Skip to content


Vishal Pharmaceuticals and anr. Vs. State of M.P. - Court Judgment

SooperKanoon Citation
SubjectCriminal
CourtMadhya Pradesh High Court
Decided On
Case NumberCri. Rev. No. 174 of 1998
Judge
Reported in1999(2)MPLJ378
ActsDrugs and Cosmetics Act, 1940 - Sections 18, 24, 25 and 27; Drugs and Cosmetics Rules, 1945 - Rules 4, 6 and 46
AppellantVishal Pharmaceuticals and anr.
RespondentState of M.P.
Appellant AdvocateS.C. Bagdia, Sr. Adv. and ;S. Waghmare, Adv.
Respondent AdvocateP. Verma, Deputy Government Adv.
DispositionPetition allowed
Excerpt:
.....number. the legislature also is of view of mandatoriness of this rule, and, therefore, in addition to rule 4, rule 46 has been provided which ensures a safe course during the analysis and submission of the report which acquire special evidentiary value......samples were despatched by him to government analyst, bhopal by registered parcel. he received the report of government analyst which opined that the said samples were deficient to the prescribed quality and were not upto the standard prescribed by the provisions of the act. after that a notice was issued to the proprietor of m/s ajay khatri medical hall by the drug inspector on 11-12-1984 and he was asked to disclose the name of person from whom he had purchased the said drug. in response to that, the owner of m/s ajay khatri medical hall informed the drug inspector by his letter dated 3-1-1985 that the said drugs were purchased by him from m/s vishal pharmaceuticals, indore on 18-6-1984. after receiving that information, the drug inspector sent one of the samples to the present.....
Judgment:
ORDER

J.G. Chitre, J.

1. The petitioners are hereby assailing the correctness, propriety and legality of the order which has been passed by CJM, Dhar in the matter of Cr. Case No. 524/85 whereby he has convicted the petitioners for an offence punishable under Section 18(a)(i) read with Section 27(d) of the Cosmetics and Drugs Act, 1940 (hereinafter referred to as Act for convenience) which has been confirmed by the Sessions Judge Dhar in the matter of criminal appeal No. 229/1997.

2. The facts which need to be narrated for the purpose of unfolding the matter are as mentioned hereunder:

3. On 26-6-1984 Drug Inspector Shri Deo Kumar Barjatya visited the shop styled as M/s Ajay Khatri Medical Hall, Dhar, and purchased capsules of Vitriplex-C-Forte, batch No. 127, manufactured in the month of April 1984 and having the expiry date as October 1985 for analysis as he suspected that it was a drug below the standard prescribed under the provisions of the Act and the rules made thereunder. Those capsules were collected by the Drug Inspector in 4 parts in accordance with the rules framed under the provisions of the Act in presence of Panch witnesses and those samples were despatched by him to government analyst, Bhopal by registered parcel. He received the report of government analyst which opined that the said samples were deficient to the prescribed quality and were not upto the standard prescribed by the provisions of the Act. After that a notice was issued to the proprietor of M/s Ajay Khatri Medical Hall by the Drug Inspector on 11-12-1984 and he was asked to disclose the name of person from whom he had purchased the said drug. In response to that, the owner of M/s Ajay Khatri Medical Hall informed the Drug Inspector by his letter dated 3-1-1985 that the said drugs were purchased by him from M/s Vishal Pharmaceuticals, Indore on 18-6-1984. After receiving that information, the Drug inspector sent one of the samples to the present petitioner Vishal Pharmaceuticals, Indore along with the report of the Government analyst. Thereafter the petitioners were prosecuted in the Court of CJM Dhar for an offence punishable under the provisions of Section 18(a)(i) read with Section 27(d) of the Act.

