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CASE NO.: Appeal (crl.)  483 of 2008

PETITIONER: M/s. Medicamen Biotech Ltd. & Anr

RESPONDENT: Rubina Bose, Drug Inspector

DATE OF JUDGMENT: 13/03/2008

BENCH: TARUN CHATTERJEE & HARJIT SINGH BEDI

JUDGMENT: JUDGMENT

CRIMINAL APPEAL NO 483/2008 (arising out of SLP (Crl.) No. 13 of  2007

HARJIT SINGH BEDI,J. 1.      Leave granted. 2.        This appeal arises out of the following facts.  3.        The accused appellant No.1 is a manufacturer 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 29th September 1999 with its shelf life upto  August 2002 and in addition to other organizations 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 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  (hereinafter referred to as the ’Act’) for 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 Laboratory on 6th July 2001  declaring the drug as not conforming to the prescribed  standards.  A show cause notice was issued to the appellants  on 14th August 2001 on which the appellant once again  carried out an in-house 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  2001/17th 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 28th 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 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.    The appellant  received yet another letter dated 7th September 2001 from the  Drugs Inspector seeking certain information to which the

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appellant gave a reply on 13th September 2001 giving the  necessary information and also disputing the test report of the  Central Drugs Laboratory, Kolkata and requesting for re- 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 complaint was filed before the concerned Magistrate under  section 27 of the Act on 2nd July 2002.  The Magistrate  summoned the appellant and certain others for appearance on  several dates but the summons were finally served on the  appellant on 9th May 2005.  The proceedings initiated on  account of the complaint were challenged before the Calcutta  High Court and a prayer for quashing was made under Section  482 of the Criminal Procedure Code.  This petition has been  dismissed 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 allegations made in the petition did  indicate the commission of an offence as they did not suffer  from any "inherent absurdity so 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. 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 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 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 out despite the objections  raised by the appellants to the correctness of the 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 respondent has, however, pointed out that as  the appellant had not made any request for sending the  sample to the Central 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 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 SCC 190 and Amery  Pharmaceuticals & Anr.  Vs. State of Rajasthan (2001) 4  SCC 382. 5.              As would be evident, the matter would turn on an  examination of the legal provisions.  Section 23 of the Act  provides the procedure for taking of samples and sub-section

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(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 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.

(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 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 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 pending that he intends to  adduce evidence in controversion of the report.

(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 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 the authority of the Director of the  Central Drugs Laboratory the result thereof,  and such report 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 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  as Section 25(3) specifies that unless such a person  controverts the correctness of the report submitted by the

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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 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 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 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, 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.

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."

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:

       "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.

       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 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 was not correct.  The judgments cited by  the learned counsel for the respondent, therefore, do not apply  to the facts of the case as they were given in the context where  the dealer/manufacturer had not expressed its desire to

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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 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  (supra) :         "From a bare perusal of sub-section(3) it is  manifest that the report 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  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 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 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 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 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:                        "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 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 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

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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 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 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 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  appellant rather than that of the respondent because in spite  of two communications from the appellant that it intended to  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 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  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  Drugs Laboratory had occurred as the appellant had avoided  service of summons on it till 9th 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 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 August/September 2001 as would be  clear from the facts already given above and there is absolutely  no reason 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 quashing of the proceedings against  them.   11.             The appeal is allowed accordingly and the  proceedings against the appellants are quashed.