There is no doubt that the Report ex facie could be admitted in evidence as to its contents also, but, the issue is that if the Government Analyst were to be examined as a witness, then, his oral evidence prevails over his report. The Analyst is subjected to cross-examination and as such, the evidence of the Analyst cannot be conclusive only on the basis of the report. Once the prosecution decides to examine the Government Analyst his oral evidence would prevail over the statement contained in his written analysis report.
Print Page
Bombay High Court
The State Of Maharashtra vs Shri R.A. Chandawarkar & Other on 18 February, 1998
Equivalent citations: 1999 (5) BomCR 519, 1999 BomCR Cri, (1999) 3 BOMLR 394, 1999 CriLJ 4449, 1999 (2) MhLj 650
Bench: S Radhakrishnan
1. Heard the learned Counsel; Mr. D.S. Mhaispurkar, the learned A.P.P. for the V.B. Ganatra, the learned Counsel for the respondents.
2. This is a Criminal Revision Application filed by the State of Maharashtra against the judgment and order dated 21st March, 1991, passed by learned Chief Metropolitan Magistrate, 11th Court, Kurla, Bombay in Criminal Case No. 82/S/90 discharging the accused/respondents with regard to the offences punishable under section 18(a)(i) read with sections 16 and 34 and punishable under section 27(d) of the Drugs and Cosmetics Act, 1940.
3. The brief facts of the prosecution are that a Drug Inspector Mr. V.D. Patil, from the office of the Joint Commissioner, Gr. Bombay, Food and Drug Administration M.S. had visited the Centenary Municipal Hospital, Kandivali, Bombay on 29th September, 1987 and that he had drawn a sample of the drug namely Vanmycetin Opticop of Batch No. G.V.A 7011 manufactured by respondent No. 6 M/s F.D.C. Pvt. Ltd. being the original Accused No. 6. It appears that the said M/s F.D.C. Pvt. Ltd. had got the aforesaid Vanmycetin Opticops produced through M/s Gelsules Medicaps Pvt. Ltd. on a loan licence basis. It appears that the said M/s. F.D.C. Pvt. Ltd. viz. the respondent No. 6 herein had supplied the aforesaid Vanmycetin Opticops to the said Centenary Municipal General Hospital on 6th June, 1987. The said Drug Inspector Mr. V.D. Patil after taking the sample of the drug namely Vanmycetin Opticops from the said Hospital on 29th September, 1987, had despatched and delivered the same to the Government Analyst on 6th October, 1987. It appears that the said sample of Vanmycetin Opticops was analysed by the Government Analyst in the Drug Control Laboratory during the period from 9th October, 1987 to 15th October, 1987. The analysis was conducted under the control of Dr. A.D. Nadkarni, and was completed on 15th October, 1987. The Government Analyst had issued a report on 27th October, 1987 duly signed by Dr. A.D. Nadkarni. Thereafter it appears that on 30th October, 1987. Dr. Nadkarni seems to have signed the Protocols and other records pertaining to the aforesaid analysis of Vanmycetin Opticops.
4. One part of the sample which was to be forwarded to the Manufacturer as per the provisions of the Drugs and Cosmetics Act, 1940 was forwarded by the Drug Inspector to the said Manufacturer viz. Accused No. 6 respondent No. 6 herein, on 4th February, 1988. Thereafter it appears that the Accused No. 6 - M/s F.D.C. Pvt. Ltd. by its letter dated 8th February, 1988 had categorically informed the Drug Inspector that they would like to controvert the said Government Analyst's report and that they do not accept the same.
5. The complainant in this case viz. the Food and Drugs Administration, Maharashtra State, at the instance of Drug Inspector Mr. V.D. Patil, had seized certain records from Accused No. 6- M/s F.D.C. Pvt. Ltd. on 8th March, 1988, and ultimately, the records were returned back to the Manufacturer on 16th March, 1988. The said Food and Drugs Administration Office had seized the records from M/s Gelsules Medicaps Pvt. Ltd. and had also seized the raw material and the finished product of the said Vanmycetin Opticops. Thereafter the present complaint viz. Criminal Case No. 82/S/90 was filed on 22nd March, 1988 before the learned Additional Chief Metropolitan Magistrate, 11th Court, Kurla, Bombay.
6. Before the learned Additional Chief Metropolitan Magistrate, the prosecution had led the evidence of two witnesses viz. P.W. 1.- Mr. V.D. Patil the Drug Inspector and P.W. 2- Dr. A.D. Nadkarni, the Government Analyst. The learned Additional Chief Metropolitan Magistrate after recording of detailed evidence of both the witnesses who were subjected to cross-examination, has passed a detailed order under section 245(1) of the Code of Criminal Procedure, 1973 whereby the learned Additional Chief Metropolitan Magistrate had discharged the accused. Against the said order of discharge, the present Criminal Revision Application has been filed by the State of Maharashtra.
7. The learned Additional Chief Metropolitan Magistrate has passed the order of discharge mainly on the following grounds;
A. The appointment of Mr. V.D. Patil as a Drug Inspector for Gr. Bombay area was not valid in law on the relevant dates viz. 29th September, 1987 on which date the samples were taken, 6th October, 1987 on which date the samples were despatched to Government Analyst, and 22nd March, 1988 on which date the said complaint was lodged.
B. Similarly, even the appointment of Dr. A.D. Nadkarni as the Government Analyst was also not valid as contemplated under the provisions of Drugs and Cosmetics Act, 1940.
C. The necessary original protocol records regarding sterility test as well the working standards were not produced though demanded by the accused and in fact, Dr. Nadkarni has refused to produce the same.
D. The prosecution has failed to produce the proper records with regard to the use of Formaldehyde solution which was required to be used in assay process.
E. No records and details with regard to the micro-biological test as well as the calculations and graph with regard to the quantity of Chloramphenicol were produced.
F. No sterility test on the buffer solution was done, and even the said Laboratory did not have the sterility test equipments.
G. Proper p.H. level test was not conducted with regard to the buffer solution and the same was not tested by using Dipotassium Hydrogen Phosphate and Potassium Dihydrogen Phosphate.
H. Though the entire analysis was done by one Mrs. Saptarshi, she was not even examined.
I. The Analyst did not even have the standard preparations from the Central Drugs Laboratory, Calcutta, so as to compare the media with the said standard.
J. The prosecution did not even produce the working standards of Parke Davis on which they were relying upon.
K. During the period from 6th June, 1987 to 29th June, 1987, the said sample of Vanmycetin Opticops was not properly stored at the Municipal Hospital below the prescribed temperature of 25° C. Similarly, the said sample was also not stored below the 25° C during the period from 29th September, 1987 to 6th October, 1987, and as such the potency of the said drug getting reduced was not ruled out.
8. Thus, by taking into account all the aforesaid facts and circumstances, the learned Additional Chief Metropolitan Magistrate by his detailed order, concluded that this is a case where no prime facie case is made out by the prosecution and as such the accused are entitled to be discharged as per section 245(1) of the Code of Criminal Procedure, 1973.
9. Mr. Ganatra, the learned Counsel for the accused contended that in the instant case the prosecution ought to make out a prima fade case to frame charge and which may ultimately result in conviction. He further submits that if the evidence of the prosecution is such which would warrant an acquittal, then, the Accused must be discharged. Mr. Ganatra further contended that if the acquittal is certain, then, the accused ought to be discharged so that the public time and money are not wasted. He contends that the evidence of the prosecution at the stage of the framing of charge ought to be such that the said evidence must be almost conclusive for conviction i.e. it must be more than a mere prima fade case.
