Medicinal and Toilet Preparation Act-1955
•Alcohol has always been a fascinating friend of the mankind.
•Drinking alcohol for pleasure’s sake is an abuse.
•Use of alcohol for preparation of medicines is necessity.
•Alcohol used either for drinking or manufacture of
perfumes is subjected to higher duties than that of used in medicine preparation.
•Affordability of alcohol is to be controlled.
•This is the reason to take thisAct in existence. Act was passed in 1955 and rules were passed in 1956 To provide collection of levy and collection of duties on medicinal and the toilet preparations containing alcohol , narcotic drugs or narcotics.
Came to force on 1st April, 1957.
An excise or excise tax is a tax on production or sale
of various goods especially luxuries, tobacco, alcohol etc.
In common terminology (but not necessarily in law), an excise is distinguished from a sales tax in three ways:
(i)an excise typically applies to a narrower range of products;
(ii)an excise is typically heavier, accounting for a higher fractionof the retail price of the targeted products; and
(iii)an excise is typically a per unit tax, costing a specific amountfor a volume or unit of the item purchased.
Alcohol- means ethyl alcohol of any strength and purity having chemical composition C2H 5OH.
Dutiable goods-means the medicinal and toilet preparations specified in the Schedule as being subject to the duties of excise levied under this act .
Excise Officer- means the officer of the Excise Department of any State and any person empowered to exercise all or
any of the powers of the excise officer under thisAct. manufactured only under the authority of a license.
License for this purpose can be issued only if the person has license for the manufacture of drugs under drugs and cosmetics act and rules.
Procedure for obtaining license.-
Application for the license or for its renewal is made to the licensing authority who is
(i)the Excise Commissioner in the case of a bonded manufactory or warehouse;
(ii) in other cases, such officer as the State Government may authorize in this behalf. A person desiring to obtain a license to establish a bonded or non-bonded manufactory shall in his application for license furnish the following particular:
On receipt of an applica
Supply of rectified spirit for manufacture of medicinal and toilet Preparation:
Manufacture in bond
➢Alcohol on which duty has not been paid is to be used
under excise supervision
Layout of in bond laboratories:
➢There shall be only one entrance to the bonded manufactory and one door to the each of the compartments.
All these doors should be secured with excise ticket locks
during the absence of officer in-charge.
A bonded manufactory has provisions for the following:
MANUFACTURE OF ALCOHOLIC PREPARATION:
Procurement of rectified spirit:
Storage of finished products:
•Medicinal and toilet preparations are to be stored in the jars or bottles each containing not less than 80 fluid ounce
•Every container of the finished preparation should bear a
label showing its name, batch number, alcoholic strength and the name of the manufacturer.
•The containers should be arranged in suitable racks that it allows the ready identification of each batch.
•Issue of alcoholic preparations from the bonded
•Alcoholic preparations from a bonded laboratory can be taken out by
a manufacturer by making an application to the excise officer in the
prescribed form after paying duty on it.
•EO after checking the entries and releasing the duty payable, allows the required quantities to be removed after issuing a permit.
•Dutiable goods cannot be delivered from a bonded manufactory or a bonded warehouse before 6 am and after 6 pm
nor at any hour on Sundays or other holidays.Disposal of sub-standard preparations.
