
March 1998 i.e. only after 4 months of submission of the reply by the
appellants, and they did not fulfill their burden of expressing intention
to adduce evidence in contravention of the report. Therefore, they
cannot raise the grievance that the complaint had been lodged at a
7much belated stage. So far as the application of I.P. 1985 or I.P. 1996
is concerned, such an issue can be agitated at the time of trial.
9. The judgment in Medicamen Biotech Limited & Anr. v.
Rubina Bose, Drug Inspector, (2008) 7 SCC 196, was heavily relied
on by Shri R. Ramachandran, learned senior counsel appearing for the
appellants. Nevertheless, the facts of the said case are quite
distinguishable. In that case, the complaint had been filed about a
month short of expiry date, and the accused therein had expressed their
option to lead evidence in contravention of the analyst’s report within
limitation time but were not able to do so as shortly thereafter the
medicine expired.
10. We agree with Ms. Makhija that the case is squarely covered by
the judgment of this Court in State of Haryana v. Brij Lal Mittal &
Ors., (1998) 5 SCC 343 wherein this Court has held as under:
“….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
8with by the person concerned he cannot avail of
his right under sub-section (4).”
In the said case, like the present case, the manufacturer did not
notify the Inspector within the prescribed period that he intended to
adduce evidence in contravention of the report. Also, akin to the case
at hand, the manufacturer’s right under section (3) of Section 25
expired few months before expiry of shelf life. Holding for the
directors of the manufacturing company on different grounds, the court
opined that the right to get drugs tested by Central Drugs Laboratory
does not arise unless requirement of sub-section (3) is complied with.
11. It is pertinent to mention herein that present appellants had
earlier also been informed by the Drug Inspector of various cities on
many occasions that the aforesaid medicine was i.e. Betnesol Tablet,
was not of standard quality and the authorities had been making an
attempt to initiate proceedings against them. As is evident from the
pleadings taken by the appellants themselves and the letter dated
1.7.1996 (Annexure P-9) wherein the appellant-company wrote a letter
to The Controller, Food and Drug Administration, Madhya Pradesh.
The relevant part thereof reads as under:
9“During the past one month we have
received requests from Drug Inspectors of Dhar,
Rewa, Seoni and Ambikapur all under your kind
control, to provide Memorandum of Articles of
Association, constitution etc. of our company to
initiate action for manufacturing Betnesol Tablets
B.No. NA 660, Mfd. Dec. 92, Exp. May 94, NB
290, Mfd. Nov. 94, Exp. Apr. 96, NB 538, Mfd.
May 95, Exp. Dec. 96 and NB 656, Mfd. Sep. 95,
Exp. Feb. 97, which were earlier declared as not
of standard quality by Government Analyst,
Bhopal for facing analytical difficulties during
the determination of uniformity of content by the
IP 1985 method.”
(Emphasis added)
In that letter also the appellant company does not make its
intention clear to adduce any evidence to controvert the Government
Analyst’s report rather made the following request:
“Under these circumstances, we respectfully
reiterate that our product Betnesol Tablets
referred above are of standard quality and request
you to kindly treat all the matter as closed.”
12. As explained hereinabove, the appellants and other co-accused
did not give any option to adduce evidence in contravention of the
analyst’s report within statutory limitation period. Even if there was
inordinate delay in launching the criminal prosecution or filing the
complaint, it is thereby of no consequence. We do not find any ground
10to interfere with the well reasoned judgment of the High Court. The
appeal lacks merit and is, accordingly, dismissed.
……………………………J.
(P. SATHASIVAM)
……………………………J.
(Dr. B.S. CHAUHAN)
New Delhi,
July 28, 2011
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