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Medicinal and toilet preparation act 1955

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CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES
CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES

The document summarizes the key aspects of the Medicinal and Toilet Preparations Act and Rules, 1955 in India. The objectives of the act are to provide for excise duties on medicinal and toilet preparations containing alcohol, narcotics or drugs and to control their manufacture and misuse. The act defines relevant terms and outlines the licensing process and requirements for the manufacture of such preparations both within bonded premises and outside. It also describes the duties and powers of excise officers, search and seizure procedures, offenses and penalties. The schedule lists the categories of dutiable goods and applicable rates of duty.

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MEDICINALAND TOILET PREPARATIONS ACT AND RULES,1955 G.TANUJA LAKSHMI Y18MPHRA464 UNDER THE GUIDENCE Dr. N.L. PRASANTHI
CONTENTS 1. Short Title, Extent and Commencement 2.Objective Of The Act 3. Definitions 4. Duties of Excise to Be Levied And Collected On Certain Goods. 5.Officers Required to Assist Excise Officers 6. Certain operations to Be Subject To Licences 7.Licensing 8.Manufacture 9. Power of Courts to order Forfeiture 10. Punishment For Connivance At Offence 11.Searches And Arrests How to be Made 12. Disposal of Persons Arrested 13. Failure of Excise Officers On Duty 14. Power to Make Rules 15.Schedule 3 16.Offences And Penalties.
(1) This Act may be called the Medicinal and Toilet Preparations (Excise Duties) Act, 1955. (2) It extends to the whole of India. (3) It shall come into force on such date 2 , as the Central Government may, by notification in the official Gazette, appoint.
2. OBJECTIVES OF THE ACT The Medicinal and Toilet preparation(Excise Duties) Act,1955 was passed with the following objectives :  To provide for the collection of levy and duties of excise on medicinal and toilet preparation containing alcohol, narcotic drugs or narcotics.  To provide for uniformity in the rules and rates of Excise duties livable on such preparation throughout the country  To provide the misuse of alcohol its issue transport and use should be controlled.  To provide for exhaustive rules and provisions are provided to cover all types of preparations containing alcohol, including homeopathic preparations.
3. DEFINITIONS In this Act unless the context otherwise requires- (a) "alcohol" means ethyl alcohol of any strength and purity having chemical compositio C2H5OH (aa) "Coca derivative" means – (i) crude cocaine that is any extract of coca leaf which can be used directly or indirectly, for the manufacture of cocaine; (ii) ecgonine, that is laevo-ecgonine having the chemical formula, C9H15NO3H2O, and all the derivatives of laevo-ecgonine from which it can be recovered, and (iii) cocaine, that is, methyl-benzoyl-laevo-ecgonine having the chemical formula, C1H2NO4 and its salts;
(ab) "coca-leaf" means – (i) the leaf and young twigs of any coca plant, that is, of the Erythroxylo coca (Lamk.) and the Erythroxylon novo-granatense (Hiern.) and their varieties, and of any other species of this genus which the Central Government may, by notification in the official Gazette, declare to be coca plants for the purposes of this Act, and (ii) any mixture thereof, with or without neutral materials; ( bb) derivative of opium, means – (i) medicinal opium, that is, opium which has undergone the processes necessary to adopt it for medicinal use; (ii) prepared opium, that is, any product of opium obtained by any series of operations designed to transform opium into an extract suitable for smoking and the dross or other residue remaining after opium is smoked ; (iii) morphine, that is, the principal alkaloid of opium having the chemical formula C17H19NO8,
4. DUTIES OF EXCISE TO BE LEVIED AND COLLECTED ON CERTAIN GOODS. (1) There shall be levied duties of excise, at the rates specified in the schedule, on all dutiable goods manufactured in India. 2) The duties aforesaid shall be leviable (a) where the dutiable goods are manufactured in bond, in the State in which such goods are released from a bonded warehouse for home consumption, whether such State is the State of manufacture or not; (b) where dutiable goods are not manufactured in bond, in the State in which such goo Subject to the other provisions contained in this Act, the duties aforesaid shall be collected in such manner as may be prescribed.
