Title 10. MEDICINAL AND TOILET PREPARATION ACT –1955.pdf ✅

PHARMD GURU Page 1 INTRODUCTION: Alcohol has excellent solvent properties apart from its preservative mechanism and hence it has found a very important role in the manufacturing of drugs and medicines. Drinking alcohol is an abuse whereas its usage in toilet preparations may be considered as a luxury. For this reason, alcohol, which is used either for drinking or for the manufacture of toilet preparations such as perfumes, is subject to a much higher rate of excise duty than that used for the manufacture of medicinal preparations which cannot be used as ordinary alcoholic beverages. Prior to the enactment of this act, each state in India had an Excise manual and a set of rules of its own. Thus, differences existed in the rates of excise duty for the same item in different states, leading to large scale inter-state smuggling of such preparations. The Act was passed mainly to curb this evil and repealed the laws in force in any state prior to the commencement of this Act. However, any state rules not inconsistent with this Act are still valid and have the same force as if they have been made by an authority in this behalf under this Act. The Medicinal and Toilet preparations Act was passed in the year 1955 and the Rules were passed in 1956. The Act extends to the whole of India and came into force on 1st April 1957. OBJECTIVES OF THE ACT: This Act was passed with the following objectives:  To provide the collection of levy and duties of excise on medicinal and toilet preparations containing alcohol, narcotic drugs or narcotics.  To provide for uniformity in the rules and rates of Excise duties leviable on such preparations throughout the country. MEDICINAL AND TOILET PREPARATION ACT –1955
PHARMD GURU Page 2 DEFINITIONS:  Alcohol: Alcohol means ethyl alcohol of any strength and purity having the chemical composition C2H5OH. Absolute alcohol means alcohol conforming to the British Pharmacopoeial specifications for dehydrated alcohol.  Dutiable goods: Dutiable goods means the medicinal and toilet preparations specified in the Schedule as being subject to the duties of excise levied under the Act.  Medicinal preparation: Medicinal preparation includes all drugs which are a remedy or prescription prepared for internal or external use of human being or animals and all substances intended to be used for or in the treatment, mitigation or prevention of disease in human beings or animals.  Toilet preparation: Toilet preparation means any preparation which is intended for use in the toilet of the human or in perfuming apparel of any description, or any substance intended to cleanse, improve or alter complexion, hair, skin or teeth, and includes deodorants and perfumes.  Bonded manufactory: Bonded manufactory means the premises approved and licensed for the manufacture and storage of medicinal and toilet preparations containing alcohol, opium, Indian hemp or any other narcotic drug or narcotics on which duty has not been paid.  Non-bonded manufactory: Non-bonded manufactory means the premises approved and licensed for the manufacture and storage of medicinal and toilet preparations containing alcohol, opium, Indian hemp or any other narcotic drug or narcotics on which duty has been paid.  Patent or Proprietary medicines: Patent or Proprietary medicines means any medicinal preparation which bears either on itself or on its container or both, a name which is not specified in a monograph in a Pharmacopoeia, formulary or other publications notified in this behalf by the Central Government in the Official Gazette, or which is a brand name or any other mark such as a symbol, monogram, label, signature or invented words or any writing which is used in relation to that medicinal preparation for the purpose of indicating or so as to indicate a connection in the course of trade between the preparation and some
PHARMD GURU Page 3 person having the right either as proprietor or otherwise to use the name or mark with or without any indication of the identity of that person.  Denatured alcohol or Denatured spirit: Denatured alcohol or Denatured spirit means alcohol of any strength which has been made unfit for human consumption by the addition of substances approved by the Central Government or by the State Government with approval of the Central Government.  Rectified spirit: Rectified spirit means plain denatured alcohol of strength not less than 50.0° over proof and includes absolute alcohol.  London proof spirit: London proof spirit means that mixture of ethyl alcohol and distilled water which at the temperature of 51°F weighs exactly 12/13th parts of an equal measure of distilled water at the same temperature.  Restricted preparation: Restricted preparation means every medicinal and toilet preparation specified in the Schedules and includes every preparation declared by the Central Government as restricted preparation.  Unrestricted preparation: Unrestricted preparation means any medicinal or toilet preparation containing alcohol but other than restricted preparation or a spurious preparation. LICENSING PROCEDURE: Manufacturing of alcoholic and narcotic preparations can only be undertaken under the authority of a license granted for the purpose and such a license is issued only if the requisite license for manufacture of drugs under the 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 in the case of a bonded manufactory or ware house and in other cases, such officer as the State government may authorize in this behalf. A separate application is to be made if more than one kind of license is desired. Where the applicant has more than one place of business, he should obtain a separate license in respect of each such place of business. The application for the license should be submitted in the prescribed form accompanied by the prescribed fee, at least two months before the proposed date of commencement of the manufacture. The following particulars are required to be submitted in the application for obtaining a license to manufacture dutiable goods in or outside bond:
PHARMD GURU Page 4 1) Name and address of the applicant and place and site on which the manufactory is situated or to be constructed. If the applicant is a firm, the name, and address of every partner of the firm, and if it is a company, its registered name, and address, and the names and addresses of its directors, managers, and managing agents. 2) The amount of capital proposed to be invested in the venture. 3) Approximate date from which the applicant desires to commence the manufactory and the statement whether the bonded laboratory will require the services of a whole-time or part time excise officer and whether quarters for the excise staff will be provided within the manufactory. 4) The number and full description of vatts, still and other permanent apparatus and the machinery which the applicant wishes to get up together with the maximum quantity of alcohol and alcohol content in the finished preparations and the maximum quantities by weight of opium, Indian hemp or other narcotic drugs or narcotic and their contents in finished and unfinished preparations. 5) The site and elevation plans of the manufactory/building and also similar plans for the quarter of the Excise Officer together with relevant records. 6) The amount in cash or Government Promissory Notes which the applicant is prepared to furnish for the due performance of the conditions on which the license may be granted. 7) The kind and number of each license under the Drugs and Cosmetics Act held by applicant. 8) A list of all preparations which the applicant proposes to manufacture and/or those manufactured during the preceding year showing the percentage or proportion of alcohol in alcoholic preparations or opium, Indian hemp or another narcotic drug in terms of weight in proportion containing those substances, quoting the pharmacopoeia under which such preparations were proposed to be manufactured. On receipt of the application, the Licensing Authority may enquire into the following:  The qualifications and previous experience of technical personnel engaged in the manufacturing operations.  The equipment of the bonded and non-bonded laboratory.  The soundness of the applicant's financial position.  Suitability of the proposed building for the establishment of the manufacturing unit.