M/S. MEDICAMEN BIOTECH LTD. AND ANR.versusRUBINA BOSE, DRUG INSPECTOR

                                 [2008) 4 S.C.R. 936


 A            M/S. MEDICAMEN BIOTECH LTD. AND ANR.
                                         v.
                   RUBINA BOSE, DRUG INSPECTOR
                    (Criminal Appeal No. 483 of 2008)
                                 MARCH 13, 2008
       [TARUN. CH.~TTERJEE AND HARJIT SINGH BED~, JJ~]

                   Drugs and Cosmetics Act, 1940 - ss. 25(3) and 25(4) -
             Right under - Violation of - Drug sample - Testing of -
:c .         Procedure - Delayed filing of complaint - Drugs Inspector
·.,          collected samples of drug manufactured by Appellant and
             divided the samples into four equal parts - One part was sent
             to the Government Analyst for test/analysis - Government
             Analyst gave report declaring the drug as sub-standard -
             Appellant disputed accuracy of the report and twice requested
    .0 for a re-testing of the drug - Drugs Inspector filed complaint
             before Magistrate under s. 27 - Proceedings initiated on
             account of the complaint challenged - Prayer for quashing
             under s.482 CrPC - Rejection of, by High Court - Propriety of
            . - Held: Not proper -    In spite of two communications from
       1
     ·

  · E · Appellant that it intended to adduce evidence to controvert
         , the facts given in the report of Government Analyst, the fourth
          · sample with the Magistrate had not been sent for re-analysis
            .-Also, the complaint itself had been filed about a month before
            'expiry of the shelf life of the drug - No reason as to why the
     F qomplaint could not have been filed earlier - Appellants had
           - been deprived of a valuable right under s.25(3) and 25(4) -
             Hence, proceedings against them liable to be quashed - Code
             of Criminal Procedure,. 1973 - s. 48f..
          \                  .                .! .   ·.
 G         ·\The Drugs Inspector collected samples of the drug
       manufactured by Appellal'lt No.1 and divided the samples
       into four equal parts. One part was sent to ttie Government
       Ana.lyst for test/analysis. The Government Analyst gave
       report declaring the .drug as sub-standard. Appellant
 H                                      936
               M/S. MEDICAMEN BIO. LTD: AND ANR. v. RUBINA         937
                         BOSE, DRUG INSPECTOR

         ~   disputed the accuracy of the report and requested for a A
             re-testing of the drug. However, the Drugs Inspector filed
•·1          complaint before the Magistrate under s.27 of the Act. The
             proceedings initiated on account of the complaint were
             challenged before the High Court and prayer f9r quashing
             was made under s.482 of the Cr.P.C. This petition was B
             dismissed. Hence the present appeal.
                 Allowing the appeal,· the Court · .
                   HELD:1.1. S.23 of the Drugs and Cosmetics Act, 1940
             provides the procedure for taking of samples and sub- c
             section (4) thereof, as already mentioned above, provides
             that the sample shall be divided into four portions and be
             kept/disposed of in the manner laid therein including one
             sample to be produced before the Magistrate. S.25(3)
             specifies that unless 'a person, from whom a drug has
                                                                         D
             been seized for analysis or testing, controverts the
      ....   co~rectness of the report submitted by the Government
             Analyst within 28 days in writing that he intends to adduce
             evidence to controvert the report of the Analyst, it would
             be deemed to be conclusive evidence of the quality of
             the drug whereas sub-section (4) of Section 25 obliges E
             the Magistrate on the request of the complainant or the
             accused or on in his own motion to send the fourth sample
             which has been disputed for fresh testing to the Director
             of the Central Drugs Laboratory. [Paras 5, 6] [942-8, C;
             943-E, F]                                                   F
  '
 ="
 I
      -<I



                  1.2. The argument raised by the Respondent that the
             appellant had never expressed a desire to controvert the
             report of the Drug Analyst is not correct as is clear from
             the letter dated 28th August 2001 addressed to the
                                                                        G
             Assistant Djrector General, Government Medical Stores
             Depot. Concededly a copy of this letter was addressed to
             and received by the Drugs Inspector, Kolkata. [Paras 6, 7]
             [943-G, H; 944-A, D]
                  1.3. The appellant had not once but on at least two    H
    938      SUPREME COURT REPORTS                 [2008] 4 S.C.R.


