Section 33

Amendment status not verified — confirm the current text below against the official source.

Power of Central Government to make rules. – (1) The Central Government may after consultation with, or on the recommendation of, 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 : Provided that consultation with the Board may be dispensed with if the Central Government is of opinion that circumstances have arisen which render it necessary to make rules without such consultation, but in such a case the Board shall be consulted within six months of the making of the rules and the Central Government shall take into consideration any suggestions which the Board may make in relation to the amendment of the said rules. (2) Without prejudice to the generality of the foregoing power, such rules may – (a) provide for the establishment of laboratories for testing and analyzing drugs or cosmetics; (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 or cosmetic is of standard quality; (d) prescribe, in respect of biological and organ metallic compounds, the units or methods of standardization; (dd) prescribe under clause (d) of section 17-A the colour or colours which a drug may bear or contain for purposes of colouring; (dda) prescribe under clause (d) of section 17-E the colour or colours which a cosmetic may bear or contain for purposes of colouring; (e) prescribe the forms of licences for the manufacture for sale or for distribution, for the sale and for the distribution of drugs or any specified drug or class of drugs or of cosmetic or any specified cosmetic or class of cosmetics, the form of application for such licences, the conditions subject to which such licences may be issued, the authority empowered to issue the same the qualifications of such authority and the fees payable therefore and provide for the cancellation or suspension of such licences in any case where any provision of this Chapter or the rules made there under is contravened or any of the conditions subject to which they are issued is not complied with; 28 (ee) prescribe the records, registers or other documents to be kept and maintained under section 18-B; (eea) prescribed the fees for the inspection (for the purposes of grant or renewal of licences) of premises, wherein any drug or cosmetic is being or is proposed to be manufactured; (eeb) prescribe the manner in which copies are to be certified under sub-section (2-A) of section 22; (f) specify the diseases or ailments, which a drug may not purport or claim to prevent, 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 or cosmetics including the use of packing material which comes into direct contact with the drugs and prohibit the sale, stocking or exhibition for sale, or distribution of drugs or cosmetics packed in contravention of such conditions; (j) regulate the mode of labeling packed drugs or cosmetics, 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 there under; (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) omitted. (n) prescribe the powers and duties of and the qualifications of the authority to which such Inspectors shall be subordinate and specify the drugs or classes of drugs or cosmetics or classes of cosmetics in relation to which and the conditions, limitations or restrictions subject to which, such powers and duties may be exercised or performed; 29 (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 there under in relation to which an order of confiscation may be made 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 there under, of any specified drug or class of drugs or cosmetic or class of cosmetics; and (r) sum which may be specified by the Central Government under section 32-B. 33-A. Chapter not to apply to Ayurvedic, Siddha or Unani drugs. – Save as otherwise provided in this Act, nothing contained in this Chapter shall apply to Ayurvedic, Siddha or Unani drugs. CHAPTER IV-A PROVISIONS RELATING TO AYURVEDIC, SIDDHA AND UNANI DRUGS 33-B. Application of Chapter IVA. – This Chapter shall apply only to Ayurvedic, Siddha and Unani drugs. 33-C. Ayurvedic and Unani Drugs Technical Advisory Board. – (1) The Central Government shall, by notification in the Official Gazette and with effect from such date as may be specified therein, constitute a Board (to be called the Ayurvedic, Siddha and Unani Drugs Technical Advisory Board to advise the Central Government and the State Governments on technical matters arising out of this Chapter and to carry out the other functions assigned to it by this Chapter. (2) The Board shall consist of the following members, namely, - (i) The Director General of Health Services, ex officio; (ii) The Drugs Controller, India, ex officio, (iii) The principal officer dealing with Indian systems of medicine in the Ministry of Health, ex-officio; (iv) The Director of the Central Drugs Laboratory, Calcutta, ex-officio; (v) One person holding the appointment of Government Analyst under section 33-F, to be nominated by the Central Government; (vi) One Pharmacognocist to be nominated by the Central Government; (vii) One Phyto-chemist to be nominated by the Central Government; 30 (viii) Four persons to be nominated by the Central Government, two from amongst the members of the Ayurvedic Pharmacopoeia Committee, one from amongst the members of Unani Pharmacopoeia Committee and one from amongst the members of the Siddha Pharmacopoeia Committee; (ix) One teacher in Darvyaguna, and Bhaishajya Kalpana, to be nominated