10. Whereas, the learned A.P.P, Mr. Mhaispurkar for the State of Maharashtra, strongly contended that what is contemplated under section 245(1) of the Code of Criminal Procedure, 1973 cannot be read in isolation and the same has to be read with section 246(1) of the Code of Criminal Procedure. In as much as, sections 244, 245, 246 and 247 constitute a Code andsection 245(1) alone cannot be read. In this behalf the learned A.P.P. brought to my notice the judgement of the Apex Court in R.S. Nayak v. A.R. Antulay and another, . While analysing the scope of section 245(1) and 246(1) of the Code of Criminal Procedure the Apex Court has categorically held as under :-
"Notwithstanding this difference in the position there is no scope for doubt that the stage at which the Magistrate is required to consider the question of framing of charge under section 245(1) is a preliminary one and the test of "prima facie" case has to be applied. Inspite of the difference in the language of the three sections, the legal position is that if the trial Court is satisfied that a prima facie case is made out, charge has to be framed."
11. The learned A.P.P. also relied upon another judgment the Apex Court in State of Maharashtra v. Som Nath Thapa, reported in 1997 Bom.C.R.(Cri.) 279 : 1996 Criminal Law Journal 2448. In this case also the Apex Court has considered the scope of prima fade case and the law in that behalf has been succinctly expressed in paragraph Nos. 30, 31, and 32 of the said Judgment which read as under:-
Para 30---In Antulay's case . Bhagwati C.J., opined after noting the difference in the language of the three pairs of section that despite the difference there is no scope for doubt that at the stage at which the Court is required to consider the question, of framing of charge, the test of "prima facie" case has to be applied. According to Shri Jethmalani, a prima facie case can be said to have been made out when the evidence, unless rebutted would make the accused liable to conviction. In our view, better and clearer statement of law would be that if there is ground for presuming that the accused had committed the offence, a Court can justifiably say that a prima facie case against him exists, and so, frame charge against him for committing that offence."
Para 31:---"Let us note the meaning of the word presume. In Black's Law Dictionary, it has been defined to mean "to believe or accept upon probable evidence" . In Shorter Oxford English Dictionary it has been mentioned that in law "Presume" means "to take as proved until evidence to the contrary is forthcoming". Stroud's Legal Dictionary has quoted in this context a certain judgment according to which "A presumption is a probable consequence drawn from facts (either certain, or proved by direct testimony) as to the truth of a fact alleged." In Law Lexicon by P. Ramanath Aiyer the same quotation finds place at page 1007 of 1987 edition."
Para 32:---"The aforesaid shows that if on the basis of materials on record, a Court could come to the conclusion that commission of the offence is a probable consequence, a case for framing of charge exists. To put it differently, if the Court were to think that the accused might have committed the offence it can frame the charge, though for conviction the conclusion is required to be that the accused has committed the offence. It is apparent that at the stage of framing of charge, probative value of the materials on record cannot be gone into: the materials brought on record by the prosecution has to be accepted as true at that stage."
12. In the abovementioned judgment the Supreme Court has very categorically observed that if the Court were to think that the accused might have committed the offence it can frame the charge, though for conviction the conclusion is required to be that the accused has committed the offence.
13. In view of the abovementioned observation of the Apex Court, it is very clear that at the stage of framing of charge, even after recording of evidence as contemplated under sections 245 and246 of the Code of Criminal Procedure, the learned Magistrate must come to a prima facie finding against the accused so as to proceed to frame charge, i.e. that the prosecution has to make out prima facie case that the accused might have committed an offence. If this is not made out, the accused is entitled to be discharged.
14. From the facts and circumstance of this case, the following issues arise for my consideration:-
A. Whether the prosecution has been able to establish that the Accused Nos. 1, 3, 4 and 5 (the Directors of Accused No. 6, Company) were incharge of and were responsible to the Company at the time of commission of the offence?
B. Whether the complainant viz. the prosecution witness No. 1- the Drug Inspector Mr. V.D. Patil was a validly appointed Drug Inspector as contemplated under section 21 of the Drugs andCosmetics Act, 1940?
C. Whether Dr. A.D. Nadkarni, was the validly appointed Government Analyst as contemplated under section 20 of the Drugs and Cosmetics Act, 1940?
D. Whether there was any breach of the statutory provisions under section 23 of the Drugs andCosmetics Act, 1940 as well as Rules 46 and 57 of the Drugs and Cosmetics Rules, 1945?
E. Whether the Government Analyst's report is reliable and can be acted upon?
F. Whether the said sample of Vanmycetin Opticops was stored at a temperature below 25°c, and if not, is it ruled out that the potency of the said Vanmycetin Opticops could have been reduced?
15. So far as the first issue viz. whether the Prosecution has been able to establish that the Accused Nos. 1, 3, 4 and 5 (the Directors of the Company-
Accused No. 6) were incharge of and were responsible for the Company at the time of the commission of the offence, is concerned, the accused No. 6- M/s.
F.D.C. Pvt Ltd. had informed the complainant that only accused No. 2 was the incharge of and responsible for the conduct of the business of the Company. Therefore the question arises as to whether Accused Nos. 1,3,4 and 5 were incharge of and were responsible to the Company for the conduct of its business. In this regard section 34(1) of the Drugs and Cosmetics Act, 1940 very categorically provides that "where an offence under this Act has been committed by a Company, every person who at the time the offence was committed, was incharge of, and was responsible to the Company for the conduct of the business of the Company, as well as the Company shall be deemed to be guilty of the offence and shall be liable to be proceeded against and punished accordingly.
16. In the original complaint filed by the State of Maharashtra before the learned Additional Chief Metropolitan Magistrate there is no averment that the Accused Nos. 1, 3, 4 and 5 were incharge of and responsible to the Company at the time of the commission of the offence. Similarly, even in the examination-in-chief of P.W. 1 Mr. V.D. Patil, there is no evidence to the effect that they were incharge of and responsible to the Company with regard to the conduct of its business. On the contrary, in cross-examination, Mr. V. D. Patil has deposed as under:-
"I have no evidence to show that Accused No. 1 Mr. R. A. Chandawarkar, Accused No. 3 Mr. G.D. Kamath, Accused No. 4 Dr. S.S. Ugrankar and Accused No. 5 Mr. A.A. Chandarwarkar are incharge of and responsible for day to day business of Accused No. 6 Company."
17. In this behalf Mr. Ganatra, the learned Counsel for the respondents brought to my notice the judgment of this Court in Shyam Madan Mohan Ruia & others v. M.R. Mahakalkar & another, reported in 1998 All India Prevention of Food Adulteration Journal 239. In this case, in the complaint, the Drug Inspector had not even made any averment that some of the accused directors were incharge of and responsible to the Company in the conduct of its business. This Court has taken a view that there must be an averment to the effect that the concerned Directors were incharge of and responsible towards the day to day conduct of the business of the Company and that there must also be some evidence to that effect, failing which, no such prosecution can lie against such Directors against whom there is no averment and no such evidence.
18. Mr. Ganatra, the learned Counsel for the respondents has also brought to my notice the judgment of the Apex Court in Sham Sunder and others v. The State of Haryana, . In this case, the Supreme Court was considering the provisions of section 10 of the Essential Commodities Act which is paramateria similar to section 34 of the Drugs and Cosmetics Act, 1940. The saidsection 10 of the Essential Commodities Act, also contemplates that in case of a Company every person who is the incharge of and responsible to the Company in the conduct of its business, can be proceeded against. The Supreme Court has held that there is no vicarious liability in the Criminal Law unless the statute takes that into its fold. The Supreme Court has also held thatsection 10 of the Essential Commodities Act does not make all the partners liable for the offence whether they do business or not. In this case the Supreme Court has emphasised that some of the partners may not be knowing what is going on day to day, and there may be partners better known as sleeping partners who are not required to take part in the business. Therefore, the Supreme Court has held, that the requisite condition, that the partner was responsible for carrying on the business and was during the relevant time incharge of the business, will have to be established by the prosecution and in the absence of such proof, no such partner could be convicted.
