' YAHYA AFRIDI, J.---Appellants Messrs Parke Davis and Company Limited and Dr. Iftekhar Ahmad Jafri have filed the instant appeal against the judgment and sentence passed by the Drugs Court, N.-W.F.P. Vide judgment dated 23-10-2007, whereby the appellant-Company, Messrs Parke Davis is sentenced to a fine of Rs,50,000 and whereas Dr. Iftekhar Ahmad Jafri is sentenced and fined Rs,30,000 or in default of payment, they are to undergo one year's simple imprisonment.
2. The appellant-Company is a public limited company manufacturing pharmaceutical drugs under drug manufacturing licence issued under the enabling.Provisions of the Dugs Act 1976 ("Act").
' Amongst the registered drugs being manufactured by the present appellant-Company, Choloromycetin Palmitate Suspension is one of the drugs manufactured by the appellant company as is duly registered under the Act, bearing Drugs Registration No,000131 ("Drug"). The Drug was manufactured by, the appellant-Company in the manufactured batch No,0020030 of 60 ml amber glass bottles in May, 2000 with expiry dated of April 2004. The Drug through the distributor of the present appellant-Company was purchased by a retailer running its business under the name and style of Messrs Mohmand Medicos, Mardan under licence No,81571 issued on 10-10-2000.
3. The Provincial Drug Inspector, Mardan on 5-6-2001, while inspecting the premises of Messrs Mohmand Medicos, took the Drug into his custody for its test and analysis. The sample of the Drug on being analyzed and tested was reported vide Test Report TRA No,12050/DTL dated 26-7-2001 by the Government Analyst, Drugs Testing Laboratory, N.-W.F.P. Peshawar ("DTL") to be "substandard".
The Provincial Drug Inspector, Mardan on receiving the said report being sought the clarification from the retailer and the distributor. Having received the warrantees required under the Act, he finally sought the explanation of the present appellant-Company. The present appellant in its explanation, inter alia, denied the Drug to be substandard.
4. The Provincial Drug Inspector, Mardan referred the case of the appellant-Company to the Provincial Quality Control Board, Health Department Government of N.-W.F.P. ("PQCB"), which took up the same for hearing in its "112th meeting" held on 20-8-2002. On the said meeting the parties were heard but the decision was deferred.
Subsequently, PQCB in its "122nd Meeting" dated 30-7-2003, after hearing the parties including the appellant company decided to refer the matter to the National Institute of Health, Islamabad ("NIH"). Sample of the Drug on testing at NIH was also reported as "Substandard" (EXPW3/26).
5. The report of NIH was finally placed before PQCB, which in its 136th Meeting on 31-12-2004 decided that the case be referred for prosecution to the Drugs Court against the present appellants in accordance with the provisions contained in the Act.
6. Pursuant to obtaining the sanction from PQCB, the Provincial Drug Inspector, Mardan filed a complaint before the Drugs Court in accordance with the provisions contained in the Act.
7. The Drugs Court on 14-4-2006 charged the present appellants for committing the offence under section 23 (1) (a) (v) punishable under section 24 (4) of the Act. The present appellants denied the charge and thus the prosecution against the present appellants commenced.
8. The prosecution produced three witnesses, namely "Mir Afzal (P.W.1)," the proprietor of Messrs Mohmand Medical Store, Mardan (retailer), "Azizur Rehman (P.W.2)" Deputy Manager of Messrs Muller and Philips, Mardan (Distributors) and finally Muhammad Israr Rahi (P.W.3) Drug Inspector, Mardan.
' P.W.1 in his statement admitted that the drug was taken into custody by the Provincial Drug Inspector from his store and he stated that he had purchased the same from the distributor of the appellant Company, namely, Messrs Muller and Philips. The said witness also explained the place where the Drug was stored and when the same was taken into custody by the Drug Inspector.
' Azizur Rehman (P.W.2) brought on record the letter received from the Drug Inspector and the warranty of Messrs Muller and Philips, being the lawful distributor of the Drug, manufactured by the present appellant-Company.