A occasions and within 28 days of the receipt of the show
  cause notice clarified that it intended to adduce evidence         "'
  to show that the test report of the Government Analyst
  was not correct. lnspite of two communications from the
  appellant that it intended to adduce evidence to controvert
B the facts given in the report of the Government Analyst,
  the fourth sample with the Magistrate had not been sent
  for re-analysis. The appellants had been deprived of the
  right to have the fourth sample tested from the Central
  Drugs Laboratory. [Paras 8, 10] [944-G, H; 946-H; 947-A, B]
c        1.4. Also, the r,omplaint had been filed on the 2nd July
    2002, about a month short of the expiry date of the drug
    and as such had the accused appellant appeared before
    the Magistrate even on 2nd July 2002 it would have been
    weli nigh impossible to get the sample tested before its
D   expiry. In the affidavit filed to the petition by Deputy Drugs
    Controller, and in arguments before this Court, it has been      ...
    repeatedly stressed that the delay in sending of the
    sample to the Central Drugs Laboratory had occurred as
    the appellant had avoided service of summons on it till
E   9th May 2005. This is begging the question. There is no
    explanation as to why the complaint itself had been filed
    about a month before the expiry of the shelf life of the
    drug and concededly the filing of the complaint had
    nothing to do with the appearance of the accused in
F   response to the notices which were to be issued by the           ~     ..,,.
    Court after the complaint had been filed. Likewise, the
    requests for retesting of the drug had been made by the
    appellant in August/September 2001 as would be clear
    from the facts and there is absolutely no reason as to why
    the complaint could not have been filed earlier and the
G
    fourth sample sent for retesting well within time.
    Therefore, the facts of the case suggestlhat the appellants
    have been deprived of a valuable right under s. 25(3) and
    25(4) of the Act which must necessitate the quashing of
    the proceedings against them. [Paras 8] [947-B-G]
H
            M/S. MEDICAMEN BIO. LTD. AND ANR. v. RUBINA              939
           BOSE, DRUG INSPECTOR [HARJIT SINGH BEDI, J.]

               State of Haryana v. Unique Farmaid (P) Ltd. & Ors. (1999) A
          8 SCC 190 and Amery Pharmaceuticals & Anr. v. State of
          Rajasthan (2001) 4 sec 382 - relied on.
               State of Haryana v. Brij Lal Mittal and Ors. (1998) 5 SCC
          343 - referred to.
                                                                           B
              CRIMINAL APPELLATE JURISDICTION : Criminal
          Appea1No.483of2008
               From the final Judgment and Order dated 19.05.2006 of
          the High Court of Calcutta in Criminal Revision Petition No.
          C.R.R. No. 2850of2005.
                                                                           c
              Arun Kumar and Rameshwar Prasad Goyal for the
          Appellants.
              B.B. Singh and Binu Tamta (for Sushma Suri) for the
          Respondent.                                                      D

               The Judgment of the Court was delivered by
               HARJIT SINGH BEDI, J. 1. Leave granted.
               2. This appeal arises out of the following facts.           E
                3. The accused appellant No.1 is a rn:1:,rnufacturer of
          Enalapril Maleate tablets, a drug which is being manufactured
          under licence in its factory premises. The drug was released
          for sale only after it quality had been certified by an independent


•
'   -"(
          laboratory. One such batch bearing No. NT 6000 was sold on F
          29th September 1999 with its shelf life upto August 2002 and in
          addition to other orga.nizations some of the drug from the batch
          was supplied to the Government Medical Stores Depot, Kolkata.
          The Drugs Inspector, Central Drugs Standard Control
          Organisation, Kolkata visited the Government Medical Stores G
          Depot at Belvedere, Kolkata on 14th June 2000 and collected
          samples of the drug and after dividing the sample into four equal
          parts, sent one portion to the Central Drugs Laboratory, Kolkata
          under Clause (i) sub-section(4) of Section 23 of the Drugs and
          Cosmetics Act, 1940 (he.ffeinafter referred to as the 'Act') for H
    940      SUPREME COURT REPORTS                 [2008] 4 S.C.R.


