P.R. Naik and M.J. Brahmabhatt v. The State of Maharashtra

1. Heard Ms. Vrishali Raje, learned Advocate appearing for the Applicants and Dr. Krishnaiyer, learned APP for the State-Respondent.

2. This Criminal Revision Application is filed by Original Accused No.1 and Accused No.8 taking exception to the twin judgments of conviction and sentence dated 26.4.2001 passed by the Trial Court and dated 19.7.2002 passed by the Sessions Court. Originally there were ten accused in the case. Indictment has been translated into conviction and sentence against Accused Nos. 1 and 8 only. Prosecution is alleged for offences punishable under the provisions of Section 18(a) (i) r/w. Section 17(b) and punishable under Section 27(d) of the Drugs and Cosmetics Act, 1940 (for short "the said Act") under Rule 19 of the Drugs and Cosmetics Rules. Complaint was filed by the Drug Inspector against four persons initially viz. Shri P.R. Naik, Proprietor of M/s. Weldon Pharmaceuticals (Accused No.1), Mr. M.J. Brahmabhatt (Accused No.8), Mrs. Ranikumar (Accused No.9) and M/s. Healer (India) Laboratories (Accused No.10) on the above charges.

3. By judgment dated 26.4.2001, appended at Exhibit 'A' page No.23, Trial Court convicted Accused No.1 Mr. P.R. Naik, Accused No.8 Mr. M.J. Brahmbhatt and Accused No.9 Mrs. Ranikumar having found them guilty of the aforesaid offences and sentenced them to undergo simple imprisonment for one year and to pay fine of Rs.1000/- and in default thereof to undergo simple imprisonment for one month. In so far as Accused No.10- M/s. Healer (India) Laboratories is concerned, it was awarded sentence of fine of Rs.1000/- only. Being aggrieved with the above conviction, the convicted accused filed two separate Criminal Appeals viz. Criminal Appeal No. 128 of 2001 filed by Mrs. Ranikumar -Accused No.9 and Criminal Appeal No. 131 of 2001 filed by Mr. P.R. Naik (Accused No.1) and Mr. M.J. Brahmabhatt (Accused No.8) before the Sessions Court. Both appeals were decided by a common judgment dated 19.7.2002, whereby Accused No.8 Mrs. Ranikumar was acquitted and her Appeal came to be allowed. Appeal filed by Mr. P.R. Naik- Accused No.1 and Mr. M.J. Brahmabhatt - Accused No. 8 was dismissed thereby upholding their conviction.

4. At this stage, it needs to be mentioned that Mrs. Ranikumar - Accused No.10 was employed as Quality Consultant by M/s. Healer (India) Laboratories in their laboratory whereas, Mr. M.J. Brahmabhatt was employed as Production Chemist in the same laboratory. In the above backdrop, the facts of the case, which are in a narrow compass, need to be appreciated in the Revision before this Court. This Court is aware of its revisional powers under Section 397 of Cr.P.C. in as much as the evidence on record cannot be re-appreciated by the Court and this Court will have to consider the validity, legality and propriety of the impugned judgments passed by the Courts below. Though there are concurrent judgments passed, however, to determine the case and plea of the Revision Applicants to that extent the Court will have to go into the relevant evidence considered by the Courts below. Prosecution has led evidence of four witnesses in the present case. Out of which the evidence and more particularly cross examination of three witnesses viz. PW-2, PW-3 and PW-4 is relevant, rather directly relevant for considering the present Revision Application.

5. Briefly stated, Accused No. 1 Mr.P.R. Naik is the Proprietor of M/s. Weldon Pharmaceuticals situated at 8-B, Owner's Colony, Cittaranjan Nagar, Vidyavihar (East), Mumbai - 400 077. He held a statutory licence dated 31.12.1987, selling licence dated 31.12.1997 and manufacturing licence dated 23.3.1987 in Statutory Form Nos.21A, 21B and 25A for manufacture of drug 'ZEPTONE SYRUP' under the said Act. On the basis of the above statutory licences, he executed an agreement with M/s. Healer (India) Laboratories having its premises at 213/14, Premson's Industrial Estate, Caves Road, Jogeshwari (E) allowing them to manufacture Zeptone Syrup on loan licence basis which was perfectly valid in law. There is no dispute about these facts. M/s. Healer (India) Pharmaceuticals was a partnership firm of which one Mr. Kantilal Shah was the partner and looking after M/s Healer (India) Laboratories. Accused No.8 viz. Mr. M.H. Brahmabhatt was working as Production Chemist whereas Accused No.9 Mrs. Ranikumar was working as Quality Control Chemist with M/s. Healer (India) Laboratories. Independently, M/s. Healer (India) Laboratories also held its own manufacturing licence in Form Nos.25 and 28 since 1985 for manufacture of drug 'Zeptone Syrup'.

