Updated: Sunday November 29, 2009/AlAhad Thoul Hijjah 12, 1430/Ravivara Agrahayana 08, 1931, at 07:53:15 PM

The Drugs’ Act, 1940

 

Act No. XXIII of 1940

 

(For Statement of Objects and Reasons, see Gazette of India, 1940, Pt. V, p. 34; for Report of Select Committee, see ibid., p. 143.

 

This Act has been applied to,---

 

(i) Baluchistan, see Notification No. 168N, dated the 17th October, 1940, Gazette of India, 1940, Pt. I, p. 1478; and

 

(ii) Phulera in the Excluded Area of Upper Tanawal to the extent the Act is applicable in the N.W.F.P., and extended to the Excluded Area of Upper Tanawal (N.W.F.P.) other than Phulera with effect from such date and subject to such modifications as may be notified, see N.W.F.P. (Upper Tanawal) (Excluded Area) Laws Regulation, 1950.

 

It has been extended to,---

 

(i) the Leased Areas of Baluchistan by the Leased Areas (Laws) Order, 1950 (G. G. O. 3 of 1950);

 

(ii) the Baluchistan States Union by the Baluchistan States Union (Federal Laws) (Extension) Order, 1953 (G. G. O. 4 of 1953), as amended;

 

(iii) the State of Bahawalpur by the Bahawalpur (Extension of Federal Laws) Order, 1953 (G. G. O. 11 of 1953), as amended; and

 

(iv) the whole of West Pakistan by West Pakistan Act 14 of 1958 (with effect from the 26th December, 1957).

 

The Act has been and shall be deemed to have been brought into force in Gwadur with effect from the 8th September, 1958, by the Gwadur (Application of Central Laws) Ordinance, 1960 (37 of 1960), s. 2.)

 

[10th April, 1940]

 

An Act to regulate the import, export, manufacture, distribution and sale of drugs

 

(Ins. by the Drugs (Arndt.) Act, 1963 (22 of 1963), ss. 2 and 3.)

 

WHEREAS it is expedient to regulate the import into, (Ins. by the Drugs (Arndt.) Act, 1963 (22 of 1963), ss. 2 and 3.)[export from,] and the manufacture, distribution and sale in, (Subs. by the Central Laws (Statute Reform) Ordinance, 1960 (21 of 1960), s. 3 and 2nd Sch. (with effect from the 14th October, 1955), for "the Provinces and the Capital of the Federation" which had been subs. by A. O., 1949. for "British India".) [Pakistan] of drugs;

 

AND WHEREAS the Legislatures of all the Provinces have passed resolutions in terms of section 103 of the Government of India Act, 1935, in relation to such of the abovementioned matters and matters ancillary thereto as are enumerated in List II of the Seventh Schedule to the said Act, 26 Geo. 5, c. 2;

 

It is hereby enacted as follows:-

 

CHAPTER I

 

INTRODUCTORY

 

1. Short title, extent and commencement. (1) This Act may be called the Drugs’ Act, 1940.

 

(Subs. by the Central Laws (Statute Reform) Ordinance, 1960 (21 of 1960), s. 3 and 2nd Sch. (with effect from the 14th October, 1955), for the original subsection (2), as amended by A. O., 1949.)[(2) It extends to the whole of Pakistan.]

 

(3) It shall come into force at once; but effect only from such date(The 1st April 1947, as the date from which Chapter III shall take effect, see Gazette of India, 1946, Pt. I, p. 1349.) as the Central notification in the official Gazette, appoint in this Chapter IV shall take effect in a particular Province such date as the Provincial Government may, by like appoint(The 1st September, 1954, as the date on which Chapter IV shall take in Baluchistan, see Gaz. of P., 1954, Pt. 1, p. 215.) in this behalf.

 

COMMENTS

 

----Ss.3, 4 & 5---Anti-Narcotics Task Force Ordinance (XLI of 1991), S.6--Drugs Act (XXXI of 1976), S. 1---Overriding effect of Protection of Economic Reforms Act, 1992---Effect---Before enforcement of Protection of Economic Reforms Act, 1992, Drugs Act, 1976 and Anti-Narcotics Task Force Ordinance, 1991, were already enforced, therefore, such laws could not be taken away out of hitting scope of S. 3, Protection of Economic Reforms Act, 1992.[1]

 

2. Application of other laws not barred. The provisions of this Act shall be in addition to, and not in derogation of, the Dangerous Drugs Act, 1930, and any law for the time being in force, II of 1930.

 

3. Definitions. In this Act, unless there is anything repugnant in the subject or context,

 

(a) "the Board" means the Drugs Technical Advisory Board constituted under section 5 ;

 

(Subs. by the Drugs (Amdt.) Act, 1963 (22 of 1963), s. 4, for the original cl. (b).) [(b) “drug" includes,---

 

(i) all medicines for internal or external use of human beings or animals, and all substances intended to be used for or in the treatment, mitigation or prevention of diseases in human beings or animals, not being medicines and substances exclusively used or prepared for use in accordance with the ayurvedic, unani, homoeopathic or biochemic system of medicine,

 

(ii) diagnostic, abortive and contraceptive substances, surgical ligatures, sutures, bandages, absorbent cotton, bacteriophages, adhesive plaster, gelatine capsules and antiseptic solutions,

 

(iii) such substances (other than food) intended to affect the structure or any function of the human body or intended to be used for the destruction of vermins or insects which cause disease in human beings or animals,

 

(iv) any substance, mentioned as monograph in any of the editions of the British Pharmacopoeia or the British Pharmaceutical Codex or the United States Pharmacopoeia or the National Formulary of the United States or the International Pharmacopoeia, whether alone or in combination with any substance exclusively used in the unani, ayurvedic, homoeopathic or biochemic system of medicine and intended to be used for any of the purposes mentioned in subclauses (i), (ii) and (iii), and

 

(v) any other substance which the Central Government may, by notification in the official Gazette, declare to be a "drug" for the purposes of this Act ;]

 

(Cls. (ba), (bb) and (bc), ins. by the Drugs (Amdt.) Act, 1963 (22 of 1963), s. 4.)[(ba) "to export" means to take out of Pakistan by sea, land or air;

 

(bb) "licensing authority" means such authority as may be prescribed;

 

(bc) 'manufacture,' in relation to any drug includes any process or part or stage of process for making, altering, ornamenting, finishing, packing, labelling, breaking up or otherwise treating or adopting any drug with a view to its sale and distribution, but does not include the compounding and dispensing or the packing of any drug in the ordinary course of retail business or on a prescription of a registered medical practitioner or dentist or of a veterinarian, and to manufacture' shall be construed accordingly ;]

 

(c) "to import", with its grammatical variations and cognate expressions, means to bring into (Subs. by the Central Laws (Statute Reform) Ordinance, 1960 (21 of 1960), s. 3 and 2nd Sch. (with effect from the 14th October, 1955), for "the Provinces and the Capital of the Federation" which bad been subs. by A. O., 1949, for ''British India".) [Pakistan];

 

(d) "patent or proprietary medicine" means a drug which is a remedy or prescription prepared for internal or external use of human beings or animals, and which is not for the time being recognised by the Permanent Commission on Biological Standardisation of the (Subs. by Act 22 of 1963, s. 4, for "League of Nations".) [World Health Organisation] or in the latest edition of the British Pharmacopoeia or the British Pharmaceutical Codex or any other pharmacopoeia authorised in this behalf by the Central Government after consultation with the Board:

 

(e) "prescribed" means prescribed by rules made under Chapter II or Chapter III (Ins. by the Drugs (Amdt.) Act, 1963 (22 of 1963), s. 4.)[or Chapter IIIA] by the Central Government, or under Chapter IV by the Provincial Government.