A  test/analysis. The sample portion of the drug was received in
   the laboratory at Kolkata on 23rd June 2000. The Drugs Inspector
   received the test report from the Drugs Laborator-Y on 6th July
   2001 declaring the drug as not conforming to the prescribed
   standards. A show cause notice was issued to the appellants
8 ·on 14th August 2001 on which the appellant once again carried
   out an in-hou$e test and also obtained an analysis report from
   another approved laboratory. Both the reports opined that the
   sample satisfied the prescribed norms. The appellant also
   received a show-cause notice dated 14th August 2001117th
C August 2001 from the Ministry of Health and Welfare from the
   Government Medical Stores Depot, Kolkata informing the
   appellant that the drug in question had been declared sub-
   standard: On 2ath August 2001 the appellant sent a detailed
   reply to the show-cause notice to the Medical Stores Department
   with copies to the Drugs Inspector disputing the report of the
D Government Analyst and requesting for a re-testing of the drug.
   On 31st August 2001 the appellant received a letter dated 22nd
   August 2001 from the Drugs Inspector once again pointing out
   that the sample seized was not of the prescribed standard and
   also called for the comments of appellant No.1 within 10 days.
E The appellant received yet another letter dated 7th September
   2001 from the Drugs Inspector seeking certain information to
   which the appellant gave a reply on 13th Sept1ember 2001 giving
   the necessary information and also disputing the test report of
   the Central Drugs Laboratory, Kolkata and requesting for re-.
F analysis. On 26th September 2001 the appellant No.1 received
   a communication from the Drugs Inspector that the test report
   submitted by the Central Drugs Laboratory was conclusive
   evidence of the facts stated therein under section 25 of the Act
   and declined to consider any other report and on the contrary, a
G complaint was filed before the concemed Magistrate under
   section 27 of the Act on 2nd July 2.002. The Magistrate
   summoned the appellant and certain ot1hers for appearance on
   several dates but the summons were finally served on the
   appellant on gth May 2005. The proceedings initiated on accoU1nt
   of the complaint were challenged befor;a the Calcutta High Court
H and a prayer for quashing was made under Section 482 of ttle
              M/S. MEDICAMEN BIO. LTD. AND ANR. v. RUBINA                  941
             BOSE, DRUG INSPECTOR [HARJIT SINGH BEDI, J.]
     ...    Criminal Procedure Code. This petition has been dismissed A
            by the impugned order dated 19th May 2006. The learned Judge
            held that it would be premature to look into the matter and to
            take a decision on the basis of affidavits and documents filed
            in Court as they were not evidence strictu sensu. The Court also
            opined that from the facts of the case, it appeared that the B
            allegations made in the petition did indicate the commission of
            an offence as they did not suffer from any "inherent absurdity so
     t      as to raise controversy in regard to its maintainability". It also
            held that one portion of the sample had been given to. the
            accused and the necessary formalities had been complied with.
            It is in this situation the matter is before us in appeal.
                                                                               c
                   4. The learned counsel for the appellants has raised
             several arguments in the course of the hearing. He has pointed
             out that section 23(4) of the Act visualized that one portion of
             the sample was to be sent to the Government Analyst for test or D
             analysis, a second to be produced in court, if proceedings were
-"           to be initiated and the third to be sent to the person, if any, whose
             name and address have been disclosed under section 18A. It
             has also been submitted that as per sub-section (4) of Section
             25 of the Act unless a drug had been tested in the Central Drugs
                                                                                   E
             Laboratory a person was entitled, within 28 days of the receipt
             of a copy of the report from the Government Analyst, to request
             the Magistrate to send for analysis the sample, which had to be
             filed in court, to the Director, Central Drugs Laboratory and it
             appeared that this exercise had not been carried outdespite
             the objections raised by the appellants to the correctness of the F
             report of the Government Analyst. It has further been .highlighted
           . that in any event the complaint having been filed on the 2nd July
             2002, no request for re-analysis could have been effectively
             made as the shelf life expiry date of the drug was August 2002
             and there was, thus, paucity of time. The learned counsel for the G
             respondent has, however, pointed out that as the appellant had
             not made any request for sending the sample to the Central
J.
             Drugs Laboratory and had not disputed the accuracy of the
             report of the Government Analyst and had not stated that it
            needed to adduce evidence to controvert the report, the appellant H
    942        SUPREME COURT REPORTS                    [2008] 4 S.C .R.
                                                                           '