5.1. On 30.10.1993, A.N. Khadtare, (Prosecution Witness No. 2) visited the laboratory of M/s. Healer (India) Pharmaceuticals and drew 3 samples of 200 ml of 'Zeptone Syrup' from batch No. WL-116, having manufacturing date of September, 1993 and expiry date of August, 1994 manufactured by M/s. Healer (India) Pharmaceuticals for M/s. Weldon Pharmaceuticals i.e. Accused No.1. The dichotomy in the name of M/s. Healer (India) Pharmaceuticals and M/s. Healer (India) Laboratories is not clear from the record as both names are referred to at different places. After drawing the sample, Mr. Khadtare - PW-2 in the presence of Kantilal Shah sent one sealed counter part of the sample drug 'Zeptone Syrup' along with original form No. 18 bearing No. 41471 and serial number of the memorandum as AMK/282/10/93 dated 1.11.1993 to the Government Analyst, Drug Control Laboratory, Mumbai -52 for forensic analysis and test report. As seen, the sample was drawn on 30.10.1993 whereas it was sent to the Government Analyst for forensic after two days on 1.11.1995 by Mr. Khadtare. According to prosecution, Government Analyst sent his Report after analysis on 04.05.1994. However the date on the report was 22.4.1993 even though the covering letter was dated 26.4.1994. It is seen that the reference on the covering letter is admittedly of the year