' Finally, Muhammad Israr Rahi (P.W.3), the Drug Inspector deposed and explained the entire sequence of events, which commenced with his taking into custody the Drug, sending samples thereof for analysis to DTL, receiving the report of DTL, seeking explanation from the retailer, whole seller and finally the manufacturer i,e, the appellant-Company regarding their response to the DTL report. Finally, he stated that he submitted the report before the PQCB. He also discussed that the sample was sent for re-verification to NIH and after receiving report from NIH stating the Drug to be substandard, PQCB sanction the prosecution of the present appellant.
9. The appellants, inter alia, in their statement under section 342, Code of Criminal Procedure, 1898 denied and disputed the two reports of the DTL and NIH. They also stated that the Drug was within the limits of the potency limits as registered under the provisions of the Act and thus there was nothing, which could lead to criminal prosecution against them, much less a conviction thereon.
10. The trial Court after considering the evidence produced, came to the conclusion that the prosecution had proved its case. Accordingly, the appellants were convicted and sentenced to fine only, appellant-Company was fined Rs,50,000 and appellant No,2 was fined Rs,30,000 and in default of payment they were to undergo one year of simple imprisonment.
11. Being aggrieved of the decision of the trial Court, the appellants have invoked the appellate jurisdiction of this court under the enabling provisions of the Act.
12. The learned counsel for the appellants contended that the report of the NIH, (Exh.P.W.3/26) was not signed by the competent authority as required under section 22 of the Act read with section 17 of the Rules and thus any proceedings based thereon would be a nullity in the eyes of law, The learned counsel relied on Hafiz Khalil v. The State (1996 PCr.LJ 1183) and The State v. Iqbal Ahmad Khan (1996 SCM R 767). The learned counsel further contended that the Provincial Government Analyst, was not appointed in a manner as required under section 16 of the Act. The learned counsel further contended that the report of National Institute of Health. Islamabad (Exh.P.W.3/26) was also not in accordance with the express provision of section 22 (2) of the Act which clearly stipulated a period of 60 days from the receipt of the sample of the drug. In the present case the learned counsel contended that the date of receipt of the sample was clearly stated to be 27-10- 2003 but no date of test or analysis was mentioned therein. He thus contended that the benefit in this regard would surely be in favour of the appellants. The learned counsel relied upon State v.
Messrs Apro Nicholas Pakistan Ltd. (1991 PCr.LJ 1363). The learned counsel further contended that the NIH. Islamabad report (Exh.P.W.3/26) established that the lesser potency declared on the report of DTL Peshawar was not correct and the potency of the drug remained within the limits of manufacturer specification. Thus the Drug could not be declared, on any ground whatsoever, as 'Substandard'. The learned counsel also stated that there was no proper storage condition and the liability of the shopkeeper/ retailer for keeping the drugs in condition not conducive for proper storage had resulted the substandard results. The learned counsel relied on Khalid Mansoor v. The State (1985 PCrLJ 281), Muhammad Amin Khan v. Muhammad Siddique (1984 PCr.LJ 1580). The learned counsel also contended that there was a denial of statutory rights of show cause to the appellant by Provincial Quality Control Board, Peshawar. He contended that this was a mandate under Rule 3 (5) of the N.-W.F.P. Drug Rules 1982. The learned counsel relied upon Basharat Ali v.
Director Excise and Taxation (1987 SCM R 1543), Shahid Habib v. State (2000 PCr.LJ 808).
