LexGLAXO SMITHKLINE PHARMACEUTICALS LTD. & ANR versus STATE OF MADHYA PRADESH
Open in Lexace · Ask the AI about this caseJudgment (excerpt)
[2011J 9 S.C.R. 606
A
GLAXO SMITH KLINE PHARMACEUTICALS LTD. & ANR
B
v.
STATE OF MADHYA PRADESH
(Criminal Appeal No. 1489 of 2011)
JULY 28, 2011
[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
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•
..
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.,
F
1970 (1) SCR 736 =AIR 1970 SC 318 - relied on.
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
D
1.3 It is pertinent to mention that the appellants had
,.
earlier also been informed by the Drug Inspector of
various cities on many occasions that the medicine in
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question, i.e., BetnExcerpt shown. Read the full judgment & AI analysis in Lexace.