5. OFFICERS REQUIRED TO ASSIST EXCISE OFFICERS.  All officers of Customs and Central Excise, and such other officers of the Central Government as may be specified in this behalf,  All police officers and all officers engaged in the collection of land revenue are hereby empowered and required to assist excise officers in the execution of this Act.
6. CERTAIN OPERATIONS TO BE SUBJECT TO LICENCES. (1) The Central Government may, by notification in the official Gazette, provide that from such date as may be specified in the notification, no person shall engage in the production or manufacture of any dutiable goods or of any specified component parts or ingredients of such goods or of specified container of such goods or of labels of such containers except under the authority and in accordance with the terms and conditions of a licence granted under this Act. (2) Every licence under sub-section shall be granted for such area, if any, for such period, subject to such restrictions and conditions, and in such form and containing such particulars as may be prescribed.
7. LICENSING Manufacturing of alcoholic and narcotic preparations can only be under taken the authority of a license granted  For the purpose and such a license is issued only if the requisite license for the manufacture of drugs under Drugs and Cosmetics Act and Rules has been first obtained.  Application for the license or for its renewal is to be made to Licensing authority who is the excise commission in the case of a bonded manufactory or warehouse and in other cases, such officer as the government may authorize in this behalf.  The applicant for the license should submitted in the prescribed form accompanied with the prescribed fee, at least two months from the proposed date of commencement of the manufacture
8. MANUFACTURE The manufacture of alcoholic and other narcotic drugs can be undertaken only under the authority of a licence granted for purpose.  Such licence is issued only when the requisite licence for the manufacture of drugs under the drugs and cosmetic act has been first obtained.  The licence cannot be transferred or sold and has to be exhibited in a conspicuous part of the licensed premises. Manufacture of medicinal and toilet preparations containing alcohol is permitted both ‘in bond’ as well as ‘outside bond’.
Manufacture in bonded laboratories The license is issued from office of the Excise Commissioner of the State for alcohol. Application should be made two months in advance prior to date of manufacturing along with requisite fee as indicated. The application should include:  Name, addresses and site of bonded laboratory if it is a firm name and address of every partner of the firm if it is a company its registered name, address of the managing director and directors.  Capital to be invested for bonded appreciation.  Number and description of apparatus, machinery, still and maximum amount of alcohol to remain at one time  Approximate date of starting manufacturing ; requirement of excise officer, either whole time or part time
Structures of the Bonded Manufactory  A separate plain spirit store is required to be provided in the bonded premises.  There should be only one entrance to the laboratory, only one door for each of its compartments a separate room for manufacturing of medicinal preparations ,one or more rooms for storage, a separate room for manufacturing of toilet preparations and their storage, a room for excise officer In charge near the entrance with furniture.  The bonded laboratory should be opened and closed in presence of excise officer in charge and secured with excise ticket locks.  Every window in the bonded laboratory should be provided with iron rods not less than 19 mm in thickness set apart at a distance of not more than 102 mm
 The iron rods should be embodied in brick construction toa depth of 51 mm at each end.  The windows should be covered from inside with strong wire netting, the aperture of which should not exceed 25 mm in diameter.  Each room in bonded laboratory should have a board indicating name and a serial number of the room and the purpose for which it is used, painted in oil color.  The pipes from sinks in the laboratory should be connected to closed drainage ultimately, forming part of general drainage system.  The gas and electric supply should be arranged in such a way that they are cut off at the end of day's work from one place.
Manufacturing Outside Bond(Non-bonded Manufactory)  The manufacturing and sale operations are restricted only between sunrise and sunset and days and hours as fixed by the Excise Commissioner. Essential requirements of  Manufactory are: (i) Separate laboratory spirit store and finished store. (ii) Only one entrance to non-bonded manufactory and one door each to laboratory, spirit store and finished store. (iii) The iron bars in windows should be not less than 19 mm in thickness, set not more than 102 mm apart and fixed in brick construction to the depth of not less than 51 mm. The aperture of wire netting to the window should not exceed 25 mm in diameter. (iv) A separate spirit store for rectified spirit purchased at the specified duty.
(v) All pipes from wash basins and sinks are connected to closed drainage forming part of general drainage system. (vi) All electric and gas connections should be well secured with one cut off switch. The State Government may relax conditions of requirements of infrastructure if alcohol consumption is less.  Alcohol is procured by the manufacturer after payment of excise duty.  The form for payment of duty is filled up in triplicate, one copy is to be given to spirit warehouse keeper, second to officer in charge and third to be retained by the licensee.  The duty for alcohol purchased is to be paid to Government treasury and challan enclosed.