13. The learned counsel representing the State contended that the report of NIH, (Exh.P.W.3/26) was in accordance with section 22 (5) of the Act. It also contended that Dr. Farnaz Malik had been appointed vide notification dated 10-9-1976 to sign test report in capacity as official incharge in accordance with the provisions of Rule 17 of Drugs (Federal Inspectors, Federal Drug Laboratory and Federal Government Analyst) Rules, 1976. It was further contended that the Provincial Government Analyst was duly appointed vide notification dated 25-4-1991, whereby he fulfilled the requirements as provided under Section 16 of the Act. The report of NIH (Exh.P.W.3/26) was not time-barred but in fact came within the time period provided under the provisions contained in section 22(2) of the Act. The learned counsel further specified that the reports of the two tests conducted were in accordance with the relevant procedure provided for analysis and that technically the same were correct and there could be no question about the veracity of the said test as the due requirements as provided under the Remington Pharmaceutical Addition 21st was complied with and the definition of lumps and the methodology of assay analysis was in accord with the norms of such analysis. In regard to the storage condition of the Drug, the learned counsel for the respondent emphasized that it had been brought on record through evidence that the Drug was not exposed to direct heat and that it was stored properly by the retailer namely, Messrs Mohmand Medicos at Mardan. The learned counsel further argued that the Drug Court comprised of three members including qualified eminent persons, who were well versed in the field of pharmacy and their opinion regarding a particular reports should not be brushed aside lightly. In regard to delay in testing and disposal of samples, the learned counsel contended that the said tests were within the prescribed period. He explained that the samples were drawn from the retailer on 15-6-2001 and they were sent for testing within 7 days and the report thereof was duly prepared on 26-7-2001 and thus it came within the purview of the time provided under section 22 of the Act. As far as denial of show-cause notice and hearing to the appellant by PQCB, the learned counsel contended that the requisite requirement for natural justice was duly complied with and the appellants were duly informed about each and every proceedings of the said committee.
14. The valuable arguments of the learned counsel for the parties duly heard. The available record of the case has been considered with the assistance of the learned counsel for the parties.
15, We would like to first address the challenge made by the present appellants regarding the appointments of the Government Analyst and the Drug Inspector appointed under sections 16 and 17 of the Act, respectively. This challenge of the present appellants was essentially to question the legal authority of the reports made by the Government Analyst in Peshawar and. NIH, Islamabad and finally the very complaint, which initiated the trial of the present appellants before the Drug Court.
"Mr. Muhammad Khalid Khan" was appointed as the Government Analyst vide notification dated 25-4-1989 (Exh.P.W.3/30). The said notification reads as follows:-- ""Notification 23-4-1989 No,SO (Drugs) 1-1(83)/DC." The Govt. Of N.W.F.P. Is pleased to appoint and notify Mr. Muhammad Khalid Khan as Government Analyst under the provisions of section 16 of the Drugs Act, 1976 with effect from 30 March, 1989 (forenoon) for the purpose of test/analysis of all classes of drugs samples sent to the drug testing laboratory, N.-W.F.P. By drug inspectors of N.- W.F.P.
(Sd.)
Secretary Govt. Of N.-W.F.P. Health Social Welfare and Population Welfare Department.
' Dr. Farnaz Malik signed the report prepared by National Institute of Health, Islamabad (Exh.P.W.3/31) is dated 15 January, 2001 and reads as follows:-- "In pursuance with section 17 of the Drugs (Federal Inspectors) Federal Drugs Laboratory and Federal Government Analyst Rules, 1976 as well as Ministry of Health Notification No,F-2-12/76-QCA dated 10-9-1976 and in pursuance of section 22(5) of the Drugs Act 1976, Dr. Farnaz Malik, Acting Chief Drugs Control and Traditional Medicine Division, National Institute of Health, Islamabad is the authorized officer to sign the certificates of test and analysis in respect of all drugs for the whole of Pakistan."
' Mr. Israr Rahi, the officer who conducted the search and filed the complaint against the appellants was duly notified as a Drug Inspector, Mardan by the, Government of N.-W.F.P. (Exh.P.W.3/29). The said notification reads as follows:-- ""Notification 19th November 1999. NOSO (Drugs) Health/6-22/99." In exercise of powers conferred by section 17 of the Drugs Act, 1976 and supersession of all previous notifications of this Department made in this behalf, the Govt. Of N.-W.F.P. Is pleased to appoint the following Drug Inspectors for the purpose of the said (sic) within the local limits given as under with immediate effect.
' S. No, Name of Person and Designation Local Limits 6 Mr. Israr Rahi Distt. Drug Inspector, Mardan."
Mardan.