 

COMMENTS

 

Drugs Act 1940 S. 3---Customs Act (IV of 1969), First Sched.---Central Excise Rules, 1944, R. 10---Constitution of Pakistan (1973), Art. 199---"Strepsils" manufactured by petitioners was a medicament and being a drug was exempted from sales tax-.-Strepsils lozenges was in fact a medicinal preparation within the meaning of Drugs Act, 1976 and that being so, it could not be termed as sugar confectionary and as such could not be charged for purposes of sales tax--Ministry of Health had uniformly pointed out that strepsils lozenges were used as a remedy for treatment of infections of the mouth and throat and a valuable adjunct to the systematic treatment of tonsils and other deep throat infections---Levy of sales tax on such product would not be justified---Circulars issued for imposition of sales tax were declared to be without lawful authority, of no legal effect and were quashed.[2]

 

Drugs Act 1940 ----S.3(g)(i)---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 definition of "Drug ".occurring in section 3(g)(i) of the Drugs Act.[3]

 

4. Presumption as to poisonous substances. Any substance specified as poisonous by rule made under Chapter III or Chapter IV shall be deemed to be a poisonous substance for the purposes of Chapter III or Chapter IV, as the case may be.

 

5. The Drugs Technical Advisory Board. (1) The Central Government shall, as soon as may be, constitute a Board (to be called the Drugs Technical Advisory Board) to advise the Central Government (The words "and the Provincial Governments" omitted by A. O., 1964, Art. 2 and Sch.)* * * on technical matters arising out of the administration of this Act and to carry out the other functions assigned to it by this Act.

 

(Subs. by Act, (22 of 1963), s. 5, for the original subsection (2), as amended by A. O., 1949 and the Federal Laws (Revision and Declaration) Act. 1951 (26 of 1951), s. 4 and 3rd Sch.) [(2) The Board shall consist of the following members, namely:

 

(i) The Director General, Health, exofficio, who shall be Chairman;

 

(ii) The Director of the Central Government Bureau of Laboratories, Pakistan, ex-officio;

 

(iii) The Director, Central Drugs Laboratory, ex-officio;

 

(iv) The Head of the Pakistan Animal Husbandry Research Institute, ex-officio;

 

(v) One person directly connected with the administration of this Act to be nominated by the Central Government;

 

(vi) Two persons directly connected with the administration of this Act, one to be nominated by each Provincial Government;

 

(vii) Two persons holding the appointment of Government Analyst under this Act, one to be nominated by each Provincial Government;

 

(viii) One person to be nominated by the Central Government from amongst the professors of medicine serving in the medical colleges affiliated to universities in Pakistan;

 

(ix) One person to be nominated by the Central Government from amongst the pharmaceutical chemists recommended by the universities in Pakistan;

 

(x) One person to be elected by the Medical Council of Pakistan from amongst the professors of medicine serving in the medical colleges affiliated to universities in Pakistan;

 

(xi) One person belonging to pharmaceutical profession to be nominated by the Central Government; and

 

(xii) One person to be elected by the Central Council of the Pakistan Medical Association:

 

Provided that the members shall be so elected or nominated as to secure, as far as practicable, equality in the number of members belonging to each Province.

 

(2a) The meetings of the Board shall be held alternatively in East Pakistan and West Pakistan.]

 

(3) The nominated and elected members of the Board shall hold office for three years, but shall be eligible for renomination and reelection.

 

(4) The Board may, subject to the previous approval of the Central Government, make (For the Drugs Technical Advisory Board ByLaws, 1963, see Gaz, of P., 1963, Pt. 1, pp. 469471.) by-laws fixing a quorum and regulating its own procedure and the conduct of all business to be transacted by it.

 

(5) The Board may constitute sub-committees and may appoint to such sub-committees for such periods, not exceeding three years, as it may decide, or temporarily for the consideration of particular matters, persons who are not members of the Board.

 

(6) The functions of the Board may be exercised notwithstanding any vacancy therein.

 

(7) The Central Government shall appoint a person to be Secretary of the Board and shall provide the Board with such clerical and other staff as the Central Government considers necessary.

 

6. The Central Drugs Laboratory. (1) The Central Government shall, as soon as may be, establish a Central Drugs Laboratory under the control of a Director to be appointed by the Central Government, to carry out the functions entrusted to it by this Act or any rules made under this Chapter:---

 

Provided that, if the Central Government so prescribes, the functions of the Central Drugs Laboratory in respect of any drug or class of drugs shall be carried out at (Subs. by A. O., 1949, for "the Central Research Institute, Kasauli, or at any other".) [any (The word "prescribed" omitted by the Federal Laws (Revision and Declaration) Act, 1951 (26 of 1951), s. 3 and 2nd Sch.)*] prescribed Laboratory and the functions of the Director of the Central Drugs Laboratory in respect of such drug or class of drugs shall be exercised by the Director of that (The words "institute or of that other" omitted by A. O., 1949.)* * * Laboratory, (The words "as the case may be" rep. by Act (26 of 1951, s. 3 and 2nd Sch.)***

 

(2) The Central Government may, after consultation with the Board, make rules prescribing‑‑

 

(a) the functions of the Central Drugs Laboratory;

 

(Cls. (b) and (c) omitted by the Drugs (Amdt.) Act, 1963 (22 of 1963), section 6.)*     *          *            *          *          *

 

(d) the procedure for the submission to the said Laboratory under Chapter IV of samples of drugs for analysis or test, the forms of the Laboratory's reports thereon and the fees payable in respect of such reports;

 

(e) such other matters as may be necessary or expedient to enable the said Laboratory to carry out its functions;

 

(f) the matters necessary to be prescribed for the purposes of the proviso to sub-section (1).

 

7. The Drugs Consultative Committee. (1) The Central Government may constitute an advisory committee to be called "the Drugs Consultative Committee" to advise the Central Government, (The words "the Provincial Governments" omitted by A. O., 1964, Art. 2 and Sch.)* * * and the Drugs Technical Advisory Board on any matter tending to secure uniformity throughout (Subs. by the Central Laws (Statute Reform) Ordinance, 1960 (21 of 1960), s. 3 and 2nd Sch., for "the Provinces" (with effect from the 14th October, 1955).) [Pakistan] in the administration of this Act.

 

(2) The Drugs Consultative Committee shall consist of two representatives of the Central Government to be nominated by that Government and one representative of each Provincial Government to be nominated by the Provincial Government concerned.

 

(3) The Drugs Consultative Committee shall meet when required to do so by the Central Government and shall have power to regulate its own procedure.

 

8. Standards of quality. (1) For the purposes of this Chapter the expression "standard quality" when applied to a drug means that the drug complies with the standard set out in the Schedule.

 

(2) The Central Government, after consultation with the Board and after giving by notification in the official Gazette not less than three months' notice of its intention so to do, may by a like notification add to or otherwise amend the Schedule for the purposes of this Chapter, and thereupon the Schedule shall be deemed to be amended accordingly.

 

9. Misbranded drugs. For the purposes of this Chapter a drug shall be deemed to be misbranded,---

 

(a) if it is an imitation of, or substitute for, or resembles in a manner likely to deceive, another drug, or bears upon it or upon its label or container the name of another drug, unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other drug; or

 

(b) if it purports to be the product of a place or country of which it is not truly a product; or

 

(c) if it is imported under a name which belongs to another drug; or

 

(d) if it is so coloured, coated, powdered or polished that damage is concealed, or if it is made to appear of better or greater therapeutic value than it really is; or

 

(e) if it is not labelled in the prescribed manner; or

 

(f) if its label or container or anything accompanying the drug bears any statement, design or device which makes any false claim for the drug or which is false or misleading in any particular; or

 

(g) if the label or container bears the name of an individual or company purporting to be the manufacturer or producer of the drug, which individual or company is fictitious or does not exist.

 

10. Prohibition of import of certain drugs. From such date (The 1st April, 1947, for cls. (a), (b), (c), (e) and (f), see Gazette of India, 1947, Pt. 1, p. 189; the 1st July, 1950, for clause (d), see Gaz. of P., 1950, Pt. I, p. 25.) as may be fixed by the Central Government by notification in the official Gazette in this behalf, no person shall import

 

(a) any drug which is not of standard quality;

 

(b) any misbranded drug;

 

(c) any drug for the import of which a licence is prescribed, otherwise than under, and in accordance with, such licence;

 

(d) any patent or proprietary medicine, unless there is displayed in the prescribed manner on the label or container thereof either the true formula or list of ingredients contained in it in a manner readily intelligible to members of the medical profession, (Certain words omitted by the Drugs (Amdt.) Act, 1963 (22 of 1963), section 7.)* * *

 

(e) 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;

 

(f) any drug the import of which is prohibited by rule made under this Chapter:

 

Provided that nothing in this section shall apply to the import, subject to prescribed conditions, of small quantities of any drug for the purpose of examination, test or analysis or for personal use:

 

Provided further that the Central Government may, after consultation with the Board, by notification in the official Gazette, permit, subject to any conditions specified in the notification, the import of any drug or class of drugs not being of standard quality.

