IN THE HIGH COURT OF KARNATAKA AT BENGALURU DATED THIS THE 11TH DAY OF OCTOBER, 2019 BEFORE THE HON'BLE MR. JUSTICE K.N.PHANEENDRA CRIMINAL APPEAL NO.341/2011 BETWEEN:
STATE OF KARNATAKA BY DRUGS INSPECTOR, BANGALORE III CIRCLE, BANGALORE (BY SRI ROHITH B J, HCGP) AND:
... APPELLANT 1. BIMAL KUMAR GUPTA MANAGING DIRECTOR M/S L A GRANDE (PVT.) LTD., G. 40/2, LAWRENCE ROAD, DELHI, R/O NO.20/21, SHAKTINAGAR, DELHI 110 007 2. SMT SWAGATHA BISWAS MANUFACTURING CHEMIST M/S L A GRANDE (PVT.) LTD., G. 40/2, LAWRENCE ROAD, DELHI, R/O NO.2/31, ASHOK VIHAR - II, DELHI - 110 052 ... RESPONDENTS (BY SRI P N HEGDE, ADVOCATE FOR R1 NOTICE TO R2 IS DISPENSED WITH VIDE ORDER DTD. 11/10/2019) THIS CRIMINAL APPEAL IS FILED UNDER SECTION 378(1) & (3) CR.P.C PRAYING TO GRANT LEAVE TO FILE AN APPEAL AGAINST THE JUDGMENT DT:29.9.10 PASSED BY THE P.O., FTC-IX, BANGALORE IN CRL.A.NO.351/02 - ACQUITTING THE RESPONDENT FOR THE OFFENCE P/U/S 27(d) OF THE DRUGS AND COSMETICS ACT, 1940 AND CONFIRM THE JUDGMENT AND ORDER OF CONVICTION AND SENTENCE DATED 21.06.2002 PASSED BY THE P.O., SPL. COURT FOR ECONOMIC OFFENCES, BANGALORE IN C.C.NO.32/1998 THIS CRIMINAL APPEAL COMING ON FOR ADMISSION THIS DAY, THE COURT DELIVERED THE FOLLOWING:-
JUDGMENT This appeal is preferred by the State through Drugs Inspector, Bangalore III Circle, Bangalore, challenging the judgment of acquittal recorded by the First Appellate Court i.e., the Presiding Officer, Fast Track Court-IX, Bangalore City in Crl.A.No.351/2002 in acquitting the respondents herein for the offence punishable under Section 27(d) of The Drugs and Cosmetics Act, 1940 (hereinafter referred to as ‘Act’ for short).
2. Heard the learned Counsels and perused the records.
3. It is worth to mention here that, the Trial Court i.e., the Special Court for Economic Offences, Bangalore, in C.C.No.32/1998 vide its order dated 21.06.2002 convicted the respondents herein for the offence under Section 27(d) of the Act.
4. The main crux of the matter involved in this case is that whether the appellant/complainant i.e., the Drugs Inspector, Bangalore, has established beyond reasonable doubt that the accused persons-respondents herein (hereinafter referred to as ‘the accused’ for the purpose of avoiding confusion) are responsible for the manufacturing and sale of a medicine “Not of standard quality drug” named as “Leotrim suspension” batch No.3750295.
5. On careful perusal of both the judgments of the Trial Court and the First Appellate Court, there is absolutely no dispute with regard to the fact that the said drug having batch No.3750295 has been sold by the accused persons to M/s.Multi Pharma International, Vijayanagar Bangalore, according to the invoice raised by accused No.1-Firm. There is also no dispute that the accused persons are the manufacturers of the said drug. It is also an undisputed fact that the Drug Inspector on 15.05.1995 has visited M/s.Multi Pharma International Ltd., Vijayanagar, Bangalore, and found the presence of the drug ‘Leotrim Suspension’ Batch No.3750295 in the shop. Having suspected that the drug is not upto the standard, the Drug Inspector, has taken three samples as contemplated under law and out of three samples sent one sample to the Court and another sample to the Government for analysis to the Government Analyst and one sample was given to the person from whom samples were collected. The sample sent to the Government Analyst was tested and the Government Analyst has issued a report in Form No.13 as per Ex.P40 and in fact, the Analyst has categorically stated that the said batch of drug was ‘Not of standard quality’. Of course, the respondents have taken up the contention that they have written a letter to the Drug Inspector as per the provisions of the Drugs and Cosmetics Act, 1940 under Section 25(3) of the said Act, disputing, the contents of the Government Analysts’ report and expressed their intention to adduce evidence in order to challenge the report. It is the case of the respondents that the notice issued as per Ex.D1 was served on to the Drugs Inspector within 28 days of receipt of the copy of the report from the Government Analyst. Therefore, the respondents’ contention is that, the test conducted by the State Analyst was disputed and controverted. It is also not in dispute that neither the respondents nor the complainant or the Court have sent the sample which was furnished to the Court to the Central Drugs Laboratory for further analysis as contemplated under Section 25(4) of the Drugs and Cosmetics Act. Therefore, it remains for consideration that whether the analysis made by the State Drug Analyst is conclusive in nature as per Section 25(3) of the Act.
