This document discusses the Medicinal and Toilet Preparations Act of 1955 which established uniform rules and rates for excise duties on preparations containing alcohol across India. It summarizes key aspects of the act including definitions of terms, licensing procedures for manufactories, regulations around production and storage of alcoholic preparations, export procedures, and classifications of ayurvedic, homeopathic, and proprietary preparations. A standing committee is also established to advise the central government on technical administration of the act.

1. Medicinal and
Toilet
Preparations

2. The Role of Alcohol in Medicinal
and Toilet Preparations
Alcohol's dual purpose: solvent and preservative.
Used in drug manufacturing and luxury toilet preparations.
Distinction between drinking alcohol and its usage in toilet
preparations.

3. Excise Duty on Alcohol
Higher excise rate for drinking and luxury purposes.
Reduced excise for medicinal preparations.
Prior state-wise rules led to differences in duty rates.

4. Why the Medicinal and Toilet
Preparations Act was Needed?
State-wise differences in excise duties.
Resulting inter-state smuggling of preparations.

5. The Medicinal and Toilet Preparations
Act, 1955
PASSED IN 1955,
RULES IN 1956.
OVERRULED STATE
LAWS AND BROUGHT
UNIFORMITY.
CAME INTO FORCE
ON 1ST APRIL 1957.

6. Objectives
Key Objectives of the Act
Collection of levy and duties of excise.
Applicable on preparations containing alcohol, narcotic
drugs, or narcotics.
Ensuring Uniformity
Uniform rules and rates for excise duties.
Consistency across the country for medicinal and toilet
preparations.

7. Types of Alcohol-
Definitions
Alcohol: Ethyl alcohol (C2H5OH) of any
strength/purity.
Absolute Alcohol: Conforms to British
Pharmacopoeial specs for dehydrated alcohol.
Denatured Alcohol: Made unfit for human
consumption by approved substances.
Rectified Spirit: Plain denatured alcohol, strength
>50.0° over proof.
London Proof Spirit: Ethyl alcohol + distilled
water mix weighing 12/13th parts of distilled water
at 51°F.

8. Goods and Preparations-
Definitions
Dutiable Goods: Specified medicinal and toilet
preparations under the Act.
Medicinal Preparation: Drugs for treating or preventing
diseases in humans/animals.
Toilet Preparation: Used in human toilet or apparel
perfuming; includes deodorants, perfumes, and cosmetics.

9. Manufacturing Types-Definitions
Bonded Manufactory: Licensed premises for making and
storing unpaid duty products.
Non-bonded Manufactory: Licensed premises for making
and storing paid duty products.

10. Medicinal Classifications-
Definitions
Patent or Proprietary Medicines: Medicines with brand
names or marks not specified in official publications.
Restricted Preparation: Specified in Schedules or
declared by the Central Government.
Unrestricted Preparation: Contains alcohol but isn't
restricted or spurious.

11. Licensing

12. Licensing Procedure Overview
Licenses are required for manufacturing.
Need to first obtain a license under the Drugs and
Cosmetics Act.
Licensing authority differs for bonded and non-bonded
manufactories.

13. Application Details
Apply at least two months
before production starts.
Separate applications for
multiple licenses or places of
business.
Application form + prescribed
fee.

14. Required Particulars
Applicant's name, address, and business details.
Capital investment.
Desired start date and bonded lab details.
Description of apparatus, alcohol, and narcotic contents.
Manufactory building plans and staff housing.
Security deposit details.
Existing licenses under the Drugs and Cosmetics Act.
List of intended products and past manufactured items.

15. Investigation by Licensing Authority
Evaluating technical
personnel's qualifications
and experience.
Assessing equipment
quality.
Reviewing the applicant’s
financial stability.
Checking the suitability of
the proposed building.

16. License Terms & Conditions
Non-transferable and
must be visibly
displayed.
Business
sales/transfers require
a fresh license.
Reporting partnership
changes or
dissolutions.
Moving business
needs prior
notification.

17. Maintaining and Renewing License
License
revocation/suspension
conditions.
Validity: 1 year (needs
renewal).
Renewal application to
be submitted 1 month
prior.
Mandatory
maintenance of a Visit
Book.

18. Documentation Responsibilities
Preserve invoices, cash
memos, permits for a year.
Return Visit Book,
accounts, and license
upon termination.
Preserve related
documents for a year post
termination.