 

Explanation. The formula or list of ingredients mentioned in clause (d) shall be deemed to be true and a sufficient compliance with that subclause if, without disclosing a full and detailed recipe of the ingredients, it indicates correctly all potent or poisonous substances contained therein together with an approximate statement of the composition of the medicine.

 

11. Application of law relating to sea customs and powers of Customs officers. (1) The law for the time being in force relating to sea customs and to goods, the import of which is prohibited by section 18 of the Sea Customs Act, 1878, shall, subject to the provisions of section 13 of this Act, apply in respect of drugs the import of which is prohibited under this Chapter, and officers of Customs and officers empowered under that Act to perform the duties imposed thereby on a Customs Collector and other officers of Customs, shall have the same powers in respect of such drugs as they have for the time being in respect of such goods as aforesaid, VIII of 1878.

 

(2) Without prejudice to the provisions of subsection (1), the Customs Collector, or any servant of the (Subs. by A. O., 1961, Art. 2 and Sch., for "Crown" (with effect from the 23rd March, 1956).)[State] authorised by the Provincial Government in this behalf, may detain any imported package which he suspects to contain any drug the import of which is prohibited under this Chapter, and shall forthwith report such detention to the Director of the Central Drugs Laboratory and, if required by him, forward the package or samples of any suspected drug found therein to the said Laboratory.

 

12. Power of Central Government to make rules. (1) The Central Government may, after consultation with the Board and after previous publication by notification in the official Gazette, make rules for the purpose of giving effect to the provisions of this Chapter.

 

(2) Without prejudice to the generality of the foregoing power, such rules may,---

 

(a) specify the drugs or classes of drugs for the import of which a licence is required, and prescribe the form and conditions of such licences, the authority empowered to issue the same, and the fees payable therefore;

 

(b) prescribe the methods of test or analysis to be employed in determining whether a drug is of standard quality;

 

(c) prescribe, in respect of biological and organo-metallic compounds, the units or methods of standardisation;

 

(d) specify the diseases or ailments which an imported drug may not purport or claim to cure or mitigate and such other effects which such drug may not purport or claim to have;

 

(e) prescribe the conditions subject to which small quantities of drugs, the import of which is otherwise prohibited under this Chapter, may be imported for the purpose of examination, test or analysis or for personal use;

 

(f) prescribe the places at which drugs may be imported, and prohibit their import at any other place;

 

(g) require the date of manufacture and the date of expiry of potency to be clearly and truly stated on the label or container of any specified imported drug or class of such drug, and prohibit the import of the said drug or class of drug after the expiry of a specified period from the date of manufacture;

 

(h) regulate the submission by importers, and the securing, of samples of drugs for examination, test or analysis by the Central Drugs Laboratory, and prescribe the fees, if any, payable for such examination, teat or analysis;

 

(i) prescribe the evidence to be supplied, whether by accompanying documents or otherwise, of the quality of drugs sought to be imported, the procedure of officers of Customs in dealing with such evidence, and the manner of storage at places of import of drugs detained pending admission;

 

(j) provide for the exemption, conditionally or otherwise, from all or any of the provisions of this Chapter and the rules made thereunder of drugs imported for the purpose only of transport through, and export from, (Subs. by the Central Laws (Statute Reform) Ordinance, 1960 (21 of 1960), s. 3 and 2nd Sch. (with effect from the 14th October, 1955), for "the Provinces and the Capital of the Federation" which had been subs. by A. O., 1949, for "British India".)[Pakistan];

 

(k) prescribe the conditions to be observed in the packing in bottles, packages or other containers, of imported drugs;

 

(l) regulate the mode of labelling drugs imported for sale in packages, and prescribe the matters which shall or shall not be included in such labels;

 

(m) prescribe the maximum proportion of any poisonous substance which may be added to or contained in any imported drug, prohibit the import of any drug in which that proportion is exceeded, and specify substances which shall be deemed to be poisonous for the purposes of this Chapter and the rules made thereunder;

 

(n) require that the accepted scientific name of any specified drug shall be displayed in the prescribed manner on the label or wrapper of any imported, patent or proprietary medicine containing such drug;

 

(o) provide for the exemption, conditionally or otherwise, from all or any of the provisions of this Chapter or the rules made thereunder, of any specified drug or class of drugs.

 

13. Offences. (1) Whoever contravenes any of the provisions of this Chapter or of any rule made thereunder shall, in addition to any penalty to which he may be liable under the provision of section 11, be punishable with imprisonment which may extend to one year, or with fine which may extend to five hundred rupees, or with both.

 

(2) Whoever, having been convicted under subsection (1), is again convicted under that subsection shall, in addition to any penalty as aforesaid, be punishable with imprisonment which may extend to two years, or with fine which may extend to one thousand rupees, or with both.

 

COMMENTS

 

Drugs Act 1940 ----Ss. 18(a) & 27 read with Ss. 30, 31 & 32 [as repealed by Drugs Act (XXI of 1976)]--Cognizance--Jurisdiction, propriety of-Question : Whether accused would be tried by Drugs Court constituted under S. 31 of Drugs Act, 1976, for an offence committed by him under repealed Drugs Act of 1940-Jurisdiction of Drugs Court to try cases arising under Drugs Act, 1940-Held, restricted to only such cases as pending in Courts immediately before establishment of Drugs Court-Jurisdiction, however, not extended to cases committed under Drugs Act, 1940 but in respect of which no complaints made before any Court-Case against accused not coming up before any Court after repeal of Drugs Act, 1940 and before establishment of Drugs Court under Drugs Act, 1976-Provisions of subsection (3) of S. 30 of Drugs Act, 1976, held, inapplicable to vest Drugs Court to try case against such accused.-[Cognizance-Jurisdiction-Interpretation of statutes].[4]

 

Ss. 18, 19(3) & 27 read with Companies Act (VIII of 1913), S. 23(2)-Substandard drug-Foisting liability-Substandard drug actually manufactured by a. Company-Company being a private limited Company, a "person" in its own right within meaning of such expression as appearing in Ss. 18, 19(3) & 27-Company, prima facie, bringing itself within mischief of law but no proceedings drawn up against Company-Company, had prosecution proceeded against it, barred from pleading in defence its being ignorant of nature, substance, or quality of substandard drug or of circumstances of its manufacture, and liable to be punished-Liability of Managing Director of Company, held, could arise only when such person shown to have manufactured such substandard drug for and on behalf of Company--No such allegation having been made in challan submitted to trial Court and Managing Director being assisted by various executives and workers, difficult to presume respondent being guilty of manufacture of substandard drug in question for and[5]

 

14. Confiscation. Where any offence punishable under section 13 has been committed, the consignment of the drug in respect of which the offence has been committed shall be liable to confiscation.

 

CHAPTER III

 

IMPORT OF DRUGS

 

15. Jurisdiction. No Court inferior to that of a (The words "Presidency Magistrate or of a" omitted by the Pakistan Drugs Act Adaptation Order, 1948 (G. G. O. 5 of 1948), Art. 3.)* * * magistrate of the first class shall try an offence punishable under section 13.

 

[CHAPTER IIIA]

 

(Chapter III A (containing sections 15A, 15B and 15C), ins. by the Drugs (Amdt.) Act, 1963 (22 of 1963), s. 8.)

