PLD 1978

P L D 1978 Lahore 445 (PLP)

Messrs HARMANN PHARMACEUTICAL LABORATORIES (REGD.), LAHORE-Petitioner Versus GOVERNMENT OF PAKISTAN THROUGH SECRETARY MINISTRY OP HEALTH & POPULATION PLANNING (HEALTH DIVISION), ISLAMABAD AND 2 OTHERS-Respondents

Jurisdiction / Court
-- Ss. 5 & 18 read with Drugs (Licensing, Registering and Advertising) Rules, 1976, rr. 4, 10. 11, 15, 16, Sched. B, para. 2 and Sched. B. -II, pares. 1(1), (2), 2(a), (c) & 3(2)-Interpretation of statutes-Words and phrased--Words "building", and "premises"-Meaning-Licence, refusal to renew on ground of unsuitability of building-Word "building" in Sched. B, para. 2-Synonymous with word 1'premises"-Word "premises" as used in various rules acid Schedule-Does not mean a detached or separate building or structure-Mere user of a portion of premises or building for residential purpose-Held t Does not render same unsuitable for a licensed premises and manufacturing place only required to be separate from Residential place.-Words and phrases.
Decided Date
Writ Petition No. 2405 of 1977, decided on 18th December 1977.
Honorable Judges
Gul Muhammad Khan, J
Case Reference Summary (AEO Optimized)
Citation P L D 1978 Lahore 445 (PLP)
Forum / Court -- Ss. 5 & 18 read with Drugs (Licensing, Registering and Advertising) Rules, 1976, rr. 4, 10. 11, 15, 16, Sched. B, para. 2 and Sched. B. -II, pares. 1(1), (2), 2(a), (c) & 3(2)-Interpretation of statutes-Words and phrased--Words "building", and "premises"-Meaning-Licence, refusal to renew on ground of unsuitability of building-Word "building" in Sched. B, para. 2-Synonymous with word 1'premises"-Word "premises" as used in various rules acid Schedule-Does not mean a detached or separate building or structure-Mere user of a portion of premises or building for residential purpose-Held t Does not render same unsuitable for a licensed premises and manufacturing place only required to be separate from Residential place.-Words and phrases.
Bench Members Gul Muhammad Khan, J
Parties Messrs HARMANN PHARMACEUTICAL LABORATORIES (REGD.), LAHORE-Petitioner Versus GOVERNMENT OF PAKISTAN THROUGH SECRETARY MINISTRY OP HEALTH & POPULATION PLANNING (HEALTH DIVISION), ISLAMABAD AND 2 OTHERS-Respondents
Primary Law (b) Drugs Act (XXXI of 1976), (c) Drugs Act (XXXI of 1976), (a) Drugs (Licensing, Registering and Advertising) Rules, 1976
💡 Quick Legal QA & Summary / سوال و جواب خلاصہ
Q1: What are the key laws and sections cited in P L D 1978 Lahore 445 (PLP)?

This judgment primarily cites: (b) Drugs Act (XXXI of 1976), (c) Drugs Act (XXXI of 1976), (a) Drugs (Licensing, Registering and Advertising) Rules, 1976 as referenced in Pakistani case law index.

Q2: Which judicial bench decided the case P L D 1978 Lahore 445 (PLP)?

The case was heard and decided by the -- Ss. 5 & 18 read with Drugs (Licensing, Registering and Advertising) Rules, 1976, rr. 4, 10. 11, 15, 16, Sched. B, para. 2 and Sched. B. -II, pares. 1(1), (2), 2(a), (c) & 3(2)-Interpretation of statutes-Words and phrased--Words "building", and "premises"-Meaning-Licence, refusal to renew on ground of unsuitability of building-Word "building" in Sched. B, para. 2-Synonymous with word 1'premises"-Word "premises" as used in various rules acid Schedule-Does not mean a detached or separate building or structure-Mere user of a portion of premises or building for residential purpose-Held t Does not render same unsuitable for a licensed premises and manufacturing place only required to be separate from Residential place.-Words and phrases. bench comprising: Gul Muhammad Khan, J.

Q3: What is the official citation format for this judgment on Pakistan Law Portal?

Cite this legal precedent as: P L D 1978 Lahore 445 (PLP) (Messrs HARMANN PHARMACEUTICAL LABORATORIES (REGD.), LAHORE-Petitioner Versus GOVERNMENT OF PAKISTAN THROUGH SECRETARY MINISTRY OP HEALTH & POPULATION PLANNING (HEALTH DIVISION), ISLAMABAD AND 2 OTHERS-Respondents). Read the full summary and cross-referenced laws free on Pakistan Law Portal.