Establishment of bonded warehouses.-
The manufacturers or dealers in dutiable goods may establish bonded warehouses anywhere in India. No duty paid goods and no goods other than dutiable goods shall be deposited in such bonded warehouses. The Excise Commissioner shall license
- Subject:- pharmaceutical Jurisprudence
- Course:- B.pharm (pharmacy),
- Semester:- 4th sem , sem :- 4
Medicinal and Toilet Preparation Act-1955 www.remixeducation.in â€¢Alcohol has always been a fascinating friend of the mankind. â€¢Drinking alcohol for pleasureâ€™s sake is an abuse. â€¢Use of alcohol for preparation of medicines is necessity. â€¢Alcohol used either for drinking or manufacture of perfumes is subjected to higher duties than that of used in medicine preparation. www.remixeducation.in â€¢Affordability of alcohol is to be controlled. â€¢This is the reason to take this Act in existence. 2 Prior to the enactment of â€˜Medicinal and toilet preparation actâ€™, each state had different set of rules for the spirituous medicinal preparations. Same item had different excise duty in different states, leading to inter-state smuggling of such preparations. This is the reason to take this Act in existence. www.remixeducation.in 3 Act was passed in 1955 and rules were passed in 1956 To provide collection of levy and collection of duties on medicinal and the toilet preparations containing alcohol , narcotic drugs or narcotics. Came to force on 1st April, 1957. www.remixeducation.in 4 An excise or excise tax is a tax on production or sale of various goods especially luxuries, tobacco, alcohol etc. In common terminology (but not necessarily in law), an excise is distinguished from a sales tax in three ways: (i)an excise typically applies to a narrower range of products; (ii)an excise is typically heavier, accounting for a higher fraction of the retail price of the targeted products; and (iii)an excise is typically a per unit tax, costing a specific amount for a volume or unit of the item purchased. www.remixeducation.in 5 Definitions Alcohol- means ethyl alcohol of any strength and purity having chemical composition C2H 5OH. Dutiable goods-means the medicinal and toilet preparations specified in the Schedule as being subject to the duties of excise levied under this act . Excise Officer- means the officer of the Excise Department of any State and any person empowered to exercise all or any of the powers of the excise officer under thisAct. www.remixeducation.in 6 Medicinal Preparation- includes all drugs which are remedy or prescription prepared 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. Toilet preparation- means any preparation which is intended for use in the toilet of the human body or in perfuming apparel of any description, or any substance intended to cleanse, improve, or alter the complexion, hair, skin or teeth and includes deodorants and perfumes. Absolute alcohol- means alcohol confirming to the British Pharmacopoeial specification for dehydrated alcohol www.remixeducation.in 7 Bonded manufactory- means the premises or any part of the premises approved and licensed for the manufacture and storage of medicinal and toilet preparations containing alcohol, opium, Indian hemp and other narcotic drugs or narcotics on which duty has not been paid. Non-bonded manufactory-means the premises or any part of the premises approved and licensed for the manufacture and storage of medicinal and toilet preparations containing alcohol, opium Indian hemp and other narcotic drugs or narcotics on which duty has been paid. www.remixeducation.in 8 â€œDenatured spiritâ€� or â€œ Denatured alcoholâ€� means alcohol of any strength which has been rendered unfit for human consumption by the addition of substances approved by the Central Government or by the State Government with the approval of the Central Government. finished store- means that portion of a non bonded or bonded manufactory which is set apart for the storage of its finished preparations â€œlaboratoryâ€� â€œ means that part of a non-bonded or bonded manufactory in which the actual manufacture of dutiable goods takes place. rectified spiritâ€� means plain un-denatured alcohol of a strength not less than 50.0Â° over proof and includes absolute alcohol. www.remixeducation.in 9 Restricted preparationâ€� means every medicinal preparation specified in the schedule and includes every preparation declared by the Central Government as restricted preparation. â€œUnrestricted preparationâ€� means any medicinal preparation containing alcohol but other than a restricted preparation or a spurious preparation; www.remixeducation.in 10 â€œspirit storeâ€� means that portion of the bonded or non- bonded manufactory which is set apart for the storage of alcohol, opium, Indian hemp and other narcotic drugs or narcotics purchased free of duty or at prescribed rates of duty specified in the schedule to theAct. Sub-standard preparation- is -- (a)a pharmaceutical preparation in which the amount of any of the various ingredients is below the minimum that the pharmacopoeial composition would require , or (b)a proprietary medicine which does not conform to the formula or the list of ingredients disclosed on the label on the container or on the container www.remixeducation.in 11 Standard preparation- means a preparation other than a â€œ sub-standards preparation. Warehouse-means any place or premises licensed under rule 70. www.remixeducation.in 12 manufactured only under the authority of a license. License for this purpose can be issued only if the person has license for the manufacture of drugs under drugs and cosmetics act and rules. Procedure for obtaining license.