 

EXPORT of DRUGS

 

15A. Prohibition of Export of drugs without licence. (Chapter III A (containing sections 15A, 15B and 15C), ins. by the Drugs (Amdt.) Act, 1963 (22 of 1963), s. 8.) From such date as may be fixed by the Central Government by notification in the official Gazette in this behalf, no person shall export any drug for the export of which a licence is prescribed, otherwise than under, and in accordance with, such licence:

 

Provided that nothing in this section shall apply to the export, subject to the prescribed conditions, of small quantities of any drug for the purpose of examination, test or analysis or for personal use.

 

15B. Power of Central Government to make rules. ( Chapter III A (containing sections 15A, 15B and 15C), ins. by the Drugs (Amdt.) Act, 1963 (22 of 1963), s. 8.)(1) The Central Government may, after consultation with the Board and after previous publication by notification in the official Gazette, make rules for the purpose of giving effect to the provisions of this Chapter.

 

(2) Without prejudice to the generality of the foregoing power, such rules may

 

(a) specify the drugs or classes of drugs for the export of which a licence is required, and prescribe the form and conditions of such licences, the authority empowered to issue the same, and the fees payable therefore;

 

(b) prescribe the conditions subject to which small quantities of drugs, the export of which is otherwise prohibited under this Chapter, may be exported for the purpose of examination, test or analysis or for personal use;

 

(c) prescribe the places at which drugs may be exported, and prohibit their export at any other place;

 

(d) regulate the submission by exporters of samples of drugs for examination, test or analysis by the Central Drugs Laboratory, and prescribe the fees, if any, payable for such examination, test or analysis;

 

(e) prescribe the evidence to be supplied, whether by documents or otherwise, of the quality of drugs sought to be exported.

 

15C. Penalty. (Chapter IIIA (containing sections 15A, 15B and 15C), ins. by the Drugs (Amdt.) Act, 1963 (22 of 1963), s. 8.) Whoever contravenes any of the provisions of section 15A or of any rule made under section 15B shall be punishable with fine which may extend to five thousand rupees.]

 

THE SCHEDULE

 

(See sections 8 and 16)

 

Standards to be complied with by imported drugs and by drugs manufactured for sale, sold, stocked or exhibited for sale, or distributed.

 

Class of drug.

Standard to be complied with.

 

1. Patent or proprietary medicines  

The formula or list of ingredients displayed m the prescribed manner on the label or container, (The words and comma "or the formula disclosed to the Central Drugs Laboratory, as the case may be" omitted by the Drugs (Amdt.) Act, 1963 (22 of 1963), s. 1.6.) * * *.

 

2. Substances commonly known as vaccines, sera, toxins, toxoids, antitoxins, and antigens and biological products of such nature.      

The standards maintained at the National Institute for Medical Research, London, and such further standards of strength, quality and purity as may be prescribed.

 

3. Vitamins, hormones and analogous products.   

The standards maintained at the National Institute for Medical Research, London, and such further standards of strength, quality and purity as may be prescribed.

 

(Entry 3 A ins. ibid.) [3A. Substances (other than food) intended to affect the structure or any function of the human body or intended to be used for the destruction of vermins or insects which cause disease in human beings or animals.     

Such standards as may be prescribed.]

 

4. Other drugs           

The standards of identity purity and strength specified in the latest edition of the British Pharmacopoeia or the British Pharmaceutical Codex or any other prescribed pharmacopoeia, or adopted by the Permanent Commission on Biological Standardisation of the (Subs. ibid., for "League of Nations".) [World Health Organisation].

 

CHAPTER IV

 

MANUFACTURE, SALE AND DISTRIBUTION of DRUGS

 

16. Standards of quality. (1) For the purposes of this Chapter the expression "standard quality" when applied to a drug means that the drug complies with the standard set out in the Schedule.

 

(2) The Provincial Government (The words "after consultation with the Board and" omitted by A. O. 1964, Art. 2 and Sch.)* * * after giving by notification in the official Gazette not less than three months' notice of its intention so to do, may by a like notification add to or otherwise amend the Schedule for the purposes of this Chapter, and thereupon the Schedule shall be deemed to be amended accordingly.

 

CHAPTER IV

 

MANUFACTURE, SALE AND DISTRIBUTION of DRUGS

 

17. Misbranded drugs. For the purposes of this Chapter a drug shall be deemed to be misbranded

 

(a) if it is an imitation of, or substitute for, or resembles in a manner likely to deceive, another drug, or bears upon it or upon its label or container the name of another drug, unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other drug; or

 

(b) if it purports to be the product of a place or country of which it is not truly a product; or

 

(c) if it is sold, or offered or exposed for sale, under a name which belongs to another drug; or

 

(d) if it is so coloured, coated, powdered or polished that damage is concealed, or if it is made to appear of better or greater therapeutic value than it really is; or

 

(e) if it is not labelled in the prescribed manner; or

 

(f) if its label or container or any thing accompanying the drug bears any statement, design or device which makes any false claim for the drug or which is false or misleading in any particular; or

 

(g) if the label or container bears the name of an individual or company purporting to be the manufacturer or producer of the drug which individual or company is fictitious or does not exist.

 

18. Prohibition of manufacture and sale of certain drugs. From such date as may be fixed by the Provincial Government by notification in the official Gazette in this behalf, no person shall himself or by any other person on his behalf

 

(d) manufacture for sale, or sell, or stock or exhibit for sale, or distribute

 

(i) any drug which is not of standard quality;

 

(ii) any misbranded drug;

 

(This subclause was brought into force in

 

(i) the Capital of the Federation, with effect on and from the 1st July, 1953, see Gaz. of P., 1952, Pt. VI, p. 154.;

 

(ii) Sind, with effect from the 1st July, 1953, see Sind Govt. Gazette 1952, Pt. 1, p. 638.

 

(iii) East Bengal, with effect on and from the 1st January, 1955, see Dacca Gazette, 1954, Pt. 1, p. 1218; and

 

(iv) Punjab, with effect on and from the 1st July, 1951, see Punjab Gazette, 1950, Pt. 1, p. 372.)(iii) any patent or proprietary medicine, unless there is displayed in the prescribed manner on the label or container thereof either the true formula or list of ingredients contained in it in a manner readily intelligible to members of the medical profession, (The commas and certain words omitted by the Drugs (Amdt.) Act, 1963 (22 of 1963), s. 9.)* * *.

 

(iv) 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;

 

(v) any drug, in contravention of any of the provisions of this Chapter or any rule made thereunder;

 

(b) sell, or stock, or exhibit for sale, or distribute any drug which has been imported or manufactured in contravention of any of the provisions of this Act or any rule made thereunder;

 

(c) manufacture for sale, or sell, or stock or exhibit for sale, or distribute any drug, except under, and in accordance with the conditions of, a licence issued for such purpose under this Chapter:

 

Provided that nothing in this section shall apply to the manufacture, subject to prescribed conditions, of small quantities of any drug for the purpose of examination, test or analysis:

 

Provided further that the Provincial Government may, (The words and comma "after consultation with the Board," omitted by A. O. 1964, Art. 2 and Sch.)* by notification in the official Gazette, permit, subject to any conditions specified in the notification, the manufacture for sale, sale or distribution of any drug or class of drugs not being of standard quality.

 

Explanation.The formula or list of ingredients mentioned in subclause (iii) of clause (a) shall be deemed to be true and a sufficient compliance with that subclause if, without disclosing a full and detailed recipe of the ingredients, it indicates correctly all the potent or poisonous substances contained therein together with an approximate statement of the composition of the medicine.

