16. (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 Government 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.

17. 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 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.

18. From such date as may be fixed by the Government by notification in the official Gazette in this behalf, no person shall himself or by any other person on his behalf (a) 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; (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; (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 Government may, 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 sub clause (iii) of clause (a) shall be deemed to be true and a sufficient compliance with that sub clause 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.

19. (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 Bangladesh 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.

20. The 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. ¹[* * *]

21. (1) The 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 Chapter 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 sub section. (2) Every Inspector shall be deemed to be a public servant within the meaning of the ²[Penal Code], and shall be officially subordinate to such authority as the Government may specify in this behalf.

22. (1) Subject to the provisions of section 23 and of any rules made by the 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 and 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, cash memos, 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;(h) lock and seal any factory, laboratory, shop, building, store house 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, in so far as they are not inconsistent with the provisions of this Act, shall apply to searches and seizures made under this Chapter. (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. [Sub-section (1) was omitted by section 11 of the Drugs (Amendment) Act, 1963 (Act No. XXII of 1963).] (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 wilfully 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 sub section (3) of section 19. (5) Where an Inspector takes any action under 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 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 section.

24. 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. (1) The Government Analyst to whom a sample of any drug has been submitted for test or analysis under sub section (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 sub section (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 saidwarrantor 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 controversion of the report. (4) Unless the sample has already been tested or analysed in the Central Drugs Laboratory, where a person has under sub-section (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 sub section (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 sub section (4) shall be paid by the complainant or accused as the Court shall direct.

26. 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. 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 three years or with fine, or with both.

28. (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 Taka, or with both.

29. 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 Taka.

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. 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. (1) No prosecution under this Chapter shall be instituted except by an Inspector. (2) No Court inferior to that of a 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.

33. (1) The Government may, 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) 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 organo metallic 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 to cure or mitigate and 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 sub section (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. [Protection to persons acting under this Chapter.- Omitted by section 14 of the Drugs (Amendment) Act, 1963 (Act No. XXII of 1963).]