9. POWER OF COURTS TO ORDER FORFEITURE 1) Any excise officer duly empowered by rules made in this behalf may arrest any person whom he has reason to believe to be liable to punishment under this Act. 2) Any person accused or reasonably suspected of committing an offence under this Act or any rules made there under, who, on demand of any excise officer duly empowered by rules made under this Act, refuses to give his name and residence, or 3) who gives a name or residence which such officer has reason to believe to be false may be arrested by such officer in order that his name and residence may be ascertained.
10. PUNISHMENT FOR CONNIVANCE AT OFFENCES Any owner or occupier of land or any agent of such owner or occupier in charge of the management of the land, who willfully connives at any offence against the provisions of this Act or any rules made there under shall, for every such offence, be punishable with imprisonment for a term which may extend to six months, or with fine which may extend to five hundred rupees, or with both.
11. SEARCHES AND ARRESTS HOW TO BE MADE All arrests and searches made under this Act or under any rules made there under shall be carried out in accordance with the provisions of the Code of Criminal Procedure, 1898 (5 of 1898) 6 , relating respectively to searches
12. DISPOSAL OF PERSONS ARRESTED (1) Every person arrested under this Act shall be forwarded without delay to the nearest Excise Officer empowered to send persons so arrested to a Magistrate or if there is no such excise officer within a reasonable distance to the officer- in-charge of the nearest police station. (2) The officer-in-charge of a police station to whom any person is forwarded under sub-section (1) shall either admit him to bail to appear before a Magistrate having jurisdiction or in default of bail forward him without delay in custody to such Magistrate.
13. FAILURE OF EXCISE OFFICERS ON DUTY Any Excise Officer who ceases or refuses to perform, or withdraws himself from the duties of his office, unless he had obtained the express written permission of his superior officer or has given such superior officer two month's notice in writing of his intention or has other lawful excuse, shall be punishable with imprisonment for a term which may extend to three months, or with fine which may extend to three months' pay, or with both.
14. POWER TO MAKE RULES (1) The Central Government may, by notification in the official Gazette, make rules to carry out the purposes of this Act. (2) In particular, and without prejudice to the generality of the foregoing power, such rules may (i) provide for the assessment and collection of duties levied under this Act, the authorities by whom functions under this Act are to be discharged, the issue of notices requiring payment, the manner in which the duties shall be payable and the recovery of the duty not paid;
Item No. Description of dutiable goods Rate of duty Medicinal preparations 1 Allopathic Medicinal Preparations:- (i) Medicinal preparations containing alcohol which are not capable of being consumed as ordinary alcohol beverages (a) Patent of proprietary medicines Twenty per cent, ad valorem b)others Twenty per cent, ad valorem (ii) Medicinal preparations containing alcohol which are capable of being consumed as ordinary alcoholic beverages (a) Medicinal preparations which contain known active ingredients in therapeutic quantities. Twenty per cent, ad valorem b)others Twenty per cent, ad valorem 15. SCHEDULE 3
Item No. Description of dutiable goods Rate of duty 2 Medicinal preparations in Ayurvedic, Unani or other indigenous systems of medicine 3 (i) Medicinal preparations containing self generated alcohol which are not capable of being consumed as ordinary alcoholic beverages. Four per cent, ad valorem 4 b)others Twenty per cent, ad valorem 5 Homoeopathic preparations containing alcohol Fifty percent ad- valorem Toilet preparations Toilet preparations containing alcohol or narcotic drug or narcotic Fifty percent ad- valorem CONT…
16. OFFENCES AND PENALTIES. If any person (a) contravenes any of the provisions of a notification issued under Sec. 6; or (b) evades the payment of any duty of excise payable under this Act; or (c) fails to supply any information which he is required by rules made under this Act to supply or (unless with a reasonable belief, the burden of proving which shall be upon him, that the information supplied by him is true) supplies false information; or (d) attempts to commit or abets the commission of any offence mentioned in Cl. (a) or Cl. (b). He shall for every such offence be punishable with imprisonment for a term which may extend to six months, or with fine which may extend to two thousand rupees, or with both
Medicinal and toilet preparation act 1955

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Medicinal and toilet preparation act 1955

  • 1. MEDICINALAND TOILET PREPARATIONS ACT AND RULES,1955 G.TANUJA LAKSHMI Y18MPHRA464 UNDER THE GUIDENCE Dr. N.L. PRASANTHI
  • 2. CONTENTS 1. Short Title, Extent and Commencement 2.Objective Of The Act 3. Definitions 4. Duties of Excise to Be Levied And Collected On Certain Goods. 5.Officers Required to Assist Excise Officers 6. Certain operations to Be Subject To Licences 7.Licensing 8.Manufacture 9. Power of Courts to order Forfeiture 10. Punishment For Connivance At Offence 11.Searches And Arrests How to be Made 12. Disposal of Persons Arrested 13. Failure of Excise Officers On Duty 14. Power to Make Rules 15.Schedule 3 16.Offences And Penalties.
