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PLD 1992 Karachi 347

STATE Through The Advocate-General Sindh And Ex-Officio Public

CitationPLD 1992 Karachi 347
CourtSindh High Court
Judge(s)Syed Abdur Rahman, Muhammad Aslam Arain
Resultanswered in negative

SYED ABDUR RAHMAN, J.-This acquittal appeal is directed against the judgment of Drug Courtfor Sindh and -Balochistan at Karachi dated 14-171987, whereby the, above _named respondents were acquitted.

2. The prosecution story is that on 25-7-1981 Drug Inspector, Karachi, took sample of the-world renowned 'drug 'Woodward Gripe Water' from the shop -premise's' of M/s,. ., Khawer air Medicine and" after observing necessary legal formalities of' sealing etc. Sent one I sample to Government Analyst/Director Central Drug' Laboratory . For the purpose of test/analysis.. The test report declared that the sample was not of standard quality as it was mis-branded and contained 'Oleorc-sins, of ginger The Inspector sent a. Copy of the test report to., M/,s.Khawar Medical, Store, who informed him that, the same was purchased from. M/s.Woodwards (Pak.) Ltd. Rock Court, Abdullah Haroon Road, Karachi under a cash-merno/warranty. The Inspector there--upon sent the copy of the test report to M/s. Woodwards (Pak.) Ltd., but the same was not replied. Consequently he reported the matter to the! Chairman, -Provincial Quality Control Board, Karachi, who sanctioned the prosecution of the respondents.

3. The respondents, who were the company itself and its officers did not deny that the sample in question was manufactured by 'them and was' sold to the, Medical Store, concerned under warranty. Their defence in short was that 'Olcoresi,ns of Ginger' was, being added by the manufacturers as a flavouring agent and was, not an, active ingredient of the drug. Hence it was not necessary to mention the same on the label and carton thereof. Therefore, it was neither misbranded nor substandard. Secretary Registration Board Chad directed 'them to mention Ginger Tincture as an ingredient on the label and carton of Gripe --water. These instructions could not be complied with regard to the disputed sample because the same was manufactured prior to the receipt of the above direction. The learned Drug Court, inter alia, took up the point as to whether the drug which was manufactured by name 'Gripe-Water' was mis-branded because it contained 'Oleorensins of Ginger' and was substandard. The point was answered in negative.

4. We have heard Mr. Hayat Oureshi, learned c'ounsel for the appellant/State and Mr. Munawar Malik, learned counsel for the respondents.

5. Before we proceed to examine the finding of acquittal recorded by the learned Drug Court in favour of respondents, it will be proper for us to set out the grounds on which this Court normally exercises its powers in such a case when the Government files appeal against the acquittal. It has been laid down in the following cases:-

(1) PLD 1983 Quetta 122. (State v. Muhammad Rafiq) and

(2) . PLD 1988 Kar. 409 (State v. Abbas Ali Shah), and

(3) 1983 SCMR 117 (Said Baghdad v. Said Mian) that in an appeal by Government from acquittal, Court starts with double presumption in favour of the accused, firstly that there is a rule that it is for the prosecution to make out their case. Until it does so beyond reasonable, doubt I the accused must be presumed to be innocent. Secondly, the accused having A succeeded in securing acquittal from the trial Court, superior Court will not interfere until the State shows conclusively that the finding is perverse, foolish and contrary to facts on record and the 'inference as to guilt is irresistible. We are in full agreement with the views expressed in the above rulings. It will, therefore, be necessary to assume that as the respondents in this case were found innocent and were acquitted by the learned Drug Court, the prosecution has to show that its case is irresistibly strong in order to persuade us to set aside the acquittal of the respondents. Moreover, it is the settled law that it is not only necessary for the prosecution to prove to the satisfaction of this Court that the accused ~s guilty, but also to prove that the grounds given by the trial Court in at-quitting, the accused are un-reasonable and unsound. -6. - That there is no dispute on the factual aspects ofthis caseAt the time of admission of appeal, it was argued by the A.A.-G. That the Drug Court had not relied upon the report of Government Analyst and therefore, had contravened the' provisions of, subsection (4) of sections-22 of the Drugs Act, 1976, particularly when no challenge was thrown to it by the party affected for getting it tested in another laboratory of its choice. In this connection it will be useful to reproduce subsection (4) of section 22 of the Drugs Act, 1970 which reads as under:- "(4)Notwithstanding anything contained in any other law for the time being in force, any document purporting to be a report signed by a Government Analyst shall be admissible as evidence of the facts stated therein without formal proof and such evidence shall be conclusive unless the person from whom the sample was taken or the said warrantor has, within thirty days of the receipt of a copy of the report notified in writing to the Inspector or the Drug Court or, as the case may be, the Central Licensing Board or the Registration Board before which any proceedings in respect of the sample are pending that he intends to adduce evidence in controversion of the report."

7. From perusal of the judgment of the learned trial Court as well as record of the appeal, it appears that this is not at all the point in dispute in this appeal. The accused had not challenged the report of the Government Analyst, as there was no necessity to do so. As we have already pointed out the only point for determination in this case is as to whether the 'non-mention Of Oleoresins of Ginger' on the label of drug would be a ground for treating it as misbranded or sub-standard as required by section 23 (1) (a) read with section 27 (2) of the Drugs Act, 1976.