Laws Cited

(b) Drugs Act (XXXI of 1976) (c) Drugs Act (XXXI of 1976) (a) Drugs (Licensing, Registering and Advertising) Rules, 1976

Representation

  • Sh. Zia Ullah for Petitioner.
  • Zia Mahmud Mirza for Respondents.
  • Date of hearing : 27th November 19777.

Headnotes / Summary

R. 15-Rerewal of licence to manufacture drugs-Discriminatory treatment -Persons situated in same position as petitioner granted licences by Central Appellate Board and actually manufacturing drugs-Refusal to revalidate petitioner's hence for simple reason of upper floor being used for residential purposes, held, in circumstances, discriminatory and arbitrary exorcise of discretion. -- S. 44 -Rules, imposition of conditions-Conditions allowed by Legislature to be attached to grant of licence by a subordinate authority-%lust fairly and reasonably relate to objects and purposes of law. Ikram Bus Service v. Board of Revenue, West Pakistan and 2 others P L D1963 S C 564 ref. -- Ss. 5 & 18 read with Drugs (Licensing, Registering and Advertising) Rules, 1976, rr. 4, 10. 11, 15, 16, Sched. B, para. 2 and Sched. B. -II, pares. 1(1), (2), 2(a), (c) & 3(2)-Interpretation of statutes-Words and phrased--Words "building", and "premises"-Meaning-Licence, refusal to renew on ground of unsuitability of building-Word "building" in Sched. B, para. 2-Synonymous with word 1'premises"-Word "premises" as used in various rules acid Schedule-Does not mean a detached or separate building or structure-Mere user of a portion of premises or building for residential purpose-Held t Does not render same unsuitable for a licensed premises and manufacturing place only required to be separate from Residential place.-[Words and phrases]. Gardiner v. Sevenoaks Rural District Council (1950; 2 A E R 84 and Moir v. Williams (1892) 1 Q B 264 ref. (d) Drugs (Licensing, Registering and Advertising) Rules, 1976.

R. 16-Jurisdiction--Licensing Boards relying on a consideration extraneous to law and travelling beyond territory allowed-Held, committed an illegality to be termed as excess of jurisdiction.[Jurisdiction]. Taj Bibi v. Ijaz Hussain Shah I' L D 1966 Lah. 939 a Ashbridge Investments Ltd v. Minister of Housing and Local Government (1965) 1 W L R 13210 and Fazle Rozzak v. Mardan Transport Co. 1968 S C M R 1139 ref.

Judgment & Decree

10. The contention being raised by the learned counsel is not of much help to him. It is not the commitment of the petitioner that matters, but it is law which has to prevail. The learned counsel relied on section 44 of the Drugs Act to show that such a condition could be imposed by rules but could not point to any such provision. Nothing contained therein supports the plea of the two Boards that the building should be detached or that no person should live upstairs. It is a well established position of law that whenever Legislature empowers a subordinate authority to attach any conditions to the grant of a licence, the conditions lobe valid must fairly and reasonably relate to the objects ant purposes of law. Reference in this connection be made to 1krum Bas Service's case (P L D 1963 S C 564) wherein the Supreme Court hold, that the act of Regional Transport Authority introducing new criterion for judging the suitability of an applicant contrary to the provisions of section 47 of the Motor Vehicles Ordinance attracted interference by the superior Courts.

11. Section 21(1) (a) (iv) of the Drugs Act provides that no person shall, himself or by any other person on his behalf, manufacture for sale or sell any adulterated drug. 'Adulterated' drug has been defined in section 3 (a) as follows : "3 (a) "adulterated drug" means a drug (i) which consists in whole or in part of any filthy, putrid or decomposed substance or which contains any foreign matter, vermin, worm, rodent or insect ; or (ii) which has been manufactured, packed, or held under unsanitary conditions whereby it may have been contaminated with dirt, filth or any other foreign matter or whereby it may have been tendered injurious to health ; or (iii) the container of which releases any poisonous or deleterious substance which may render the contents injurious to health ; or (iv) which bears or contains as an ingredient a substance other than the prescribed substance ; or (v) with which any substance has been mixed or packed so as to reduce its quality or strength or for which any substance has been substituted wholly or in part ;" Thus one of the purposes of the law is to ensure manufacture of unadulterated drugs. Rule 15 which is meant for grant or renewal of a licence to manufacture drugs by way of basic or semi-basic manufacture stipulates that the applicant shall provide premises suit sale for the intended use in size and construction and shall be located in an area free from offensive and obnoxious odours and other possible sources of contamination. Rule iii which specifies conditions for the grant or renewal of licence to manufacture drugs by way ref formulation requires that the factory premises shall comply with conditions specified in Schedule B. The additional conditions are given in the Schedule B-Il. The form of the application and the licence for both the types of manufacture is the same.