1993. By virtue of this report, sample of the drug 'Zeptone Syrup' drawn by Mr. Khadtare which was having expiry date of August, 1994 was declared to be 'NOT OF STANDARD QUALITY' on account of its contents of Vitamin B[1] and Vitamin B[2] being less than the Schedule threshold limit by a couple of percentage points. Further according to prosecution, Accused were liable for not labeling the said drug properly and therefore liable under Section 17(b) of the said Act for misbranding as per rules by depicting the labeling of Vitamin B[1] as Vitamin B[1] hydrochloride. Mr. Khadtare delivered one copy of the Government Analyst report to Accused Nos.[1] viz. Mr. P.R. Naik and one copy to Mr. Kantilal Shah, partner of Accused No.10 M/s. Healer (India) Laboratories and thereafter, investigation was handed over to Drugs Inspector Mr. S.K. Jambholkar (Prosecution Witness No.3) on 28.07.1994 after a lapse of almost 85 days from the date of receipt of the above report. 5.[2] Prosecution Witness No.3 Mr. Jambholkar- Drugs Inspector visited the premises of M/s. Weldon Pharmaceuticals (Accused No.1) to collect certified copy relevant documents pertaining to the said drug, sale details, correspondence with its distributors and sought withdrawal of the stock and reply from Accused No.1. Two days prior to visiting Accused No.1, Mr. Jambholkar visited M/s. Healer (India) Laboratories to undertake the aforesaid exercise from Mr. Kantilal M. Shah. Complaint is filed immediately thereafter under the said Act against the accused persons for above mentioned offences. Accused persons pleaded not guilty to the charges leveled by the prosecution. Before proceeding further it needs to be observed that the above time limit clearly suggests and shows the gross delay and laches on the part of the statutory officers of the FDA in dealing with the above case promptly. This is so because filing of the complaint in August, 1994 and calling upon the accused to withdraw their stocks from the distributors on 28.7.1994 would be completely meaningless as the same already stood distributed and sold in the market since it had the manufacturing date as September, 1993 and expiry date of August, 1994. The above timeline shows the gross delay on the part of the FDA officers under the said Act. Prosecution led evidence of four witnesses. PW-1 is the Drug Inspector, Mumbai who received the investigating papers and who scrutinized the papers. He is the Complainant. He filed complaint against all accused. His evidence is of no relevance in the present case for decision and hence discarded. PW-2 is Mr. Arjun Maruti Khadtare, the Drugs Inspector who in the inception visited the premises of M/s. Healer (India) Laboratories and collected the sample of 'Zeptone Syrup' on 30.10.1993. He has deposed that on 30.10.1993 he visited the premises of M/s. Healer (India) Laboratories and took the sample of the drug viz. Zeptone Syrup alongwith Form No.17 under the said Act. He has specifically deposed in his examination-in-chief that the drawn sample was shown to Kantilal M. Shah partner of M/s. Healer (India) Laboratories, who was present at that time. He has deposed that he handed over the sealed part of the sample of the drug in question to Mr. Kantilal M. Shah along with the original of Form No. 17 and obtained his acknowledgment on the reverse of the copy of the said form. He has produced the said acknowledgment in evidence, but it is of no avail to the prosecution because the prosecution has not proceeded against Mr. Kantilal Shah and made him an Accused in this case. Prosecution has proceeded against M/s. Healer (India) Laboratories, which incidentally by virtue of the Trial Court's judgment has been awarded a sentence of fine of Rs.1000/- only. He has next testified that on 1.11.1993 he sent the sealed counter part of the drawn up sample of the drug in question along with Original Form No. 18 and the specimen impression of the seal along with the impression of seal separately by hand delivery to the Analyst. The Government Analyst incidentally is Prosecution Witness No.4 who has testified independently and has however, denied the above testimony of PW-3. I will come to that later separately as his testimony is in contradiction with the testimony of PW-3 on this count. PW[3] has stated that he received report from the Government Analyst on 4.5.94 and most importantly on 5.5.1994 he followed all protocol and handed over a copy of the report along with covering letter to Mr. Kantilal Shah and once again obtained his acknowledgment to that effect. As against the aforesaid Examination-in-Chief, cross examination of PW-3 is extremely crucial and pertinent. In his cross examination, PW-3 has admitted that it is true that no sealed counter part of the sample of the drug in question was handed over to Accused No.1 i.e. M/s. Weldon Pharmaceuticals. Therefore, indictment and consequential conviction of Accused No.1 could not have been proceeded with. Next he has admitted in his cross examination that even after he received the report on 5.5.1994, he did not show the sample of the drug in question to Accused No.1 i.e. M/s. Weldon Pharmaceuticals and did not attempt to find out whether the same was the product of M/s Weldon Pharmaceuticals Ltd. On the aspect of drawing sample and purchasing the same and giving receipt, he has categorically deposed that he did not purchase the sample of the drug in question from Mr. Kantilal Shah as prescribed by the statutory provisions nor the gate pass which he referred to and relied upon disclosed removal of the drug in question from the premises of M/s. Healer (India) Laboratories. In his cross examination he has stated that he searched his record for the gate pass regarding removal of the drug in question and whether it was available with him and stated that he would produce it on next time, but it was not produced. He has also admitted the suggestion put to him in cross-examination that the subject drug in question was a patented drug and a proprietary medicine but he could not answer about the manufacturing method of the patented proprietary medicine and analysis procedure to be followed. In the background of this cross examination, which was prior to the framing of the charge, PW-3 has also deposed before the Trial Court after framing of the charge and his cross examination which has been recorded by the Trial Court after framing of the charge on 17.11.2000 is further pertinent.