  • 3. (1) This Act may be called the Medicinal and Toilet Preparations (Excise Duties) Act, 1955. (2) It extends to the whole of India. (3) It shall come into force on such date 2 , as the Central Government may, by notification in the official Gazette, appoint.
  • 4. 2. OBJECTIVES OF THE ACT The Medicinal and Toilet preparation(Excise Duties) Act,1955 was passed with the following objectives :  To provide for the collection of levy and duties of excise on medicinal and toilet preparation containing alcohol, narcotic drugs or narcotics.  To provide for uniformity in the rules and rates of Excise duties livable on such preparation throughout the country  To provide the misuse of alcohol its issue transport and use should be controlled.  To provide for exhaustive rules and provisions are provided to cover all types of preparations containing alcohol, including homeopathic preparations.
  • 5. 3. DEFINITIONS In this Act unless the context otherwise requires- (a) "alcohol" means ethyl alcohol of any strength and purity having chemical compositio C2H5OH (aa) "Coca derivative" means – (i) crude cocaine that is any extract of coca leaf which can be used directly or indirectly, for the manufacture of cocaine; (ii) ecgonine, that is laevo-ecgonine having the chemical formula, C9H15NO3H2O, and all the derivatives of laevo-ecgonine from which it can be recovered, and (iii) cocaine, that is, methyl-benzoyl-laevo-ecgonine having the chemical formula, C1H2NO4 and its salts;
  • 6. (ab) "coca-leaf" means – (i) the leaf and young twigs of any coca plant, that is, of the Erythroxylo coca (Lamk.) and the Erythroxylon novo-granatense (Hiern.) and their varieties, and of any other species of this genus which the Central Government may, by notification in the official Gazette, declare to be coca plants for the purposes of this Act, and (ii) any mixture thereof, with or without neutral materials; ( bb) derivative of opium, means – (i) medicinal opium, that is, opium which has undergone the processes necessary to adopt it for medicinal use; (ii) prepared opium, that is, any product of opium obtained by any series of operations designed to transform opium into an extract suitable for smoking and the dross or other residue remaining after opium is smoked ; (iii) morphine, that is, the principal alkaloid of opium having the chemical formula C17H19NO8,
  • 7. 4. DUTIES OF EXCISE TO BE LEVIED AND COLLECTED ON CERTAIN GOODS. (1) There shall be levied duties of excise, at the rates specified in the schedule, on all dutiable goods manufactured in India. 2) The duties aforesaid shall be leviable (a) where the dutiable goods are manufactured in bond, in the State in which such goods are released from a bonded warehouse for home consumption, whether such State is the State of manufacture or not; (b) where dutiable goods are not manufactured in bond, in the State in which such goo Subject to the other provisions contained in this Act, the duties aforesaid shall be collected in such manner as may be prescribed.
  • 8. 5. OFFICERS REQUIRED TO ASSIST EXCISE OFFICERS.  All officers of Customs and Central Excise, and such other officers of the Central Government as may be specified in this behalf,  All police officers and all officers engaged in the collection of land revenue are hereby empowered and required to assist excise officers in the execution of this Act.
