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MEDICINAL & TOILET
PREPARATION ACT, 1955 AND
RULES THEREUNDER 1976
• 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 this Act in existence.
 The Excise Duties Act came in force in 1955.
 For excise duty to be an effective alcohol control
measure, duty need to increase annually in relation
to inflation and income.
 An excise or excise tax is an inland tax.
 It is different from Customs duties.
 In other words, an excise is considered an indirect tax.
 Levy and collection of duties
 Curb all irregularities of previous Act
18/05/2018 smbtiodp 5
• Alcohol- alcohol means ethyl alcohol of any strength
and purity 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 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 treatment,
mitigation or prevention of disease in human being or
animals
18/05/2018
smbtiodp 6
 Toilet Preparation- the preparation intended to be
used in the toilet of human body or in perfuming
apparel of any description, or any substances
intended to cleanse, improve or alter the
complexion, skin, hair or teeth, and includes
deodorants and perfumes
18/05/2018 smbtiodp 7
 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 narcotic drugs or 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 narcotic drugs or narcotics on which duty
has been paid.
18/05/2018 smbtiodp 8
18/05/2018 smbtiodp 9
MANUFACTURE OFALCOHOLIC PREPARATIONS
 Denaturated Spirit or Denatured alcohol- it means
alcohol of any strength which has been rendered unfit
for human consumption by the addition of substances
approved by the central Govt. or by the State Govt.
with the approval of the Central Govt.
 Spirit Store- it is the part of the bonded or non-
bonded manufactory used 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 the Act.
18/05/2018 smbtiodp 10
• There are two modes of manufacture of
medicinal and toilet preparation containing
alcohol,
– Manufacture in bond; and
– Manufacture outside bond
• In first case, alcohol on which duty has not been paid
shall be used under the excise supervision and in the
case of manufacture outside bond, only the alcohol on
which duty has already been paid shall be used.
18/05/2018 smbtiodp 11
 For the preparation containing alcohol and
narcotic substances
 Obtained from narcotic commissioner
 Applied with prescribed fee and format
18/05/2018 smbtiodp 12
 Details required:
 Name and address of applicant
 Place/site of the bonded laboratory
 If applicant is a firm then name and address of
partners
 If applicant is a company then name address of
directors, managers and managing agents and
reg. no. of company.
 Amount of capital proposed.
 Number and full description of vats, stills and
other apparatus and machinery.
 Maximum quantity of alcohol remain at one
time in the form of finished and unfinished
preparations
18/05/2018 smbtiodp 13
 Approximate date of starting production
 Statement indicating that excise officer required
full time or part time
 Site and elevation plant of laboratory building
 Incase of firm, true copy of partnership deed
 Incase of company, list of directors managers,
copies of memorandum of association, articles of
association and latest balance sheet
 On receiving application licensing authority
verify
1. Qualification and experience of technical staff
2. Equipments
3. Suitability of proposed building
4. Soundness of applicant financial position
18/05/2018 smbtiodp 14
 Without payment of duty rectified spirit is issued
with sufficient securities and bond.
 Bonded laboratory:
 Ideal requirements
1. Spirit store
2. Room for manufacturing of medicinal
preparations.
3. Room for storage of finished preparations.
4. Room for manufacturing and storage of Toilet
preparations
5. Accommodations for excise officer with
furniture.
18/05/2018 smbtiodp 15
1. Obtaining the spirit
2. Verification and storage of received spirit
3. Issue of spirit from warehouse to manufacturing
4. Storage of finished product.
5. Issue of alcoholic preparations from bonded
laboratory.
6. Exemptions
18/05/2018 smbtiodp 16
Manufacturing
room
Finished good
storage
Spirit store Excise officer
 To store alcoholic preparation on which duty has not
been paid.
 License can be issued by payment of fees Rs.25 with
bond and security.
 Duty will be paid at the time of removal of goods from
warehouse.
 All goods should be weighed, gauged and assessed the
duty and recorded.
 No goods can be issued without payment of duty
except export from India or transfer to another bonded
warehouse.
 Movement of goods between two warehouse should be
done by bond and security of twice amount of duty.
 Goods can be stored for maximum period of 3 years.
18/05/2018 smbtiodp 17
 Powers:
1. Inspection
2. Entry, search and seizure
3. Detention of person.
4. Suspension-revoke of license.
5. Summons/ notices.
6. Prosecutions.
7. Disposal of seized article/ arrested persons.
8. Power to arrest
9. Power to make rules.
18/05/2018 smbtiodp 18
 Duties:
1. Checking the qualifications and experience of
technical staff, equipments, suitability of
building and applicants financial position.
2. Visit the premises at regular intervals
3. Countersign on indent to get alcohol from
distillery
18/05/2018 smbtiodp 19
 Responsibility
1. Correct collection of duty and penalty
2. Articles seized should handed over to officer
in charge of police station
3. Articles seized should be disposed speedily.
4. Persons arrested should be forwarded without
delay to excise officer who is empowered to
produce against magistrate.
18/05/2018 smbtiodp 20
 A Textbook of Forensic Pharmacy, by B.M. Mithal,
Vallabh Prakashan, page no.48-72
 Pharmaceutical Jurisprudence, by B.S. Kuchekar,
Nirali Prakashan, page no.153-170
 http://www.ato.gov.au/government/content
Thank you
18/05/2018 smbtiodp 22

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Medicinal and toilatory preparation act 1955

  • 1. MEDICINAL & TOILET PREPARATION ACT, 1955 AND RULES THEREUNDER 1976
  • 2. • 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 this Act in existence.