19. The learned Counsel for the respondents also brought to my notice another judgment of the Supreme Court in Smt. Manibai and another v. The State of Maharashtra, . This was the case under the Prevention of Food Adulteration Act, 1954. In the said Act, section 17 contemplates that, in case of a Company, every person who was at the time of the commission of the offence was incharge of and responsible for the conduct of the business of the Company shall be deemed to be guilty of the offence and shall be liable to be proceeded against and punished. In the said case before the Supreme Court, though the said Manibai was the partner of the firm, there was no proof that she was incharge of and responsible for the conduct of the business of the firm and in the absence of any such evidence, the Supreme Court took a view that no criminal liability can be fastened on the said Manibai, and accordingly the Manibai was acquitted.
20. Under the aforesaid facts and circumstances, the learned Counsel for the respondents submits that the position of law under section 34 of the Drugs and Cosmetics Act, 1940 is very clear, viz. unless and until the prosecution makes an averment and produces the evidence to the effect that the concerned Director was incharge of and responsible to the conduct of the business, the prosecution cannot lie against such a Director against whom no such evidence is produced.
21. In view of the aforesaid decisions: of this Court and of the Apex Court, it is very clear that in the instant case, there is no averment against the Accused Nos. 1, 3, 4 and 5 and there is no evidence also against the said accused. Whereas in cross-examination, P.W. 1 Mr. V.D. Patil has conceded that there was no evidence for showing that the Accused Nos. 1, 3, 4 and 5 were incharge of and responsible for the conduct of the business of the Company. The learned A.P.P. has also fairly conceded that there is no material or evidence against the said Accused Nos. 1, 3, 4 and 5 and he also does not dispute the above proposition of law that the said Directors must be incharge of and responsible for the Company in its conduct of the business, failing which they cannot be proceeded against.
22. Under the aforesaid facts and circumstances, I do not find anything erroneous in the approach of the learned Additional Chief Metropolitan Magistrate discharging the Accused Nos. 1, 3, 4 and 5.
23. The second Issue to be considered is whether the Drug Inspector Mr. V.D. Patil-P.W. 1, was a properly appointed Drug Inspector as contemplated under section 21 of the Drugs andCosmetics Act, 1940. In this behalf, it is relevant to note the provisions of section 21(1) and 21(2)of the Drugs and Cosmetics Act, 1940, which read as under:-
Section 21(1)---The Central Government or a State Government may, by notification in the Official Gazette, appoint such persons as it thinks fit, having the prescribed qualifications, to be inspectors for such areas as may be assigned to them by the Central Government or the State Government, as the case may be.
Section 21(2)---The powers which may be exercised by an Inspector and the duties which may be performed by him, the drugs or classes of drugs or cosmetics or classes of cosmetics in relation to which and the conditions, limitations or restrictions subject to which, such powers and duties may be exercised or performed shall be such as may be prescribed.
24. Strongly relying upon the aforesaid section 21 of the Drugs and Cosmetics Act, 1940, Mr. Ganatra, the learned Counsel for the respondents, raised the basic issue, that the appointment of Drug Inspector Mr. V.D. Patil, ought to be notified in the Official Gazette, failing which the said Drug Inspector cannot act as a Drug Inspector. He further pointed out that as contemplated under section 21 of the said Act, either the State Government or Central Government may by notification in the Official Gazette, appoint such persons as Drug Inspectors for such areas as may be assigned to them. Thus, The statute itself provides the mode of appointment viz. the appointment should be made by notifications in the Official Gazette, and that it should also be indicated in the said Official Gazette that within which area the said Drug Inspector should act as a Drug Inspector. Accordingly, the learned Counsel for the respondents submits that unless and until Mr. V.D. Patil's appointment as a Drug Inspector was specifically notified in the Official Gazettle either by State Government or by Central Government, mentioning therein an area in which the said Mr. V.D. Patil will be able to exercise his powers and duties as a Drug Inspector, the said appointment of Mr. V.D. Patil as a Drug Inspector will not be valid in law.
25. In the instant case, the Drug Inspector Mr. V.D. Patil, was appointed as a Drug Inspector on a two years probation and for Amaravati area on 1st August, 1981. The said appointment of Mr. V.D. Patil as a Drug Inspector for Amaravati area was duly notified by notification dated 7th August, 1981 which was duly published in the Maharashtra Government Gazette on 27th August, 1981. Thereafter, by another Notification dated 30th July, 1982 which was duly published in Maharashtra Government Gazette dated 19th August, 1982 it is mentioned that Mr. V.D. Patil was appointed as a Drug Inspector for Amaravati area has taken charge as a Drug Inspector on 10th August, 1981. The Government of Maharashtra by its Notification dated 11th October, 1984 published in Official Gazette dated 20th December, 1984 mentions that Mr. V.D. Patil, the Drug Inspector of Amaravati area has been transferred to Jalgaon area with effect from 23rd May, 1984. Thereafter the Government of Maharashtra issued a Resolution dated 31st October, 1984 which confirms that Mr. V.D. Patil had successfully completed two years of probation and with effect from 10th August, 1983 he has been confirmed in the said post. It maybe noted that this is not the Government Gazette Notification, but, is only a Resolution.
26. Finally, by a Notification dated 25th November, 1986 duty published in Maharashtra Government Gazette dated 21st April, 1988 it is mentioned that Mr. V.D. Patil has been transferred from Jalgaon to Gr. Bombay area and that the said Mr. V.D. Patil has taken charge at Gr. Bombay with effect from 13th August, 1986.
27. The learned A.P.P. brought to my notice the Government Notification dated 11th February, 1975 duly published in Maharashtra Government Gazette on 27th February, 1975 which is Exh. F-33. The said Notification dated 11th February, 1975 contains almost 77 categories of posts who are empowered to exercise the powers of Drug Inspectors conferred by sub-section (1) ofsection 21 of the Drugs and Cosmetics Act, 1940 within the area specified against them in column 2 of that schedule. These categories consist of various personnel, of whom, some are conferred with the powers within the whole of Maharashtra State and some are conferred with the powers within the specified areas of certain Districts.
28. The learned A.P.P. firstly submits that it is not mandatory that the appointment of Drug Inspector under section 21 of the Drug and Cosmetics Act, 1940 must be notified in an Official Gazette. The learned A.P.P. further stressed that the wording of section 21 of the Drugs andCosmetics Act provides that the State Government may by notification in Official Gazette appoint such persons. The learned A.P.P. tried to submit that the word may does not make it mandatory on the part of the Government to officially notify any such appointment. In the alternative, the learned A.P.P. argued that even if it were to be construed that such appointment are to be notified in the Official Gazette, he strongly relied on Exhibit P-33, being the Government Notification dated 11th February, 1975 published in the Official Gazette on 27th February, 1975. According to the learned A.P.P. though Mr. V.D. Patil was not appointed on that date, however, as mentioned in the notification any Drug Inspector for the area of Jalgaon was entitled to exercise his powers as a Drug Inspector even for Gr. Bombay area. Thus, according to the learned A.P.P. the Drug Inspector appointed for the area of Jalgaon was also empowered to exercise his powers as a Drug Inspector for the area of Gr. Bombay.
29. Testing this argument, it is found that, as on the date of the said notification viz. 11th February, 1975 as well as on the date of its publication viz. 27th February, 1975, Mr. V.D. Patil was not appointed as a Drug Inspector. Even assuming that the argument of learned A.P.P. were to be accepted that Mr. V.D. Patil who was the Drug Inspector for the Jalgaon area was also entitled to exercise his powers for Gr. Bombay area, it is relevant to analyse the date on which Mr. V.D. Patil took charge at Jalgaon. It is clear from the Government Gazette Notification dated 11th February, 1984, being Exh. P-35 that Mr. V.D. Patil was transferred to Jalgaon and that he had taken charge at Jalgaon on 23rd May, 1984. It is also relevant to note that Mr. V.D. Patil was transferred from Jalgaon to Gr. Bombay with effect from 13th August, 1986 viz. the date on which he had taken charge as a Drug Inspector. Even if one were to apply the said Notification dated 11th February, 1975 being Exh. P-33 being the General Notification, then obviously Mr. V.D. Patil could have exercised his powers from Jalgaon area to Gr. Bombay area only up to 12th August, 1986, being the last date when he was posted at Jalgaon. From 13th August, 1986, Mr. V.D. Patil was not posted at Jalgaon and as such, he was not entitled to take recourse to that earlier Government Resolution dated 11th February, 1975 being Exh. P. 33.