  • 9. 6. CERTAIN OPERATIONS TO BE SUBJECT TO LICENCES. (1) The Central Government may, by notification in the official Gazette, provide that from such date as may be specified in the notification, no person shall engage in the production or manufacture of any dutiable goods or of any specified component parts or ingredients of such goods or of specified container of such goods or of labels of such containers except under the authority and in accordance with the terms and conditions of a licence granted under this Act. (2) Every licence under sub-section shall be granted for such area, if any, for such period, subject to such restrictions and conditions, and in such form and containing such particulars as may be prescribed.
  • 10. 7. LICENSING Manufacturing of alcoholic and narcotic preparations can only be under taken the authority of a license granted  For the purpose and such a license is issued only if the requisite license for the manufacture of drugs under Drugs and Cosmetics Act and Rules has been first obtained.  Application for the license or for its renewal is to be made to Licensing authority who is the excise commission in the case of a bonded manufactory or warehouse and in other cases, such officer as the government may authorize in this behalf.  The applicant for the license should submitted in the prescribed form accompanied with the prescribed fee, at least two months from the proposed date of commencement of the manufacture
  • 11. 8. MANUFACTURE The manufacture of alcoholic and other narcotic drugs can be undertaken only under the authority of a licence granted for purpose.  Such licence is issued only when the requisite licence for the manufacture of drugs under the drugs and cosmetic act has been first obtained.  The licence cannot be transferred or sold and has to be exhibited in a conspicuous part of the licensed premises. Manufacture of medicinal and toilet preparations containing alcohol is permitted both ‘in bond’ as well as ‘outside bond’.
  • 12. Manufacture in bonded laboratories The license is issued from office of the Excise Commissioner of the State for alcohol. Application should be made two months in advance prior to date of manufacturing along with requisite fee as indicated. The application should include:  Name, addresses and site of bonded laboratory if it is a firm name and address of every partner of the firm if it is a company its registered name, address of the managing director and directors.  Capital to be invested for bonded appreciation.  Number and description of apparatus, machinery, still and maximum amount of alcohol to remain at one time  Approximate date of starting manufacturing ; requirement of excise officer, either whole time or part time
  • 13. Structures of the Bonded Manufactory  A separate plain spirit store is required to be provided in the bonded premises.  There should be only one entrance to the laboratory, only one door for each of its compartments a separate room for manufacturing of medicinal preparations ,one or more rooms for storage, a separate room for manufacturing of toilet preparations and their storage, a room for excise officer In charge near the entrance with furniture.  The bonded laboratory should be opened and closed in presence of excise officer in charge and secured with excise ticket locks.  Every window in the bonded laboratory should be provided with iron rods not less than 19 mm in thickness set apart at a distance of not more than 102 mm
  • 14.  The iron rods should be embodied in brick construction toa depth of 51 mm at each end.  The windows should be covered from inside with strong wire netting, the aperture of which should not exceed 25 mm in diameter.  Each room in bonded laboratory should have a board indicating name and a serial number of the room and the purpose for which it is used, painted in oil color.  The pipes from sinks in the laboratory should be connected to closed drainage ultimately, forming part of general drainage system.  The gas and electric supply should be arranged in such a way that they are cut off at the end of day's work from one place.
  • 15. Manufacturing Outside Bond(Non-bonded Manufactory)  The manufacturing and sale operations are restricted only between sunrise and sunset and days and hours as fixed by the Excise Commissioner. Essential requirements of  Manufactory are: (i) Separate laboratory spirit store and finished store. (ii) Only one entrance to non-bonded manufactory and one door each to laboratory, spirit store and finished store. (iii) The iron bars in windows should be not less than 19 mm in thickness, set not more than 102 mm apart and fixed in brick construction to the depth of not less than 51 mm. The aperture of wire netting to the window should not exceed 25 mm in diameter. (iv) A separate spirit store for rectified spirit purchased at the specified duty.
  • 16. (v) All pipes from wash basins and sinks are connected to closed drainage forming part of general drainage system. (vi) All electric and gas connections should be well secured with one cut off switch. The State Government may relax conditions of requirements of infrastructure if alcohol consumption is less.  Alcohol is procured by the manufacturer after payment of excise duty.  The form for payment of duty is filled up in triplicate, one copy is to be given to spirit warehouse keeper, second to officer in charge and third to be retained by the licensee.  The duty for alcohol purchased is to be paid to Government treasury and challan enclosed.