4. The prosecution examined necessary witnesses to establish the guilt of the petitioners. Petitioners also examined some witnesses in defence. The learned Magistrate after appreciating the evidence on record held that the petitioners were guilty of committing an offence punishable under the provisions of the Act for which they are prosecuted. The petitioners preferred an appeal in the Sessions Court Dhar against the said order of conviction and sentence challenging its correctness, propriety and legality. The learned Sessions Judge, Dhar heard the said appeal finally and dismissed the same by maintaining the order of conviction and sentence passed against the petitioner by the Chief Judicial Magistrate, Dhar and the judgments and orders which were passed by the Courts below mentioned hereinabove, have been assailed by this revision petition by the petitioners.

5. Shri S. C. Bagdia, senior advocate instructed by Mrs. S. Waghmare challenged the said judgments of Courts below convicting and sentencing the petitioners on following grounds:

(i) That the right of the petitioners accused under Section 25 of the Act has been infringed on account of the default on the part of the prosecution when there was no default on the part of the petitioners.

(ii) The drug inspector did not follow the provisions of rules which are mandatory and it adversely effected the report of government analyst,

(iii) The government analyst did not follow the provisions of rules which are mandatory and, therefore, the defence of the petitioners was prejudiced.

(iv) The conviction and sentence is bad in law as the same is defective.

He prayed that the said order of conviction and sentence passed by the trial Court and which has been confirmed by the appellate Court be set aside and petitioners be acquitted.

6. Shri Prakash Verma, Dy. G. A. appearing for the prosecution submitted that an application was moved by the petitioners for making a prayer to the Court for sending the samples to Central Laboratory, Calcutta after lapse of sufficient days and, therefore, they were blamable in respect of the delay. He submitted further that no sanction is required by the prosecution under the provisions of the Act and, therefore, the trial has not been vitiated on account of defect in the order of sanction. He submitted that no prejudice has been caused to the defence of petitioners on account of non-compliance of provisions of rules. He submitted that the judgments of the Courts below are perfectly correct and legal and the resultant order of conviction and sentence is also correct and legal and, therefore, this petition be dismissed.

7. The samples were collected on 26-6-1984. Those samples were despatched to the office of government's analyst on 29-6-1984. The drug inspector had received the report of government analyst on 27-11-1984. The copy of that report of government analyst has been sent to owner of Ajay Khatri Medical Hall, Dhar on 11-12-1984. The copy of the government analyst has been sent to the petitioners on 11-1-1985. The complaint has been filed in the Court on 16-5-1985. The application has been preferred by the petitioners in the Court making a prayer to the Court for sending the samples which were in the custody of the Court to the Central Drug Laboratory, Calcutta on 30th July, 1985. Therefore, this application has been preferred by the petitioners 75 days after the complaint was lodged in the Court. Shri Bagdia submitted that the petitioners themselves appeared in the Court in the year 1985. The application making a prayer to send the samples to the Central Drug Laboratory has been submitted on 30th July, 1985. It means that their appearance in the Court must have been prior to that. The order sheet shows that on 6-8-1985 the Court has taken the steps for the purpose of sending the samples which were in possession of drug inspector to Central Drug Laboratory, Calcutta. The order sheet shows that on 6-9-1985 the drug inspector Shri Badjyata produced the required form No. 1 as required by the Central Drug Laboratory, Calcutta and the said form was sent on 6-9-1985 by registered post. The record shows that the Central Drug Laboratory opined that the sample was not fit for analysis. That has been indicated by the order sheet dated 7-7-1997. On 7-7-1997 an application was moved on behalf of the prosecution for calling the government analyst for giving evidence in the Court in this case. The Court did not examine him as a prosecution witness.