6. The star witness of the prosecution is PW-3. He is Sunil Kashinath Jambholkar, Drug Inspector who had taken over the charge from Mr. Khadtare for investigation. Though it is the prosecution case that Mr. Khadtare had carried out investigation and drawing of sample in the premises of M/s. Healer (India) Laboratories, he deposed in his Examination-in-Chief that he visited the manufacturing premises of M/s. Healer (India) Laboratories on 26.7.1994 for further investigation. This was however after 85 days after the report of the Government Analyst was received. He has deposed that he collected the relevant material in the form of xerox copies pertaining to manufacture of the subject product in question and the analytical record of its raw material along with all details. In his cross examination, he has admitted the fact that he did not attempt to find out about the storage condition of the subject drug in question and also did not make any inquiry to find out whether the Government Analyst tried to follow the manufacture method / analysis of a patented drug. This cross examination of Mr. Jambholkar was prior to framing of the charge. In view of the provisions of the said Act, cross examination of the prosecution witness was resumed subsequent to framing of charge. In his further cross examination after framing of charge, Mr. Jambholkar has categorically admitted the fact at the outset that there was no notification appointing him as Drugs Inspector of the area of the Head Quarter of Greater Mumbai during the entire period when sample was drawn and investigation was carried out. He has in his cross examination admitted that he did not find any discrepancies in the manufacturing and the sales record produced by the Accused regarding the "Zeptone Syrup" drug. In the backdrop of the above testimony of PW-2 and PW-3 which is entirely based on the Government Analyst Report, the testimony of the Government Analyst viz. Dr. Prabhakar Pilankar, Prosecution Witness No.4 is therefore required to be seen. Perusal of his Examination-in-Chief reveals that the sample 1X200 ml of the subject drug was received by the Laboratory under covering letter dated 1.11.1993 from the Drugs Inspector Mr. Khadtare (PW-2). In his Examination-in-Chief he has stated that the sample was analyzed by three Analysts under his supervision and it was declared not of standard quality in respect of contents of Vitamin B[1] and B[2] in the sample and they found that the available content of B[1] and B[2] was not upto the threshold limit as per the labeling on the sample. However, in his cross examination he has stated that he was unable to produce any separate notification appointed him as Government Analyst for ascertainment and scrutiny of the Vitamin class of drugs and the document/ Report which he produced below Exhibit P-25 did not mention so. He has categorically admitted the fact and position that he did not tally the seal of the sample with the specimen seal impression. He has next deposed that the tallying of the seal of the sample with the specimen seal impression was done by some other Government Analyst by the name of Mr. M.B. Kadam. Prosecution has not lead the evidence of Mr. M.B. Kadam. The three Analysts who were supervised by Dr. Pilankar, have been named by him in his Examination-in-Chief viz. Mr. Desai, Mr. Gokhale and Mr. Kolhatkar who have analyzed the sample but in his cross examination he has admitted the fact that before beginning the analysis, the tallying of the seal of the sample with the specimen seal impression was done by some other Government Analyst and not him or by any of his team member. Next he has stated and admitted the fact that his analyst started analysis of the subject drug on 5.4.1994 and completed the analysis on 22.04.1994. He has also admitted the fact that from 1.10.1993 until the analysis was completed, the sample was lying in his laboratory at room temperature in the wooden cupboard. He has categorically admitted the fact and position that analysis was started after seven months from the drawing of the sample. The aforesaid testimony of PW-3 is shocking. In view of the strict timeline prescribed under Rule 45 of the Drugs and Cosmetics Rules, 1945 of 60 days, the Analyst clearly breached the statutory Rule. In his further cross examination he has deposed that he had received the sample for analysis after coding under Code No.D-7122/92 but in the Analyst report which he has submitted he has not mentioned the Code No. qua the subject sample in question. In the backdrop of the above evidence, the prosecution has rested its case and the learned Trial Court has given the judgment dated 26.4.2001 by concluding that report of the Government Analyst has become conclusive and all charges against the Applicant stand proved. There is one finding in the Trial Court’s judgment which needs to be revisted. Admittedly the sample was required to be analyzed under the provisions of Rule 45 and dealt with within a period of 60 days. When such a statutory provision exists it cannot lie in the mouth of the trial Court to conclude that in the absence of Government Notification, the said statutory provision would not apply. There is no question of the accused leading any evidence in rebuttal on this count because it is an admitted position of law on record testified by the prosecution’s own witnesses viz. PW-3 and PW-4 that for more than seven months the sample was not analyzed and it remained in the laboratory of the Government. Therefore, a finding returned by the learned Trial Court that the statutory provisions cannot be the prescription is stated to be rejected. Such a finding cannot be countenanced. The second aspect which goes to the root of the matter is the fact that as per Indian Pharmacopia storage of the sample is very critical in such cases. The subject drug being a patented and proprietary medicine is required to be stored in a cool place which is admittedly stated on its label. This is admitted by the prosecution also. Despite which, it was stored in the wooden cupboard of the Government Laboratory for more than seven months. The standard meaning of cool place means a place which has a temperature range between 8 degrees and 25 degrees as per Indian Pharmacopia. The sample was received by the Government Analyst in his laboratory on 1.11.1993 and it remained in place as it is until 5.4.1994 where after it was taken up for analysis by the team of PW-4 as stated by him in his evidence. Hence it cannot be said that the said sample was stored in a cool place during the aforesaid period of 185 days during winter and summer season in the city of Mumbai. There is absolutely no consideration of this aspect by both the Courts below, save and except to record the submissions of the witnesses and nothing else. The decision and judgment of the trial Court indicting the accused was challenged in appeal. Both criminal appeals were however dealt with superficially by the learned Sessions Court in such a manner that it has turned a blind eye to the above mentioned issues in the present case as also the testimony of the prosecution witnesses. While exonerating Mrs. Ranikumar, who was the Quality Control Chemist of Accused No.10 viz. M/s. Healer (India) Laboratories, the Appellate Court has come to a conclusion that there is no evidence brought before the Trial Court by the prosecution that Smt. Ranikumar was in fact positively involved in manufacture of the subject drug ‘Zeptone Syrup’ as she was in fact appointed for testing of the subject drug and not for any other purpose. This very finding of the learned Appellate Court is itself surprising. Because the testing would be of the subject drug i.e. ‘Zeptone Syrup’ as nothing else. The learned Appellate Court has on the basis of the aforesaid finding completely exonerated Ms. Ranikumar - Original Accused No. 9 from any liability so as to attract any of the provisions of the said Act against her and has set aside her conviction all together. However, insofar as Accused No.1 M/s. Weldon Pharmaceuticals and Accused No.8 Mr. P. M. Brahmabhatt are concerned, the learned Appellate Court has upheld the finding of the learned Trial Court. How is the role of a Production Chemist different than the Quality Control Expert is not discussed by the Courts below.