12. The relevant provisions of paras. (1) and (2) of the Schedule B are as follows : "(1) Location and surroundings.-The factory shall be situated in a place which shall not be adjacent to an open sewage, drain, public lavatory or any factory which produces a disagreeable or obnoxious odour of fumes or large quantities of soot, dust or smoke which may interfere or contaminate the drug being manufactured or adversely affect its quality. The factory shall be located in a sanitary place, remote, from filthy surroundings, preferably not in congested residential area. (2) Buildings.-Buildings shall be of suitable size and construction to facilitate adequate cleaning, maintenance and permit manufacture of drugs under the hygienic conditions. The building shall- (a) be so designed and constructed as to prevent the entry of animals and insects. Interior surfaces, including walls, floors and ceilings, shall be smooth and free from cracks, shall not shed particulate matter and shall permit easy cleaning and, if necessary, disinfections. The building shall not be used for any purpose other than manufacturing purposes of the manufacturing firms. The staying place for watch men shall also be separate from manufacturing area? :??????????????????????? (e) provide for safe and sanitary disposal of sewage, trash and other refuse from the building; ?????????????????????????.. (1) In factories where operations involving the use of containers, such as mottles, vials, jans, ampoules, are conducted provide adequate arrangements, separated from the manufacturing operations for washing, cleaning and drying such containers with suitable equipment foe the purpose. Sterilizing facilities where necessary shall also be provided." Schedule B-II contains the following relevant provisions t 4 toil; "1 (2) The workers shall be required

(a) to wash and change into clean overalls before entering the rooms where the manufacturing operations require such a precaution ; 3 (2) Eating, smoking and unhygiento practices shall not be permitted in the manufacturing area." The above provisions only require that the premises to be used for the manufacture of the drugs should be such as do rot permit adulteration or contamination. They specifically provide that the manufacturing area should he separate. The two Boards. therefore, should have applied their minds to those requirements and should have formed an opinion about the suitability of the premises of the petitioner on that acorn.?

13. Section 18 of the Drugs Act and the rules 4,10,11,15 and 16 referred to above speaks of premises. The word 'premises', however, is not defined in the Act. In Webster's Third New international Dictionary 'premises' means, a building, buildings or a part of a building or a place of business of an enterprise or institution. According to Law Lexicon 1957 Edition, 'premises' under various Public Health Acts include, house, part of a house, buildings, tenements, messuages, lands etc. In the Concise Law Dictionary by Osborn the 'premises' means house or buildings. Stroud's Judicial Dictionary describes the 'premises' as appurtenant to a house or a mansion. In popular language it is stated to mean building. land or land with building upon it. It was held to Gardiner v. Sevenoaks Rural District Council ((1950) 2 A E R 84) that a cave may be a premises. Section 1 (1) of the Act which was under consideration in that case read; "No premises shall be used for any purpose to which this Act applies;" unless certain information has been given.

14. A building, on the other hand, moans anything built or a house. Lord Esher in Mofr v. Williams ((1892) 1 Q B 264), defined it as en enclosure of brick or stone covered by a roof, though law provided that every building shall be separated by external or party walls from adjoining buildings. In Webster's Third New International Dictionary a building means a conetructod edifice designed to stand more or less permanently, covering a spice of land, usually covered by a roof and more or less completely enclosed by walls and serving. as a dwelling, store-house, factory. : . : . : : . a portion of a house occupied as a separate dwelling.

15. The word 'building' in pare. 2, Sohodule B, therefore is synonymo to the word 'premises'. This view will conciliate it with rules 10 and 16 In view of the above discussion the 'premises' as mentioned in various rule and schedule would not mean a detached or a separate building or a structure. The last line of pare. 2 of Schedule B providing separate staying place for watchman also makes it clear that though watchman may stay in the same building or promises yet it should be separate from the manufacturing area. It is thus clear that a more user of a portion of the premises or building for residential purpose does not render it unsuitable for a licensed promises. This view will also be in conformity with the legal requirement that every factory must have wash-rooms, toilets, cafeteria and the like. Paras. 1 (1) and (2) read with para. 3 (2) of Sahedula B-II, only say that such places should be separate from the rooms where the manufacturing, operations are carried out.