by the Central Government; (x) One teacher in ILM-UL-ADVIA and TAKLIS-WA-DAWASAZI, to be nominated by the Central Government; (xi) One teacher in Gunapadam to be nominated by the Central Government; (xii) Three persons, one each to represent the Ayurvedic, Siddha and Unani drug industry, to be nominated by the Central Government; (xiii) Three persons, one each from amongst the practitioners of Ayurvedic, Siddha and Unani Tibb systems of medicine to be nominated by the Central Government. (3) The Central Government shall appoint a member of the Board as its Chairman. (4) The nominated members of the Board shall hold office for three years but shall be eligible for recombination. (5) The Board may, subject to the previous approval of the Central Government, make bye-laws fixing quorum and regulating its own procedure and conduct of all business to be transacted by it. (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. 33-D. The Ayurvedic, Siddha and Unani Drugs Consultative Committee. – (1) The Central Government may constitute an Advisory Committee to be called the Ayurvedic, Siddha and Unani Drugs Consultative Committee to advise the Central Government, the State Governments and the Ayurvedic, Siddha and Unani Drugs Technical Advisory Board on any matter for the purpose of securing uniformity throughout India in the administration of this Act in so far as it relates to Ayurvedic, Siddha or Unani drugs. (2) The Ayurvedic, Siddha and Unani Drugs Consultative Committee shall consist of two persons to be nominated by the Central Government as representatives of that Government and not more than one representative of each State to be nominated by the State Government concerned. 31 (3) The Ayurvedic, Siddha and Unani Drugs Consultative Committee shall meet when required to do so by the Central Government and shall regulate its own procedure. 33-E. Misbranded drugs. – For the purposes of this Chapter, an Ayurvedic, Siddha or Unani drug shall be deemed to be misbranded – (a) 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 (b) If it is not labeled in the prescribed manner; or (c) 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. 33-EE. Adulterated drugs. – For the purposes of this Chapter, an Ayurvedic, Siddha or Unani drug shall be deemed to be adulterated, - (a) If it consists, in whole or in part, of any filthy, putrid or decomposed substance; or (b) It has been prepared, packed or stored under in sanitary conditions whereby it may have been contaminated with filth or whereby it may have been rendered injurious to health; or (c) If its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or (d) If it bears or contains, for purposes of colouring only, a colour other than one which is prescribed; or (e) If it contains any harmful or toxic substance which may render it injurious to health; or (f) If any substance has been mixed therewith so as to reduce its quality or strength. Explanation. – For the purpose of clause (a), a drug shall not be deemed to consist, in whole or in part, of any decomposed substance only by reason of the fact that such decomposed substance is the result of any natural decomposition of the drug: Provided that such decomposition is not due to any negligence on the part of the manufacturer of the drug or the dealer thereof and that it does not render the drug injurious to health. 33-EEA. Spurious drugs. – For the purposes of this Chapter, an Ayurvedic, Siddha or Unani drug shall be deemed to be spurious – 32 (a) If it is sold, or offered or exhibited for sale, under a name which belongs to another drug; or (b) If it is an imitation of, or is a substitute for, another drug or resembles another drug in a manner likely to deceive, 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 (c) If the label or container bears the name of an individual or company purporting to be the manufacturer of the drug, which individual or company is fictitious or does not exist; or (d) If it has been substituted wholly or in part by any other drug or substance; or (e) If it purports to be the product of a manufacturer of whom it is not truly a product. 33-EEB. Regulation of manufacturer for sale of Ayurvedic, Siddha and Unani drugs. – No person shall manufacture for sale or for distribution any Ayurvedic, Siddha or Unani drug except in accordance with such standards, if any, as may be prescribed in relation to that drug. 33-EEC. Prohibition of manufacture and sale of certain Ahyurvedic, Siddha and Unani drugs. – From such date as the State Government may, by notification in the Official Gazette, specify in this behalf, no person, either by himself or by any other person on his behalf, shall – (a) Manufacture for sale or for distribution – (i) Any misbranded, adulterated or Ayurvedic, siddha or Unani drug; (ii) Any patent or proprietary medicine, unless there is displayed in the prescribed manner on the label or container thereof the true list of all the ingredients contained in it; and (iii) Any Ayurvedic, Siddha or Unani drug in contravention of any of the provisions of this Chapter or any rule made thereunder; (b) Sell, stock or exhibit or offer for sale or offer for sale or distribute any Ayurvedic, Siddha or Unani drug which has been manufactured in contravention of any of the provisions of this Act, or any rule made thereunder: (c) Manufacture for sale or for distribution, any Ahyurvedic, Siddha or Unani drug, except under, and in accordance with the conditions of, a licence issued for such purpose under this Chapter by the prescribed authority. 