 

COMMENTS

 

Drugs Act 1940 ----Ss. 18(a) & 27 read with Ss. 30, 31 & 32 [as repealed by Drugs Act (XXI of 1976)]--Cognizance--Jurisdiction, propriety of-Question : Whether accused would be tried by Drugs Court constituted under S. 31 of Drugs Act, 1976, for an offence committed by him under repealed Drugs Act of 1940-Jurisdiction of Drugs Court to try cases arising under Drugs Act, 1940-Held, restricted to only such cases as pending in Courts immediately before establishment of Drugs Court-Jurisdiction, however, not extended to cases committed under Drugs Act, 1940 but in respect of which no complaints made before any Court-Case against accused not coming up before any Court after repeal of Drugs Act, 1940 and before establishment of Drugs Court under Drugs Act, 1976-Provisions of subsection (3) of S. 30 of Drugs Act, 1976, held, inapplicable to vest Drugs Court to try case against such accused.-[Cognizance-Jurisdiction-Interpretation of statutes].[6]

 

Ss. 18, 19(3) & 27 read with Companies Act (VIII of 1913), S. 23(2)-Substandard drug-Foisting liability-Substandard drug actually manufactured by a. Company-Company being a private limited Company, a "person" in its own right within meaning of such expression as appearing in Ss. 18, 19(3) & 27-Company, prima facie, bringing itself within mischief of law but no proceedings drawn up against Company-Company, had prosecution proceeded against it, barred from pleading in defence its being ignorant of nature, substance, or quality of substandard drug or of circumstances of its manufacture, and liable to be punished-Liability of Managing Director of Company, held, could arise only when such person shown to have manufactured such substandard drug for and on behalf of Company--No such allegation having been made in challan submitted to trial Court and Managing Director being assisted by various executives and workers, difficult to presume respondent being guilty of manufacture of substandard drug in question for and[7]

 

(c) Criminal Procedure Code (V of 1898), S. 436-Revision against order of discharge-Order of discharge passed after recording whole evidence-Filing of revision application against such order not barred-Drugs Act (XXIII of 1940), S. 18 (a) (i) read with S. 27.[8]

 

Drugs Act 1940 ----S. 18(a)(i) read with Ss. 27 & 19(3)(b)--Dealer in medicines purchasing drugs (subsequently found not of standard quality) front manufacturer, obtaining warranty of there having been no contravention of S. 18 from manufacturer, sending a copy of warranty with written notice to inspector of drugs and warrantor within 7 days of service of summons on him-Dealer, in circumstances, held, could not be found guilty of offence under S. 18.[9]

 

(a) Criminal Procedure Code (V of 1898), S. 561-A-Quashment-Respectability of accused or bias in complainant-No ground for quashment of proceedings-Drugs Act (XXIII of 1940) p S. 18 (a) (i) read with S. 27.[10]

 

19. Pleas. (1) Save as hereinafter provided in this section, it shall be no defence in a prosecution under this Chapter to prove merely that the accused was ignorant of the nature, substance or quality of the drug in respect of which the offence has been committed or of the circumstances of its manufacture or import, or that a pur­chaser, having bought only for the purpose of test or analysis, has not been prejudiced by the sale.

 

(2) For the purposes of section 18 a drug shall not be deemed to be misbranded or to be below standard quality only by reason of the fact that

 

(a) there has been added thereto some innocuous substance or ingredient because the same is required for the manufacture or preparation of the drug as an article of commerce in a state 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 defects; or

 

(b) in the process of manufacture, preparation or conveyance some extraneous substance has unavoidably become intermixed with it: provided that this clause shall not apply in relation to any sale or distribution of the drug occurring after the vendor or distributor became aware of such intermixture.

 

(3) A person, not being the manufacturer of a drug or his agent for the distribution thereof, shall not be liable for a contravention of section 18 if he proves

 

(a) that he did not know, and could not with reasonable diligence have ascertained, that the drug in any way contravened the provisions of that section, and that the drug while in his possession remained in the same state as when he acquired it; or

 

(b) that he acquired the drug from a person resident in (Subs. by the Central Laws (Statute Reform) Ordinance, 1960 (21 of 1960), s. 3 and 2nd Sch. (with effect from the 14th October, 1955), for "the Provinces and the Capital of the Federation" which had been subs. by A. O. 1949, for "British India.)[Pakistan] under a written warranty in the prescribed form and signed by such person that the drug does not in any way contravene the provisions of section 18, and that the drug while in his possession remained in the same state as when he acquired it:

 

Provided that a defence under clause (b) shall be open to a person only

 

(i) if he has, within seven days of the service on him of the summons, sent to the Inspector a copy of the warranty with a written notice stating that he intends to rely upon it and giving the name and address of the warrantor, and

 

(ii) if he proves that he has, within the same period, sent written notice of such intention to the said warrantor.

 

COMMENTS

 

S. 19(3)-Substandard drug-Distribution of-Liability of manufacturer of drugs and his Agent for distribution of drug-Co-extensive- Respondent not alleged .or shown to have acted as Agent of Manufacturing Company for . distribution of substandard drug, respondent not to be held guilty of offence of distribution of substandard drug.[11]

 

20. Government Analysts. The Provincial Government may, by notification in the official Gazette, appoint such persons as it thinks fit, having the prescribed qualifications, to be Government Analysts for such areas and in respect of such drugs or classes of drugs as may be specified in the notification:

 

Provided that a servant of the (Subs, by A. O., 1961, Art. 2 and Sch., for "Crown" with effect from the 23rd March, 1956).)[State] serving under the Central Government or another Provincial Government shall not be so appointed without the previous consent of the Government under which he is serving.

 

21. Inspectors. (1) The Provincial Government may, by notification in the official Gazette, appoint such persons as it thinks fit, having the prescribed qualifications, to be Inspectors for the purposes of this Chatter within such local limits as it may assign to them respectively:---

 

Provided that no person who has any financial interest in the manufacture, import or sale of drugs shall be appointed to be an Inspector under this subsection.

 

(2) Every Inspector shall be deemed to be a public servant within the meaning of the Pakistan Penal Code, and shall be officially subordinate to such authority as the Provincial Government may specify in this behalf, XLV of 1860.

 

22. Powers of Inspectors. ( Subs. by the Drugs (Amdt.) Act, 1963 (22 of 1963), s. 10, for the original section 22, as amended by the Pakistan Drugs Act Adaptation Order, 1948 (G. G. O. 5 of 1948). Art 3.)(1) Subject to the provisions of section 23 and of any rules made by the Provincial Government in this behalf, an inspector may, within the local limits for which he is appointed, and in any other area with the permission of the licensing authority,---

 

(a) inspect any premises wherein any drug is being manufactured, the plant and process of manufacture, the means employed for standardising anal testing the drugs and all records, and registers, relating thereto;

 

(b) inspect any premises wherein any drug is being sold or is stocked or exhibited for sale or is being distributed the storage arrangement and all relevant records and registers;

 

(c) take samples of any drug which is being manufactured, or being sold or is stocked or exhibited for sale or is being distributed;

 

(d) enter and search at all reasonable times, with such assistance, if any, as he considers necessary, any building, vessel or place, in which he has reason to believe, from personal knowledge or from information given by any person and taken down in writing, that an offence under this Act or any rules made thereunder, has been or is being committed;

 

(e) seize such drug and all materials used in the manufacture thereof and all other articles including registers, cashmemos, invoices, bills which he has reason to believe may furnish evidence of the commission of an offence punishable under this Act and any rules made thereunder;

 

(f) call any person from the neighbourhood to be present as witness in course of search, seizure or in connection with any other matter where the presence of witnesses is necessary;

 

(g) require any person to appear before him at any reasonable time at any proper place to give statement, assistance or information relating to, or in connection with, the investigation of an offence under this Act or rules made thereunder:

 

Provided that the exemptions under sections 132 and 133 of the Code of Civil Procedure, 1908 shall be applicable to requisitions for attendance under this clause, Act V of 1908;

 

(h) lock and seal any factory, laboratory, shop, building, storehouse or godown or a part thereof where any drug is, or is being, manufactured, stored, sold or exhibited for sale without the necessary licence under this Act, or where he has reason to believe that an offence under this Act has been committed or may continue to be committed;

 

(i) forbid for a reasonable period not exceeding three months any person in charge of any premises from removing or disposing of any drug, article or other thing likely to be used in evidence of the commission of an offence under this Act or any rules made thereunder;

 

(j) exercise such other powers as may be necessary for carrying out the purposes of this Act or any rules made thereunder.

 

(2) The provisions of the Code of Criminal Procedure, 1898, so far as they are not inconsistent with the provisions of this to searches and seizures made under this Chapter, Act V of 1898.

 

(3) If any person wilfully obstructs an Inspector in the exercise of the powers conferred upon him by or under this Chapter or disobeys the lawful authority of an Inspector, he shall be punishable with imprisonment which may extend to three years, or with fine, or with both.]

