Glaxosmithkline Pharmacet. Ltd. & Anr vs State Of M.P

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 the

provisions 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 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 3.11.1997, submitting that sample of the

aforesaid medicine ought to have been examined/analysed under Indian

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Pharmacopoeia (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

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rejected 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 respondent-

authorities 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

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justification 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

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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.

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

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was 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

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much 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

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with 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

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to 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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