7. I have perused the decision of the learned Appellate Court. Though the said decision and judgment is verbose, the sum and substance is the fact that none of the questions which have been delineated in the aforesaid facts stated by me are attempted to be answered, rather a blind exercise is undertaken by the Appellate Court to simplicitor uphold the conviction of Accused No.1 and Accused No.8 with complete non application of mind, without adherence to the evidence of the prosecution witnesses and without recourse to the provisions of Rule 45. The principal indictment under section 18(a) (i) has been categorically argued by the defense which has not found favour either by the Trial Court or learned Appellate Court. It was the case of the defence that one of the reason why there could be a negligible loss seen in the percentage of content of Vitamin B[1] and B[2] would be due to the loss of potency on account of its long storage in the Government Analyst Laboratory for seven months. According to Schedule B of the said Act, storage of a sample in a cool place is designated to be a place having temperature ranging between 10 degrees centigrade and 25 degrees centigrade and such a place is termed as ‘Cool’ place. It was argued by the defense that in the case of the subject drug ‘Zeptone Syrup’, due to wrongful condition of storage and proximity of time, different vitamins would have different rate of loss which would need to be considered by the Court. But despite the evidence available on record of having stored the sample in the Government Analyst Laboratory for seven months and that too not in a cool place as required under the said Act, the learned Appellate Court has not considered and accepted this argument.

8. The evidence of the prosecution witnesses and viz. PW-6 Sunil Kashinath Jambholkar in this regard is extremely crucial. In his cross examination, he has specifically admitted the fact that when he collected the entire documentation after taking over the investigation from Mr. Khadtare, he did not find any discrepancy in the manufacturing and the sales record of the accused. There is no consideration whatsoever of this admission since Mr. Jambholkar had undertaken the entire investigation and collected the entire material and only thereafter deposed accordingly. He has fairly deposed in his cross examination that insofar as the issue of storage condition and the length of the period of storage of the sample drug in the Government Analyst laboratory is concerned, he has not taken any steps or made inquiry to find out about the same. The evidence of Mr. Khadtare who initiated the investigation in question is also crucial. All that the learned Trial Court or the learned Appellate Court was required to apply was the provisions of Section 23 and to see whether the act of drawing the sample and producing the same for Forensic Analysis was in accordance with the statutory provisions. Section 23 of the said Act reads thus: “23. Procedure of Inspectors.—(1) Where an Inspector takes any sample of a drug 4 [or cosmetic] under this Chapter, he shall tender the fair price thereof and may require a written acknowledgment therefor. (2) Where the price tendered under sub-section (1) is refused, or where the Inspector seizes the stock of any drug 4 [or cosmetic] under clause (c) of section 22, he shall tender a receipt therefor in the prescribed form. (3) Where an Inspector takes a sample of a drug 4 [or cosmetic] for the purpose of test or analysis, he shall intimate such purpose in writing in the prescribed form to the person from whom he takes it and, in the presence of such person unless he wilfully absents himself, shall divide the sample into four portions and effectively seal and suitably mark the same and permit such person to add his own seal and mark to all or any of the portions so sealed and marked: Provided that where the sample is taken from premises whereon the drug 4 [or cosmetic] is being manufactured, it shall be necessary to divide the sample into three portions only: Provided further that where the drug 4 [or cosmetic] is made up in containers of small volume, instead of dividing a sample as aforesaid, the Inspector may, and if the drug 4 [or cosmetic] be such that it is likely to deteriorate or be otherwise damaged by exposure shall, take three or four, as the case may be, of the said containers after suitably marking the same and, where necessary, sealing them. (4) The Inspector shall restore one portion of a sample so divided or one container, as the case may be, to the person from whom he takes it, and shall retain the remainder and dispose of the same as follows:—

