' WAJIHUDDIN AHMED, J.--This appeal, under section 31(7) of the Drugs Act, 1976, emanates from the seizure and sealing of a sample of "Sun Gul Menthojelly", admittedly a preparation of the appellant, on 22-9-1981, by Altaf Hussain Hakro, Divisional Inspector of Drugs, Hyderabad. Such sample was taken from M/s. Yousuf Brothers and the purported Drug carried label and inscriptions indicative of its, having been manufactured by M/s. Anis Unani Laboratories, Karachi, proprietorship concern of the appellant. One sealed portion of the sample was sent to Government analyst/Director, Central Drugs Laboratory, Karachi, for test/analysis and another such portion was forwarded to the Chairman, Sindh Provincial Quality Control Board, Karachi. M/s. Yousuf & Brothers made over cash memo No,66, dated 20-9-1981, from M/s. Anis Unani Laboratories to the said Mr. Hakro. Test Report No, 1652/81, dated 26-10-1981, from the Director, Central Drugs Laboratory, Karachi, declaring the Drug in question to contain Menthol, Camphor, Eucalyptus Oil and Methyl Salicylate was received. A copy of such test report and one sealed portion of the sample was forwarded to M/s. Anis Unani Laboratories through letter dated 2-11-1981. The case was then referred to the Chairman, Sindh Provincial Quality Control Board, Karachi, per letter dated 29-11-1981, for permission to prosecute the offending party. Such Board issued show-cause notice to M/s. Anis Unani Laboratories on 14-12- 1981. On 6-6-1983 instructions to prosecute were issued by the Board. On 17-8-1983 the above Altaf Hussain Hakro filed a complaint against the appellant as proprietor of M/s. Anis Unani Laboratories as well as against his proprietorship firm. On the same date, the Drug Court for Sindh and Balochistan issued bailable warrants to the accused-appellant.
2. On or about 3-1-1985 an application under section 249-A, Cr.P.C: was submitted on behalf of the accused on which application the Drug Court, on 305-1983, recorded an order of discharge.
However, an Acquittal Appeal was brought to this Court and, finding a prima facie case for prosecution, an order of remand was made on 11-5-1987. On evidence being recorded, the Drug Court convicted appellant Abdullah Shamim under section 27(1)(a)(b) of the Drugs Act, 1976, and sentenced him to suffer R.I for an year and also to pay fine of Rs,50,000 or in default thereof to suffer R.I. For a further period of 6 months. The appellant was also convicted under section 27(2)(b) of the said Act and awarded R.I. For 1 year. Such sentences were to run concurrently.
3. On appeal to this Court we have examined the evidence on record as well as the legal position applicable to the case. The prosecution evidence consists of the deposition of Altaf Hussain Hakro, Drug Inspector, whereas the accused examined himself. Court witnesses Allah Bachayo, Secretary, Provincial Quality Control Board and M. Yousuf, Proprietor Yousuf Brothers were also examined.
' In a nutshell, the prosecution case is that the accused is guilty of manufacturing and selling the preparation "Sun Gul Menthojelly" from which, on examination, Methyl Salicylate, allegedly a Drug, within the meanings of section 3(g)(i) of the Drugs Act, 1976, was isolated and in which total volatile ingredients were determined to be 10.49%. The case of the accused was and is that the product known as "Sun Gul Menthojelly" is a preparation falling within and covered by the Unani system of medicine and no offence was intended or committed. The determination of this case would depend, inter alia, on the interpretation of section 3(g)(i) and (v) of the Drugs Act, 1976. Such provisions, for the sake of convenience, are reproduced herein below:- "3.(g) "drug" includes--
(i) any substance or mixture of substances that is manufactured, sold, stored, offered for sale or represented for internal or external use in the treatment, mitigation, prevention or diagnosis of diseases, an abnormal physical state, or the symptoms thereof in human beings or animals, or the restoration, correction, or modification of organic functions in human beings or animals, not being a substance exclusively used or prepared for use in accordance with the Ayurveda, unani, hoinoeopathic or biochemical system of treatment except those substances and in accordance with such conditions as may be prescribed;
(ii) abortive and contraceptive substances, agents and devices, surgical ligatures, sutures, bandages, absorbent cotton, disinfectants, bacteriophages, adhesive plasters, capsules and antiseptic solutions;
(iii) such substances intended to be used for the destruction or repulsion of such vermin, insects, rodents and other organisms as cause, carry or transmit disease in human beings or animals or for disinfection in residential areas or in premises in which food is manufactured, prepared or kept or stored;
(iv) such pesticides as may cause health hazard to the public;
(v) any substance mentioned as monograph or as a preparation in the Pakistan Pharmacopoeia or the Pakistan National Formulary or the International Pharmacopoeia or the British Pharmacopoiea or the British Pharmaceutical Codex or the United States Pharmacopoeia or the National Formulary of the United States whether alone or in combination with any substance exclusively used in the unani, anyurvedic, homoeopathic or biochemic system of treatment, and intended to be used for any of the purposes mentioned in sub-clauses (i),(ii) and (iii); and
(vi) .''