- Application for the license or for its renewal is made to the licensing authority who is (i)the Excise Commissioner in the case of a bonded manufactory or warehouse; (ii) in other cases, such officer as the State Government may authorize in this behalf. www.remixeducation.in 13 (2)If any person desires to have more than one kind of license he shall submit a separate application for every such license. (3)Where the applicant has more than one place of business he shall obtain a separate license in respect of each such place of business. â–ªApplication should be submitted in the prescribed form accompanied with prescribed fee, at least two months before the proposed date of commencement of the manufacture. www.remixeducation.in 14 A person desiring to obtain a license to establish a bonded or non-bonded manufactory shall in his application for license furnish the following particular: (i) the name, and the address of the person; place and site on which the manufactory is situated or to be constructed;. â€¢ If the applicant is a firm, the name and address of every partner of the firm; â€¢ and if a company, its registered name and address, and the names and address of its Directors, Managers and Managing Agents, should be specified. (ii) the amount of capital proposed to be invested in the venture; www.remixeducation.in 15 (iv)the approximate date from which the applicant desires to commence working the manufactory in case the required license is granted; (v)the number and full description of the vats, stills and other permanent apparatus and machinery which the applicant wishes to set up. (vi)the maximum quantities of alcohol and alcoholic content in unfinished and finished preparations and the maximum quantities by weight of opium, Indian hemp or other narcotic drugs and their content in unfinished and finished preparations. www.remixeducation.in 16 (vii)whether the proposed bonded manufactory will require the service of a whole-time or part-time Excise Officer; (viii)The site and elevation plans of the manufactory/building and also similar plans for the quarters of the excise officer. (viii) the kind and number of each license under the Drugs and CosmeticsAct held by the applicant; and www.remixeducation.in 17 (ix) a list of all preparations which the licensee proposes to manufacture in his manufactory showing the percentage or proportion of alcohol contained in each such preparation containing alcohol, or of opium, Indian hemp or other narcotic drug or a narcotic, in terms of weight in preparations containing those substances, quoting the authority (pharmacopoeia) under which such preparations are proposed to be manufactured www.remixeducation.in 18 On receipt of an application, licensing authority may enquire into the following: (I ) the qualifications and previous experience of technical personnel engaged in the manufacturing operation; (ii)the equipment of the bonded and non-bonded manufactory; (iii)soundness of the applicantâ€™s financial position ; (iv)suitability of the proposed building for the establishment of manufactory. www.remixeducation.in 19 âœ“ not transferable and cannot be sold. âœ“ exhibited in the licensed premises. âœ“In case of transfer, the purchaser has to obtain fresh license but residue of period covered by the license is issued free of cost. âœ“A licensee can enter into partnership after the prior sanction of the licensing authority and his license is then suitably amended. âœ“If licensee desires to transfer his business to new premises by getting into the notice of LA at least 15 days in advance specifying the address of the premises and getting his license suitably amended. www.remixeducation.in 20 âœ“License can be suspended or revoked by LA if the licensee or any of his employee has committed a breach of the prescribed condition of the ACT or Rules or has convicted an offense under the Indian Penal Code 1860. âœ“ License is valid for a period of 1 year and can be renewed thereafter. âœ“Any corrections in the license is valid only if it is ordered and attested by the LA www.remixeducation.in 21 Supply of rectified spirit for manufacture of medicinal and toilet Preparation: Supplied to a manufacturer from a distillery or a spirit warehouse of the State in which the manufactory is situated, or outside the state. www.remixeducation.in 22 Mode of manufacture.