19. Manufacture of
Alcoholic and
Narcotic Drugs

20. Introduction
Manufacturing under authority license only
Cannot transfer or sell license
Medicinal and toilet preparations: in bond & outside
bond

21. Manufacture in Bond - Basics
Definition of "in bond" Bond requirements: security towards due
payment of the duty

22. Bonded
Laboratory
Essentials
Spirit store provision
Separate rooms for medicinal and toilet
preparations
Storage room for finished preparations
Officer-in-charge accommodation
Window security measures
Room name and serial number
Pipe connections, gas, and electric
provisions
Entrance and security regulations

23. Alcoholic Preparations in Bond -
Procurement
Obtaining rectified spirit
Verification and storage

24. Alcoholic Preparations in
Bond - Manufacturing &
Storage
Issue of Spirit from Spirit Store
Details and labelling of manufactured
preparation
Storage of the finished product

25. Alcoholic Preparations
in Bond - Disposal
Issuing alcoholic preparations from labs
Dealing with substandard preparations
Recovered alcohol management

26. Alcoholic Preparations in
Bond - Wastage & Loss
Permissible wastage
Accidental loss of alcohol provisions

27. Manufacture Outside Bond - Basics
Definition of "outside bond" Working hours and
regulations

28. Receiving Duty Paid
Spirit
How to obtain rectified spirit
Payment methods and regulations

29. Manufacture,
Storage, and Sale
Licensing and batch number
Stock checking and sealing

30. Sampling & Analysis
Sampling regulations and frequency
Chemical examination and penalties
Labeling and storage of samples

31. Returns & Inspection
Maintenance of accounts and reports
List of employees and access regulations
Inspection authorities and frequency

32. Exportation of Alcoholic Preparations from
India
Procedures & Regulations

33. No Duty on Alcoholic Exports
Alcoholic preparations exported from India are exempt from duty.
Exportation methods:
1. Under bond
2. Claim for rebate of duty

34. Export Under Bond: Requirements for
Export Under Bond
Must have a bonded laboratory or warehouse.
Submit application in triplicate to the officer-in-charge.
Details required: Export method (land, sea, air, post) and consignment
specifics.

35. Export Under Bond:Packaging &
Verification for Bonded Export
Pack goods in cases/packages with legible markings:
Serial number, owner's details, quantity, alcohol content.
Officer verification and notes on the package: consignee info, goods
description, quantity, weight.
Sealing: Official seal for tamper-proofing.

36. Export Under Bond: Bonded Export Process
Duplicate copy is returned to consigner after official endorsement.
Dispatch details communicated to the proper officer.
For postal dispatch, get certification from destination post office.

37. Export Under Bond: Procedure for Export of
Duty Paid Goods
Provide 48-hour notice for supervising the packing.
Present the consignment to the proper officer.
Chemical analysis of samples.
Present results to the Excise Commissioner for rebate claims.

38. Export Under Bond: Packaging &
Verification for Duty Paid Goods
Package markings: consignee info, goods description, quantity, weight.
Sealing: Official seal for tamper-proofing.
Export process is similar to bonded goods.

39. Claim for Rebate of Duty
Submit within one month of export certificate issuance.
Present duplicate certified application to Excise Commissioner.
Rebate sanctioned if the claim is verified.
Extension for rebate claim may be granted by the Excise
Commissioner.

40. Manufacture of
Ayurvedic,
Homeopathic, and
Patent & Proprietary
Preparations

41. Ayurvedic Preparations:
Types & Alcohol Content
Principal types: 'Asavas' and 'Aristas'.
Alcohol content ≤2% proof spirit
considered non-alcoholic.
Exempt from excise duty if alcohol
content >2% but not consumable as an
ordinary beverage.

42. Ayurvedic Preparations:
Duties & Regulations
Preparations consumable as alcoholic
beverages: `1 per L.P. litre.
Registered Ayurvedic Practitioners: Can
manufacture and dispense duty-free if
licensed.
Daily accounts & samples needed for
excise inspection.

43. Ayurvedic Preparations:
Alcohol-Added
Preparations made with added alcohol:
`30 per L.P. litre duty.

44. Homeopathic Preparations:
In Alcohol
Classified as consumable ordinary
alcoholic beverages.
Attracts duties for restricted preparations.

45. Allopathic Preparations: Types
Official preparations: Adhere to
recognized pharmacopoeias.
Non-official or proprietary
preparations: Follow formula on
label.

46. Restricted vs. Unrestricted Preparations
Restricted preparations:
Consumable as ordinary
alcoholic beverages.
Unrestricted preparations: Not
consumable as alcoholic
beverages.
Changes can be made by the
Central Government.

47. Members of
the Standing
Committee
Drugs Controller of India.
Chief Chemist, Central Revenues
Laboratory.
Nominated pharmacologist.
Adviser on Indigenous System of
Medicine.

48. Responsibilities of the
Standing Committee
Advises Central Government on the Act's
technical administration.
Assesses:
If preparation is genuine medicinal or toilet
preparation.
If it should be restricted or unrestricted.

49. OFFENCES AND PENALTIES

50. OFFENCES AND PENALTIES