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CHAPTER III
Prohibitions

23. Import, manufacture and sale of drug: (1) No person shall himself or by any other person on his behalf--
(a) export, import or manufacture for sale or sell ·
(i) any spurious drug;
(ii) any counterfeit drug;
(iii) any misbranded drug;
(iv) any adulterated drug;
(v) any substandard drug;
(vi) any drug after its expiry date;
(vii) any drug which is not registered or is not in
accordance with the conditions of registration;
(viii) any drug which, by means of any statement, design or device accompanying it or by any other means, purports or claims to cure or mitigate .any such disease or ailment, or to have any such other effect, as may be prescribed;
(ix) any drug if it is dangerous to health when used in the dosage or with the frequency, or, for the duration specified, recommended or suggested in the labelling thereof; or
(x) any drug in contravention of any of the provisions of this Act or any rule;

(b) manufacture for sale any drug except under, and in accordance with the conditions of, a licence issued under this Act;

(c) sell any drug except under, and in accordance with the conditions of, a licence issued under this Act;

(d) import or export any drug the import or export of which is prohibited by or under this Act;

(e) import or export any drug for the import or export of which a licence is required, except under, and in accordance with the conditions of, such licence;

(f) supply an incorrect, incomplete or misleading information, when required to furnish any information under this Act or the rules;

(g) peddle, hawk or offer for sale any drug in a park or public street or on a highway, footpath or public transport or conveyance;

(h) import, manufacture for sale, or sell any substance, or mixture of substances, which is not a drug but is presented in a form or a manner which is intended or likely to cause the public to believe it to be a drug;

(i) sell any drug without having a warranty in the prescribed form bearing the name and batch number of the drug issued,--

(i) in the case of a drug manufactured in Pakistan, by the manufacturer holding a valid licence to manufacture drugs and permission to manufacture that drug or by his authorised agent;

(ii) in the case of an imported drug, by the manufacturer or importer of that drug or, if the drug is imported through an indentor by such indentor; and

(j) apply an incorrect batch number to a drug.

(2) Nothing in sub-section (1) shall apply to the manufacture or subject to prescribed conditions, of small quantities or any drug for the purpose of clinical trial examination, test, analysis or personal use.

Scope: Where drugs are stocked in a shop the presumption is that they have been stocked for sale. Distributing includes dispensing and the Mens rea is not necessary for conviction of the accused. It is not necessary that the accused should have known that it was an offence to stock drugs for sale without licence. P L D 1957 Kar. 671.

The charge against the accused was under section 18(b) of the Drugs Act and therefore an essential ingredient of the evidence was that the drugs sold by the accused were drugs which has been manufactured by an unlicensed manufacturer. And it was in order to prove this ingredient of the offence that the Inspector of P.W. had produced the letter of the Health Department, that the alleged manufacturers did not have any licence to manufacture drugs. But the burden was on the prosecution to prove that the manufacturers did not have any licence under the Drugs Act and as the accused had taken objection to the production of this letter the prosecution should have prove it in the manner prescribed under Section 67 of the Evidence Act. This it did not care to do. It was contended that the letter had not been proved : Held : This submission was supported by the unanimous view of the Supreme Court in the case of Muhammad Khattak v. S.M. Ayub, 1974 P Or, L J Note 81. Additionally there was also no provision in the Drugs Act which could relieve the prosecution of its obligation to prove this letter under section 67 of the Evidence Act, held the letter had not been proved.

The substandard drug for the manufacture of which the respondent herein was sought to be prosecuted was actually manufactured by Laboratories which being a private Limited Company, incorporated under the Companies Act, 1913, would be a 'person' in its own right within the meaning of that expression as appearing in section 18, section 19(3) and section 27, Drug Act, 1940. By the plain language of the said three sections, therefore, prima facie Messrs. Laboratories seemed to have brought itself within the mischief of the law. Therefore if the prosecution had proceeded against the said Company, in view of the bar contained in section 19, it would not be open to it to plead in defence that it was ignorant of the nature, substance or quality of the said substandard drug or of the circumstances in which it was manufactured. In point of fact under section 19(3), its liability would seem to be total. And consequently upon its conviction it could under section 27 be awarded the punishment of fine. The difficulty in the way of the appellants, however, is that no proceedings were drawn up against the said Company. Nor indeed the Company was made a co-accused in the challan submitted against the respondent, herein in the criminal Court. In so far as the liability of the respondent is concerned, it would not only arise if he can be shown to have manufactured the said substandard drugs for and on behalf of Messrs. Nawabsons Laboratories Limited, as in the nature of things the said Company had to act through a living person. It was true that at the relevant time respondent was the Managing Director of the said Company. But then in the challan submitted against him in the trial Court no allegation was made that it was he who had manufactured the said drug on behalf of the said company. Furthermore, it is common knowledge that in the hierarchy of a Limited Company, the Managing Director was assisted by other directors as well as executives, officers and workers. There was no reason to believe that in the case of Laboratories the system was any different. Therefore, it would be difficult .to presume that the respondent was guilty of the manufacture of the said substandard drug for and on behalf of the Company, just because he happened to be its Managing Director. P L D 1978 S C 193; N L R 1978 S C 768; P L J 1978 S C 283.