4. An examination of the cited provisions in the Drugs Act would show that if "any substance or mixture of substances" is manufactured or sold etc. For treatment, prevention or diagnosis etc. Of diseases in human beings or animals but such substance is "exclusively used or prepared for use in accordance with the ayurvedic, unani, homoeopathic or biochemic system of treatment", subject to prescribed exceptions and conditions, the sale or manufacture etc. Thereof would not fall to be included in the concept of Drug as defined in section 3(g)(i) above.
' In elaboration, it is to be observed that any substance or mixture of substances would not constitute a Drug within the meanings of section (3)(g)(i) if it is exclusively used in accordance with the ayurvedic, unani, homoeopathic or biochemic system of treatment, its exclusive use in such systems guaranteeing to it due exclusion from the concept of Drug, as envisaged in the provision under reference. Another exclusion from the concept is postulated in relation to any substance or mixture of substances, if such is "prepared for use in accordance with" the above noted four systems of treatment. Here it falls to be noted that the disjunctive word "or" occurring between the phrases "exclusively used or prepared for use" appearing in section 3(g)(i) above, separates and isolates the adverb "exclusively" and if any substance or mixture of substances is merely "prepared" for use in accordance with the four referred systems of treatment then even if such substance or mixture of substances is also prepared in accordance with any other system, such substance or mixture so prepared would still not fall within the purview of the word "drug" defined in section 3(g)(i) above. This is for good and understandable reasons. Many a substance and preparation in the four excluded systems of medicine may have some common features with what is termed a Drug in the Act and unless these safeguards were provided, it would expose practitioners, manufacturers and laboratories connected with such systems to endless prosecutions and uproot these very systems which, clearly, could not have been the intention of the legislature. If, therefore, in a proceeding under the Drugs Act an accused person is able to show, either that the substance or mixture of substances alleged to be a Drug under such Act is to be "exclusively" used in the four referred systems of treatment, or that it has been "prepared for use in accordance with" the said systems, such substance or mixture of substances would not fall within the purview of the concept of "Drug" within the meanings of section 3(g)(i) of the Drugs Act.
5. Similarly, a substance, mentioned as monograph or as a preparation in the Pakistan Pharmacopoeia or the Pakistan National Formulary or the International Pharmacopoeia or the British Pharmacopoeia or the British Pharmaceutical Codex or the United States Pharmacopoeia or the National Formulary of the United States would constitute a Drug within the meanings of section 3(g)(v) only if such substance is mentioned as monograph or as a referred preparation, as such, "and is intended to be used for any of the purposes in sub-clauses (i), (ii) and (iii)" of section 3(g) in the Act. In such a case it is irrelevant whether such monograph or preparation, which is intended to be used for the purposes mentioned in section 3(g)(i)(ii) and (iii)", is so intended either alone or in conjunction with any substance exclusively used in the four systems of treatment in question. The intention, however, seems to be, as, inter alia, indicated in the British Phamacopoeia, 1973, and in the General Notes under the heading "Biological Assays and Tests", referred to by Mr. Fazle Ghani Khan, that only an active ingredient or preparation of such ingredients, duly isolated, or synthetic version thereof should, subject as above, by itself, constitute a Drug. Conversely, unless an active ingredient is isolated or synthetically prepared, which, as stated, itself qualifies to be a Drug, such would not fall within the purview of section 3(g)(v) ibid. ' We are fortified in the foregoing reasoning and for these views, since a Federal Government notification dated 17-11-1977 bearing No, SRO 1123(1)/77, under section 36 of the Drugs Act, 1976 purporting to be an exemption, also provides a parable. The same excludes, though in the view we take such exclusion is already there in the Act of 1976, from the purview of "Drug" as defined, "Medicinal plants or any part thereof including their fruits, seeds, exudates, gums and resins but excluding any of the pure active constituents isolated from such materials which in itself is a Drug."