- In the case of manufacture in bond ( bonded=on which duty has not been paid), alcohol shall be used under excise supervision; and in the case of manufacture outside bond(non- bonded=on which duty has already been paid), only alcohol shall be used. www.remixeducation.in 23 Manufacture in bond âž¢Alcohol on which duty has not been paid is to be used under excise supervision Layout of in bond laboratories: âž¢There shall be only one entrance to the bonded manufactory and one door to the each of the compartments. All these doors should be secured with excise ticket locks during the absence of officer in-charge. www.remixeducation.in 24 âž¢A bonded manufactory has provisions for the following: i.one plain spirit store unless the manufactory is attached to a distillery or a rectified spirit warehouse from which rectified spirit is made available as and when necessary. ii.at least one large room for manufacturing medicinal preparations. iii.one or more rooms for storing finished medicinal preparations. iv.separate arrangement for manufacture of toilet preparations. www.remixeducation.in 25 v. the storage of finished toilet preparations. vi.accommodation with necessary furniture in the bonded premises for the officer-in-charge vii.malleable iron rods not less than Â¾â€� in thickness, setnot more than 4â€� apart, embodied in brick work up to a depth of at least 2 inches and covered on the inside with strong wire netting or expanded metal of a mesh not exceeding 1inch in diameter or length in every window of the bonded premises. viii.a board on which the name of the room and a serial number, if any, are legibly painted in oil colour on the outside of every such room in the manufactory. www.remixeducation.in 26 ix.all pipes from sinks or wash-basins inside manufactory premises discharging into drains forming part of the general drainage system of the premises. x.all gas and electric connections within the licensed premises so fixed as to admit of the supply of gas or electricity being cut off and all the regulators or switches being securely locked at the end of the dayâ€™s work. Prior permission of the Excise Commissioner is a must for making alterations or additions in the bonded premises. www.remixeducation.in 27 www.remixeducation.in MANUFACTURE OF ALCOHOLIC PREPARATION: Procurement of rectified spirit: â€¢Rectified spirit required for manufacturing medicinal and toilet preparations shall be obtained on an indent countersigned by the officer-in-charge, from any distillery or spirit warehouse. â€¢If the distillery or warehouse officer has received the duplicate of the indent from the officer-in-charge of the bonded manufactory, he shall issue the spirit required, in duly sealed containers and send an advice of the consignment to the officer in-charge. www.remixeducation.in 29 Verification of rectified Spirit received.- Consignments of rectified spirit received under bond shall be verified in volume and strength and the amount entered in register maintained for the purpose. Then the spirit is stored in spirit store. www.remixeducation.in 30 Storage of rectified spirit.- (1)After the rectified spirit received has been verified, it shall be stored in one or more vessels in the spirit store. (2)If, in any particular case, it is proved to the satisfaction of the Excise Commissioner that the loss is bonafied and not due to negligence or connivance on the part of the manufacturer, the duty payable in respect of such loss may be waived in full in part according to the merits of the case. www.remixeducation.in 31 â€¢Rectified spirit shall be issued on a requisition of the licensee, to the officer in-charge. â€¢The manufacturer should keep all ingredients of the preparation ready and mix the alcohol immediately in the presence of officer in-charge. â€¢Every time percolator or any vessel intended for alcohol is being charged, a label should be attached showing the following particulars: â€¢ Name and batch no of preparation. â€¢ Description and quantity of alcohol placed in it. â€¢ The date of removal of such preparation and quantity removed. www.remixeducation.in 32 After completion of manufacture, preparation is transferred to â€¢ finished goods stores where it is measured and stored in the vessels provided for the purpose and accounted for in a register. â€¢ Licensee is permitted to take the free samples required for analysis as the officer in charge considers necessary for analysis and declaration of the strength of alcohol and medicaments. â€¢ Any quantity left over after analysis should be mixed with the main bulk of the batch before it is measured and stored. Quantity used by licensee should be accounted separately. â€¢ All the samples for analysis should be supplied free of cost by the licensee www.remixeducation.in 33 Storage of finished products: â€¢Medicinal and toilet preparations are to be stored in the jars or bottles each containing not less than 80 fluid ounce volume. â€¢Every container of the finished preparation should bear a label showing its name, batch number, alcoholic strength and the name of the manufacturer. â€¢The containers should be arranged in suitable racks that it allows the ready identification of each batch. www.remixeducation.in 34 â€¢A record of all deficiencies in bulk content of finished preparation should be kept by the officer â€“in-charge and reported