Holding

The analyst’s report is conclusive; a manufacturer must notify its intention to adduce evidence within 28 days under Section 25(3), otherwise the complaint stands.

Summary

The Drug Inspector seized a sample of Betnesol tablets manufactured by Glaxo Smith Kline Pharmaceuticals and sent it to the Government Analyst, who certified on 27 August 1997 that the sample was not of "standard quality". A show‑cause notice was issued on 29 September 1997, to which the company replied on 3 November 1997, contending that the analysis should have been done under the 1996 Indian Pharmacopoeia rather than the 1985 edition. The State filed a criminal complaint under Section 35 of the Drugs and Cosmetics Act on 3 July 2001, and the company sought to quash the proceedings by invoking Section 25(3), claiming a right to have the sample re‑tested at the Central Drugs Laboratory. The Supreme Court held that the analyst’s report is conclusive and that a manufacturer may only contest it if it expressly notifies its intention to adduce evidence within the statutory 28‑day period prescribed by Section 25(3). Because the company failed to make such a notice within the limitation period, the delay in filing the complaint was deemed immaterial and the High Court’s order refusing to quash the proceedings was affirmed.

Issues considered

The report of the Government Analyst is conclusive and cannot be challenged without complying with Section 25(3) of the Drugs and Cosmetics Act.
Whether the failure to express intention to adduce evidence within the 28‑day limitation period bars the manufacturer from contesting the analyst’s report.
Whether the delay in filing the criminal complaint affects the validity of the proceedings.

Legislation cited

Drugs and Cosmetics Act, 1940s. 18(a)(i), s. 25(3), s. 35

Subjects

Drugs and Cosmetics Actanalyst reportstandard qualitySection 25(3)Section 35substandard drugcriminal prosecutionquashing of complaintlimitation periodconclusive evidence

Judgment

A
[2011J 9 S.C.R. 606

GLAXO SMITH KLINE PHARMACEUTICALS LTD. & ANR
~ -
v.
STATE OF MADHYA PRADESH
(Criminal Appeal No. 1489 of 2011)
•
JULY 28, 2011
B
[P. SATHASIVAM AND DR. B.S. CHAUHAN, JJ.]

The Drugs and Cosmetics Act, 1940:
c s. 25(3) and 35 - Drug manufactured by company found
not of 'standard quality' - Intention to controvert report of
analyst not expressed within the period of limitation - Delay
in filing the complaint - Effect of - HELD: The report of
analyst is conclusive - In the instant case, the manufacturers
D did not express their intention to adduce evidence to ..
controvert the report of the analyst within the period of
limitation - In the circumstances, the delay in filing the
complaint becomes immaterial - On earlier occasions a/so
the company was informed that the medicine in question was
E not of standard quality, but it did not make its intention clear
to adduce any evidence to controvert Government Analyst's
report - There is no ground to interfere with the well reasoned
judgment of High Court declining to quash the criminal
proceedings - Delay/Laches.
F The Drug Inspector, on 9.12.1996, took from a shop,
a sample of Betnesol tablets manufactured by the
appellant-company. The sample was sent for chemical
analysis to the laboratory i.e. Government Analyst,
Madhya Pradesh (Bhopal) on 10.12.1996. The
G Government Analyst by certificate dated 27.8.1997
declared that the sample was not of "standard quality"
as defined under the Drugs and Cosmetics Act, 1940 (the
Act). A show cause notice was issued to the appellant-
com pany on 29.9.1997. The reply was submitted on
H 606
GLAXO SMITHKLINE PHARMACEUTICALS LTD. v. STATE 607
OF MADHYA PRADESH

-lo 3.11.1997, stating that the sample of the medicine in A
question ought to have been examined/analysed under.
Indian Pharmacopoeia ('l.P.') 1996 and it had wrongly
been analysed under l.P. 1985. On 3.7.2001, the
department filed a complaint against the appellant-
company as well as its Managing Director and other B
• Officers for commission of offence punishable u/s 35 of
,' " the Act. The Chief Judicial Magistrate issued summons
to all the accused. The appellants filed an application u/
s 25(3) of the Act before the trial court with a prayer that
sample of Betnesol tablets be sent for chemical analysis c
to the Director, Central Drugs Laboratory for being tested
as per l.P.1996. The application stood rejected. The
appellants approached the High Court for quashing the
proceedings. The prayer was declined by the High Court.
~.
Dismissing the appeal filed by the manufacturers, the D
~ Court

HELD: 1.1 It is a settled legal proposition that the
report of the analyst is conclusive. It means that no
reasons are needed in support of conclusion given in the E
report, nor is it required that the report should contain
the mode or particulars of the analysis. [para 7] [612-C-
D]

Dhian Singh v. Municipal Board, Saharanpur & Anr.,
1970 (1) SCR 736 =AIR 1970 SC 318 - relied on. F

1.2 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 u/s 25(3) of the Act. In G
,j
the instant case, as 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 H
608 SUPREME COURT REPORTS [2011] 9 S.C.R.

A 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 much belated
B stage. So far as the application of l.P. 1985 or l.P. 1996 is •
concerned, such an issue can be agitated at the time of •
trial. [paras 7 and 8) (612-E-F; 613-B-D]

State of Haryana v. Brij Lal Mittal & Ors. 1998 (3)
c =
SCR 104 (1998) 5 sec 343 - relied on.

