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PLD 1978 Lahore 445

Messrs HARMANN PHARMACEUTICAL LABORATORIES (REGD.), LAHORE vs

CitationPLD 1978 Lahore 445
CourtLahore High Court
Judge(s)Gul Muhammad Khan
ResultPetition allowed

This petition is directed against the refusal of the Appellate Board constituted under the Drugs tact, 1976, to validate the manufacturing licence of the petitioner for manufacture of drugs. The petitioner hold two drug manufacturing licences under the Drugs Act, 1940. Licence No. 114 of 1971 was valid up to 27th of January 1975. The petitioner had duly applied for its renewal to the Provincial Licensing Authority as it was then constituted under the Drugs Act, 1940. The other Licence No. 377 of 1970 was valid up to 10th of August 1976.

2. On 17th of January 1976 the Drugs Ordinance, 1.976, was promulgated. The Director-General of Health, Government of Pakistan, who was the Ex Officio Chairman of the Central Licensing Board constituted under the Drugs Ordinance, 1976, invited applications for revalidation of the previous licences. The petitioner applied for it on 12th of February 1976. A panel of experts deputed by Central Licensing Board (hereinafter called the Board) inspected the factory premises of the petitioner and pointed out 10 defects. One of these was that the upper storey of the building was being used for residential purposes by a tenant. The Licensing Board vile its order dated 8-6-1916 (Annexure B) required of the petitioner to rectify all those defects after which the premises were to be re- inspected. Simultaneously, it was directed that the petitioner shall stop further manufacture.

3. On 2nd of September 1976, the petitioner informed the Central Licensing Board that the defects pointed out' had been removed and requested re-inspection. That being done by the Board, a notice, however, was issued to the petitioner on 2nd October 1976. Asking him to show cause as to why the application for re-validation of licence be not rejected as these still remained five defects.

The first defect in this case was about the upper portion of the building being used for residential purposes.

4. In his reply dated the 15th of October 1976 (Annexure'E'), the petitioner wrote that the inspection team was quite happy with the rectification of the defects as the same had been removed to its entire satisfaction. It eves further clarified that the petitioner bad rather made further improvements and renovations which were appreciated by the Inspection Team. He also informed that the premises were in a better position than those of other manufacturers whose licences had been re-validated. As regards the defect No. 1, it was specifically stated as follows : "'The building was being utilised for the residential purposes and, therefore, the defects had not been rectified.

Rectification.--The buildings new arid in A-one condition. All Rooms are capacious and have been painted with plastic emulsion which give neat, clean and elegant lock. Each room has an independent sad safe approach fop easy material flow. The whole area Is provided with double- door and wire-netting system which prevent outside dust, dirt and insects. In short the building is suitable for manufacturing safe, efficacious and duality drugs.

Only a small portion of the building is being utilized as residential and that also has an entirely independent and absolutely separate entrance. Therefore, there is no direct hindrance or interference in our working.

Further, a request has already been merle to the landlord to get that portion vacated as soon as possible and we trust this shall be done very soon and the entire area will b4 in our possession."

The Central Licencing Board, however, rejected the petitioner's application and communicated the same vide letter dated 13ta of January 1977 (Annexure'F'). The reason given was that the conditions as laid down in rule 16 were not being observed.

5. The petitioner toot an appeal before the Appellate Board as constituted under section 9 of the Drugs Act. The Board also deputed an Inspection Team but- no copy of their report has been placed on the record. The appeal wag, ho-ever; rejected by the Board and a communication to that effect sent on 28th of August 1977. The relevant portion which necessitated the rejection of the appeal reads as under : "Whereas the report of the inspection team of the Appellate Board revealed that the upper storey of the building was still being utilized for the residential purposes. And whereas the remaining defects mentioned by the Central Licensing Board were not present at the time of inspection.

Whereas the appellant was provided an opportunity of presenting his cast before the Board on 5- 7-77 where before the appellant confirmed the above-mentioned fact regarding use of building for other purposes."

The petitioner has now coarse to this Court against the refusal. The short question arising in the case is whether the two aforementioned Boards were empowered arid justified to refuse to revalidate the petitioner's licence simply because the upper portion of the budding is being occupied for residential purposes.

6. It has been admitted by respondents in their para. 11 (h) of the comments that the Central Licensing Board did issue licences to other three applicants who also had residences at their upper portions and also to a number of others who had residences or shops on the ground or lower floors.

It has also been stated by the Appellate Board that it was intending to take up such cases under its suo motu power of revision. It, however, cannot be said, at this stage, as to what will be the ultimate view of the Board. The fact of the matter, however, is that the persons situated in the same position as the petitioner have been granted licences by the Central Appellate Board and they had boon manufacturing drugs. The refusal to revalidate licence in the case of the petitioner for the simple reason that the upper floor was being used for residential purpose is, therefore, discriminatory and arbitrary exercise of discretion. The impugned order is thus bad and liable to be struck down on that short ground.

7. It was contended by the learned counsel that the upper portion being used for residential purposes by a tenant is quite independent with a separate entrance and has nothing to do with the manufacturing promises.

Reliance In this respect was placed on the portion of the reply reproduced above. It was also argued that nether the Inspection Team nor did the Central Licensing Board or the Appellate Board give a finding that the residence of a tenant on the upper floor would in any way interfere with the hygienic manufacture or efficient running of the factory. The law, it was pleaded, contained no prohibition for mere utilization of as upper storey of the building far residential purposes. The learned counsel relies on a portion of pare. 2 (a) of Schedule 'B' to the Drugs (Licensing, Registering and Advertising) Rules, 1976 (hereinafter coiled, the Rules) which reads that : '-'The staying place for watchmen shall also be separate from manufacturing area '

According to him this provision makes it abundantly clear that mere situation. Of a residential area near or around is not fatal and that what the law requires is that the residence should be separate from the manufacturing area. It was further submitted that the word 'building' as used in paras. 2

(a) and 2 (c) of Schedule 'B' to the Rules was actually synonymous with the premises of the factory whether situate in a part o' a building, on one of the floors of a multi-storey building or in a detached construction. He also referred to pare (1) (ii) (a) of Schedule 8-I1 to say that as workmen are required to wash and change into clean overalls before entering the rooms of manufacturing operations, the Legislature was mindful of the fact that a factory would have; wash-rooms, toilets etc. Situate in the premises. The learned counsel also relied in this connection, on the wording of Rules 4, 10 (1), 11 (1), 15 (a) and 16 (a) to argue that the Legislature always equated 'building' with "premises' and, therefore, the use of word 'building' in the above provision does not mean actually a detached structure.

8. The learned counsel for the petitioner also submitted that if the Legislature meant that the manufacturing premises should be independent and separate from the residential area, it would have said so specifically, because if no person can be allowed to live on the upper storey of a manufacturing premises, then no licence should be granted in respect of premises which adjoins on the sides or at the back with other residential buildings.

9. Mr. Zia Mahmood Mirza, the learned counsel for the respondent submitted that the petitioner himself in his reply had been assuring the two Boards that he had asked the landlord to get the upper portion vacated and the same was likely to be done soon. It is contended that the petitioner could not turn round later to say that a9 the upper storey could not be vacated the order is unlawful.

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 (PLD 1963 SC 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 (PLD 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 andan 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.

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