to the Excise Commissioner quarterly. â€¢If EC is satisfied that the deficiency was due to natural or unavoidable reasons and that alcoholic preparation has not gone into consumption he may remit the duty payable. www.remixeducation.in 35 â€¢Issue of alcoholic preparations from the bonded laboratory: â€¢Alcoholic preparations from a bonded laboratory can be taken out by a manufacturer by making an application to the excise officer in the prescribed form after paying duty on it. â€¢EO after checking the entries and releasing the duty payable, allows the required quantities to be removed after issuing a permit. â€¢Dutiable goods cannot be delivered from a bonded manufactory or a bonded warehouse before 6 am and after 6 pm nor at any hour on Sundays or other holidays. www.remixeducation.in 36 Disposal of sub-standard preparations.â€” (1) A finished medicinal or toilet preparation which is or is suspected to have deteriorated in quality, may be destroyed by the manufacturer with the permission of the Excise Commissioner and relevant entries made in the register . (2)The Excise Commissioner may allow the manufacturer to re- process a sub-standard preparation. (3)Excise duty shall not be levied on the preparation so destroyed provided the Excise Commissioner is satisfied that the deterioration of the preparation or its improper manufacture was due to reasons beyond the control of the licensee. www.remixeducation.in 38 Disposal of recovered alcohol.--- â€¢Alcohol recovered in the course of production of a medicinal or toilet preparation or distilled separately from the mark of such preparation may be used for subsequent production of the same preparation provided such alcohol is collected separately and accounted for separately. â€¢In cases where the alcohol recovered from a preparation liable to duty at the lower rate is sought to be used in the manufacture of a preparation subject to higher rate of duty, the duty on the preparation so manufactured shall be collected or made leviable on determination of the spirit strength of the preparation. www.remixeducation.in 39 (3)An account of recovered alcohol in a recovered alcohol vat shall be maintained by the officer-in-charge (4)Recovered alcohol declared by the licensee to unfit for use shall be destroyed by him in the presence of the officer-in- charge on submission of written application. www.remixeducation.in 40 â€¢The State Government may, from time to time, fix the percentage of wastage in the production of a particular medicinal or toilet preparation . â€¢Any wastage that exceeds the allowable limit and is not properly accounted, shall be charged with the duty together with such penalty not exceeding the duty leviable thereon as the Excise Commissioner may deem fit. â€¢If the alcohol in strength of a preparation is found by the Chemicals Examiner to exceed the highest allowable limit by more than 3 proof degrees or to be below the lowest allowable limit, its issue from the bonded manufactory, shall be withheld. www.remixeducation.in 41 Remission of duty in case of loss due to accident.â€” â€¢In case of any accidental loss of alcohol In a bonded manufactory, the officer in-charge shall institute necessary enquiries without delay to ascertain the cause of such loss. â€¢If such loss is found to be beyond the control of the licensee the duty on the alcohol so lost shall be remitted with the approval of the Excise Commissioner or may Exercise office subordinate to, the Excise Commissioner specially empowered by him in this behalf. www.remixeducation.in 42 Manufacture outside the bond â€¢Manufacture and sale in non-bonded manufactory is conducted between sunrise and sunset and on such days and hours fixed by the Excise Commissioner. â€¢There should be a spirit store, a laboratory, a finished store, each having one door and only one entrance to the non bonded laboratory. â€¢Construction of premises is same as bonded manufactory. â€¢Any alteration in the arrangements of the buildings should be made with prior permission of Excise Officer. â€¢Permanent vessels , macerators and percolators or carboys and filled bottles should be labeled properly. www.remixeducation.in 43 Obtaining duty paid spirit : â€¢obtained from spirit warehouse on an indent prepared in triplicate. â€¢Original copy sent to the distiller or spirit warehouse keeper, the duplicate to the officer-in-charge of the distillery or spirit warehouse and triplicate with licensee â€¢Duty is paid to the Govt Treasurer and challan in token of such payment should be enclosed along with the duplicate copy of the indent which is being sent to the officer in charge of the distillery who shall issue spirit along with the permit covering the issue. www.remixeducation.in 44 â€¢The spirit brought should be immediately transferred to spirit store and necessary account written up in the prescribed register. â€¢Manufacturer cannot seal the spirit issued to him and at any cost the spirit in possession with manufacturer should not exceed the limit fix by licensing authority. www.remixeducation.in 45 Manufacture , storage and sale: â€¢Carried out in licensed premises only. â€¢Each preparation should be registered and bear a batch number. â€¢All the finished preparation should be stored in finished store and arranged such that checking of stock of every batch of preparation from register is facilitated. â€¢The quantities taken out from time to time should be entered in stock and maintained for the purpose. www.remixeducation.in 46 Samples to be taken by the Excise Officer at least once a month for analysis.