6. The upshot of the above discussion is that firstly, if any substance or mixture of substances is exclusively used or prepared for use in accordance with the Ayurvedic, Unani, Homoeopathic or Biochemic system of treatment then (unless such substance is excepted in accordance with such conditions as may be prescribed) the same would not be included in the defamation of Drug as it occurs in section 3(g)(i) of the Drugs Act. Secondly, any isolated or synthesised substance mentioned as monograph or as a preparation appearing in the several publications referred to in section 3(g)(v) ibid. Would by itself constitute a Drug and fall within the fold of the said definition clause irrespective of the fact whether the same is used alone or in combination with any other substance exclusively used in any of the four excepted systems of medicine in question, in the latter case, if intended to be used for any of the purposes mentioned in sub-clauses (i), (ii) & (iii) of clause (g) of section 3 of the Drugs Act. In such category would fall such isolated or synthesized active constituents as are covered in the publications referred to in section 3(g)(v) of the Act.
7. Now the case of the appellant is that the alleged offending substance for which he was prosecuted is an ingredient of the bark of a plant known as "Khizrat-Shitta" commonly and generally used in the Unani system of medicine. Such plant is botanically known as "Gaultheria" or "Gultheria Fragrantissima" (see Indian Materia Medica and Hamdard's Pharmacographia Indica). In the West it is popularly known as "Indian Wintergreen". In the various works dealing with the Ayurvedic, Unani, Homoeopathic etc. Systems of medicine it finds mention that Volatile Oil is distilled from the leaves of such plant and the oil "contains Methyl Salicylate 99.00%". Tibbi Pharamcopoiea approved by the Board of Unani and Ayurvedic stystems of medicines established under Act II of 1965 also similarly deals with the matter. In other references it is stated that such oil is obtainable either from the bark of a particular plant or leaves of Gaultheria and this oil contains more than 90% natural Methyl Salicylate. Significantly, the following observation occurs in British Pharmacopoeia 1973 under the heading "Methyl Salicylate":-- "When oil of Wintergreen, Wintergreen, or Wintergreen Oil is prescribed or demanded, Methyl Salicylate shall be dispensed or supplied."
' It is clear from the foregoing discussion that very high percentage of Methyl Salicylate is to be found in the leaves of Gultheria and in the bark of a similar plant herb. It is also equally clear that Methyl Salicylate would be dispensed if Wintergreen or Oil of Wintergreen is prescribed or demanded.
8. Therefore, if a purportedly Unani preparation is found, prima facie, to contain, say, Methyl Salicylate and the defence plea is that such substance has not been used as an active constituent but purely as an extract from a plant or part of a plant mere presence of such ingredient in the preparation cannot establish the commission of an offence since, for that, something substantially more has to be shown. The report on which the conviction of the Drug Court is based (Ex.18) indicates that, inter alia, Methyl Salicylate was identified during the course of examination and that total volatile ingredients in the offending article were determined to be 10.49%. The various ingredients in such article could not, however, be quantitatively analysed. Question, therefore, already adverted to above, which arises is whether mere presence of Methyl Salicylate in a purported medical preparation under the Unani system of treatment would constitute preparing or dealing in a Drug as contemplated in the Drugs Act. The defence in the case is that such a substance, even though it may appear in one or more of the Pharmacopoieas referred to in section 3(g)(v), if the same is not isolated as an active constituent and is used merely as an extraction with other substances from a plant or part thereof such cannot be a Drug. The argument has substance for in the referred pharmacopoieas it is essentially, the isolated active ingredients or their specified preparations, which are covered and if such are not used after having been isolated or chemically formed but, on the contrary, are employed in the form of or as natural extracts from herbs/plants or parts thereof, it cannot be said that a substance exclusively used in or a preparation in accordance with the indigenous systems of treatment has not been utilized.
9. The only way in which a case against the appellant could have been built was on the basis of a thorough qualitative and quantitative analysis of the ingredients in the allegedly offending preparation. If on such analysis, it was shown that besides Methyl Salicylate, which may be found to the extent of 99% in Wintergreen, the residue or remainder 1%, an essential in an extraction from the herbs/plants, was not there in the preparation, it could be established and proved that the active ingredient/constituent Methyl Salicylate itself had been used, which formed part of the protected pharamcopoieas and, thus, the corresponding offence was committed. This, admittedly, was not done and the Analyst's report does not determine the ingredients in the offending preparation quantitatively or, if we may say so, perhaps even fully.
10. On the facts of this case, therefore, it cannot be found that the appellant did not use merely a herbal extract in its natural form for the purposes of his preparation. Penal liability, as has been visited on the appellant, cannot be sustained unless the offence alleged against him had been proved beyond all reasonable doubt. This by no means can be said on the evidence on record.
Since the conviction calls to be set aside on merits, we refrain to express any opinion on the ancillary contention of Mr. Fazle Ghani Khan, for the appellant, that the prosecution was bad as the complainant Drug Inspector was, allegedly, not duly appointed and notified to launch the same.
For the foregoing reasons, we had through a short order, allowed this appeal and such reasons we have recorded now. Bail bonds in the case stand cancelled.