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  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:

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“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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