30. The learned A.P.P. strongly relied upon the Gazette Notification dated 25th November, 1986 duly published in the Maharashtra Government Gazette on 21st April, 1988 wherein it is mentioned that Mr. V.D. Patil, the Drug Inspector has been transferred from Jalgaon area to Gr. Bombay with effect from 13th August, 1986, the date from which Mr. V.D. Patil took charge at Gr. Bombay. The learned A.P.P. further submitted that though the Gazette Notification was published on 21st April, 1988, it should be deemed to have come in effect from the date on which Mr. Patil had taken charge viz. the 13th August, 1986 and as such the learned A.P.P. submitted that the Government has complied with the requirement under section 21 of the Drugs and Cosmetics Act, 1940, and as such, the appointment of Mr. V.D. Patil as a Drug Inspector was valid and proper.
31. The learned Counsel for the respondents Mr. Ganatra strongly contended that this notification which was published on 21st April, 1988 being Exh. P-36 is not a notification of appointment as contemplated under section 21 of the Drugs and Cosmetics Act, 1940. However, it is only a transfer order and not an appointment order. Over and above, the learned Counsel submitted that the said notification published in Maharashtra Government Gazette on 21st April, 1988 could not have any retrospective effect and all the more in view of the provisions of Article 20 of the Constitution of India, in as much as, there cannot be any ex post facto law whereby a person can be punished i.e. if no retrospective effect is given to the aforesaid Gazette notification published on 21st April, 1988, then Mr. V.D. Patil could not have acted as a Drug Inspector and could not have taken samples and could not have launched the prosecution. In the light of the above, Mr. Ganatra, the learned Counsel for the respondents, submitted that no retrospective effect can be given. In as much as, giving retrospective effect to that notification would virtually violate the provisions of Article 20 of the Constitution of India whereby there can be no ex post facto law to punish for a crime. Factually, the said notification could have only the prospective effect viz. from 21st April, 1988 and not prior thereto. In the instant case, the sample was taken on 29th September, 1987 and the same was sent to Government Analyst on 6th October, 1987 and the complaint was filed on 22nd March, 1988 and during this period, the said notification was not in force and it came in force only on 21st April, 1988.
32. In this behalf, the learned Counsel for the respondents relied upon the judgment of the Apex Court in Sh. Govind Prasad v. R.G. Parsad & others, . In this case, the Supreme Court has categorically held that it is the settled law that the executive order of the Government cannot be made operative with retrospective effect. However, Mr. Ganatra, the learned Counsel for the respondents submitted that this was a civil service matter, whereas, the instant case before us is a criminal matter, and all the more no retrospective effect should be given.
33. Mr. Ganatra, the learned Counsel for the respondents relied upon another judgment of the Madras High Court in the case of Public Prosecutor v. Kamakshi Animal and others, reported in Madras Law Journal Reports (Criminal) Vol. XXVII Page 617. In this judgment the Madras High Court has considered in detail the meaning of the Notification and as to how the judicial notice can be taken with regard to such Notification, After considering the various judgments, the Madras High Court came to the conclusion as under:---
"Any notification issued under any statute, in order to be valid and proper, should have been made in pursuance of the power conferred upon the authority by the particular statute and also should have been published in the Official Gazette, and the said notification takes effect only from the date of its publication."
34. The learned Counsel Mr. Ganatra for the respondents also relied upon another judgment of the Supreme Court in A.K. Roy and another v. State of Punjab and others, . In this case, the Supreme Court was considering whether the prosecution launched by the Food Inspector was proper or not. In this case the Apex Court has interpreted the provisions of sections 20 and 24 of the Prevention of Food Adulteration Act, 1954, which contemplates that the prosecution can be by a designated person and the same cannot be delegated by such a person. In that context, the Supreme Court has held as under :---
"Where a power is given to do a certain thing in a certain way, the thing must be done in that way or not at all. Other modes of performance are necessarily forbidden. The intention of the Legislature in enacting section 20(1) was to confer a power on the authorities specified therein which power had to be exercised in the manner provided and not otherwise."
35. Mr. Ganatra also relied upon unreported judgment of the Division Bench of this Court in State v. Balwantrai Balubhai Bhayani and another, decided on 18th September, 1956. This was a case of prosecution under the Drugs and Cosmetics Act, 1940. The contention raised was that the concerned Drug Inspector was not appointed under section 21 of the Drugs and Cosmetics Act. In that case there were 10 Drug Inspectors appointed for the whole of Maharashtra State and that the notification issued did not mention any local area for which these Inspectors were appointed or within which they were to exercise their powers, and thus all the 10 Drug Inspectors were having jurisdiction all over the State. It was mainly challenged on the ground that the notification does not lay down the area in which the said Drug Inspectors can exercise the powers. Since the said notification did not clearly specify the area, the prosecution launched therein, was held defective. This Court after considering the issue has held that as the local areas were not clearly mentioned in the said notification, the Drug Inspector was not competent to institute the said prosecution. In fact, in the said judgment this Court had suggested to the Government that they should consider the desirability of issuing another notification in conformity with the provisions of section 21 of the Drugs and Cosmetics Act, 1940.
36. Mr. Ganatra, the learned Counsel for the respondents also relied upon the various judgments of various High Courts so as to point out that if the appointment of a Drug Inspector was invalid and improper, the prosecution launched by the said Drug Inspector was therefore also defective and bad in law. In this behalf Mr. Ganatra has cited following judgments:--
a) Shakti Kumar Agarwala v. State of Orissa, in Criminal Revision No. 472/87 decided on 8th August, 1991 by the Orissa High Court.
b) Nand Lal v. The State of Rajasthan, 1988(1) Prevention of Food Adulteration Cases, page 25.
c) Shanti Lal v. State of Rajasthan, 1989(1) Prevention of Food Adulteration Cases, page 289.
d) Basantu v. State of U.P., 1982(1) Prevention of Food Adulteration Cases, page 258.
e) Kanhai Lal v. State of U.P., 1984(11) Prevention of Food Adulteration Cases, page 269.
f) Raj Kumar Prasad v. State of Bihar, 1997(IV) All India Prevention of Food Adulteration Journal, page 153.
37. Mr. Ganatra, the learned Counsel for the respondents emphasised on the well known principle that as far as the penal provisions are concerned, the Court should always adopt rule of strict construction /interpretation and if two interpretations are possible, then, the interpretation in favour of the accused should always be adopted. In this behalf Mr. Ganatra relied upon the judgment of the Supreme Court in Bijaya Kumar Agarwal etc. v. The State of Orissa, . In the said judgment at para 17, the Supreme Court has referred to the ruling in the case of Tolaram v. State of Bombay, which reads as under:-
"If two possible and reasonable constructions can be put upon a penal provision, the Court must lean towards that construction which exempts the subject from penalty rather than the one which imposes penalty. If it not competent to the Court to stretch the meaning of an expression used by the Legislature in order to carry out the intention of the Legislature."
38. In the said judgment Bijaya Kumar Agarwal etc. v. The State of Orissa, at para 18, the Supreme Court has also referred to another ruling in the case of Niranjan Singh Karam Singh Punjabi v. Jitendra Bhimraj Bijava and others, , which reads as under :--
"Therefore, when a law visits a person with serious penal consequences extra care must be taken to ensure that those whom the legislature did not intend to be covered by the express language of the statute are not roped in by stretching the language of the law."