â€” 1)The Excise Officer, in which jurisdiction the manufactory is situated , shall , without previous notice to the manufacturer , take samples of not less than 10 per cent and not more than 15 per cent (save in exceptional circumstances) of the total number of the medicinal and toilet preparations containing alcohol from the finished stocks at least once every month and forward them to the Chemical Examiner for analysis and report whether the alcoholic contents thereof tally with the percentage of alcohol shown on the labels affixed to the bottles. www.remixeducation.in 47 2) If the proof strength reported by the Chemical Examiner is more than 3 percent proof spirit than the strength declared by the manufacturer on the labels pasted on such bottles, the manufacturer is liable to a penalty at the rate of 10 items the difference in duty in the quantity so manufactured but not exceeding Rs. 2,000 â€¢If such differences are found to occur frequently , the Excise Commissioner may order the cancellation of the licence held by the manufacturer. â€¢All samples are to be taken by excise officer only in presence of manufacturer or his authorized agent. www.remixeducation.in 48 â€¢The cork of every bottle in which sample is kept shall be fixed with the officerâ€™s personal seal or the official seal and the name of the preparations and batch number shall be stated on label of each such bottle. â€¢The label of the bottle shall be signed by the officer taking the sample â€¢The manufacturer, if he so desires, shall be allowed to affix his own seal and sign the labels. www.remixeducation.in 49 Employees.â€”(i) The manufacturer shall furnish to the Excise Commissioner a list containing the names of the manager or assistant manager employed by him and of all other employees working under non bonded manufactory. (ii)He shall promptly inform the Excise Commissioner and the proper officer of any changes which he may choose to make in the list from time to time. (iii)No person other than the person whose name is contained in the list shall enter the manufactory without the special permission of the proper officer. www.remixeducation.in 51 Inspection. â€“ (1)The non-bonded manufactory shall at all reasonable times be open for inspection by the Excise Commissioner and other Excise Officer having jurisdiction over the area in which the manufactory is situated. (2)The proper officer shall inspect the non-bonded manufactory at least once every month. (3)The State Government may authorize any officer of the prohibition, land revenue , medical and public health department to inspect the non-bonded manufactory. www.remixeducation.in 52 Types of preparations- Asavas and Aristas are the principal types of Ayurvedic preparations in which alcoholic contents is self-generated and not added to such. Until a standard Ayurvedic pharmacopoeia has been evolved by the Central Government, the pharmacopoeias that are in the various States shall be recognized as standard Ayurvedic pharmacopoeias www.remixeducation.in 53 â€¢No duty shall be levied on Ayurvedic preparations containing self-generated alcohol in which the alcoholic content does not exceed 2 percent proof spirit. â€¢Preparations containing more than 2% alcohol but are not . suitable to be consumption are also exempted from the duty. â€¢But preparation that can be consumed are liable to a duty of Rs 1 per L. P. liter. www.remixeducation.in 54 Homeopathic preparations: containing alcohol are classified as being consumed as ordinary alcoholic beverages and attract duties prescribed for such class of preparation falling under the category of restricted preparations. www.remixeducation.in 55 Establishment of bonded warehouses.- The manufacturers or dealers in dutiable goods may establish bonded warehouses anywhere in India. No duty paid goods and no goods other than dutiable goods shall be deposited in such bonded warehouses. www.remixeducation.in 56 The Excise Commissioner shall license a private warehouse for the storage of dutiable goods on which duty has not been paid and may direct in what manner and on what terms such goods shall be stored and how and in what manner such warehouse shall be secured by locks or fastenings. . â€¢Licensee to enter into a bond.- excise commisioner require the licensee to furnish a bond with security, in such amount and under such conditions, as the Excise Commissioner approves binding the licensee to pay duty on the goods deposited therein and for the due and safe removal of such goods to another warehouse and for the due observance of the terms, conditions and requirements of theAct www.remixeducation.in 57 www.remixeducation.in www.remixeducation.in