 

23. Procedure of Inspectors. (Sub-section (1) omitted by the Drugs (Amdt.) Act, 1963 (22 of 1963), 11.)*     *          *          *          *          *          *

 

(Subs. ibid., for the original subsection (2).)[(2) Where the Inspector seizes any drug or any other article under section 22, he shall tender a receipt therefore in the prescribed form.]

 

(3) Where an Inspector takes a sample of a drug for the purpose of test or analysis, he shall intimate such purpose in writing in the prescribed form to the person from whom he takes it and, in the presence of such person unless he willfully absents himself, shall divide the sample into four portions and effectively seal and suitably mark the same and permit such person to add his own seal and mark to all or any of the portions so sealed and marked:

 

Provided that where the sample is taken from premises whereon the drug is being manufactured, it shall be necessary to divide the sample into three portions only:

 

Provided further that where the drug is made up in containers of small volume, instead of dividing a sample as aforesaid, the Inspector may, and if the drug be such that it is likely to deteriorate or be otherwise damaged by exposure shall, take three or four, as the case may be, of the said containers after suitably marking the same and, where necessary, sealing them.

 

(4) The Inspector shall restore one portion of a sample so divided or one container, as the case may be, to the person from whom he takes it, and shall retain the remainder and dispose of the same as follows:

 

(i) one portion or container he shall forthwith send to the Government Analyst for test or analysis;

 

(ii) the second he shall produce to the Court before which proceedings, if any, are instituted in respect of the drug; and

 

(iii) the third, where taken, he shall send to the warrant or, if any, named under the proviso to subsection (3) of section 19.

 

(5) Where an Inspector takes any action under (The words, letter and parenthesis "clause (c) of" omitted. ibid.)* * * section 22,---

 

(a) he shall use all despatch in ascertaining whether or not the drug contravenes any of the provisions of section 18 and, if it is ascertained that the drug does not so contravene, forthwith revoke the order passed under the said (Subs. by the Drugs (Amdt.) Act, 1963 (22 of 1963), s. 11, for "clause".)[section] or, as the case may be, take such action as may be necessary for the return of the stock seized;

 

(b) if he seizes the stock of the drug, he shall as soon as may be, inform a Magistrate and take his orders as to the custody thereof;

 

(c) without prejudice to the institution of any prosecution, if the alleged contravention be such that the defect may be remedied by the possessor of the drug, he shall, on being satisfied that the defect has been so remedied, forthwith revoke his order under the said (Subs. by the Drugs (Amdt.) Act, 1963 (22 of 1963), s. 11, for "clause".)[section].

 

COMMENTS

 

----Ss. 27(i) & 23(i)(c) --- Appreciation of evidence---In order to bring home the guilt to the accused onus was heavily on the complainant (Drug Inspector) to establish that he was involved in the business of the Medical Store in question or the same was owned by him or he had any interest in the said business or was found selling any drug or in any way was found connected with the sale of drugs of the said Medical Store where he was found present at the time of raid, but no evidence in support of the accusation about the sale of drugs or involvement of accused in the said business had been produced at the trial so as to attract the penal provisions of S.27 of the Drugs Act, 1976 on account of the alleged contravention of the provisions of S.23(i)(c) of the said Act-Complainant had made material improvements in his evidence in order to prove the case against the accused---Mere presence of accused at the relevant time in the Medical Store in absence of any other supporting evidence was not enough to prove the accusation that he was involved in illegal business of the Medical Store without any Drugs Sale Licence---Accused was acquitted in circumstances.[12]

 

----S. 497 read with Drugs Act (XXI of 1976), Ss. 23 & 27-----Bail---Offences falling under S. 23 of Drugs Act, being punishable up to 10 years prohibition under S. 497, Cr. P. C., held, attracted-Offences relating to clandestine sale of stolen Government medicines as well as their genuineness-Bail declined, in circumstances,[13]

 

Drugs Act 1940 ------ Ss. 25, 27 & 23(4)-Interpretation of S. 25-Report of Government Analyst and Chemical Examiner Report, though in terms of second part of S. 25(3) cannot be treated as conclusive evidence where no copy of report was supplied to person from whore sample was taken-Presumption under first part of S. 25(3) unless rebutted by contrary Evidence can be sufficient basis for conviction of offence under S. 27-Lapse of 4 years since prosecution started-Sentence: fine of Rs. 500 only.[14]

 

24. Persons bound to disclose place where drugs are manufactured or kept. Every person for the time being in charge of any premises whereon any drug is being manufactured or is kept for sale or distribution shall, on being required by an Inspector so to do, be legally bound to disclose to the Inspector the place where the drug is being manufactured or is kept, as the case may be.

 

25. Reports of Government Analysts. (1) The Government Analyst to whom a sample of any drug has been submitted for test or analysis under subsection (4) of section 23, shall deliver to the Inspector submitting it a signed report in triplicate in the prescribed form.

 

(2) The Inspector on receipt thereof shall deliver one copy of the report to the person from whom the sample was taken and another copy to the warrantor, if any, named under the proviso to subsection (3) of section 19, and shall retain the third copy for use in any prosecution in respect of the sample.

 

(3) Any document purporting to be a report signed by a Government Analyst under this Chapter shall be evidence of the facts stated therein, and such evidence shall be conclusive unless the person from whom the sample was taken or the said warrantor has; within twentyeight 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 controversion of the report.

 

(4) Unless the sample has already been tested or analysed in the Central Drugs Laboratory, where a person has under subsection (3) notified his intention of adducing evidence in controversion of a Government Analyst's report, the Court may, of its own motion or in its discretion at the request either of the complainant or the accused, cause the sample of the drug produced before the Magistrate under subsection (4) of section 23 to be sent for test or analysis to the said Laboratory, which shall make the test or analysis and report in writing signed by, or under the authority of, the Director of the Central Drugs Laboratory the result thereof, and such report shall be conclusive evidence of the facts stated therein.

 

(5) The cost of a test or analysis made by the Central Drugs Laboratory under subsection (4) shall be paid by the complainant or accused as the Court shall direct.

 

COMMENTS

 

- S. 540 read with Drugs Act (XXIII of 1940), Ss. 25(3) & 46Witness, summoning of-Report of Public Analyst not complete with "full protocols of test" 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 set aside, in circumstances-Court further directed to summon witness to produce full protocols of tests, in interest of justice.-[Witness][15]

 

S. 25-Mere non-compliance with provision of subsection (2) of S. 25 in not supplying to person, from whom sample taken, a copy of report of Government Analyst-Does not make report inadmissible in evidence-Contents of report not only prove themselves but are considered conclusive unless objection taken.[16]

 

Drugs Act 1940 ------ Ss. 25, 27 & 23(4)-Interpretation of S. 25-Report of Government Analyst and Chemical Examiner Report, though in terms of second part of S. 25(3) cannot be treated as conclusive evidence where no copy of report was supplied to person from whore sample was taken-Presumption under first part of S. 25(3) unless rebutted by contrary Evidence can be sufficient basis for conviction of offence under S. 27-Lapse of 4 years since prosecution started-Sentence: fine of Rs. 500 only.[17]

 

- S. 540 read with Drugs Act (XXIII of 1940), Ss. 25(3) & 46Witness, summoning of-Report of Public Analyst not complete with "full protocols of test" 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 set aside, in circumstances-Court further directed to summon witness to produce full protocols of tests, in interest of justice.-[Witness][18]

 

26. Purchaser of drug enabled to obtain test or analysis. Any person shall, on application in the prescribed manner and on payment of the prescribed fee, be entitled to submit for test or analysis to a Government Analyst any drug purchased by him and to receive a report of such test or analysis signed by the Government Analyst.

 

27. Penalty for manufacture, sale, etc., of drugs in contravention of this Chapter. Whoever himself or by any other person on his behalf manufactures for sale, sells, stocks or exhibits for sale, or distributes any drug in contravention of any of the provisions of this Chapter or any rule made thereunder shall be punishable with imprisonment which may extend to (Subs. by the Drugs (Amdt.) Act, 1963 (22 of 1963), s. 12, for "one year, or with fine which may extend to five hundred rupees,") [three years or with fine], or with both.