39. Mr. Ganatra, the learned Counsel for the respondents also pointed out that the issuance of notification thereby appointing the Drug Inspector for a particular area, as contemplated undersection 21 of the Drugs and Cosmetics Act, 1940, is very essential, and in the instant case it can be seen that the Government has been issuing notifications with regard to the appointment made under section 21 of the Drugs and Cosmetics Act, 1940. He submits that accordingly on 21st April, 1988 the Government had published the notification. If that was not really needed, then, the Government might not have published the same. Mr. Ganatra contended that the only mode of appointment permitted under section 21 of the Drugs and Cosmetics Act, 1940 is by way of publication of the notification in Government Gazette. Whereas, the learned A.P.P. contended that it was not mandatory to publish any such notification with regard to the appointment of the Drug Inspector, and even if it were to be construed that it was necessary, then, the original notification being Exh. P-33 dated 11th February, 1975 published in Government Gazette on 27th February, 1975 was sufficient. In fact Mr. Mhaispurkar, the learned A.P.P. pointed out that at present there are 35 Drug Inspectors appointed for Gr. Bombay area and each one can exercise powers in the entire Bombay area, and by internal office instructions certain areas have been allocated to each one of them. Learned A.P.P. also contended that the Assistant Commissioner of Ayurvedic and Homeopathy Medicines, can also function as a Drug Inspector for Allopathy medicines also.
40. It is to be noted here that the provision of section 21 of the Drugs and Cosmetics Act, 1940, makes it abundantly clear that the post of Drug Inspector is a very vital public post with wide range of powers to take samples and seize the samples and prosecute the persons for selling the adulterours, suprious and sub-standard quality drugs. In view of such vital powers conferred bysection 21 of the Drugs and Cosmetics Act, 1940 on such Drug Inspectors, the said section clearly, mandates that the Central Government or the State Government, may issue notification in Official Gazatte so as to appoint such Drug Inspectors for such areas as assigned to them. The intention of the legislature is very clear from the said section 21 of the Drugs and Cosmetics Act, 1940 that the appointment of such a person holding such an important post as a Drug Inspector, especially in the interest of public heath, obviously will have to be notified in the Official Gazette and that the said notification should indicate the area in which the said Drug Inspector can exercise his powers. In fact, section 21 does not say that the publication of notification in Official Gazette is discretionary. If one were to look at the wording of the said section carefully, the Central Government or the State Government may appoint such qualified persons as the Drug Inspectors as it thinks fit. In fact, the wording of the said section 21 shows that there is coma after the word may and not before the said word so as to construe that the issuance of the notification in the Official Gazette is discretionary.
41. Taking into account all the purposes and objects of the Act and the powers conferred on the Drug Inspector who is the vital authority to initiate the prosecution, I hold that the appointment of Drug Inspector can only be through an Official Gazette Notification and not otherwise. I am also of the opinion that such a notification should also indicate the area in which such a Drug Inspector can operate and exercise his powers, and the same should not be left to conjectures and surmises of the public.
42. In the instant case, admittedly, there is no Official Gazette Notification appointing Mr. V.D. Patil as a Drug Inspector for Greater Bombay area and as such, Mr. V.D. Patil cannot claim to be a Drug Inspector for Greater Bombay area atleast up to 21st April, 1988 on which date the said notification was published. In the instant case, as observed earlier, the sample was taken on 29th September, 1987, was sent for analysis on 6th October, 1987 and the complaint was filed on 22nd March, 1988. Till such time there was no Official Gazette Notification notifying Mr. V.D. Patil as a Drug Inspector for Greater Bombay area. In view of the aforesaid very serious infirmity which goes to the root of the matter, I hold that the said Drug Inspector Mr. V.D. Patil had no authority whatsoever to seize the said samples of Drug Vanmycetin Opticops and forward the same for analysis to the Government Analyst and that he had no jurisdiction whatsoever to launch the said prosecution and file the criminal complaint against the accused on 22nd March, 1988.
43. The next issue is whether the Government Analyst namely, Mr. A.D. Nadkarni was validly appointed in pursuance of the provisions of section 20 of the Drugs and Cosmetics Act, 1940, and if not, his analysis report has no sanctity in law and the same cannot be acted upon or relied upon.
44. Section 20 of the Drugs and Cosmetics Act, 1940 provides that the State Government may, by notification in Official Gazette, appoint such persons as it thinks fit, having the prescribed qualifications, to be Government Analysts for such areas in the State and in respect of such drugs or classes of drugs or such cosmetics or classes of cosmetics as may be specified in the notification.
45. The above provision also makes it clear that the Government Analysts having the prescribed qualifications can be appointed by the State Government by the notification in the Official Gazette. The said notification should also specify the area in which the said Analyst is required to exercise his powers and should also specify the drugs or classes of drugs or the cosmetics or the classes of the cosmetics in respect of which the said Analyst is entitled to analyse.
46. In this behalf the learned A.P.P. Mr. Mhaispurkar had relied upon Exh. P-32 which is the Government Official Gazette Notification dated 15th October, 1971 duly published on the same day by the Urban Development, Public Health and Housing Department. In the said notification, the persons specified in column 1 of the schedule, were appointed as Government Analyst for the whole of the State of Maharashtra, and they were empowered in respect of the products specified against them in column 2 of the schedule. The said notification Exh. P-32 contains five categories of persons which are as under:-
(i) Assistant Director, Drugs Control Laboratory, Maharashtra State, Bombay.
(ii) Senior Scientific Officers, Class-I, Drugs Control Laboratory, M.S. Bombay,
(iii) Senior Scientic Officers, Class-II, Drugs Control Laboratory, M.S. Bombay,
(iv) Senior Scientific Officer, Class-I (Pharmacology) Department of Pharmacology, Haffkine Institute, Bombay.
(v) Senior Scientific Officer, Class-II (Biochemistry) Department of Pharmacology, Haffkine Institute, Bombay.
47. Column 2 of the said notification states that all the above mentioned officers were entitled to test and analyse the biological and special products specified in schedules C and C (1) of the Drugs and Cosmetics Rules, 1945 and in respect of the products other than those specified in schedules C and C(1) of the said Rules.
48. The learned A.P.P. thereafter had relied upon the Government Resolution dated 26th August, 1975. By this Resolution, the Government of Maharashtra had appointed P.W. 2 Mr. A.D. Nadkarni as a Sr. Scientific Officer, Class-I (Microbiology) at the Drugs Control Laboratory, under the Food and Drug Administration. The said Resolution makes it clear in para 2 of the said Resolution that the necessary notification should be published in the Maharashtra Government Gazette. The learned A.P.P. has fairly stated that there is no such Gazette Notification published with regard to the aforesaid appointment of Dr. A.D. Nadkarni as a Senior Scientific Officer class-1 (Microbiology) at the Drug Control Laboratory under the Food and Drug Administration.
49. The learned A.P.P. had also relied upon another Government Resolution dated 6th December, 1978 being Exh. P-31 which states that Dr. Nadkarni has been appointed as a Senior Scientific Officer Class-1 (Microbiology) at the Drugs Control Laboratory under the Food and Drugs Administration on probation for a period of two years with effect from the 1st September, 1975, and he has completed his probationary period satisfactorily. In the said Resolution the Government has also directed that his probationary period should be terminated with effect from the 11th November, 1977 and that he should be continued in that post on regular basis.
50. It may be noted that both the aforesaid Government Resolutions dated 26th August, 1975 and 6th December, 1978 are only Government Resolutions and they have not been published in any of the Official Gazette. The learned A.P.P. contended that section 20 of the Drugs andCosmetics Act, 1940 does not cast any mandatory obligation on the part of the State of Maharashtra so as to issue any Official Gazette Notification with regard to the appointment of the Government Analyst. In the alternative, the learned A.P.P. had also argued that even if it is construed that it is mandatory, then, the earlier Government Gazette Notification dated 15th October, 1971 being Exh. P-32 contains various categories of persons who were entitled to act as Government Analyst for the whole of the Maharashtra and virtually for all kinds of products. The learned A.P.P. further contended that in the light of the above, it should be construed that Dr. A.D. Nadkarni was validly and properly appointed Government Analyst as per the provisions ofsection 20 of the Drugs and Cosmetics Act, 1940 and as such, he was entitled to analyse the drug samples and as such, his report ought to be accepted. Mr. Ganatra the learned Counsel for the respondents contended that the post of Government Analyst is a very important and vital post in the interest of public health and as such, it is mandatory on the part of the Government to publish the said appointment in the Official Gazette Notification. He further contended that the appointment of the Government Analyst must not only be notified in the Gazette, but, the said Gazette must also indicate the area and also the specific products in respect of which is empowered to act and operate.
