Pharmaceutical Jurisprudence

1. Medicinal & Toilet preparations act
(Excise duties), 1955
and rules thereunder 1976
By
Mr. Vinayak R. Bodhankar
Assistant Professor
M. Pharm (QA)

2. CONTENTS
 Introduction
 Excise
 Objective
 Definitions
 Manufacture
 Procedure for license
 Bonded laboratory
 Non-bonded laboratory
 Offences and penalties
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3. INTRODUCTION
 Alcohol has always been a fascinating friend of the mankind.
 Drinking alcohol for pleasure is an abuse.
 Use of alcohol for preparation of medicines is necessity.
 Alcohol used for drinking or manufactures of perfumes is subjected to higher
duties than that of used in medicine preparation.
 Affordability of alcohol is to be controlled.
 This was the reason to take this act in existence.
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4. EXCISE DUTY
 The excise duties act came in force in 1955.
 An excise or excise tax is an indirect tax.
 In common words, an excise is distinguished from sales tax or VAT in three ways:
a. An excise typically applies to a narrower range of the products.
b. An excise is typically heavier
c. An excise is typically a per unit tax.
OBJECTIVE
It provides for the leavy and collection of duties of excise on medicinal and toilet
preparations containing alcohol, opium, indian hemp, or other narcotics drugs.
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5. DEFINITIONS
Alcohol: it means ethyl alcohol of any strength or any substance having chemical composition
C2H6OH.
Dutiable goods: it includes the medicinal and toilet preparations specified in the schedule as
being subject to the duties of excise levied under this act.
Medicinal preparation: it includes the drugs used as remedy for internal or external use of
human being and all substances used for diagnosis, treatment, mitigation or prevention of
disease in human being or animals.
Toilet preparation: Any substance intended to cleanse, improve or alter the complexion, skin,
hair or teeth, and includes deodorants and perfumes.
Bonded manufactory: it 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 narcotics on which duty has not been paid.
Non-Bonded manufactory: it 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 narcotics on which duty has been paid. 5

6. Restricted preparation: these are medicinal preparations which are considered as
capable of being misused as ordinary alcohol beverages.
Unrestricted preparation: these are medicinal preparations which are considered
as not capable of being misused as ordinary alcohol beverages.
Substandard preparations: it includes:
a. a pharmacopoeial preparation in which the amount of any of the ingredients is
below the minimum.
b. a medicine not conforming to the formula displayed on the label.
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7. MANUFACTURE
 Manufacturer gets the rectified spirit required for the manufacture of medicinal and
toilet preparations from a spirit warehouse of the state.
 If there is loss of rectified spirit due to wastage in transit, and if the excise
commissioner satisfies that the loss is bonafide and due to negligence by the
manufacturer, the duty payable in respect of such loss.
 There are two modes of manufacture of medicinal and toilet preparations containing
alcohol,
1. Manufacture in bond
2. Manufacture outside the bond.
 In the first case, alcohol on which duty has not been paid shall be used and in
second case, only the alcohol on which duty has been paid shall be used.
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8. PROCEDURE FOR LICENSE.
Every person desiring to manufacture medicinal and toilet preparation containing alcohol
or other narcotic substance is required to obtain a license,
1. From the Excise Commissioner in case of manufacture in Bond and
2. From the officer as the state government may authorise in this behalf in case of
manufacture outside bond.
 Application for grant of licence should be submitted in the prescribed form together
with prescribed fee so as to reach the licensing authority at least two month before the
proposed date of the commencement of the manufacture.
Search application should contain the following particulars:
 The name and address of the applicant.
 Name and address of the place and the site on which the bonded or non bonded
laboratory situated or to be constructed.
 The amount of capital to be invested.
 Approximate date from which the applicant desire to start the manufacture.
 The number and full description of the permanent machinery which the applicant
wishes to set up.
 The maximum quantity in L.P. litres of alcohol is required.
 In case of bonded laboratory whether the proposed bonded manufactory will require
the services of a full-time or part-time excise officer. 8

9.  A list of all preparations that the licensee proposed to manufacture showing the
percentage of alcohol and the quantities of narcotics.
 The kind and number of licences held by the applicant under the drugs and
cosmetic act 1940.
 Detailed site plan of the bonded manufactory.
 In case of firm a true copy of the partnership deed and in case of company the
list of the directors and managers together with the copies of memorandum of
the association and articles of association.
On receipt of such application the licensing authority makes the following
enquiries:
 The qualification and experience of the technical persons.
 The equipment of the bonded laboratories.
 Suitability of the proposed building for the establishment of a laboratory.
 After satisfying all these requirements, the licensing authority shall issue a
license and approve the plan of building.
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10. BONDED LABORATORY
Requirements of the bonded laboratory:
 A spirit store.
 Rooms for the manufacture of medicinal preparations.
 Rooms for the storage of finished medicinal preparations.
 Separate rooms for the manufacture of toilet preparations.
 Rooms for the storage of finished toilet preparations.
 Accommodation near the entrance for the officer-in-charge with necessity furniture.
 The pipes from sinks or wash basins should be connected with the general drainage of the
laboratory.
 The arrangement of gas and electric connections should be such that their supply should be cut
off at the end of day’s work.
 Every window should be provided with specific arrangement of iron rods and window should
be covered on the inside with strong wire netting of mesh not exceeding 25 mm.
 There shall be only one entrance to the laboratory and one door to each of its compartments.
 All vessels intended to hold alcohol and other liquid preparations should bear a distictive serial
number and full capacity.
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11. NON-BONDED LABORATORY
 The manufacture and sale in non-bonded laboratory should be conducted between
sunrise and sunset only and on such days and hours as may be fixed by the excise
commissioner.
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12. OFFENCES AND PENALTIES
Offence Penalty
 By Licensee
Failure to follow license conditions Imprisonment up to 6 months or fine up to ₹2000
Disorderly keeping of stocks or accounts fine up to ₹2000
Illegal sale of duitable goods fine up to ₹1000
False information to officer. fine up to ₹20000
Failure to maintain measuring devices. fine up to ₹1000
Failure to provide locking facilities. fine upto ₹200
 By Excise officers
Failure to do duty Imprisonment up to 3 months or fine or both
Disclosure of information. fine up to ₹1000
 By Public
Malicious information Imprisonment up to 2 years or fine up to ₹2000 or
both
Connivance by owners Imprisonment up to 6 months or fine up to ₹500 or
both
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13. REFERENCES
1. A textbook of Forensic Pharmacy, by B.M. Mithal, Vallabh Prakashan, page no.
48-72.
2. Pharmaceutical Jurisprudence, by B.S. Kuchekar, Nirali Prakashan, page no.
153-170.
3. A textbook of Forensic Pharmacy, by C.K. Kokate, Vallabh PharmaMed press,
page no. 135-147.
4. A textbook of Pharmaceutical Jurisprudence, by A.V. Yadav, Trinity Publishing
House, page no. 140-151.
5. Pharmaceutical Jurisprudence, by Sandeep D.S, Nirali Prakashan, page no. 4.1-
4.12.
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