Medicamen Biotech Limited & Anr. v. Rubina Bose,
Drug Inspector 2008 (4) SCR 936 =
(2008) 7 SCC 196 •
distinguished

1.3 It is pertinent to mention that the appellants had ,.
D
earlier also been informed by the Drug Inspector of
•
various cities on many occasions that the medicine in
question, i.e., Betnesol Tablet, was not of standard quality
and the authorities had been making an attempt to initiate
E 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, it did not
make its intention clear to adduce any evidence to
F
controvert the Government Analyst's report. [para 11)
[614-D-F; 615-B]
1.4 The appellants and other co-accused did not give
any option to adduce evidence in contravention of the
G analyst's report within statutory limitation period. Even if
there was inordinate delay in launching the criminal .. ;
prosecution or filing the complaint, it is of no
consequence. There is no ground to interfere with the
well reasoned judgment of the High Court. [para 12) [615·
IH D]
GLAXO SMITH KLINE PHARMACEUTICALS LTD. v. STATE 609
OF MADHYA PRADESH

:;.. -Ir
Case Law Reference: A
1970 (1) SCR 736 relied on para 7

2008 (4) SCR 936 distinguished para 9
1998 (3) SCR 104 relied on para 10
B
" "' CRIMINAL APPELLATE JURISDICTION : Criminal Appeal
No. 1489 of 2011.

From the Judgment & Order dated 14.09.2010 of the High
Court of Madhya Pradesh at Jabalpur in Criminal Misc. Case c
No. 6315 of 2008.
'
R. Ramachandran , U.A. Rana, M. Majumbar, Gagrat &
Co. for the Appellants.

> Vibha Datta Makhija for the Respondent. D

• The Judgment of the Court was delivered by

DR. B.S. CHAUHAN, J. 1. Leave granted.

2. This appeal has been preferred against the judgment E
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 the provisions of The Drugs and
Cosmetics Act, 1940 (hereinafter called 'the Act 1940'). F
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 G
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. H
610 SUPREME COURT REPORTS [2011] 9 S.C.R.

A 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
B of content.
•
C. In view thereof, a show cause notice was issued to the >

appellant-company 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
c 3.11.1997, submitting that sample of the aforesaid medicine
ought to have been examined/analysed under Indian
Pharmacopoeia (hereinafter called 'l.P.') 1996 and it had
wrongly been analysed under l.P. 1985. Subsequent thereto,
the department filed a complaint against the appellants on
D 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
E 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
F 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 l.P.1996 on
1.10.2007. The said application stood rejected vide order
G
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 rejected by the impugned judgment
and order dated 14.9.2010. Hence, this appeal.
H
GLAXO SMITHKLINE PHARMACEUTICALS LTD. v. STATE 611
OF MADHYA PRADESH [DR. B.S. CHAUHAN, J.]
... _...
4. Shri R. Ramachandran, learned senior counsel A
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 respondent- authorities to file a complaint,
<I that is too afterthe expiry of more than 3 years and 9 months B
.. 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 chemicalcapalyst's report was not clear
at all. The certificate declared that the medicine ''was not of the c
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
D
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 justification for the State to file the complaint at such a
belated stage. Thus, the High Court erred in rejecting the E.
application for quashing the complaint.

5. On the other hand, Ms. Vibha Datta Makhija, learned
counsel appearing for the respondent-State, has vehemently
:;1
opposed the appeal contending that the applicants are the F
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 G
; 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 H
612 SUPREME COURT REPORTS [2011] 9 S.C.R.

A 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
B raised before the High Court in the gravity in which it is being •
agitated before 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.
c
7. The issue involving herein is no more res integra matter.
The ii;sues 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 4
D 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
E
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 '
~

F 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
was not filed within the period of 28 days i.e. limitation
prescribed for it. The appellants are the persons who knew the
G date on which the show cause notice was received. For the
reasons best known to them, they have not disclosed the said
., I

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
H the willingness to controvert the report. In fact, such application
GLAXO SMITHKLINE PHARMACEUTICALS LTD. v. STATE613
OF MADHYA PRADESH [DR. B.S. CHAUHAN, J.]
iii><
~ had only been made on the technique adopted for analysis. It A
has been the case that instead of testing the medicine under
the l.P. 1985, it could have been done under l.P. 1996 because
the 1.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
B
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 c
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 much
belated stage. So far as the application of l.P. 1985 or l.P. 1996
' is concerned, such an issue can be agitated at the time of trial. D
t . .
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 E
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 F
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: G
t
".... 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 H
614 SUPREME COURT REPORTS [20111 9 S.C.R.
...__
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
B 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
c 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

D
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 ..;:.iality and the authorities
E 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
F part thereof reads as under: '
"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
G 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,
H Bhopal for facing analytical difficulties during the
GLA.XO SMITHKLINE PHARMACEUTICALS LTD. v. STATE 615
OF MADHYA PRADESH [DR. B.S. CHAUHAN, J.]
determination of uniformity of content by the IP 1985 A
method."

(Emphasis added)

In that letter also the appellant company does not make
its intention clear to adduce any evidence to controvert the B
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 c
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 D
criminal prosecution or filing the complaint, it is thereby of no
consequence. We do not find any ground to interfere with the
well reasoned judgment of the High Court. The appeal lacks
merit and is, accordingly, dismissed.
E
R.P. Appeal dismissed.