51. Mr. Ganatra, the learned Counsel for the respondents states that the General Notification issued and published on 15th October, 1971 cannot be acted upon, in as much as, the said notification does not mention any particular individual to be a Government Analyst and it also does not mention any particular area or any specified products. Mr. Ganatra in this behalf relied upon the judgment of the Apex Court in I.T.C. Bhadrachalam Paperboards and another v. Mandal Revenue Officer, A.P. and others., . In the said judgment the Supreme Court has considered the necessity of publication of certain appointments in the Official Gazette. Therein it is quoted with approval two observations of earlier Supreme Court judgments viz, in the case ofSammbhu Nath Jha v. Kedar Prasad Sinha, , and in the case of B.K. Srinivasan v. State of Karnataka, .
52. The observations in the case of Sammbhu Nath Jha v. Kedar Prasad Sinha, , at Paragraph No. 17 are as follows:-
"The commission of inquiry is appointed for the purpose of making an inquiry into some matter of public importance. The schedule containing the various allegations in the present case was a part of the notification, dated 12-3-1968 and specified definite matters of public importance which were to be inquired into by the commission. As such, the publication of the schedule in the Official Gazette should be held to be in compliance with the statutory requirement. The object of publication in an Official Gazette is two fold: to give publicity to the notification and further to provide authenticity to the contents of that notification in case some dispute arises with regard to the contents."
53. Whereas, the observations made by the Apex Court in the case of B.K. Srinivasan v. State of Karnataka, , at para 15 are as follows:
"But unlike Parliamentary legislation which is publicly made, delegated or subordinate legislation is often made unobtrusively in the chambers of a Minister, a Secretary to the Government or other official dignitary. It is, therefore, necessary that subordinate legislation, in order to take effect must be published or promulgated in some suitable manner, whether such publication or promulgation is prescribed by the parent statute or not. It will then take effect from the date of such publication or promulgation where the parent statute prescribes the mode of publication or promulgation that mode must be followed Where the parent statute is silent, but the subordinate legislation itself prescribes the manner of publication, such a mode of publication may be sufficient, if reasonable. If the subordinate legislation does not prescribe the mode of publication or if the subordinate legislation prescribes a plainly unreasonable mode of publication, it will take effect only when it is published through the customarily recognised official channel, namely, the Official Gazette or some other reasonable mode of publication,"
54. After referring to the above mentioned observations in the judgment in the case of I.T.C. Bhadrachalam Paperboards v. Mandal Revenue Officer, the Supreme Court has held as under:-
"The above decisions of this Court make it clear that where the parent statute prescribes the mode of publication or promulgation that mode has to be followed and that such a requirement is imperative and cannot be dispensed with."
55. In view of the above, the learned Counsel for the respondents strongly contended that when the statute very clearly provides a particular mode of appointment, the State cannot deviate from the said mode. Thus, the State can appoint the said Government Analyst only by means of publishing in Official Gazette and mentioning therein the area in which they are entitled to empower and also specifying therein the products with which they can analyse and test.
56. Considering the clear wording of section 20 of the Drugs and Cosmetics Act, 1940, I have no doubt that the provisions therein are mandatory and thus, the State must publish in an Official Gazette the appointment of the Government Analyst specifying therein the area wherein the Government Analyst can operate and also specifying therein the products with which the Government Analyst can test and analyse. Specially, in view of the aforesaid observations of the Supreme Court, the State can appoint the Government Analysts only by publication of Government Gazette Notification as contemplated under section 20 of the Drugs and Cosmetics Act, 1940, and not otherwise. The general notification dated 15th October, 1971 being Exh. P-32 referred to and relied upon by the learned A.P.P. would not suffice for the purposes of compliance with section 20 of the said Act. Since the said notification dated 15th October, 1971 published in the Government Official Gazette is totally ambiguous and uncertain, in as much as, it is difficult to ascertain as to who exactly will be the Government Analyst and for which area and for which products. The said notification is totally vague. In any event, the Government ought to have issued a notification and published the same in an Official Gazette with regard to the appointment of Dr. A.D. Nadkarni, which has not been done at all in the instant case. Hence I hold that Dr. A.D. Nadkarni was not appointed as a Government Analyst validly and properly as per the provisions of section 20 of the Drugs and Cosmetics Act, 1940.
57. The next issue for my consideration is that whether there is any breach of statutory provisions under section 23 of the Drugs and Cosmetics Act, 1940 as well as Rules 46 and 57 of the Drugs and Cosmetic Rules, 1945.
58. In this behalf the learned Counsel for the respondents Mr. Ganatra pointed out that as persection 23(4) of the Drugs and Cosmetics Act, 1940, the Drug Inspector ought to have sent the seized samples forthwith to the Government Analyst for test or analysis. Mr. Ganatra further pointed out that in the instant case the sample of the said Drug viz. the Vanmycetin Opticops was taken by the Drug Inspector Mr. V.D. Patil on 29th September, 1987, and was despatched only on 6th October, 1987, and it was received by the Government Analyst on 6th October, 1987. Mr. Ganatra further pointed out that in the evidence also there is no explanation for delay of about 8 days in sending the said sample to the Government Analyst. Secondly, Mr. Ganatra pointed out that the Drug Inspector ought to have sent one portion of the sample to the Accused. However, in the instant case, though the sample of the drug was taken on 29th September, 1987 by the Drug Inspector Mr. V.D. Patil the same was despatched to the accused No. 6-Company on 4th February, 1988 and that there is no explanation whatsoever for this delay of more than four months in sending the portion of sample to the accused No. 6 Company.
59. Mr. Ganatra, the learned Counsel for the respondents further states that the sample was not properly sent in a sealed packet and that the specimen of the seal was not sent in a separate packet. Mr. Ganatra further contended that there is no clear evidence to show that the said sample was sent in a sealed packet and that the specimen seal was sent separately. In this behalf, Mr. Ganatra relied upon the judgment of this Court in State of Maharashtra v. Jawaharlal Shamlal Ujwane, reported in 1979 Cri.L.J. 530. In this case, the Division Bench of this Court has taken a view that Rule 46 and Rule 57 of the Drugs and Cosmetics Rules, 1945 are mandatory and that they must be fully complied with.
60. Similarly, Mr. Ganatra, the learned Counsel for the respondents also relied upon the judgment of this Court in State of Maharashtra v. Trilokchand Bhivraj Jain, reported in 1978 U.C.R. (Bom.) 244 : 1979(11) Prevention of Food Adulteration Cases 14. In this case, the Court was dealing with the Rules 17 and 18 of the Prevention of Food Adulteration Rules, 1955. These Rules 17and 18 of the Prevention of Food Adulteration Rules, 1955 are similar to the Rules 57 and 46 of the Drugs and Cosmetics Rules, 1940. In this case, this Court has taken a view that the aforesaid Rules should be strictly complied with.