(i) one portion or container he shall forthwith send to the Government

(ii) the second, he shall produce to the Court before which proceedings, if any, are instituted in respect of the drug 1 [or cosmetic]; and [(iii) the third, where taken, he shall send to the person, if any, whose name, address and other particulars have been disclosed under section 18A. ] (5) Where an Inspector takes any action under clause (c) of section 22,— (a) he shall use all despatch in ascertaining whether or not the drug 1 [or cosmetic]; contravenes any of the provisions of section 18 and, if it is ascertained that the drug 1 [or cosmetic]; does not so contravene, forthwith revoke the order passed under the said clause or, as the case may be, take such action as may be necessary for the return of the stock seized; (b) if he seizes the stock of the drug 1 [or cosmetic]; he shall as soon as may be inform 3 [a Judicial Magistrate] and take his orders as to the custody thereof;

(c) without prejudice to the institution of any prosecution, if the alleged contravention be such that the defect may be remedied by the possessor of the drug 1 [or cosmetic]; he shall, on being satisfied that the defect has been so remedied, forthwith revoke his order under the said clause. [(6) Where an Inspector seizes any record, register, document or any other material object under clause (cc) of sub-section (1) of section 22, he shall, as soon as may be, inform 3 [a Judicial Magistrate] and take his orders as to the custody thereof. "

9. In the facts and circumstances of the present case which are delineated hereinabove there is an admitted violation of Section 23(1), 23(4), Section 23 (5) (a), Section 23 (5) (b), and Section 23(5) (c) of the said Act and Rule 45. None of the steps stated above as envisaged in the aforesaid provisions have been adhered to by Mr. Khadtare and in fact he has accepted so in his cross examination.

10. In the present case the aforesaid timeline would clearly suggest that the entire sample drawn from the subject drug ‘Zeptone Syrup’ would be rendered completely infructuous and if the same timeline is required to be adhered as the entire stock of ‘Zeptone Syrup’ on that count in the particular batch from which the sample was drawn, was due to expire in August 1994. It is seen that there can be no direction whatsoever on the protocol and time frame enlisted in the aforesaid provisions. Any slight or negligible deviation of the time frame is fatal in the case of the prosecution. In the present case the deviations and directions, rather the delay is not small. The DRA has taken more than seven months to simply analyze the sample. During this time frame the sample was admittedly not stored in the appropriate condition as required and called for by the statute itself in accordance with Schedule B and the Rules of the Indian Pharmacopia. The aforesaid provisions called for the fastest course of action as it relates to drugs which are consumed by the consumer and public at large. It relates to the life of the consumer who consumed these drugs across the counter as they are prescription drugs. Therefore any action taken by the Drugs Inspector in accordance with the provisions of the said Act and more specifically the provisions delineated hereinabove have to be in strict compliance of the said Act and timelines have to be scrupulously followed for taking and initiating any action. This is so because once the stocks are released to the stockiest and distributed to the market, if no timely action is taken and if its later found that the stocks are required to be withdrawn there should not be delay in taking such action. In the present case, under sub-section (4) of Section 25 assuming for the sake of argument that the sample was sent for analysis to the Government Analyst and the report was not submitted, in time, then the Government Analyst is required to seek leave of the Magistrate for extension of time to submit the report.