33 Provided that nothing in this section shall apply to Vaidyas and Hakims who manufacture Ayurvedic, Siddha or Unani drug for the use of their own patients: Provided further that nothing in this section shall apply to the manufacture, subject to the prescribed conditions, of small quantities of any Ayurvedic, Siddha or Unani drug for the purpose of examination, test or analysis. 33-EED. Power of Central Government to prohibit manufacture, etc., of Ayurvedic, Siddha or Unani drugs in public interest. – Without prejudice to any other provision contained in this Chapter, if the Central Government is satisfied on the basis of any evidence or other material available before it that the use of any Ahyurvedic, Siddha or Unani drug is likely to involve any risk to human beings or animals or that any such drug does not have the therapeutic value claimed or purported to be claimed for it and that in the public interest it is necessary or expedient so to do then, that Government may, by notification in the Official Gazette, prohibit the manufacture, sale or distribution of such drug. 33-F. Government Analysts. – (1) The Central Government or a State 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 as may be assigned to them by the Central Government or the State Government, as the case may be. (2) Notwithstanding anything contained in sub-section (1), neither the Central Government nor a State Government shall appoint as a Government Analyst any official not serving under it without the previous consent of the Government under which he is serving. (3) No person who has any financial interest in the manufacture or sale of any drug shall be appointed to be a Government Analyst under this section. 33-G. Inspectors. – (1) The Central Government or a State Government may, by notification in the Official Gazette, appoint such persons as it thinks fit, having the prescribed qualifications, to be Inspectors for such areas as may be assigned to them by the Central Government or the State Government as the case may be. (2) The powers which may be exercised by an Inspector and the duties which may be performed by him and the conditions, limitations or restrictions subject to which such powers and duties may be exercised or performed shall be such as may be prescribed. (3) No person who has any financial interest in the manufacture or sale of any drug shall be appointed to be an Inspector under this section. (4) Every Inspector shall be deemed to be a public servant within the meaning of section 21 of the Indian Penal Code and shall be officially sub-ordinate to such authority as the Central Government appointing him may specify in this behalf. 34 33-H. Application of provisions of sections 22, 23, 24 and 25. – The provisions of sections 22, 23, 24 and 25 and the rules, if any, made there under shall, so far as may be, apply in relation to an Inspector and a Government Analyst appointed under this Chapter as they apply in relation to an Inspector and a Government Analyst appointed under Chapter IV, subject to the modification that the references to "drug" in the said sections, shall be construed as references to Ayurvedic, Siddha or Unani drug. 33-I. Penalty for manufacture, sale, etc., of Ayurvedic, Siddha or Unani drug in contravention of this Chapter. – Whoever himself or by any other person on his behalf— (1) Manufactures for sale or for distribution – (a) Any Ayurvedic, Siddha or Unani drug – (i) Deemed to be adulterated under section 33EE, or (ii) Without a valid licence as required under clause ( c) of section 33EEC, shall be punishable with imprisonment for a term which may extend to one year and with fine which shall not be less than twenty thousand rupees or three times the value of the drugs confiscated, whichever is more; (b) Any Ayurvedic, Siddha or Unani drug deemed to be spurious under section 33EEA, shall be punishable with imprisonment for a term which shall not be less than one year but which may extend to three years and with fine which shall not be less than fifty thousand rupees or three times the value of the drugs confiscated, whichever is more: Provided that the Court may, for any adequate and special reasons to be mentioned in the judgment, impose a sentence of imprisonment for a term of less than one year and of fine of less than fifty thousand rupees or three times the value of the drugs confiscated, whichever is more; or (c) any Ayurvedic, Siddha or Unani drug in contravention of the provisions of any notifications issuedunder Section 33-EED shall be punishable with imprisonment for a term which may extend to three years and with fine which may extend to fifty thousand rupees or three times the value of the drugs confiscated, whichever is more. (2) Contravenes any other provisions of this Chapter or of section 24 as applied by section 33H or any rule made under this Chapter, shall be punishable with imprisonment for a term which may extend to six months and with fine which shall not be less than ten thousand rupees. 