61. Mr. Ganatra further relied upon the judgment of this Court in Mohd. Ismail Mohd. Ibrahim and another v. State of Maharashtra, reported in 1968 (II) Prevention of Food Adulteration, Cases 281. In this case also this Court has taken a view that the provisions of Rule 17 of the Prevention of Food Adulteration Rules, 1955, which is similar to Rule 37 of the Drugs and Cosmetics Rules, 1945 are mandatory and the failure to comply with the same would result in a serious flaw. The learned A.P.P. had pointed out that the said sample was received in a separate sealed packet and that the specimen seal was also received separately, and there is an endorsement to that effect. As far as delay of about 7 to 8 days in receiving the said sample by the Government Analyst viz. from 29th September, 1987 to 6th October, 1987, the learned A.P.P. contended that the delay was not very material. As far as delay in sending the portion of the said sample to the accused Company, the learned A.P.P. had pointed out that, only on 2nd February, 1988 the said Drug Inspector Mr. V.D. Patil had come to know under section 18(a) of the Drugs and Cosmetics Act, 1940 that the same was manufactured by the accused No. 6 company. Accordingly, the said sample was immediately sent to the accused No. 6 Company on 4th February, 1988, and thus, according to learned A.P.P. there was no delay.
62. Taking an overall view of the aforesaid facts and circumstances and after perusal of the records, I do not find any material to substantiate the contention of non-compliance of Rule 46 or Rule 57 of the Drugs and Cosmetics Rules, 1945.
63. Next issue for consideration is that whether the Government Analyst's report is reliable and can be acted upon, in the sense whether the Government Analyst had analysed the said sample properly in accordance with the prescribed procedure as per the Indian Pharmacopoeia Vol. I and II. The methodology to be adopted for the analysis of various drugs mentioned therein has been prescribed in detail in the said Indian Pharmacopoeia. The Indian Pharmacopoeia, Volume-I, 3rd Edition 1985 published by the Government of India, Ministry of Health and Family Welfare, on its page Nos. 103-104 provides for Chloramphenicol Eye Ointment; its category standards, identification, other requirements, assay methods, storage and labelling. On page 104, two methods of analysis are given, one is the chemical method and the other is of microbiological method. It is an admitted position that in the instant case the analysis was done under mircobiological method. In Volume-II of the Indian Pharmacopoeia the procedure prescribed for such microbiological method is to be found on page A-97 under the head Turbidimetric or Tube Assay Method. It is explained therein that the Turbidimetric or Tube Assay Method depends upon the growth of a microbial culture in a uniform solution of the antibiotic in a fluid medium that is favourable to its rapid growth in the absence of the antibiotic. It is also stated therein that the said method has the advantage of a shorter incubation period for the growth of the test organism (usually 3 to 4 hours) but the presence of solvent residues or other inhibitory substances affects this assay more than the cylinder-plate assay and care should be taken to ensure freedom from such substances in the final test solutions. On page A-88 of the Indian Pharmacopoeia Volume-II, under the head Mircobiological Assay of Antibiotics it is explained that the inhibition of microbial growth under standardised conditions may be utilised for demonstrating the therapeutic efficacy of antibiotic. Any subtle change in the antibiotic molecule which may not be detected by chemical methods will be revealed by a reduction in the antimicrobial activity and hence microbiological assays are very useful for resolving doubts regarding possible loss of potency of antibiotics and their preparations. It is also explained that the microbiological assay is based upon a comparison of the inhibition of growth of bacteria by measured concentrations of the antibiotics to be examined with that produced by known concentrations of a standard preparation of the antibiotic having a known activity. Under the head Standard Preparation and Units of Activity it is explained that a Standard Preparation is an authentic sample of the appropriate antibiotic for which the potency has been precisely determined by reference to the appropriate international standard. The potency of the standard preparation may be expressed in International Units or in per mg. of the pure antibiotic. It is stated therein that the standard preparations for India are maintained at the Central Drugs Laboratory, Calcutta. A Unit referred to in the official assays and tests, is the specific activity contained in such an amount of the respective Standard Preparation as is indicated by the Ministry of Heath & Family Welfare, Government of India, from time to time. A Standard Preparation may be replaced by a working standard prepared by any laboratory which should be compared at definite intervals under varying conditions with the standard. On page A-88 of Indian Pharmacopoeia, Volume-II, under the head Apparatus it is stated that all equipments are to be thoroughly cleaned before and after each use. Glassware for holding and transferring test organisms is sterilized by dry heat, or by steam. On page A-89, under the head Turbidimetric assay receptacles it is stated that for assay tubes, use glass or plastic test-tubes, e.g. 16 mm x 125 mm or 18 mm x 150 mm that are relatively uniform in length, diameter, and thickness and substantially free from surface blemishes and scratches. Cleanse thoroughly, to remove all antibiotic residues and traces of cleaning solution, and sterilize tubes that have been used previously before subsequent use. On page A-90 methodology of Buffer Solutions is explained. After conducting all these tests, as stated on page A-98 under the head Estimation of Potency it is required to plot the average extinctions for each concentration of the standard on semi-logarithmic paper with the extinctions on the arithmetic scale and concentrations on the logarithmic scale and the potency must be calculated as per the formula mentioned on page A-98.
64. In the instant, case, we are concerned with the capsules of Vanmycetin Opticops. Each capsule contains 250 mg of creamy substance. Out of 250 mg which is used as an eye ointment only 2.5 mg of chloramphenicol is to be found. The rest of 247.5 mg are inert paraffin i.e. harmles base. Even with regard to the said 2.5 mg of chloramphenicol which should be found, as provided in Indian Pharmacopoeia it should be in the range of 90 % to 120% e.g. if 100% were to be 2.5 mg it can vary from 90% to 120% i.e. from 2.25 mg to 3.00. mg. So therefore it is very essential to find out as to the exact quantity of Chloramphenicol in each of these capsules. The quantity should be between 2.25 mg to 3.00 mg each to constitute 90% to 120%. Whereas as per the Government Analyst's report it was only 69.92% instead of 90% to 120% i.e. the Chloramphenicol contained was much lessor as compared to 90%.
65. Mr. Ganatra, the learned Counsel for the respondents, had submitted that the Indian Pharmacopoeia, 1985 3rd Edition page A-88, very explicitly provides that there has to be a Standard Preparation from Central Drugs Laboratory or atleast a working standard prepared by any laboratory which should be compared at definite intervals under varying conditions with the standard. In this context, the learned Counsel for the respondents took me through the evidence of Dr. A.D. Nadkarni, the Government Analyst, wherein Dr. Nadkarni has deposed in his evidence that Mrs. Saptarshi was the Batch chemist and the analysis of the sample in question viz. the Vanmycetin Opticops and the assay was done by Mrs. Saptarshi. The Dr. Nadkarni has clearly admitted in his evidence as under:-
"We do not do sterility test as required facility was not available at that time in our laboratory".
Similarly, the said witness Dr. Nadkarni has also deposed as under :--
"Protocols regarding all tests were consolidated and written in Form 13 by Mrs. Saptarshi on 27th October, 1987 and submitted to me. I signed them on 30th October, 1987".
Dr. Nadkarni has also further admitted in his cross-examination as under :--
"I agree that for my microbiological assay of Vanmycetin sample, use of standard preparation is necessary".
Dr. Nadkarni has also further admitted that he had not compared the working standard used for the purpose of assay with the National standards in the following words:--
"I have not compared the working standard used by me in this assay with the National Standard Preparation, but the working standard used by me for assay was compared with the standard for its potency prepared by another laboratory."
Dr. Nadkarni, in his cross-examination has further admitted as under:--
"I cannot say that the working standard prepared by the laboratory, used by me was of which laboratory. I cannot say as to whether it was compared at definite intervals under the varying conditions with the standard ratio unless I refer in the office about the same."
66. Ultimately, the said witness Dr. Nadkarni in his re-examination has stated that the working standard was supplied by M/s. Parke Davis, the potency of which was tested on 19th October, 1987 and found to be as per level.
67. Dr. Nadkarni was specifically asked to produce the tests records and protocols with regard to the same. However, this witness has deposed as under:--
"I do not want to produce the full test record concerning the test of standard preparation of Chloramphenicol which was received from M/s Parke Davis and used by me, which was received from the laboratory on 12-11-86. I did not feel it necessary to call the standard preparation from Central Drug Laboratory, hence, I did not call for it. 1 did not feel it necessary to call for standard preparation from Central Drug Laboratory as per para 6 of Page A-88 and Table 4 page A-93. I could use working standard preparation."