Omission by the prosecution to bring on record expert's opinion in proof of the allegation that drug allegedly recovered from accused's premises was spurious and such omission entitles the accused to a clean acquittal even at the preliminary stage. Drug Court accepted accused's application under section 249-A, Cr.P.C. on additional grounds that complaint was incompetently lodged and recovery was in contravention of section 103, Cr.P.C. N L R 1985 Or. L J 266.

Prosecution on the basis of complaint of 'the Drug Inspector who is not duly notified under Section 17, cannot be sustained in a case where recovery was not witnessed according to section 103, Cr.P.C. The Drug Court accepted accused's application and ordered their acquittal. N L R 1985 U C 386 (2),

Where a dealer in medicines purchased drugs from a manufacturer and obtained a warranty that there had been no contravention of this section from the manufacturer and sent a copy of warranty with written notice to Inspector of Drugs and warrantor within 7 days of the service of .summons upon him, it was held that in such circumstances the dealer could not be held guilty. 1973 P Cr. L J 218.

The word "building" in Schedule B, para. 2 of the Drugs (Licensing, Registering and Advertising) Rules is synonymous with the word "premises". The word "premises" as used in various rules and the Schedule does not mean a detached or separate building or structure. Mere use of a portion of premises or building for residential purposes does not render it unsuitable for a licensed premises and manufacturing place is only required to be separate from the residential place. P L D 1978 Lah. 445.

Where the applicant committed a breach of the provisions of this section and also of rule, a charge can be framed even if the complaint does not expressly state the provision of law which has been contravened. 1955 All. W.R. (HC) 328.

For committing an offence under this section, intention to do the guilty act which is made penal by the statute is not required. The Act creates an absolute liability and rules out mens rea as a constituent part of the crime. It would only affect the question of punishment. 1958-2 Mad. L Jour. 308.

The complaint against the accused for manufacturing for sale substandard Ampicillin Dry Syrup containing 89% Ampicillin against U.S.P. limits of 90% to 120% and thus violating provisions of the Drugs Act. The accused, however, explaining carton of drug containing instructions for its keeping in a cool and dark place and as per WHO pamphlet loss of activity of international standard if drug stored at temperature less than 20oC and such requirements having not been fulfilled, there appeared a slight discrepancy in quantum of active agent. Ampicillin according to B.P. to be in a well closed container at a temperature not exceeding 25oC but climatic conditions in Pakistan ranging from 30oC to 40oC. Drug after the purchase remaining in normal temperature and possibility of deficiency in contents as required by B.P. existing. The accused was given the benefit of doubt and acquitted, in circumstances. 1979 P Cr. L J 872.

Offences falling under section 23 of the Drugs Act, being punishable up to 10 years, the prohibition under section 497, Cr.P.C., was attracted, the offences related to clandestine sale of stolen Government medicines as well as their genuineness, hence bail is declined. 1981 P Cr. L J 243.

Instructions against provisions of Section 23 could not be relied upon. Petitioner has referred to Section 23 of the Drugs Act, 1976 which provide that any drug of which the expiry period had not expired could be imported. In view of the provision of Section 23 of the Drugs Act, respondent No. 1, could not decline permission to the petitioner company to clear any drug of which the period of expiry had not been completed as was the present case, therefore, the reliance on the instructions as against the express provisions of Section 23 of the Act, could not have been made. 1994 C L C 2270.

Self-contradictory order: Acquittal of the accused under section 265-K, Cr.P.C. with observation tantamounting to punish him while the order is impugned. Petitioner was acquitted and convicted by one and the same order being self-contradictory, petition was converted into appeal and impugned observations were expunged. 1987 S C M R 2100.

Quashment of F.I.R. : Registration of the F.I.R. in respect of the offence was not a case classified by the Provincial Quality Control Board. nor the Provincial Inspector had submitted a report to the said Board Provincial Inspector had also not obtained instructions from the Provincial Quality Control Board regarding the registration of the F.I.R. and on his own had got the same registered which act being without lawful authority was declared to be of no legal effect. Constitutional petition was accepted accordingly. 1994 P Cr. L J 1065.

Quashment of proceedings : Only allegation against the manufacturer being that sample pack of drug contained 15 mi. of drug and that under R. 32 contents should have been less than 15 mi. No allegation made to the effect that manufacturer sold physician's sample to any one in contravention of the provisions of the Act or Rules. Nowhere in the complaint it was urged that quantity impact was unreasonable or that unreasonably large quantity of sample was supplied to any physician or institution. No fresh case could be permitted to be argued against the manufacturer in that behalf. Complaint being based on erroneous view of law no case, held, was made out against the manufacturer for violation of R. 32 which could entail any punishment under section 27(4) or 23(1)(x), Drug Act, 1976, therefore, the proceedings were quashed. P L D 1985 Lah. 503.