16. The aforementioned notifications of appointments clearly reveal that the Government Analysts and the Drug Inspector were duly appointed with lawful authority and in accordance with the legal mandate provided under the enabling provisions of the Act. Moreover, the objection raised by the learned counsel for appellants regarding the appointments of the Provincial Drug Analyst, wherein he has been appointed to test all classes of drugs within the territorial limits of the Province does not appears to be valid. In fact, the appointment is within the mandate provided under the Act.
17. There is no bar provided under the Act to limit the authority of any drug analyst to only a limited number of drugs or to a specified restricted area. The provisions of the Act are clear. When the words in a statute are clear, the ordinary and simple meaning of the words used in the section have to be applied in interpreting the same. Nothing is to be imported to restrict or expand the meaning of clear words. The interpretation sought by the learned counsel for the appellants would result in "reading into" Section 16 of the Act, which is against the basic principles of interpretation of statutes. Hence, this contention of the learned counsel for the appellants cannot be accepted.
18. Moving on to the next ground of appeal regarding the Report of DTL, (Exh.P.W,3/6), we need not comment on the same as the challenge made by the present appellants was duly considered by the PQCB and the matter was referred to NIH. Hence the objection on the DTL report by the appellants was addressed and thus it would not be of much legal avail. The actual basis, which moved the PQCB to sanction the prosecution against the present appellants under Section 30 of the Act, was the report of NIH (Exh.P.W.3/26). The said report has been duly singed by Dr. Farnaz Malik, who had been authorized and notified to sign the same under the enabling provision of the Act. Hence, the report of NIH has been prepared by a person, who is duly competent to E sign the same.
19. Now to the conditions of storage of the Drug. The impugned judgment has very carefully and reasonably explained that the Drug was stored properly. The impugned judgment explained as follows:-- "it is not the case of the manufacturer that there were directions for keeping the suspension in refrigerator. The suspension has been made for keeping in room temperature in shelf. It is true that in this part of the country the temperature goes at times to 45 degree centigrade to 50 in rare case in summer season. However, the room temperature does not rise to that much extent. The limit of drug and duration is given keeping in view the shelf like of the drug. It has been stated by the shopkeeper that to avoid the entry of sunlight in the shop he used to hang the cartels. There is no admission that the drug before taking the sample was exposed to light. It has not been proved the shopkeeper from who sample was taken ignored the instruction of the manufacturer. The drug is prepared for room temperature and there is limit even if there is hot temperature in the summer.
The limit has been prescribed and the drug remains in the limit even if the temperature is a bit high. Both the technical members are of the view that it does not effect much the drug of Choloromycitin Palpitate which is suspension made for the room temperature as the said drug is made for keeping in room temperature. If the temperature is high, the potency is affected but even if it remains within limit. The suspension is not salable and settles down. However, it is essential that on shaking it should again be dispursed and be proper for use. However, the drug has been converted to lumps and mass which even on shaking was not disbursed so it is clear that is faulty formulation which prevented the drug to disperse on shaking which is essential for suspension "if there had been heat it would have affected the potency of the drug, which is not in the present case as is clear from the report of NIH which under the law would be conclusive as far as signing by Dr. Farnaz Malik is concerned."
20. As to the contention that the present appellants were deprived of a show-cause notice prior to the sanctioning of prosecution. The PQCB proceeded with great caution and provided all possible facility and opportunity to the present appellants to put up their case. It is on record that on the very challenge thrown by the present appellants on the report of the DTL, Peshawar, PQCB referred the matter to NIH, Islamabad for verification of the Drug. The record shows that in the 112th meeting of PQCB held on 20-8-2002, the appellants were heard and their case was differed to the next meeting (Exh.P.W.3/22). Accordingly, in the 125th Meeting of PQCB held on 30-7-2003, the appellant-Company was heard and thereafter it was decided that the sample be sent to NIH, Islamabad (Exh.P.W.3/24). In the 136th Meeting of the PQCB (Exh.P.W.3/27) held on 31-12-2004, the present appellants were on notice but they failed to appear. However, on reviewing the report received from NIH, the Board decided to refer the matter to the Drugs Court for the prosecution against the present appellants. The record reveals that the appellants have been provided sufficient opportunity of representing their case and thus the principles of natural justice have not been violated. Moreover, there is no express requirement under the Act to provide a show-cause notice to the accused before prosecution is sanctioned by PQCB.