6. There are serious grounds raised before this Court with reference to the observations made by the Appellate Court. The Appellate Court has considered a ground that Rule 4 of the Drugs and Cosmetics Rules, 1945, has not been followed by the Drugs Inspector in sending the said sample of the drug to the State Analyst. Therefore it is in violation or contravention of the mandatory Rules under the said Rules, therefore, the Appellate Court has made it as a ground to acquit the accused. Another important point which is observed by the Appellate Court to acquit the accused is that the sample of the drug has not been sent to the analyst by registered post, but by hand the same has been delivered to the Analyst and there is no explanation by the Drugs Inspector as to why he has done so. It is also made clear from the judgment of the First Appellate Court that the respondents have issued Ex.D1, a letter to the Drugs Inspector within the time of 28 days expressing their desire to controvert the report of the State Drug analyst and further observed that the Drug Inspector who was examined before the Court as PW2, has not, in specific words stated that he has not received Ex.D1 on or before 28th day as prescribed under Section 25(3) of the Act. Further the Appellate Court has also taken into consideration the non-sending of the sample to the Analyst as early as possible and there is a delay in sending the same to the Analyst.
7. Controverting the above said observations made by the Fast Track Judge in the appeal, the learned HCGP submitted before the Court that Rule 4 of the Rules, is actually not applicable but Rule 57 of the Drugs and Cosmetics Rules, is applicable which provides authority to the Drugs Inspector to handover the sample of the drug to the Analyst by hand. He further contends before the Court that the delay in sending the sample to the analyst is of no consequence in this particular case. The respondents have accepted the said Drug Inspector’s report and they intend to controvert the same. Therefore, contents have to be controverted but not the delay in sending the sample to the Drug Inspector. He further contends before the Court that so far as Ex.D1 is concerned, there is no date mentioned in the said document and in the evidence also, the respondents have not entered into the witness box in order to prove the contents of Ex.D1. Though an evasive answer was given by PW2 with regard to the receipt of the said letter, the onus is upon the accused persons to show that the said letter has been conveyed to the Drugs Inspector within 28 days and receipt of the same by the Drugs Inspector within that particular time, if not the State analyst’s report becomes conclusive. As the said proof has not been given by the accused persons, the question of the complainant requesting the Court under Section 25(4) of the Act, for sending the said sample to the Central Analyst does not arise for consideration. Therefore, it is contended that the Appellate Court has committed serious error in acquitting the accused wherein the Trial Court has discussed all the above said facts in detail and correctly convicted the accused persons. Hence, this Court has to interfere with the judgment of the Appellate Court in order to restore the judgment of conviction and sentence passed by the Trial Court.
8. Per contra, the learned Counsel appearing for the respondents strenuously submitted that though Rule 4 of the Rules, is not applicable to the present facts and circumstances of the case, but the analyst’s report at Ex.P40 itself is not acceptable, which point has lost sight of by both the Courts. The First Appellate Court has also not discussed about the contents of the analyst report and the Trial Court has also not properly looked into the contents of the analyst report with reference to Rule 46 of the Drugs and Cosmetics Rules. Therefore, he contends that, even accepting the arguments of the learned HCGP so far as Rules 4 and 57 of The Drugs and Cosmetics Rules, are concerned and that there is a delay in sending the sample to the analyst, even all these things are ignored and the letter sent under Ex.D1 by the respondent is also not within time, but the fact remains that, the analyst report cannot be treated as conclusive by the Court in order to convict the accused persons.