  • 17. 9. POWER OF COURTS TO ORDER FORFEITURE 1) Any excise officer duly empowered by rules made in this behalf may arrest any person whom he has reason to believe to be liable to punishment under this Act. 2) Any person accused or reasonably suspected of committing an offence under this Act or any rules made there under, who, on demand of any excise officer duly empowered by rules made under this Act, refuses to give his name and residence, or 3) who gives a name or residence which such officer has reason to believe to be false may be arrested by such officer in order that his name and residence may be ascertained.
  • 18. 10. PUNISHMENT FOR CONNIVANCE AT OFFENCES Any owner or occupier of land or any agent of such owner or occupier in charge of the management of the land, who willfully connives at any offence against the provisions of this Act or any rules made there under shall, for every such offence, be punishable with imprisonment for a term which may extend to six months, or with fine which may extend to five hundred rupees, or with both.
  • 19. 11. SEARCHES AND ARRESTS HOW TO BE MADE All arrests and searches made under this Act or under any rules made there under shall be carried out in accordance with the provisions of the Code of Criminal Procedure, 1898 (5 of 1898) 6 , relating respectively to searches
  • 20. 12. DISPOSAL OF PERSONS ARRESTED (1) Every person arrested under this Act shall be forwarded without delay to the nearest Excise Officer empowered to send persons so arrested to a Magistrate or if there is no such excise officer within a reasonable distance to the officer- in-charge of the nearest police station. (2) The officer-in-charge of a police station to whom any person is forwarded under sub-section (1) shall either admit him to bail to appear before a Magistrate having jurisdiction or in default of bail forward him without delay in custody to such Magistrate.
  • 21. 13. FAILURE OF EXCISE OFFICERS ON DUTY Any Excise Officer who ceases or refuses to perform, or withdraws himself from the duties of his office, unless he had obtained the express written permission of his superior officer or has given such superior officer two month's notice in writing of his intention or has other lawful excuse, shall be punishable with imprisonment for a term which may extend to three months, or with fine which may extend to three months' pay, or with both.
  • 22. 14. POWER TO MAKE RULES (1) The Central Government may, by notification in the official Gazette, make rules to carry out the purposes of this Act. (2) In particular, and without prejudice to the generality of the foregoing power, such rules may (i) provide for the assessment and collection of duties levied under this Act, the authorities by whom functions under this Act are to be discharged, the issue of notices requiring payment, the manner in which the duties shall be payable and the recovery of the duty not paid;
  • 23. Item No. Description of dutiable goods Rate of duty Medicinal preparations 1 Allopathic Medicinal Preparations:- (i) Medicinal preparations containing alcohol which are not capable of being consumed as ordinary alcohol beverages (a) Patent of proprietary medicines Twenty per cent, ad valorem b)others Twenty per cent, ad valorem (ii) Medicinal preparations containing alcohol which are capable of being consumed as ordinary alcoholic beverages (a) Medicinal preparations which contain known active ingredients in therapeutic quantities. Twenty per cent, ad valorem b)others Twenty per cent, ad valorem 15. SCHEDULE 3
  • 24. Item No. Description of dutiable goods Rate of duty 2 Medicinal preparations in Ayurvedic, Unani or other indigenous systems of medicine 3 (i) Medicinal preparations containing self generated alcohol which are not capable of being consumed as ordinary alcoholic beverages. Four per cent, ad valorem 4 b)others Twenty per cent, ad valorem 5 Homoeopathic preparations containing alcohol Fifty percent ad- valorem Toilet preparations Toilet preparations containing alcohol or narcotic drug or narcotic Fifty percent ad- valorem CONT…
  • 25. 16. OFFENCES AND PENALTIES. If any person (a) contravenes any of the provisions of a notification issued under Sec. 6; or (b) evades the payment of any duty of excise payable under this Act; or (c) fails to supply any information which he is required by rules made under this Act to supply or (unless with a reasonable belief, the burden of proving which shall be upon him, that the information supplied by him is true) supplies false information; or (d) attempts to commit or abets the commission of any offence mentioned in Cl. (a) or Cl. (b). He shall for every such offence be punishable with imprisonment for a term which may extend to six months, or with fine which may extend to two thousand rupees, or with both