The learned trial Court has made it quite clear that the respondents were challaned in this case only because the sample contained 'Oleoresins of Ginger' which was not written on the label. Their defence is that 'Oleoresins of Ginger' is added in the drug 'Gripe Water' as a flavouring agent to make it more palatable and not as an active ingredient. The learned trial Court accepted this plea of the respondents. We also have no reason to take a different view in the matter. Wood Wards Gripe Water is being manufactured and used world over for the last 100 years and '01coresins of Ginger' is being added in it without mentioning it on the label, for the simple reason that it is the principal flavouring agent and is being so used in pharmacy product, as has been described in British Pharmacopoeia, 1980 in the Section of action and use--'Flavouring'.

8. We also agree with the trial Court that the test report does not give detailed reasons as to how the inclusion of 'Oleoresins of Ginger' made the sample to be substandard and misbranded. The word 'misbranded' has been defined in section 3 of the Drugs Act, 1976 as under- - (a)"misbranded drug" means a drug:- (i)which is not labelled in the prescribed manner, or (ii)on the label or labelling of which any word, statement or other matter or information required by the rules to appear on the label or labelling is not prominently placed with such consciousness (as compared with other words, statements, designs or devices on the label or labelling and in such terms as may render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use; or (iii)which is not labelled with such directions for use and such warnings against use in indications whether its use may be dangerous to health, or against unsafe dosage or duration of administration or application, in such manner and form as are necessary for the protection of users or as may be prescribed; or (iv)the label or container which, or anything accompanying which, bears any statement, design or device which makes any false claim for the drug or which is false or misleading in any particular; or (v)which is so coloured, coated, powdered or polished that damage is concealed, or which is made to appear of better or greater therapeutic value than it really is; or (vi)which is manufactured according to the specifications of a particular pharmacopoeia or any other document as may be prescribed and the label does not bear the name of that pharmacopoeia or document:"

9. Bare perusal of the above definition would make it clear that a drug would be deemed as mis- branded when such drug is not labelled in the prescribed manner or labelling of which is against the Rules or misleading or which is camouflaged to conceal damage etc. Or on which the name of the pharmacopoeia under specifications of which the drug is manufactured is not mentioned. We would also reproduce with approval the following extract from the judgment of the learned trial Court:- "As such the inclusion of any substance in the drug would not qualify such drug to be 'misbranded drug', but on the contrary such a drug if it contains any substance extraneous to the drug would render it an 'adulterated' drug as defined in section 3, subsection (a) of the Drugs Act, 1976. The -case of the prosecution is that the Gripe Water has not been labelled in the prescribed manner and thus the drug is misbranded. The prescribed manner of labelling is as approved by the Drug Registration Board, Ministry of , Health Islamabad while granting an application for registration of a particular drug. The approved application for registration of the drug in question has been produced before this Court and it has been admitted by the Drug Inspector that the labels of the samples of the Gripe Water are the same as the label which has been approved by the Drug RegistrationBoard, while granting the application for registration of the Gripe Water. It is worth to note that Oleoresin of Ginger has neither been shown on the approved label of the Registration Board nor on the label of the samples in question which are the subject matter of this case. It is, however, not a case whether the manufacturer has added or incorporated Oleoresin of Ginger on their own or without disclosing the same to the Drug Registration Board as the same would have rendered them liable to proceedings under the charge of 'adulteration'. On the contrary the case of the accused is that they had in their application for registration disclosed the active ingredient as mentioned on the labels in the heading composition of the drug and furthermore in annexure 4 of their application for registration under the heading 'pricing' shown as S.P. Ginger for the reasons that 'Oleoresin of Ginger' has not been used or treated by the company as an active ingredient but only as a flavouring agent.

Section 32 subsection (2) reads as under:-- A drug shall not be deemed to be misbranded or Rub standard only by reason of the fact that there has been added thereto some innocuous substance or ingredient because the same is required for the ma manufacture or preparation of the drug fit for carriage or consumption and not to increase the bulk, weight or measure of the drug or -to conceal its inferior quality or other defect or there is a decomposed substance which is the result of a natural process of decomposition: Pi6vided that such decomposition is not due to any negligence on the part of the manufacturer of the drug or the dealer thereof and that it ,does not render the drug injurious to health or does not make it substandard."

10. We feel that the prosecution in this case has been launched against the accused mainly because they did not comply with a direction of the Secretary, Registration Board to mention 'Oleoresin of Ginger' as an ingredient on the label. The explanation for this non-compliance of the, direction given. By accused is convincing i.e. That the said direction was not received prior to the manufacture of this batch of Wood Wards Gripe Waiter'. We , therefore, do not find anything manifestly wrong or reverse in the conclusion arrived at by the learned Drug Court and the same is, therefore, not such that it may call for any interference by this Court in exercise of the powers vested in it under section 417 Cr.P.C. We, therefore, dismiss the appeal.

N.H.Q./S-881/K

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