33-J. Penalty for subsequent offences. – Whoever having been convicted of an offences, - 35 (a) Under clause (a) of sub-section (1) of section 33-I is again convicted of an offence under that clause, shall be punishable with imprisonment for a term which may extend to two years and with fine which shall not be less than fifty thousand rupees or three times the value of the drugs confiscated, whichever is more; (b) Under clause (b) of sub-section (1) of section 33-I is again convicted of an offence under that clause, shall be punishable with imprisonment for a term which shall not be less than two years but which may extend to six years and with fine which shall not be less than one lakh rupees or three times the value of the drugs confiscated, whichever is more:: Provided that the Court may, for any adequate and special reasons to be mentioned in the judgment, impose a sentence of imprisonment for a term of less than two years and of fine of less than one lakh rupees or three times the value of the drugs confiscated, whichever is more; ; (c) Under sub-section (2) of section 33-I is again convicted of an offence under that sub-section, shall be punishable with imprisonment for a term which may extend to one year and with fine which shall not be less than twenty thousand rupees or three times the value of the drugs confiscated, whichever is more; . 33-K. Confiscation. – Where any person has been convicted under this Chapter, the stock of the Ayurvedic, Siddha or Unani drug, in respect of which the contravention has been made, shall be liable to confiscation. 33-KA. Disclosure of name of manufacturer etc., –Every person, not being the manufacturer of any Ayurvedic, Siddha or Unani drug or his agent for the distribution thereof, shall, if so required, disclose to the Inspector the name, address and other particulars of the person from whom he acquired the Ayurvedic, Siddha or Unani drug. 33-KB. Maintenance of records and furnishing of information.— Every person holding a licence under clause (c) of section 33-EEC shall keep and maintain such records, registers and other documents as may be prescribed and shall furnish to any officer or authority exercising any power or discharging any function under this Act such information as is required by such officer or authority for carrying out the purposes of this Act. 33-L. Application of provisions to Government departments. – The provisions of this Chapter except those contained in section 33K shall apply in relation to the manufacture for sale, sale or distribution of any Ayurvedic, Siddha or Unani drug by any department of Government as they apply in relation to the manufacture for sale, sale or distribution of such drug by any other person. 33-M. Cognizance of offences. – (1) No prosecution under this Chapter shall be instituted except by an Inspector with the previous sanction of the authority specified under sub-section (4) of section 33-G. 36 (2) No Court inferior to that of a Metropolitan Magistrate or of a Judicial Magistrate of the first class shall try an offence punishable under this Chapter. 33-N. Power of Central Government to make rules. – (1) The Central Government may, after consultation with, or on the recommendation of, 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 : Provided that consultation with the Board may be dispensed with if the Central Government is of opinion that circumstances have arisen which render it necessary to make rules without such consultation, but in such case, the Board shall be consulted within six months of the making of the rules and the Central Government shall take into consideration any suggestions which the Board may make in relation to the amendment of the said rules. (2) Without prejudice to the generality of the foregoing power, such rules may – (a) Provide for the establishment of laboratories for testing and analysing Ayurvedic, Siddha or Unani 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 any Ayurvedic, Siddha or Unani drug is labeled with the true list of the ingredients which it is purported to contain; (d) Specify any substance as a poisonous substance; (e) Prescribe the forms of licences for the manufacture for sale of Ayurvedic, Siddha or Unani drug and for sale of processed Ayurvedic, Siddha or Unani 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, and provide for the cancellation or suspension of such licences in any case where any provision of this Chapter or rules made there under is contravened or any of the conditions subject to which they are issued is not complied with; (f) Prescribe the conditions to be observed in the packing of Ayurvedic, Siddha and Unani drugs including the use of packing material which comes into direct contact with the drugs, regulate the mode of labeling packed drugs and prescribe the matters which shall or shall not be included in such labels; (g) Prescribe the conditions subject to which small quantities of Ayurvedic, Siddha or Unani] drugs may be manufactured for the purpose of examination, test or analysis; 37 (gg) Prescribe under clause (d) of section 33-EE the colour or colours which an Ayurvedic, Siddha or Unani drug may bear or contain for purposes of colouring; (gga) Prescribe the standards for Ayurvedic, Siddha or Unani drugs under section 33-EB; (h) Any other matter which is to be or may be prescribed under this Chapter. 33-O. Power to amend First Schedule. – 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 First Schedule for the purposes of this Chapter and thereupon the said Schedule shall be deemed to be amended accordingly. CHAPTER V MISCELLANEOUS 33-P. Power to give directions. - The Central Government may give such directions to any State Government as may appear to the Central Government to be necessary for carrying into execution in the State any of the provisions of this Act or of any rule or order made there under.