 

COMMENTS

 

Drugs Act 1940 ----Ss. 27(i) & 23(i)(c) --- Appreciation of evidence---In order to bring home the guilt to the accused onus was heavily on the complainant (Drug Inspector) to establish that he was involved in the business of the Medical Store in question or the same was owned by him or he had any interest in the said business or was found selling any drug or in any way was found connected with the sale of drugs of the said Medical Store where he was found present at the time of raid, but no evidence in support of the accusation about the sale of drugs or involvement of accused in the said business had been produced at the trial so as to attract the penal provisions of S.27 of the Drugs Act, 1976 on account of the alleged contravention of the provisions of S.23(i)(c) of the said Act-Complainant had made material improvements in his evidence in order to prove the case against the accused---Mere presence of accused at the relevant time in the Medical Store in absence of any other supporting evidence was not enough to prove the accusation that he was involved in illegal business of the Medical Store without any Drugs Sale Licence---Accused was acquitted in circumstances.[19]

 

Drugs Act 1940 ----Ss. 27(2-a) & 27(4)---Appreciation of evidence---No sample of the drug seized by the complainant Drug Inspector having been taken and sent to the concerned Laboratory for analysis, it could not be said to be a spurious drug--Drug Inspector although alleged that the drug seized by him resembled a medicine manufactured by a local pharmaceutical company, yet he admittedly did not contact the said pharmaceutical company in this respect and failed to obtain the view of that company regarding the drug in question---Accused was acquitted in circumstances.[20]

 

Drugs Act 1940 ----Ss.27(1)(a)(b) & 27 (2)(b)---Appraisal of evidence---It was not proved through qualitative and quantitative analysis of the ingredients in the offending preparation that the active ingredient /constituent Mathyl Salicylate had been used which formed part of the protected pharmacopieas---Analyst's report did not determine the ingredients in the offending preparation quantitatively or even fully---It could not, therefore, be found that accused did not use merely a herbal extract in its natural form for the purposes of his preparation---Offence alleged against accused, held, had not been proved beyond reasonable doubt---Accused was acquitted in circumstances.[21]

 

---Art. 185(3)--Drugs Act (XXIII of 1940), S. 27--Petitioner's conviction based on his own plea of guilty--Having admitted that drug recovered from him was sub-standard, declined to produce any evidence in defence--No interference called for--Leave to appeal refused.[22] ----S. 497 read with Drugs Act (XXI of 1976), Ss. 23 & 27-----Bail---Offences falling under S. 23 of Drugs Act, being punishable up to 10 years prohibition under S. 497, Cr. P. C., held, attracted-Offences relating to clandestine sale of stolen Government medicines as well as their genuineness-Bail declined, in circumstances,[23]

 

----Ss. 18(a) & 27 read with Ss. 30, 31 & 32 [as repealed by Drugs Act (XXI of 1976)]--Cognizance--Jurisdiction, propriety of-Question : Whether accused would be tried by Drugs Court constituted under S. 31 of Drugs Act, 1976, for an offence committed by him under repealed Drugs Act of 1940-Jurisdiction of Drugs Court to try cases arising under Drugs Act, 1940-Held, restricted to only such cases as pending in Courts immediately before establishment of Drugs Court-Jurisdiction, however, not extended to cases committed under Drugs Act, 1940 but in respect of which no complaints made before any Court-Case against accused not coming up before any Court after repeal of Drugs Act, 1940 and before establishment of Drugs Court under Drugs Act, 1976-Provisions of subsection (3) of S. 30 of Drugs Act, 1976, held, inapplicable to vest Drugs Court to try case against such accused.-[Cognizance-Jurisdiction-Interpretation of statutes].[24]

 

Ss. 18, 19(3) & 27 read with Companies Act (VIII of 1913), S. 23(2)-Substandard drug-Foisting liability-Substandard drug actually manufactured by a. Company-Company being a private limited Company, a "person" in its own right within meaning of such expression as appearing in Ss. 18, 19(3) & 27-Company, prima facie, bringing itself within mischief of law but no proceedings drawn up against Company-Company, had prosecution proceeded against it, barred from pleading in defence its being ignorant of nature, substance, or quality of substandard drug or of circumstances of its manufacture, and liable to be punished-Liability of Managing Director of Company, held, could arise only when such person shown to have manufactured such substandard drug for and on behalf of Company--No such allegation having been made in challan submitted to trial Court and Managing Director being assisted by various executives and workers, difficult to presume respondent being guilty of manufacture of substandard drug in question for and[25]

 

28. Penalties for giving false warranty or misuse of warranty. (1) Whoever in respect of any drug sold by him whether as principal or agent, gives to the purchaser a false warranty that the drug does not in any way contravene the provisions of section 18 shall, unless he proves that when he gave the warranty he had good reason to believe the same to be true, be punishable with imprisonment which may extend to one year, or, with fine which may extend to five hundred rupees, or with both.

 

(2) Whoever applies or permits to be applied to any drug sold, or stocked or exhibited for sale, by him, whether on the container or label or in any other manner, a warranty given in respect of any other drug, shall be punishable with imprisonment which may extend to one year, or with fine which may extend to five hundred rupees, or with both.

 

COMMENTS

 

-S. 561-A-Criminal trial-Quashment of proceedings-Prosecution for manufacturing sub-standard drug-Contention that order of Magistrate issuing process against petitioner without first requiring complainant to produce evidence and warranty given by petitioner was an abuse of process of Court and liable to be quashed-Held, petitioner being Manager of manufacturing firm also liable and proprietor having produced warranty petitioner not required to produce same-Drugs Act (XXIII of 1940), Ss. 27, 28 & 38.-[Quashment of proceedings].[26]

 

29. Penalty for use of Government Analyst's report for advertising. Whoever uses any report of a test or analysis made by the Central Drugs Laboratory or by a Government Analyst, or any extract from such report for the purpose of advertising any drug, shall be punishable with fine which may extend to five hundred rupees.

 

30. Penalty for subsequent offences. (Subs. by the Drugs (Amdt.) Act, 1963 (22 of 1963), s. 13, for the original section 30.)(1) Whoever, having been convicted of an offence under section 27, is again convicted of an offence under that section shall be punishable with imprisonment which may extend to five years, or with fine, or with both.

 

(2) Whoever, having been convicted of an offence under section 28 or section 29, is again convicted of an offence under either of those sections shall be punishable with imprisonment which may extend to two years, or with fine, or with both.]

 

31. Confiscation. Where any person has been convicted under this Chapter for contravening any such provision of this Chapter or any rule made thereunder as may be specified by rule made in this behalf, the stock of the drug in respect of which the contravention has been made shall be liable to confiscation.

 

32. Cognisance of offences. (1) No prosecution under this Chapter shall be instituted except by an Inspector.

 

(2) No Court inferior to that of a (The words "Presidency Magistrate or of a" omitted by the Pakistan Drugs Act Adaptation Order, 1948 (G. G. O. 5 of 1948), Art. 3.)* * * Magistrate of the first class shall try an offence punishable under this Chapter.

 

(3) Nothing contained in this Chapter shall be deemed to prevent any person from being prosecuted under any other law for any act or omission which constitutes an offence against this Chapter.

 

COMMENTS

 

----Ss. 18(a) & 27 read with Ss. 30, 31 & 32 [as repealed by Drugs Act (XXI of 1976)]--Cognizance--Jurisdiction, propriety of-Question : Whether accused would be tried by Drugs Court constituted under S. 31 of Drugs Act, 1976, for an offence committed by him under repealed Drugs Act of 1940-Jurisdiction of Drugs Court to try cases arising under Drugs Act, 1940-Held, restricted to only such cases as pending in Courts immediately before establishment of Drugs Court-Jurisdiction, however, not extended to cases committed under Drugs Act, 1940 but in respect of which no complaints made before any Court-Case against accused not coming up before any Court after repeal of Drugs Act, 1940 and before establishment of Drugs Court under Drugs Act, 1976-Provisions of subsection (3) of S. 30 of Drugs Act, 1976, held, inapplicable to vest Drugs Court to try case against such accused.-[Cognizance-Jurisdiction-Interpretation of statutes].[27]

 

33. Power of Provincial Government to make rules. (1) The Provincial Government may, (The words "after consultation with the Board and', omitted by A. O., 1964, Art. 2 and Sch.)* * * after previous publication by notification in the official Gazette, make rules(For the West Pakistan Drugs Rules, 1958, see West Pakistan Gazette, 1958, Ext., pp. 125556.) for the purpose of giving effect to the provisions of this Chapter.