  • 3.  The Excise Duties Act came in force in 1955.  For excise duty to be an effective alcohol control measure, duty need to increase annually in relation to inflation and income.
  • 4.  An excise or excise tax is an inland tax.  It is different from Customs duties.  In other words, an excise is considered an indirect tax.
  • 5.  Levy and collection of duties  Curb all irregularities of previous Act 18/05/2018 smbtiodp 5
  • 6. • Alcohol- alcohol means ethyl alcohol of any strength and purity 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 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 treatment, mitigation or prevention of disease in human being or animals 18/05/2018 smbtiodp 6
  • 7.  Toilet Preparation- the preparation intended to be used in the toilet of human body or in perfuming apparel of any description, or any substances intended to cleanse, improve or alter the complexion, skin, hair or teeth, and includes deodorants and perfumes 18/05/2018 smbtiodp 7
  • 8.  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 narcotic drugs or 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 narcotic drugs or narcotics on which duty has been paid. 18/05/2018 smbtiodp 8
  • 9. 18/05/2018 smbtiodp 9 MANUFACTURE OFALCOHOLIC PREPARATIONS
  • 10.  Denaturated Spirit or Denatured alcohol- it means alcohol of any strength which has been rendered unfit for human consumption by the addition of substances approved by the central Govt. or by the State Govt. with the approval of the Central Govt.  Spirit Store- it is the part of the bonded or non- bonded manufactory used 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 the Act. 18/05/2018 smbtiodp 10
  • 11. • There are two modes of manufacture of medicinal and toilet preparation containing alcohol, – Manufacture in bond; and – Manufacture outside bond • In first case, alcohol on which duty has not been paid shall be used under the excise supervision and in the case of manufacture outside bond, only the alcohol on which duty has already been paid shall be used. 18/05/2018 smbtiodp 11
  • 12.  For the preparation containing alcohol and narcotic substances  Obtained from narcotic commissioner  Applied with prescribed fee and format 18/05/2018 smbtiodp 12
  • 13.  Details required:  Name and address of applicant  Place/site of the bonded laboratory  If applicant is a firm then name and address of partners  If applicant is a company then name address of directors, managers and managing agents and reg. no. of company.  Amount of capital proposed.  Number and full description of vats, stills and other apparatus and machinery.  Maximum quantity of alcohol remain at one time in the form of finished and unfinished preparations 18/05/2018 smbtiodp 13
  • 14.  Approximate date of starting production  Statement indicating that excise officer required full time or part time  Site and elevation plant of laboratory building  Incase of firm, true copy of partnership deed  Incase of company, list of directors managers, copies of memorandum of association, articles of association and latest balance sheet  On receiving application licensing authority verify 1. Qualification and experience of technical staff 2. Equipments 3. Suitability of proposed building 4. Soundness of applicant financial position 18/05/2018 smbtiodp 14
  • 15.  Without payment of duty rectified spirit is issued with sufficient securities and bond.  Bonded laboratory:  Ideal requirements 1. Spirit store 2. Room for manufacturing of medicinal preparations. 3. Room for storage of finished preparations. 4. Room for manufacturing and storage of Toilet preparations 5. Accommodations for excise officer with furniture. 18/05/2018 smbtiodp 15
  • 16. 1. Obtaining the spirit 2. Verification and storage of received spirit 3. Issue of spirit from warehouse to manufacturing 4. Storage of finished product. 5. Issue of alcoholic preparations from bonded laboratory. 6. Exemptions 18/05/2018 smbtiodp 16 Manufacturing room Finished good storage Spirit store Excise officer
  • 17.  To store alcoholic preparation on which duty has not been paid.  License can be issued by payment of fees Rs.25 with bond and security.  Duty will be paid at the time of removal of goods from warehouse.  All goods should be weighed, gauged and assessed the duty and recorded.  No goods can be issued without payment of duty except export from India or transfer to another bonded warehouse.  Movement of goods between two warehouse should be done by bond and security of twice amount of duty.  Goods can be stored for maximum period of 3 years. 18/05/2018 smbtiodp 17
  • 18.  Powers: 1. Inspection 2. Entry, search and seizure 3. Detention of person. 4. Suspension-revoke of license. 5. Summons/ notices. 6. Prosecutions. 7. Disposal of seized article/ arrested persons. 8. Power to arrest 9. Power to make rules. 18/05/2018 smbtiodp 18
  • 19.  Duties: 1. Checking the qualifications and experience of technical staff, equipments, suitability of building and applicants financial position. 2. Visit the premises at regular intervals 3. Countersign on indent to get alcohol from distillery 18/05/2018 smbtiodp 19
  • 20.  Responsibility 1. Correct collection of duty and penalty 2. Articles seized should handed over to officer in charge of police station 3. Articles seized should be disposed speedily. 4. Persons arrested should be forwarded without delay to excise officer who is empowered to produce against magistrate. 18/05/2018 smbtiodp 20
  • 21.  A Textbook of Forensic Pharmacy, by B.M. Mithal, Vallabh Prakashan, page no.48-72  Pharmaceutical Jurisprudence, by B.S. Kuchekar, Nirali Prakashan, page no.153-170  http://www.ato.gov.au/government/content