The accused was proceeded against for manufacturing spurious drugs. Drug Inspector could not identify accused who was admittedly not present at the premises in question when raid was conducted. Two persons, apprehended on the spot exonerated accused and denied having any acquaintance with him or having ever seen him in the premises. Disputed premises was neither owned by the accused nor occupied by him. Lease agreement showed that premises was rented out to someone else by the owner and the proceedings were quashed in such circumstances. 1991 P Cr. L J 2329.

Constitutional petition concerned only with import of drugs and their clearance. Applicant shareholder, desirous to become a party to Constitutional petition in view of disputes inter se between shareholders of the company. Applicant's locus standi to be impleaded as a party in Constitutional petition. Clearance of drugs being for the benefit of the company of which applicants were shareholders, they were, therefore, neither necessary nor proper party in such proceedings. As for applicant's dispute with other shareholders of the company regarding the affairs of the company, they could seek remedy in accordance with law. 1994 C L C 2270(b).

Substandard drugs: Record not showing that after purchasing drugs from manufacturer whether same were stored under the conditions laid down or stated on carton. Reasonable possibility of sample obtained by the Drug Inspector and subsequently sent to the National Health Laboratory having been deteriorated due to its improper storage after the purchase from manufacturers not ruled out. Accused entitled to the benefit of doubt and the conviction and sentence were set aside. 1985 P Or. L J 281; 1985 P Cr. L J 281.

According to the case of Fazal Elahi v. The State, 1985 P Cr. L J 268, no prosecution launched against the company which manufactured drugs in question. Accused not shown to be acting as agent of the company for distribution of substandard drugs. In absence of the company, accused held, could not be prosecuted. The liability of manufacturer of the drugs and his agent for distribution thereof would be co-extensive.

Appreciation of Evidence. Evidence on record did not show that the accused was found selling the drugs recovered from his possession while keeping them in his shop without a licence. Drugs recovered could be available almost in every house for daily consumption. Defence version was believable and the possibility of false implication of accused could not be ruled out. Accused was acquitted in circumstances. 1994 P Cr. L J 2468.

Appeal against acquittal: Explanation given by the accused for not complying with a direction of the Secretary, Registration Board, to mention "Oleoresin of Ginger" as an ingredient on the label was convincing. Nothing manifestly wrong or perverse was, therefore, found in the conclusion arrived at by the trial Court, the appeal against the acquittal of the accused was consequently dismissed. P L D 1992 Kar. 347 (d).

24. Control of advertisement: No person shall himself or by any other person on his behalf advertise, except in accordance with such conditions as may be prescribed,--

(i) any drug;

(ii) any substance used or prepared for use in accordance with the ayurvedic, unani, homoeopathic or biochemic system of treatment or any other substance or mixture of substances as may be prescribed;

(iii) any remedy, treatment or offer of a treatment for any disease.

Explanation: In this section, "advertise" means to make any representation by any means whatsoever for the purpose of promoting directly or indirectly the sale or disposal of a drug, a substance or a mixture of substances, a remedy or a 'treatment except the display of sign boards for a clinic, a dispensary or a hospital or such other institution offering treatment.

Presumption of fact : No evidence having been produced by prosecution to prove factum of publication of advertisement in newspaper and souvenir by the accused. Accused having disputed the same. Mere fact that advertisement might have benefited the accused, held, would not justify raising of presumption against the accused under section 114 (f) of the Evidence Act (I of 1872), the appeal Appeal was, therefore, allowed, conviction and sentence were set aside. 1986 P Cr. L J 486.

Handbill displaying picture of healthy seminude male and female with writing "it is well-known about Knight Pills that husband who takes Knight Pills never gets old and knight Pills keeps the potency of a male ready for action". Ingredients of Knight Pills was totally missing from handbill. Language used in the handbill was calculated to induce persons interested in combating sexual weakness to buy pills mentioned in the handbill, thereby promoted sale of pills and as such handbill would fall within the definition of "advertisement". 1984 P Cr. L J 2895.

Burden of proof: Prosecution not producing any witness to prove the fact that the accused caused publication of advertisement in newspaper and pamphlet. Accused disputing publication of such advertisement to have been caused by him. Burden of proof, would lie squarely on prosecution. 1986 P Cr. L J 486.

25. Control of samplings: No person shall distribute or cause to be distributed any drug as a sample except in accordance with such conditions as may be prescribed.

26. Control of printing of labelling: No person shall print any labelling in respect of any drug which is required to be registered under this Act but is not so registered after the date fixed by the Federal Government under sub-section (6) of section 7 or for a person who does not possess a licence under this Act to manufacture that drug.

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