8. The entry in the order sheet on 7-7-1997 shows that the Central Drug Laboratory found that the said sample was having pasty-ness and the samples were in mutilated condition. It further shows that the said opinion of the Central Drug Laboratory was received by the trial Court on 29th September 1985 because the trial has blamed the petitioners for not moving an application for sending the samples which were in possession of the owner of the Ajay Khatri Medical Hall, Dhar to the Central Drug Laboratory, Calcutta for analysis. Shri Bagdia has submitted that here the Court has committed the error in blaming the petitioners for not moving an application to the Court for sending samples to Central Drug Laboratory, Calcutta which were in possession of the owner of the Ajay Khatri Medical Hall, Dhar. It is his submission that it was for the prosecution to take such steps and it was for the owner of Ajay Khatri Medical Hall, Dhar to make a prayer to the Court for sending these samples to Central Drug Laboratory, Calcutta for analysis. Shri Bagdia further submitted that as drug Inspector Shri Badjyata and owner of Ajay Khatri Medical Hall did not send those samples to Central Drug Laboratory, the important right of the petitioners under the provisions of Section 25 of the Act has been infringed and that has caused serious prejudice to their defence.

9. Section 25(3) of the Act provides that -

'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 whose 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.'

Therefore, it was the duty of the petitioners and not the prosecution to take the steps for the purpose of sending the sample which was in custody of the Court or in the custody of owner of Ajay Khatri Medical Hall, Dhar to the Central Drug Laboratory, Calcutta for procuring the evidence in controversion of the report of Government Analyst. When on 30th July, 1985 it was learned that the Central Drug Laboratory, Calcutta was not in a position to analyse the said samples as they were not fit for analysis, it was necessary for the petitioners to make a prayer to the Court to direct the owner of Ajay Khatri Medical Hall to produce the samples which were in their custody before the Court for sending those samples to Central Drug Laboratory, Calcutta for analysis. But it has not been done. It is important to note that Section 25(3) is using the word 'in controversion of the report'. It means that in a case under the provisions of the Act when the prosecution produces the report of Government Analyst for proving that the samples in question are adulterated, of sub-standard nature, not consistent with the standard prescribed by the Act, prosecution discharges its initial burden of the proof and then it becomes the duty of the accused to controvert it by the report of Central Drug Laboratory if that is in his favour. And for that purpose he is obliged to show that he intends to adduce the evidence in controversion of the report of the government analyst by notifying in writing the concerned Inspector within 28 days of the receipt of the copy of the said report that he is intending to send these samples to Central Drug Laboratory. In the present case such action was to be taken by the present petitioners within 28 days after they received the copy of the report of the government analyst. Such an accused has to move an application to the Court for asking the person from whose possession such spurious drug has been seized, substandard drug has been seized, to produce the said samples before the Court for its onward transmission to Central Drug Laboratory for analysis. Therefore, the petitioners cannot blame the drug inspector in this case also for failure on his part to take the steps for asking the owner of the Ajay Khatri Medical Hall, Dhar to produce the samples before the Court for onward transmission to Central Drug Laboratory, Calcutta for anlaysis. The petitioners have to thank themselves for losing the right which has been conferred on the accused in such a case in view of provisions of Section 25 of the Act.

10. Section 25(4) of the Act provides-

'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.'

11. When the petitioners lost their right which was conferred on them in view of Section 25(3) they could have utilised their right conferred on them in view of provisions of Section 25(4) of the Act. So also in the interest of justice and fair trial the drug inspector in question Shri Badjyata could have also taken the steps for the purpose of sending samples which were in possession of Ajay Medical Hall, Dhar to the Central Drug Laboratory, Calcutta. When both of them failed to do so, it was necessary for the trial Court to send those samples to the interest of justice in such situation for finding the truth when an attempt was made by the petitioners in that direction, because the law enjoins such an act from the Court also which is evident from the use of words 'of its own motion' which have been used in Section 25(4) of the Act. Equal duties are also cast on the complainant because Sub-section 4 of the Section 25 also used the words 'on the request either of the complainant'.

12. The provisions of Section 25 are mandatory in nature and that is a very important right which has been conferred on complainant, accused as well as the trial Court. None of them are dependent on others and none of them eclipsed by other provisions contemplate that every person who is concerned with trial either complainant or the accused or the Court, should make necessary efforts in this context for the purpose of finding out the truth in the interest of justice. Thus, the provisions of Section 25 are mandatory in nature and they cannot be ignored, dealt with in casual approach or forgotten.