9. On looking to the above said materials on record, the Court has to examine the above said aspect with reference to the report of the State Drug Analyst which is marked at Ex.P40. Before that I have also carefully observed Rule 4 which contemplates sending of the sample which was seized by the Drugs Inspector at the time of inspection of the shop from where the samples were taken. The said Rule 4 says that the samples should be sent to the State Drug Analyst by registered post. The said provision is incorporated in Part-II of the Drugs and Cosmetics Rules, which refers to the Central Drugs Laboratory. As rightly contended by the learned HCGP, Section 57, which is the provision incorporated under Part-IV of The Drugs and Cosmetics Rules, 1945 is with reference to the Government Analyst Inspector’s Licencing Authorities and Controlling authorities. Section 57 gives the authority to the Drug Inspector who has taken sample and that the sample has to be sent to the Government Analyst for test or analysis under sub-section (4) of Section 23 of the Act, by registered post or by hand in a sealed packet enclosed together with a memorandum in Form 18. Therefore, this provision slightly deviated from Rule 4. Thus it empowers the Drug Inspector to handover the sealed packet containing the sample by hand to the Government Analyst. I do not find any strong reasons to differ from the view expressed by the Trial Court so far as this aspect is concerned. The Appellate Court has committed serious error in holding that Rule 4 is applicable in connection with this case.
10. Next coming to the other provision that is Section 25 of the Act. This Section refers to the reports of the Government Analysts. There is no dispute in this case that the Government Analyst has issued the result as per Ex.P40 which was communicated to the respondents herein, as they admit the report of the Government Analyst by hand and sent a letter Ex.D1 to the Drugs Inspector who has collected the sample expressing their intention to controvert the contents of the report by adducing evidence before the Court. But this letter has to be communicated to the Drugs Inspector within 28 days from the date of receipt of a copy of the report. As rightly contended by the learned HCGP that Ex.D1 does not contain the date on which the same has been delivered to the complainant and there is no whisper in the said letter with reference to the receipt of the said letter by the complainant. Further added to that, on careful perusal of the evidence on record, of course, PW2 has stated that he do not remember on what date he actually received the said letter whether within 28 days or not. But the provision under sub-clause (3) of Section 25, the burden is on the respondents to establish before the Court that the same has been communicated to the complainant within 28 days as contemplated under the said provision. The respondents have not let in any evidence in order to show that this letter was actually delivered to the complainant within 28 days. Therefore, it cannot be said that merely because evasive reply has been given by PW2, it will substitute discharge of the burden by the respondents. Therefore the Appellate Court has also committed an error in holding that Ex.D1 has been communicated to the complainant within 28 days as contemplated under Section 25(3) of the Act.
11. Of course, there is some delay in sending the sample to the Government Analyst by the complainant, but it has to be established whether it has caused any prejudice to the accused persons and in what manner the said sending of the sample to the Analyst has caused injustice to the accused persons. In the absence of such elucidation of facts in the evidence of PW2, except eliciting that some delay has occurred in sending the sample to the Government Analyst, there is no evidence before the Court that the delay in sending the sample has caused prejudice to the case, in my opinion, that cannot be taken into consideration so far as to acquit the accused persons which has been actually done by the Appellate Court.
12. The next important aspect is that the learned Counsel for the respondents submitted that because the complaint has been filed in a delayed manner, he has last the opportunity under Section 25(4) to approach the Court requesting the Court to send the second sample which was given to the Court for the purpose of sending the same to the Central Government Analyst for test. This, in my opinion, may not be helpful to the respondents because he himself has sent the said sample given to him to another Private Laboratories which is called as Industrial Testing Laboratories as per Exs.D2 and D3 wherein the test report given by the said Laboratory was that the drugs were of ‘standard quality’. However, the learned Counsel for the respondents has not brought to the notice of this Court under which provision of law the respondents are entitled to send the sample to a private Laboratory when the law contemplates that either it should be sent to the State Analyst or to the Central Drug Analyst as per Section 25 of the Act. It is open to the respondents under Section 25(4) of the Act to request the Court to send the second sample furnished to the Court for analysis to the Central Drug analyst and there is no provision under the Act or Rules that the respondents are entitled to send the said sample to a private analyst. Therefore the said report is of no avail so far as the respondents are concerned. Therefore, I am of the opinion that the Appellate Court has committed serious error in appreciating these aspects.