68. In this behalf, Mr. Ganatra, the learned Counsel for the respondents has relied upon the judgment of this Court in K. T. Rajkotwala v. The State of Maharashtra, 1976 U.C.R. (Bom.) 474. In this case, the judgment of the Division Bench of this Court in Criminal Appeal No. 1008 to 1011 of 1967 decided on 25th April, 1969 is quoted, which reads as under :--
"In each case the certificate which the analyst has given is "I further certify that I have caused to be analysed the aforesaid sample and declare the result of the analysis to be as follows". This is a direct declaration of the result of the analysis and without anything more necessarily implies that the result was obtained on the date on which the certificate was signed. If it was the prosecution case that the Public Analyst has made his analysis soon after the receipt of the samples but had kept a record of the analysis with him and merely gave the certificate from that record then this report will loose the evidentiary value which is imparted to it by the Act. It will really be these entries which will be endowed with the evidentiary value which the act imparts to the Public Analyst's report".
69. Thus, it was held that the Public Analyst should make the report at the same time when the sample is analysed, but if made later on, it will cease to have evidentiary value. The learned Judges have observed in the abovementioned judgment that the primary evidence of analysis has not been produced and there is, therefore, no legal evidence on record to show that the sample was not of the prescribed purity, and accordingly, the report of the Public Analyst would not be relied upon and the conviction of the appellant was set aside.
70. In this behalf, the learned A.P.P. for the prosecution brought to my notice the judgment of the Supreme Court in T.A. Krishnaswamy v. The State of Madras, . Before the Apex Court, the case was prior to the amendment in Rule 46 of the Drugs and Cosmetics Rules, 1945. Now there has been a substantial amendment to the aforesaid Rule with effect from 21st July, 1962, whereby the explanation has been added explaining the meaning of supply of protocols for test or analysis. Now we are concerned with the case subsequent to the amendment. In the above case, the Supreme Court has observed that the Analyst's Report is not required to state the protocols and only to give the result of the analysis and it was held that the said report was admissible in evidence.
71. There is no doubt that the Report ex facie could be admitted in evidence as to its contents also, but, the issue is that if the Government Analyst were to be examined as a witness, then, his oral evidence prevails over his report. The Analyst is subjected to cross-examination and as such, the evidence of the Analyst cannot be conclusive only on the basis of the report. Once the prosecution decides to examine the Government Analyst his oral evidence would prevail over the statement contained in his written analysis report.
72. In fact, this issue as to the correctness of the certificate issued by the Public Analyst has been considered by the judgment of the Division Bench of this Court in Bombay Municipality v. Haridas Vallabhdas, reported in 39 Bom.L.R. 629. This Court was dealing with the interpretation of sections 14 and 16 of the Bombay Prevention of Adulteration Act, 1925. Section 14 lays down a rule of evidence and allows a presumption to be drawn. The Certificate of a Public Analyst is to be accepted as correct without further proof until the contrary is proved. Thus section 14 relieves the prosecution of the obligation to examine the Public Analyst in cases in which the correctness of the certificate is not challenged, and to enable the Court to accept the certificate without further proof of facts stated therein. But the section expressly states that the certificate can only be accepted as sufficient evidence of the acts stated in it until the contrary is proved and it is open to the accused to prove the contrary in any one of the several ways. He can do it in the manner provided in section 14(2) by asking the Court to cause a sample of the article to be sent for analysis to the Chemical Analyser to Government. He can also challenge the correctness of the certificate by producing a certificate of analysis by a private analyst. Further it was observed that the easiest and probably the best method of challenging the correctness of the public analyst's certificate in many cases, be by cross-examining the public analyst and showing that the method of analysis adopted by him was wrong.
73. Taking into account all the facts and circumstances and especially the detailed evidence of Dr. A.D. Nadkarni, and in view of the categorical statement of the said witness admitting that the Laboratory did not have any facility for sterility test and that no standard preparation was available so as to compare the accuracy of test to be conducted, refusal to produce the working standards and also the records of the actual tests conducted, it is clear that the prosecution has failed to establish that the tests were conducted in a reasonable and proper manner so as to uphold the report of the Government Analyst.
74. As pointed out in the aforesaid judgment of the Bombay Municipality v. Haridas Vallabhdas, 39 Bom.L.R. 629 the best method to check the correctness of the analysts report is to cross-examine the Public Analyst. In the instant case, there is ample evidence that the public analyst has not conducted the test properly and fairly to arrive at the correct figures, hence, the said Analyst's report could not be accepted and cannot be acted upon.
75. Lastly, there an issue of storage of Vanmycetin Opticops, viz. whether the said sample of Vanmycetin Opticops was stored at a temperature below 250 C, and if not, is it ruled out that the potency of the said Vanmycetin Opticops could have been reduced? The said sample was required to be stored below the temperature of 250 C (cool). The Indian Pharmacopoeia Vol. I page 13 defines the word Cool as any temperature between 80 C and 250 C, and the Room Temperature is defined as the temperature prevailing in a working area.
76. Mr. Ganatra, the learned Counsel for the respondents has further pointed out that in the above matter the said Vanmycetin Opticops was supplied to the said Municipal Hospital on 6th June, 1987 and thereafter only on 29th September, 1987, the said sample was drawn by the Drug Inspector Mr. V.D. Patil. Thereafter, the said sample was despatched for analysis on 6th October, 1987. In this behalf, the prosecution witness No. 1 Mr. V.D. Patil, has very categorically deposed that the above sample was stored in the Hospital in an open rack on 29th September, 1987. This witness in his cross-examination has admitted as under :--
"I agree that the stock of Vanmycetin Opticops kept in open rack was stored under temperature of more than 250 C."
77. This witness Mr. V.D. Patil, however, was unable to state under what condition the sample was kept in their office between 29th September, 1987 to 6th October, 1987.
78. Under the aforesaid facts and circumstances, Mr. Ganatra, the learned Counsel for the respondents submits that admittedly, the sample of Vanmycetin Opticops were not stored in a proper temperature as prescribed under the Indian Pharmacopoeia and for over a period of four months the same was kept exposed at a temperature much higher than 250 C, and as such, the possibility of reduction of its potency cannot be ruled out. He further submits that the respondents cannot be found at fault for the said samples being stored at the higher temperature by the Municipal Hospital, and as much, the prosecution has failed to establish that the samples were stored within the permissible temperature.
79. The learned A.P.P. contends that merely because the sample was stored at a higher temperature would not mean that its potency would have got reduced. However, to substantiate his contention, he could not point out any clear evidence to the contrary in the sense that even if it was stored at a temperature higher than 250 C, its potency would not get deteriorated.
80. Taking into consideration all the facts and circumstances of the case, I am of the view that the possibility of potency getting reduced cannot be totally ruled out, and as such, the benefit ought to go to the accused.
81. The learned Additional Chief Metropolitan Magistrate has considered in detail all the facts and circumstances as well as all the records and evidence and has rightly recorded the order of discharge. I do not find anything perverse or anything beyond the jurisdiction vested in the learned Additional Chief Metropolitan Magistrate discharging the respondents in the above case.
82. Under the facts and circumstances, I do not find any substance in the above Criminal Revision Application filed by the State of Maharashtra. Hence, Criminal Revision Application No. 228/1991 is dismissed, however, with no order as to costs.
83. The learned A.P.P. for the State of Maharashtra, at this stage, applies for the stay of the operation of this order for a period of twelve weeks, in as much as, I have held that the Drug Inspector and the Government Analyst can be appointed only by an appropriate Government Gazette /Notification which has not been done in the instant case. In view of the above, operation of this judgment and order is stayed for a period of twelve weeks from today.
Issuance of certified copy is expedited.
84. Application dismissed.
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