13. The complainant and the Court did not utilise the powers indicated by provisions of Section 25(4) of the Act and, therefore, the impact of that will have to be assessed while considering the other evidence on record as well as circumstances of the matter.

14. Shri Bagdia has submitted that the prosecution has not proved the guilt of the petitioners in this prosecution. He has submitted that the order of conviction and sentence is not correct, proper and legal. Shri Prakash Verma, Dy. G. A. submitted that no such defence has been taken specifically by the petitioners in the trial. And, therefore, this Court should not consider the submissions of Shri Bagdia on behalf of the petitioners. I am afraid, the Court cannot take such an approach because while deciding a revision petition the Court is obliged to examine the correctness, propriety and legality of the order of the Courts below which the Court has been prayed to examine. If the Court finds that the order which has been assailed has suffered from any of the infirmities which makes it unsustainable, the Court has to give necessary attention towards it and to find out whether the said order is correct, proper and legal and sustainable.

15. Rule 4 of Drugs and Cosmetics Rules, 1945 (hereinafter referred to as Rules for convenience) provides that -

'(1) The samples for test or analysis under Sub-section 1 of Section 25 of the Act shall be sent by registered post in a sealed packet, enclosed, together with a memorandum in Form 7, in an outer cover addressed to the Director.

(2) The packet as well as the outer cover, shall be marked with a distinguishing number.

(3) A copy of memorandum in Form 1 and a speciman impression of the seal used to seal the packet shall be sent separately by registered post to the Director.'

16. In each prosecution under the Act it is obligatory on the prosecution and the complainant to give evidence that he has complied with the provisions. These provisions have been brought in existence for the purpose of avoiding any possibility of tampering with the samples before they reach to the laboratory of government analyst. It ensures safeness in the analysis and report of the government analyst which is taken to be evidence against the accused in such prosecution. Special evidentiary value has been rendered to the report of the government's analyst and, therefore, the compliance of provisions of Rule 4 are mandatory in nature. In the present case there is no evidence adduced by the complainant in the prosecution to show that complainant had sent impression of seal which was used while sealing the samples separately to the Director by registered post. The report of the government's analyst does not show anything about that.

17. Rule 6 provides that -

'After test or analysis the result of the test or analysis together with full protocols of the tests applied, shall be supplied forthwith to the sender in Form 2.

Indian Pharmacopia and Pharmacopia of Britain have indicated different tests for the purpose of analysis of the drugs which are likely to be sent to the Laboratory of Government's Analyst or Director of Central Drugs Laboratory. This is also necessary because it brings the right information about test carried and Court gets sufficient material for the purpose of finding out whether there has been compliance of mandatory provisions of the Act. When the tests have been differently indicated by these two pharmacopias, the Government's analyst is obliged to indicate in his report as to which tests have been followed by him for arriving at a conclusion which gets embodied in the said report. After all, the Act has given special evidentiary value to the report of Government's analyst without he being examined in the Court of law. When that is the value given to that report, it is obligatory on the part of the complainant to adduce evidence to show that provisions of Rule 6 which are mandatory in nature, have been complied with.

18. This rule is mandatory because Rule 46 has also cast a duty on Government's analyst that he shall compare the seals on the packet or (or on portion of sample or container) with the specimen impression received separately and shall note the condition of the seals on the packet or on portion of sample or container. It is also his duty that after the test or analysis has been completed, he shall forthwith supply to the Inspector a report in triplicate in Form 13 of the result of the test or analysis, together with full protocols of the tests or analysis applied. Explanation to this provisions of Rule 46 provides-

'It shall be deemed to be full and sufficient complaince with the requirement of the rule in respect of the supply of 'protocols of the tests or analysis applied.' if

(1) for pharmacopoeial drug, where the tests or methods of analysis prescribed in the official pharmacopoeia are followed, references to the specific tests or analysis in the pharmacopoeias are given in the report.