A   was precluded from challenging the report of the Central Drugs         -;       ~



    Laboratory as provided by sub-section (4) of Section 25 of the
    Act. Reliance for this argument has been placed on State of
    Haryana vs. Brij Lal Mittal & Ors. (1998) 5 SCC 343, State
    of Haryana vs. Unique Farmaid (P) Ltd. & Ors. (1999) 8
B   SCC 190 and Amery Pharmaceuticals & Anr. Vs. State of
    Rajasthan (2001) 4 sec 382.
           5. As would be evident, the matter would turn on an
                                                                           1
    examination of the legal provisions. Section 23 of the Act
    provides the procedure for taking of samples and sub-section
c   (4) thereof, as already mentioned above, provides that the
    sample shall be divided into four portions and be kept/disposed
    of in the manner laid therein including one sample to be produced
    before the Magistrate. Section 25 is reproduced below:
          "Section 25. Reports of Government Analysts.- (1) The
D         Government Analyst to whom a sample of ay drug [or
          cosmetic] has been submitted for test or analysis under              >-
          sub-section (4) of Section 23, shall deliver to the Inspector
          submitting it a signed report in triplicate in the prescribed
          form.
E         (2) The Inspector on receipt thereof shall deliver one copy
          of the report to the person from whom the sample was
          taken [and another copy to the person , if any, whose name,
          address and other particulars have been disclosed under
          section 18A], and shall retain the third copy for use in any
F         prosecution in respect of the sample.                            ~



          (3) Any document purporting to be a report signed by a
          Government Analyst under this Chapter shall be evidence
          of the facts stated therein, and such evidence shall be
          conclusive unless the person from whom the sample was
G         taken [or the person who name, address and other
          particulars have been disclosed under section 18A) has,
          within twenty-eight days of the receipt of a copy of the
                                                                               >
          report, 'notified in writing the Inspector or the Court before
          which any proceedings in respect of the sample are
H         pending that he intends to adduce evidence in
  MIS. MEDICAMEN BIO. LTD. AND ANR. v. RUBINA               943
 BOSE, DRUG INSPECTOR [HARJIT SINGH BEDI, J.]

     controversion of the report.                                 A
     (4) Unless the sample has already been tested or analysed
     in the Central Drugs Laboratory, where a person has under
     sub-section(3) notified his intention of adducing evidence
     in controversion of a Government Analyst's report, the
     Court may, of its own motion or in its discretion at the B
     request either of the complainant or the accused : cause
     the sample of the drug [or cosmetic] produced before the
     Magistrate under sub-section (4) of Section 23 to be sent
     for test or analysis to the said Laboratory, which shall make
     the test or analysis and report in writing signed by or under C
     the authority of the Director of the Central Drugs Laboratory
     the result thereof, and such r.eport shall be conclusive
     evidence of the facts stated therein.
     (5) The cost of a test or analysis made by the Central
     Drugs Laboratory under sub-section (4) shall be paid by      D
     the complainant or accused as the Court shall direct.
       6. A reading of the aforesaid provisions would reveal that
they lay certain obligations as well as provide safeguards for a
person from whom a drug has been seized for analysis or testing E
as Section 25(3) specifies that unless such a person controverts
the correctness of the report submitted by the Government
Analyst within 28 days in writing that he intends to adduce
evidence to controvert the report of the Analyst, it would be
deemed to be conclusive evidence of the quality of the drug
whereas sub-section (4) of Section 25 obliges the Magistrate F
on the request of the complainant or the accused or on in his
own motion to send the fourth sample which has been disputed
for fresh testing to the Director of the Central Drugs Laboratory.
It is the case of the appellant that despite the fact that the
appellant had repeatedly controverted the accuracy of the report G
of the Government Analyst the fourth sample had still not been
sent to the Director for re-testing and analysis. We find that the
argument raised by the learned counsel for the respondent that
the appellant had never expressed a desire to controvert the
report of the Drug Analyst is not correct as is clear from the H
    944       SUPREME COURT REPORTS                   [2008) 4 S.C.R.


