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(6) The cost of a test or analysis made by the Federal Drug Laboratory or other laboratory under sub-section (5) shall be paid by the complainant or accused as the Drug Court or the Board concerned shall direct.

COMMENTS

Interpretation of section-Presumption: A manufacturer of drugs was prosecuted for offence under Section 27 o the Drugs Act, 1940 after a report had been received from the Government Analyst that the drug was not of standard quality. No copy of the report was supplied, as required under Section 25 (3) of the Act, to manufacturer. It was, therefore, contended that the manufacturer in the circumstances, could not be prosecuted for offence under Section 27 of the Act. It was held that the effect of the second part of sub-section (3) of Section 25 of the Drugs Act, 1940, is only this that the report of the Government Analyst cannot be treated as conclusive evidence against the person, from whom the sample was taken, where no copy of the report was supplied to him. But under the first part of the sub-section there is presumption that the facts stated in the report are correct. This presumption, unless rebutted by contrary evidence, can be a sufficient basis for the conviction of the accused.

Mere non-compliance with section does not make report inadmissible: Sub-section (2) of Section 25 of the Drugs Act, 1940 requires that a copy of the report of the Government Analysts shall be delivered to the person from whom the sample is taken and another copy to the warrantor, if any, named under the proviso to sub-section (3) of Sec. 19. Then comes sub-section (3) which makes the report evidence of the facts stated therein and furthermore makes it conclusive "unless the person from whom the sample was taken or the said warrantor has, within twenty-eight days of the receipt of a copy of the report, notified in writing the Inspector or the Court, before which any proceedings in respect of the sample are pending that he intends to adduce evidence in contraversion of the report." It will thus be seen that the contents of the report not only prove themselves but are also considered to be conclusive unless objection is made. Sub-section (3) of Section 25 provides the consequence of non-compliance with the provisions of sub-section (2) of the said section. Thus, if no report is supplied all that happens is that the contents of the report do not become conclusive evidence; but they are nevertheless evidence and rebuttable at the stage of the trial. This does not mean that at the trial the contents of the report cannot be utilised as evidence. The intention of the legislature appears to be to merely give an adequate opportunity to the person charged to challenge the correctness of the report. If this has not been done, then the contents of the report become conclusive evidence. If any event, the provisions are clear and leave no room for doubt that if the copy of the report is not supplied to the accused, the report is, nevertheless, admissible in evidence and proves itself but its contents are not conclusive evidence. On the other hand, if a copy has been supplied and the appellant does not raise any objection within the time prescribed then the report becomes conclusive evidence and cannot even be rebutted.

Report of Public Analyst did not complete with "full protocols of tests" and silent as to how he arrived at conclusion regarding low percentage of tetracycline hydrochloride in sample. Order of trial Court rejecting application for summoning Public Analyst as witness was set aside, in circumstances. Court further directed to summon witness to produce full Protocols of tests, in the interest of justice.

Accused failed to challenge the Government Analyst’s report within statutory period of 30 days by notifying to any of authorities specified in sub-section (4) of Section 22 of the Act, regarding their such intention. Report was conclusive proof of its contents. Contention that report being silent about full protocols was of no consequence.

Potency and state of certain drugs, was depended to some extent upon conditions in which they were required to be stored and had actually been stored prior to test by the concerned laboratory.

23. Import, manufacture and sale of drugs.-(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 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 import, subject to prescribed conditions, of small quantities of any drug for the purpose of clinical trial, examination, test, analysis or personal use;

COMMENTS

Where drugs are stocked in a shop the presumption is that they have been stocked for sale. Distributing includes dispensing.

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.

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 sub-mission was supported by the unanimous view of the Supreme Court in Muhammad Khattak v. S.M. Ayub. 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: therefore that the letter had not been proved.

The substandard drug or 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, prime facie Messrs. Laboratories seemed to have brought itself within the mischief of the law. Therefore if the prosecution had proceeds 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 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.

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.

The word "building" in Schedule B, para 2 of 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 licenced premises and manufacturing place is only required to be separate from the residential place.

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.

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.

Where the standard tests applied by the Government analyst showed that the medicinal preparation (liquid paraffin involved in the case) had not conformed to the B.P. specifications of carbonisable substances and sulphur compound, a sale of the same is an offence under the Act.

Mere stocking of goods of sub-standard quality unless it is for the purpose of sale, does not amount to an offence within the meaning of this section. The prosecution must prove either by direct or circumstantial evidence that the goods were stocked or exhibited for sale. (Where under a contract for supply of goods to the Government, there is a condition precedent that a sample would be tested the stocking of goods of sub-standard quality cannot come within the purview of this section).

Where a particular medicine is kept in the shop there will be a presumption that it is there for the purpose of sale unless that presumption is rebutted by the accused.

The complaint against 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 20^oC 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 25^oC but climatic conditions in Pakistan ranging from 30^oC to 40^oC. Drug after purchase remaining in normal temperature and possibility of deficiency in contents as required by B.P. existing. The accused was given benefit of doubt and acquitted, in circumstances.

Offences falling under Section 23 of the Drugs Act. being punishable up to 10 years prohibition under Section 497, Cr. P.C. was attracted. Offences related to clandestine sale of stolen Government medicines as well as their genuineness. Bail was declined, in circumstances..

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