21. As far as the reports of the DTL Peshawar and the NIH, Islamabad are concerned; the same differ on the potency of the Drug. However, the two are in consonance to declare the Drug to be substandard. The report of the DTL, Peshawar dated 26-7-2001 (Ex.P.W.3/6), inter alia, states as:-- ""Description." A white colour deformed suspension filled in amber colour glass bottle of 60 ml.
Lumps observed.
"Conclusion." The above sample of 60 ml Choloromycitin Palmitate suspension be No,0020030 is substandard drug on the basis of tests performed."
Report of NIH, Islamabad, which is "(Exh.P.W.3/26)"states that ""Description."
' White suspension in amber colour glass bottle containing solid mass which is not disbursed even on shaking."
"Conclusion." The sample is of substandard quality on the basis of tests preformed."
22. In regard to the objection raised by the learned counsel for the appellants regarding the report of NIH, Islamabad being time barred under section 22 (2) of the Act, it may be noted that the relevant clause for such report is envisaged under section 22 (5) of the Act.
' The scheme as provided under section 22 of the Act is that the sample taken into custody by the inspector is tested by the Government Analyst within a period of 60 days from the date of receipt of the samples under subsection (2) of section 22 of the Act. And in cases, where the accused challenges the report submitted, then PQCB may refer the said drug for retesting before any other laboratory and the report thereof has to be submitted within 30 days of the receipt of the sample.
The report of NIH (Exh.P.W.3/26) only states the date of receipt and not its preparation. However, no objection to the said document or relating to the said fact was taken by the present appellant at the time of its production in evidence. "What is to be noted is that the test conducted at NH-I was within the period of expiry of the" Drug. Moreover, the said 3rovision relating to time is only 'directory" and not "mandatory". This s more clearly explained in the judgment of the august Supreme Court in Viaz Muhammad v. Mian Fazal Raqib (PLD 1974 SC 134) in the ollowing words:-- "It. Is the duty of the courts to try to get at the real intention of the Legislature, by carefully attending to the whole scope of the statute to be construed. As a general rule, however, a statute is understood to be directory when it contains matter merely of direction, Nit not when those directions are followed up by an express provision that, in default of following them, the acts shall be null and void. To put it differently, if the Act is directory, its disobedience does not entail any invalidity; if the Act is mandatory, its obedience entails serious legal consequences amounting to the invalidity of the act done in disobedience to the provision".
' In this regard we may also refer to "Interpretation of Statutes" by Maxwell (Tenth Edition), which explains the issue as under:-- On the other hand, where the prescriptions of a statute relate to the performance of a public duty and where the invalidation of acts done in neglect of them would work serious general inconvenience or injustice to persons who have no control over those entrusted with the duty without promoting the essential aims of the legislature, such prescriptions seem to be generally understood as mere instructions for the guidance and Government of those on whom, the duty is imposed, or, in other words, as directory only. The neglect of them may be penal, indeed, but it does not affect the validity of the act done in disregard of them.
' It has often been held, for instance when an Act offers and pointed out the specific time when it was to be done, that the Act was directory only and might be complied with after the prescribed time."
23. Now to the case law cited by the learned counsel for the appellants. We have noted that the judgments referred by the learned counsel for the appellants are distinguishable to the peculiar circumstances of the present case.
' The State v. Iqbal Ahmad Khan (1996 SCM R 767). This case questioned the entire prosecution and conviction awarded by the Drug Court on the ground that the complainant was not an Inspector duly appointed under section 17 of the Act. In the present case, as explained hereinabove, Muhammad Israr Rahi who after obtaining the sanction for prosecution from PQCB filed the complaint against the present appellants before the Drug Court. Muhammad Israr Rahi has been duly appointed through a valid notification under the enabling provisions of the Act (Ex.P.W.3/29).
Hence, the judgment cited by the learned counsel does not relate or applies to the circumstances of the present case.