13. The fact remains that another important point raised by the respondents’ Counsel before this Court with reference to the contents of Ex.P40-the State Analyst report, is nowhere considered either by the Trial Court or by the Appellate Court. Therefore, it becomes the responsibility of this Court to examine the contents of the State Analyst’s report because of the simple reason that if the State Analyst’s report is accepted as it is, it raises a presumption that it is conclusive evidence so far as the contents of the said document is concerned. Therefore, the Court should be very careful before accepting the State Analyst’s report, but ascertain before accepting the same whether it complies with the strict mandatory provisions of law. In this background, let me consider the Analyst’s report which is marked at Ex.P40.
14. Before adverting to the Analyst’s report marked as Ex.P.40 I feel it just and necessary to have a brief look at Rule 46 of the Drugs and Cosmetics Rules, 1945 which contemplates what should be the procedure that should be followed by a Government Drug Analyst and how the report has to be given and what should be contents of the said report. The said Rule reads as follows:
“46. Procedure on receipt of sample.-On receipt of a package from an Inspector containing a sample for test or analysis, the Government Analyst shall compare the seals on the packet [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]. After the test of 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.- It shall be deemed to be full and sufficient compliance with the requirement of the rule in respect of the supply of “protocols of the tests of 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:”
15. On careful and meticulous understanding of the said Rule, it presupposes that apart from comparing seals on the packet and noting down the condition of the seal etc., and after conducting the test, the Analyst should forthwith supply to the Inspector report in triplicate in Form No. 13 together with full protocols of the tests or analysis applied. Therefore, it presupposes that the report shall contain the full details of the protocols of the test or analysis applied by the Analyst. Of-course the explanation to the provision says that it is full and sufficient compliance with the requirement of the Rule in respect of the supply of protocols of the tests or analysis applied if a pharmacopoeial drug, where tests or methods of analysis prescribed in the official pharmacopoeia are followed, reference to the specific tests or analysis in the pharmacopoeias are not given in the report. Of-course the rest of the provision may not be necessary to be quoted and discussed here. Even if the explanation is accepted that the test or method of analysis if it is prescribed in the official pharmacopoeia if they are followed then there is no necessity of giving details with reference to the specific tests or analysis in the pharmacopoeia or even in the report. Therefore, test report should contain whether there is any analysis prescribed in the official pharmacopoeia and they are followed. Therefore it presupposes that the Analyst should give full protocols of the tests or analysis or he must mention the prescribed official pharmacopoeia and those official pharmacopoeia are followed.
16. In this background now let me look into the report of the Analyst marked as Ex.P.40. Ex.P.40 if it is meticulously seen it is clear that first part of Rule 46 is strictly followed by examining the seals on the material sent for analysis. The description of the material sent has been described with reference to the colour as `Pink’ colour suspension. But, learned counsel has brought to the notice of this Court in Ex.P.39 the material which was sent to the analyst by the Drug Inspector shows that the colour of the material sent was ‘Erythrosine’. Erythrosine is actually red in colour as per Rule 127 of the Rules which provides a list of colours permitted to be used in drugs. The common name of the colour, the colour index number and chemical name has also been given under that particular Rule. Erythrosine is shown to be Red in colour which is having the colour index No. as 45430.
17. Of-course learned Government Pleader has drawn my attention to Rule 127 where there is no colour described as Pink. Therefore, perhaps Pink colour might have been confused with red colour and therefore Pink colour has been mentioned in the report in Ex.P.40. But, such clarification must be available from the evidence of the Drugs Inspector or by the Analyst. Conspicuously there is absolutely no explanation so far as this aspect is concerned. Therefore, it also creates some doubt in the mind of the Court, as to whether the drug which has been sent was the same drug seized in the case.
18. The second point that is to be noted is that, the identification of the drug or test to be answered was referred to Trimethoprim and Sulphame Thoxazole. The standard limits are mentioned and contents of the drug which has been sent for analysis is also explained. Except that, as rightly contended by the learned counsel for respondents, what are the tests those have been applied, what is the analysis that has been made is not explained in Ex.P.40. In the absence of such things in the test report, atleast the prosecution would have led evidence to explain what are the tests those have been conducted to come to the said conclusion.