 

(2) Without prejudice to the generality of the foregoing power, such rules may

 

(a) provide for the establishment of laboratories for testing and analysing drugs;

 

(b) prescribe the qualifications and duties of Government Analysts and the qualifications of Inspectors;

 

(c) prescribe the methods of test or analysis to be employed in determining whether a drug is of standard quality;

 

(d) prescribe, in respect of biological and organometallic compounds, the units or methods of standardisation;

 

(e) prescribe the forms of licences for the manufacture for sale, for the sale and for the distribution of drugs or any specified drug or class of drugs, the form of application for such licences, the conditions subject to which such licences may be issued, the authority empowered to issue the same and the fees payable therefore;

 

(f) specify the diseases or ailments which a drug may not purport or claim t o cure or mitigate anal such other effects which a drug may not purport or claim to have;

 

(g) prescribe the conditions subject to which small quantities of drugs may be manufactured for the purpose of examination, test or analysis;

 

(h) require the date of manufacture and the date of expiry of potency to be clearly and truly stated on the label or container of any specified drug or class of drugs, and prohibit the sale, stocking or exhibition for sale, or distribution of the said drug or class of drugs after the expiry of a specified period from the date of manufacture or after the expiry of the date of potency;

 

(i) prescribe the conditions to be observed in the packing in bottles, packages and other containers of drugs, and prohibit the sale, stocking or exhibition for sale, or distribution of drugs packed in contravention of such conditions;

 

(j) regulate the mode of labelling packed drugs, and prescribe the matters which shall or shall not be included in such labels;

 

(k) prescribe the maximum proportion of any poisonous substance which may be added to or contained in any drug, prohibit the manufacture, sale or stocking or exhibition for sale, or distribution of any drug in which that proportion is exceeded, and specify substances which shall be deemed to be poisonous for the purposes of this Chapter and the rules made thereunder;

 

(l) require that the accepted scientific name of any specified drug shall be displayed in the prescribed manner on the label or wrapper of any patent or proprietary medicine containing such drug;

 

(m) prescribe the form of warranty referred to in subsection (1) of section 19;

 

(n) regulate the powers and duties of Inspectors;

 

(o) prescribe the forms of report to be given by Government Analysts, and the manner of application for test or analysis under section 26 and the fees payable therefore;

 

(p) specify the offences against this Chapter or any rule made thereunder in relation to which the stock of the drug shall be liable to confiscation under section 31;

 

(q) provide for the exemption, conditionally or otherwise, from all or any of the provisions of this Chapter or the rules made thereunder, of any specified drug or class of drugs.

 

34. [Omitted.] [Protection to persons acting under this Chapter.] Omitted by the Drugs (Amdt.) Act, 1963 (XXII of 1963), s. 14.

 

[CHAPTER V]

 

(Chapter V containing sections 3541, added by the Drugs (Amdt.) Act, 1963 (22 of 1963), s. 15.)

 

MISCELLANEOUS

 

35. Sale of patent or proprietory medicines or pharmaceutical specialities. (Chapter V containing sections 3541, added by the Drugs (Amdt.) Act, 1963 (22 of 1963), s. 15.) No patent or proprietary medicine or pharmaceutical speciality or any other medicine, whether allopathic, unani, ayurvedic, homoeopathic or biochemic, for the time being not recognised by the accepted pharmacopoeias, shall be offered for sale to the public or advertised for such sale, unless two samples thereof shall have been sent to the Director, Central Drugs Laboratory, and the latter shall have determined that the medicine or specialty is suitable or proper for use by the public.

 

36. Prohibition to sell drugs in public streets, etc. (Chapter V containing sections 3541, added by the Drugs (Amdt.) Act, 1963 (22 of 1963), s. 15.) No person shall, in any public street, highway, footpath or park or on any public transport or conveyance, peddle, hawk or offer for sale or distribute free of charge any medicine of pharmaceutical speciality whether allopathic, unani, ayurvedic, homoeopathic or of any other description.

 

37. Penalty. (Chapter V Containing sections 3541, added by the Drugs (Arndt.) Act, 1963 (22 of 1963), s. 15.) Any person who contravenes any of the provisions of section 35 or section 36 shall be punishable with imprisonment which may extend to two years, or with fine, or with both.

 

38. Offences by Companies, etc. (Chapter V Containing sections 3541, added by the Drugs (Arndt.) Act, 1963 (22 of 1963), s. 15.) Where the person guilty of an offence under this Act is a company, corporation or firm every director, partner and officer of the company, corporation or firm with whose knowledge and consent the offence was committed shall be guilty of the like offence.

 

39. Powers to try offence summarily. (Chapter V Containing sections 3541, added by the Drugs (Arndt.) Act, 1963 (22 of 1963), s. 15.) Any Magistrate of the first class or any bench of Magistrates invested with the powers of a Magistrate of the first class empowered for the time being to try in a summary way the offences specified in sub section (1) of section 260 of the Code of Criminal Procedure, 1898, may, on application in this behalf being made by the prosecution, try in accordance with the provisions contained in sections 262 to 265 of that Code, any such offence punishable under this Act and any rules made thereunder as may be prescribed, Act V of 1898.

 

40. Special provision regarding imprisonment and fine. (Chapter V Containing sections 3541, added by the Drugs (Arndt.) Act, 1963 (22 of 1963), s. 15.) Notwithstanding anything contained in section 32 of the Code of Criminal Procedure, 1898, it shall be lawful for any Magistrate of the first class to pass any sentence authorised by this Act even if such sentence exceeds his powers under section 32 of that Code, Act V of 1898.

 

41. Protection to persons acting under this Act. (Chapter V Containing sections 35‑41, added by the Drugs (Arndt.) Act, 1963 (22 of 1963), s. 15.) No suit, prosecution or other legal proceeding shall lie against any person for anything which is in good faith done or intended to be done under this Act or any rules made thereunder.]



[1] 1998 PTD 370 LAHORE.

[2] 1994 CLC 1144 KARACHI.

[3] 1990 MLD 1524 KARACHI.

[4] 1980 PCRLJ 1212 BAGHDAD-UL-JADID.

[5] 1978 PLD 193 SC.

[6] 1980 PCRLJ 1212 BAGHDAD-UL-JADID.

[7] 1978 PLD 193 SC.

[8] 1973 PCRLJ 809 KARACHI.

[9] 1973 PCRLJ 218 KARACHI.

[10] 1973 PCRLJ 885 LAHORE.

[11] 1978 PLD 193 SC.

[12] 2001 YLR 3133 QUETTA.

[13] 1981 PCRLJ 243 LAHORE.

[14] 1967 PLD 80 KARACHI.

[15] 1977 PCRLJ 822 KARACHI.

[16] 1973 PLD 299 SC.

[17] 1967 PLD 80 KARACHI.

[18] 1977 PCRLJ 822 KARACHI.

[19] 2001 YLR 3133 QUETTA.

[20] 1996 PCRLJ 540 PESHAWAR.

[21] 1990 MLD 1524 KARACHI.

[22] 1985 SCMR 1405 SC.

[23] 1981 PCRLJ 243 LAHORE.

[24] 1980 PCRLJ 1212 BAGHDAD-UL-JAJID.

[25] 1978 PLD 193 SC.

[26] 1976 PCRLJ 649 LAHORE.

[27] 1980 PCRLJ 1212 BAGHDAD-UL-JADID.

Go to Index | LL. B. – I | LL. B. – II | LL. B. – III | LL. B. Directory | Home