' Hafiz Khalil v. The State (1996 PCr.LJ 1183). In the case cited, the prosecution had not brought on record the notification of the Government Analyst under section 16 and the inspector under section 17 of the Act. As the appointment of the said officials were not on the record of the case, the objection of the appellants therein were well deserved and legally well founded. Whereas in the present case, the situation is otherwise. The notifications of the Government Analyst under Section 16 of the Act and that of the Inspector under Section 17 of the Act have been duly and correctly produced in evidence by the prosecution.
' Salim Siddique v. The State (1987 SCM R 2100). The reliance of the learned counsel on citation 'A' is not legally valid. It would be pertinent to note that in the main judgment, the said citation is in fact the submissions made by the learned counsel appearing for the appellants. In fact the learned counsel has wrongly relied on the head notes of the law report rather than the very judgment itself.
' (Cr.A.No,669 of 1989) The State v. FA Zuberi and 3 others the unreported judgment of the Lahore High Court is a case, wherein the judgment is rendered in an appeal against acquittal and that the report relied upon by the prosecution did not find the drug substandard. As it is well settled that appeals against acquittal and conviction are to be decided on different consideration and standards. Moreover, the most distinguishing feature of the case cited is that there was no report declaring the Drug to be substandard. Whereas, in the present case there are reports, in fact two consistent reports, which declare the Drug to be substandard.
' Basharat Ali v. Director Excise and Taxation Lahore (1997 SCM R 1543). This case relates to the principle of natural justice. There is no cavil to the proposition that natural justice has to be substantive and meaningful. In the present case, we note that the challenge thrown by the appellants on the report of the DTL, (Exh.P.W.3/6) was positively considered and as a result thereof the same was sent for further testing to NIH Islamabad. No abrupt arbitrary action was taken by the PQCB to hastily sanction the prosecution of the appellants. Instead PQCB verified the report of DTL, by retesting the sample from NIH and only after receiving an adverse report therefrom, was the prosecution sanctioned against the present appellant. Moreover, the appellants have been tried by the Drugs Court and rendered full opportunity to plead their defence.
24. Before we part with this case, this court is irked to note that at the time of initiating prosecution, when a report of NIH had clearly declared the Drug to be 'substandard', the provision contained in Section 34 of the Act were ignored. Section 34 of the Act, as it then was read as follows:-- ""Offences of companies etc." Where the person guilty of an offence under this Act, is a company, corporation, firm or institution, every director, partner and employee of the company, corporation, firm or institution shall unless he proves that the offence was committed without his knowledge or consent, be guilty of the offence".
In the present case, we find that only one director of the appellant-Company had been charged and prosecuted for an offence provided under the Act. Hence, the inaction of the Provincial Government and in particular the inspector and the PQCB for not proceeding against the "every directors" the appellant company as was mandated by law is highly regrettable.
25. In addition to the non-prosecution of the "every director" of the appellant-Company, what is also very striking is the non-filing of an appeal against the sentence awarded to the appellant company. The report of NIH was very clear in declaring Drug to be "substandard". The sentence awarded on the appellants being fines only and that too amounting to Rs, 50,000 which in circumstances of the case appears to be "insufficient". In this regard the provision of appeal is provided under section 31 (7-A) of the Act, which reads:-- "(7-A) A Federal Inspector or a Provincial Inspector may, on being directed by the Federal Government or, as the case may be, by the Provincial Government prefer appeal against an order of acquittal or inadequacy of sentence passed by the Drug Court within 30 days of such order."
It would have been appropriate for the Provincial Government to prefer an appeal against the sentence passed by the trial Court. Thus the non-prosecution of every director of the appellant- company and the non-filing of an appeal against the appellant company does not reflect well on the Provincial Government.
26. For the reasons recorded hereinabove, this court finds that the conviction and sentence awarded by the trial Court to be based on clear evidence produced by the prosecution. Hence, the conviction and sentence awarded by the Drugs Court vide judgment dated 23 10-2007 is upheld and the present appeal of the appellants is, therefore, dismissed.