19. In this background the evidence of Analyst who was examined before the Court as P.W.3 play a dominant role. P.W.3 – one Mr. Anantharama Sharma has deposed before the Court that after receiving the sealed sample sent by Drug Control Department he compared the Specimen seal found on Form No. 18 with seal on the sample and found them to be tallied.
He subjected the sample for analysis. He further states that he carried out various tests, test of Assay for Inmethroprim Sulpha Methoxazole and he found that the contents of Sulpha Methaxazole 81 mg whereas the standard limit was 180 to 220 mg. Therefore there was shortage of nearly 90 mg in the sample. Therefore, he has declared the said sample as not of standard quality. Though he has stated that, he has conducted various tests he has not mentioned in his evidence what are those tests or analysis he has actually made in order to come to such conclusion. The word `assay’ used by him is described by the learned Government Pleader as one of the tests which is applied or analysis applied for the purpose of ascertaining the quantity in the sample sent by the Drug Inspector. In this context it is not clearly explained as to what is meant by the word used by the Analyst, that is, ‘assay’. With all curiosity the Court has examined the meaning of the said word. In fact in the Butterworth’s Medical Dictionary, II Edition meaning of the expression ‘assay’ with reference to medical drugs are concerned is as follows:
i. The estimation of the purity of precious metals ii. The analysis of ores, metals or alloys; the term has been extended to the quantitative determination of the constituents, purity or activity of drugs and biological substances.
20. Therefore, on meaningful understanding of the word assay it only defines that it is only quantitative determination of the constituents to ascertain the purity or activity of drugs in a given substance and that does not mean to say that, that itself is a test or analysis. It is only a prescription or definition given to the word assay but in my understanding that itself cannot take the place of any test or what analysis that has been conducted by the Drug Analyst.
21. It is very curious to note here that the cross-examination of this witness it further creates serious doubt with regard to the contents of the quantity as described in the said report. He admits that in Ex.P.40 he has not mentioned the full protocols, but it is mandatory as noted above under Rule 46 of the Rules. It is also admitted by him that the test period will be continuous. He also admitted that if the bottle contents are not shaken well it leads to wrong results at the time of analysis. This also creates a serious doubt as to at the time of seizure of sample which was found in the medical shop while taking sample whether the said sample was fully shaken before taking the sample has to be explained by the Drugs Inspector who actually collected sample or even the analyst who has conducted the analysis has to say before putting the sample to analysis he has shaken the said contents well in order to ascertain the correct quantitative analysis of the drug contained in the sample. Though he has stated that throughout India for drug testing there is only one procedure that is called pharmacopoeia standard and if the drug of same batch is sent to different laboratories there will not be different results. What is that procedure which is called pharmacopoeia is not even explained in the course of cross-examination of this witnesses. When he specifically states that he has conducted various tests those tests ought to have been mentioned in the report Ex.P.40. Therefore, the said report is not in full compliance with Rule 46 of the Rules.
22. In such cases the Court should be very meticulous in looking to the legal aspects and technical aspects involved in a particular case. Technically the procedure followed by the Drugs Inspector in sending the sample to the Analyst and the Analyst conducting the analysis may be sound enough. But in order to draw a conclusive proof of the said document the other legal requirements have to be complied by the Analyst. As I have already noted there is a procedure prescribed under Rule 46 of the Rules which clearly mandates as to in what manner the analysis has been done and what should be the contents of the report sent by the Analyst to the complainant (Drugs Inspector). Therefore, though the trial Court and the appellate Court have lost sight of this particular aspect and they have not in detail meticulously gone into the contents of Ex.P.40, the trial Court has raised as if a presumption that the contents of Ex.P.40 is proved and it is not controverted by means of leading any evidence by accused as contemplated under Section 25(4) of the Act. But, when the document itself is not in accordance with law the question of controverting the said document does not arise. The document becomes void abinitio for consideration by this Court if it is legally not acceptable by Courts. Therefore, in the above facts and circumstances though I differ from the opinion expressed by the appellate Court with reference to other aspects of the matter which I have discussed above, the result of acquittal of the appellant as recorded by the appellate Court is correct though reasons are not properly adverted, for the offence alleged against them under Section 27(d) of the Act. In view of the above said reasons I proceed to pass the following order;
The appeal is devoid of merits and the same is liable to be dismissed. Accordingly, it is dismissed.
Sd/-
JUDGE JT/Lrs