A   letter dated 28th August 2001 addressed to the Assistant
    Director General, Government Medical Stores Depot in which
    it was stated as under:
          "On receipt of your letter, we have got the control sample
          of same batch analysed ·from an approved test. house,
B         namely Industrial Testing Laboratory, Delhi. The test house
          has reported our control samples to be of standard_ quality
          and conforming to IP with respect to content of Enalapril
          Maleate. Copy of test report No. F- 405/8-01 dt. -25.8.2001
          enclosed.
c         In the light of above facts, we do not agree with the Govt.
          analyst report that the sample is not of standard quality
          and request you to kindly get the sample retested at your
          end."
D         7. Concededly a copy of this letter was addressed to and
    received by.the Drugs Inspector, Kolkata. The learned counsel
    for the appellant has also drawn our attention to the letter dated
    13th September 2001 addressed to the Drugs Inspector again
    reiterating:

E         ·~we have received the sealed portion of the subject sample
          sent by you, but we have not opened it yet. We sincerely
          hope that the Asstt. Director General (MS) will need our
          request and get the sample reanalyzed. Until we receive
          the result of reanalysis we will keep your subject sample
          intact.
F
          As per your directions, we are again enclosing herewith
          he manufacturing testing and distribution details of the
          batch in question. We request you to kindly get our sample
          re-analyzed at the earliest and oblige, as we do not agree
G         with the Govt. analyst's report."·
          8. It is, therefore, evident that the appellant had not once
    but on at least two occasions and within 28 days of the receipt
    of the show cause notice clarified that it intended to adduce
    evidence to show that the test report of the Government Analyst
H   was not correct. The judgments cited by the learned counsel for
          MIS. MEDICAMEN BIO. LTD. AND ANR. v. RUBINA                945
         BOSE, DRUG INSPECTOR [HARJIT SINGH BEDI, J.]

        the respondent, therefore, do not apply to the facts of the case A
        as they were given in the context where the dealer/manufacturer
        had not expressed its desire to challenge the veracity of the
        report of the Drugs Analyst. In Brij Lal Mittal's case (supra)
        this Court held that a person could not claim that the fourth
        sample should be sent to the Central Drugs Laboratory. unless B
        the requirements of sub-section (3) of Section 25 was complied
        with. In that case, despite the service of the copies of the Analyst
        report the manufacturer had not informed the Inspector within
        the prescribed period that he intended to adduce evidence to
        controvert the report. It was held in Brij Lal Mittal's case c
        (supra):
              "From a bare perusal of sub-section(3) it is manifest that
              the rep~rt of the Government Analyst shall be evidence of
              the facts stated therein and such evidence shall be
              conclusive unless the person from whom the sample was D
              taken or the person whose name, address or other
              particulars have been disclosed under Section 18-A (in this
              case the manufacturers) has within 28 days of the receipt
              of the report notified in writing the Inspector or the court
              before which any proceedings in respect of the sample E
              are pending that he intends to adduce evidence in
              controversion of the report. 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 F
  --1         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 with by the G
              person concerned he cannot avail of his right under sub-
              section (4)."
"'·          9. In Unique Farmaids's case (supra) which was a case
        under the Insecticides Act which has provisions analogous to
        Section 25(4) of the Act, the court found that the accused had     H
    946        SUPREME COURT REPORTS                   [2008] 4 S.C.R.