(2) for patent or proprietary medicines for which the tests and methods prescribed in any of the official pharmacopoeias are applicable and are followed, references to the specific tests or analysis in the pharmacopoeias are given in the report;

(3) for patent or proprietary medicines containing pharmacopoeial drugs for which the official tests or analysis or methods of assays are modified and applied, a description of the actual tests or, as the case may be, analysis or methods of assays so applied is given in the report;

(4) for patent or proprietary medicines for which no pharmacopoeial tests or methods of analysis are available or can be applied but for which tests or methods of analysis given in standard books or journals are followed, a description of such tests or methods of analysis applied together with the reference to the relevant books or journals from which the tests or methods of analysis have been adopted, is given in the report;

(5) for those drugs for which methods of test are not available and have been evolved by the Government Analyst, a description of tests applied is given in the report.'

19. The provisions of Rule 6 assume mandatory nature because there can be a case in which the public analyst may apply the tests which have been evolved by him. If no protocols are given in the report, it would not be possible for the Court to judge as to whether final opinion of the Government analyst is consistent with the provisions of the Act and soundly based on scientific knowledge and tests. If protocols have not been given, it will not be possible for the Court to note whether the Government analyst has applied the tests indicated by Pharmacopoeia of India or British Pharmacopoeia. The legislature also is of view of mandatoriness of this rule, and, therefore, in addition to Rule 4, Rule 46 has been provided which ensures a safe course during the analysis and submission of the report which acquire special evidentiary value. Needless to point out that when the law confers special evidentiary value to a particular report, law insists its safeness and acceptability beyond doubt.

20. Report of Government analyst in this case is suffering from these infirmities also.

21. When the petitioner No. 2 the accused was examined in view of provisions of Section 313 of Criminal Procedure Code, 1973, the report of Government analyst was not brought to his notice in detail so as to enable the accused to offer his explanation in that context. It is necessary for the Court to bring the circumstances which are against the accused to his notice to give him the opportunity to offer his explanation in that context. When no such opportunity is given, the document or such circumstance cannot be used against him. In the present case the report of Government analyst in its detail has not been brought to the notice of the accused and he was not given opportunity to offer his explanation in that context. That has also caused prejudice to his defence and that has also snatched out the evidentiary value of report of the Government analyst.

22. Shri Bagdia further submitted that the sanction in this case is not a valid one because it is in printed form and it shows no application of mind. Shri Verma, Dy. G. A. submitted that after examination of provisions of the Act, the defect in sanction to the prosecution is not to be viewed so seriously and it does not make a trial invalid. I uphold the submission of Shri Verma and hold that no sanction to the prosecution is necessary in the cases which are the offences under provisions of the Act. But if given, it should not be in cyclostyled form and without mentioning of reasonable facts of the case.

23. The Courts below have not noticed these glaring legal defects in the prosecution which takes out the credibility, acceptability of the report of government's analyst holding that the samples of drug sent to him were sub- standard as indicated by provisions of the Act. The prosecution is always shouldered with the burden of proving that the accused is guilty beyond reasonable doubt in every prosecution. Therefore, in this prosecution also it was obliged to prove it beyond reasonable doubt that the drug manufactured by the petitioners are sub-standard and were not consistent with the standard indicated by the provisions of the Act and the conditions of the licence granted to them by the Licencing Authority under the provisions of the Act. Thus, the courts below should have held that in the present prosecution the prosecution was unable to prove the guilt of the accused-petitioners beyond reasonable doubt and, therefore, they should have been acquitted. In view of this, the judgments and orders passed by the Courts below have to be set aside as improper, incorrect and illegal. In the result the petition needs to be allowed and the petitioners need to be acquitted.

24. The petition is allowed. The petitioners are acquitted. The fine, if any, paid by them, be refunded to them.


Save Judgments// Add Notes // Store Search Result sets // Organize Client Files //