16. In this view of the matter, it is quite clear that the intention of the Legislature never was to have required of a liaencee to provide a detached promises for the manufacture of drugs. What was required was that the; location and surroundings of the licensed premises would be such and the building so designed that it permits manufacture of drugs under hygienic conditions and that the 'manufacturing area' was not used for any other purpose. The place for residence of the watchman, washing, cleaning, smoking, eating else. was also to be separated from the 'manufacturing area'.

17. The provisions of Rules thus go to shoat/ that the vicinity of the factory should be so hygienic as to guarantee the hygienic manufacture of drugs. In such a situation the Board should have given a positive finding either on the basis of the report of the Inspection Team or on its own satisfaction that the residential premises. upstairs were so situated that the residence of a tenant there would materially interiors with tae hygienic conditions to be maintained to the manufacturing process of the factory down-stairs. The fact, that nose of the Inspection Teams gave that finding. despite the plea of the petitioner, as raised by him in Annexuro 'E' the reply to the show-cause notice and reproduced in paxa. 4 above, proves that the plea of the petitioner was correct. The more user of the upper portion as residence there did in no way Interfere with the hygienic working of the factory.

18. The discussion made above would go to show that the respondent relied on a consideration extraneous to law and travelled beyond the territory allowed to them. They, therefore, committed an illegality to be termed a excess of jurisdiction. It was held in TaJ Bibi v. Ijaz Hussar Shah (P L D 1906 Lah. 939) that the order of the Chief Settlement Commissioner which was passed on extraneous consideration wait liable to be declared as being without lawful authority. It has been held in Ashbrrdge Investment Lid. v. Minister of Housing and Local Government ((1565) 1 W L R 1320) that ; . . the Court can interfere with the Minister's decision if be has acted on no evidence p or if he has come to a conclusion to which on the evidence he could not reasonably come ; or if he-has taken into consideration matters which he ought not to have taken into account, or vice versa ; or has otherwise gone wrong in law. It is identical with the position when the Court has power to interfere with the decision of a lower tribunal which has erred in point of law: The Supreme Court in Fazle Razzak v. Mardan Transport Company (1968SCMR1139) observed as under ; "It has been repeatedly hold by this Court that when an administrative authority or tribunal acts in etce3s of jurisdiction or refuses to exercise jurisdiction or commits a patent illegality, the superior Courts can always step in to undo the wrong. In the case of Ikrarn Bus Service, cited above, it was held "that even an administrative body such as an R. T. A. is under legal obligation to deal with all applications before it fairly, justly and equitably and? an applicant has a legal right to demand that the administrative body should determine the matter with whose decision it is charged, in accordance with the late " I have, therefore, no option but to declare the impugned order refusing to revalidate the licence to the petitioner, for a consideration, foreign to the relevant law, as without lawful authority and of a ?o log 4 effect.

19. The learned counsel fob the respondent then submitted that this case may be remanded to the concerned authority to carry out fresh inspection and to see if the location of tile upper floor was such that residence therein would interfere with hygienic manufacture of drugs. It is to be noted the none of the authority expressed that view though the petitioner are officially raised that point with them. Comments had also been called for by ma, firstly, frown the Board but it did not raise any such objection. For the second time, the comments were called for from the Appellate Board but that too did not advance this plea. Instead, it had appended alongwith its reply, an application by one of the neighbours (erroneously recorded as person living upstairs, as his house bears a different number) that the existence of the factory in that locality was injurious to them. It is, therefore, neither in the interest of justice nor will it inspire any confidence in the mind of the petitioner if this case is sent back at his stage asking the two Boards or any of them to inspect the premises from that point of view. Rather, it may amount to suggesting them to say that the residence of a tenant upstairs made the premises unsuitable for the factory.?????

20. From the discussion made above. I am quite clear, that the both the Boards refused to revalidate the petitioner?s licence just because the upper portion was being used as a residence though it is not one of the factors in law making the place unsuitable for the purpose. They had never before been of the opinion that the upper floor was situated in such a way or its position vis-a-vis the lower portion was such that it would interfere with the hygienic conditions in the factory. A mere residence of a person upstairs, however, is not one of the reasons in law on which the respondents could refuse to revalidate a licence. The impugned order, therefore, cannot be maintained and it is, hereby, declared to be without lawful authority and of no legal effect. The licence of the petitioner shall, therefore, be revalidated. As the question involved-was not free from difficulty, the parties shall bear their own costs. s. A. H.??????????? - ????????? Petition allowed.