A   indeed made a request to the Inspector for sending the sample
    for re-testing within the prescribed time limit and as this request
    had not been accepted an important right given to an accused
    had been rendered ineffective on which the proceedings could
    be quashed. This is what the Court had to say:
B           "It cannot be gainsaid, therefore, that the respondents in
            these appeals have been deprived of their valuable right
            to have the sample tested from the Central Insecticides
            Laboratory under sub-section (4) of Section 24 of the Act.
            Under sub-section (3) of Section 24 report signed by the
c           Insecticides Analyst shall be evidence of the facts stated
            therein and shall be conclusive evidence against the
            accused only if the accused do not, within 28 days of the
            receipt of the report, notify in writing to the Insecticide
            Inspector or the court before which proceedings are
D           pending that they intend to adduce evidence to controvert
            the report. In the present cases the Insecticides Inspector
            was notified that the accused intended to adduce evidence
            to controvert the report. By the time the matter reached
            the Court, the shelf life of the sample had already expired
            and no purpose would have been served informing the
E
            Court of such an intention. The report of the Insecticide
            Analyst was, therefore, not conclusive. A valuable right
            had been conferred on the accused to have the sample
            tested from the Central Insecticides Laboratory and in the
            circumstances of the case the accused have been
F         . deprived of that right, thus, prejudicing them in their
            defence.
          In these circumstances, the High Court was right in
          concluding that if will be an abuse of the process of the
G         court if the prosecution is continued against the
          respondents, the accused persons. The High Court rightly
          quashed the criminal complaint. We uphold the order of
          the High Court and would dismiss the appeals."
       10. We find that this judgment helps the case of the
H appellant rather than that of the respondent because inspite of
               M/S. MEDICAMEN BIO. LTD. AND ANR. v. RUBINA               947
              BOSE, DRUG INSPECTOR [HARJIT SINGH BEDI, J.]

..     ~
             two communications from the appellant that it intended to A
             adduce evidence to controvert the facts given in the report of
             the Government Analyst, the fourth sample with the Magistrate
             had not been sent for re-analysis. The observations in Amery
             Pharmaceuticals's case (supra) are also to the same effect.
             We find that the aforesaid interpretation supports the case of B
             the appellants inasmuch they had been deprived of the right to
             have the fourth sample tested from the Central Drugs Laboratory.
             It is also clear that the complaint had been filed on the 2nd July
         ~
             2002 which is about a month short of the expiry date of the drug
             and as such had the accused appellant appeared before the c
             Magistrate even on 2nd July 2002 it would have been well nigh
             impossible to get the sample tested before its expiry. In the
             affidavit filed to the petition by Dr. D. Rao, Deputy Drugs
             Controller, and in arguments before us, it has been repeatedly
             stressed that the delay in sending of the sample to the Central
                                                                                D
             Drugs Laboratory had occurred as the appellant had avoided
             service of summons on it till gth May 2005. This is begging the
     .....
             question. We find that there is no explanation as to why the
             complaint itself had been filed about a month before the expiry
             of the shelf life of the drug and concededly the filing of the
             complaint had nothing to do with the appearance of the accused E
             in response to the notices which were to be issued by the Court
             after the complaint had been filed. Likewise, we observe that
             the requests for retesting of the drug had been made by the
             appellant in AugusUSeptember 2001 as would be clear from
             the facts already given above and there is absolutely no reason F
       --I
             as to why the complaint could not have been filed earlier and

"'           the fourth sample sent for retesting well within time. We are,
             therefore, of the opinion that the facts of the case suggest that
             the appellants have been deprived of a valuable right under
             Section 25(3) and 25(4) of the Act which must necessitate the G
             quashing of the proceedings against them.
                  11. The appeal is allowed accordingly and the proceedings
     A
             against the appellants are quashed.
             B.B.B.                                        Appeal allowed.     H