1-3Centre of Excellence in Regulatory Science, Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education and Research, SS nagara, Mysuru – 570015, Karnataka, India
The production and sale of medicinal and toilet preparations containing ingredients like alcohol, opium, Indian hemp, and narcotic drugs are governed by the Medicinal and Toilet Preparations (Excise Duties) Act of 1955. The 7th Schedule of the Indian Constitution provides exemptions for traditional medicine systems like Ayurveda, Unani, and Homeopathy. The Act's main objectives are to collect excise duties on relevant preparations and ensure uniformity in duty rates and rules across India. It has undergone amendments to adapt to changing circumstances. A critical component of this case study is an in-depth analysis of a real legal case was raised when licenses for manufacturing ayurvedic medicines were not renewed, emphasizing the importance of upholding constitutional principles and rights while regulating these products. The MNTP Act, 1955, is a crucial legislation that regulates the production and sale of controlled substances, ensuring a balance between public health and industry interests. This act regulates the manufacture sale import and export of the preparation. It empowers the Central Government for making the rules for the pricing of the duty, exemptions and remissions. It also provides for the establishment of laboratories for testing and analysis of dutiable goods. The act aims to maintain uniformity in the regulations and tax rates that apply to preparations covered by the act.
DEFINITIONS:(1)
The Main Definitions Under This Act Are
Ethyl alcohol with chemical composition C2H5OH with any strength and purity.
alcohol refers to the alcohol that has been dehydrated according to the British Pharmacopeial specifications.
it is a preparation of drugs for human or animal use, aimed at treating, mitigating, and preventing diseases.
a substance used to clean, improve the appearance of hair, skin, or teeth in cosmetics and clothing that are scented, such as deodorants and perfumes.
The premises has a license for the production and duty-free storage of medical and toilet preparations comprising alcohol, opium, Indian hemp, and other narcotic drugs.
The premises has a license for the production and storage of duty-paid medical and toilet remedies including alcohol, opium, Indian hemp, or narcotic substances.
By adding ingredients allowed by the Central or State Governments, with authority from the Central Government, strength of alcohol is rendered unfit for human consumption.
The Schedules specify medicinal and toilet preparations, including all declared by the Central Government, which are known as restricted preparations.
Unrestricted preparations refer to medicinal and toilet products containing alcohol, excluding restricted or spurious preparations.(2)
INTRODUCTION:
The main aim of the 1955 Medicinal and Toilet Preparation Act was to control the manufacture, marketing, and distribution of these products.(3) It ensures the public health and safety efficiency of the preparation. MNTP act provides levy collection of excise duties on alcohol-containing preparations is being implemented.(4) The act also establishes quality control laboratories for testing and analysis of these products, ensuring they meet the prescribed standards.(5) Authorized officers are designated under the act to inspect premises, records, and products suspected of non-compliance, with the power to take appropriate action against violators.(6) Each state government in India used to set its own rates of duty and regulations for imports and exports of medicinal and toilet preparation containing alcohol due to which industries faced challenges.(7) To attain the uniformity responsibility for regulating the excise duty on such preparations was shifted from the State List to Union List.(8) This helps to attain the standardized the framework for industry and eliminate the negative effects. This act was effective from 1st April 1957. (1)
History:
The Medical and Toilet Preparations (Excise Duties) Act of 1955 was created in response to the requirement for a thorough legal framework to regulate the manufacture and distribution of the preparations.(9) This act aimed to consolidate and amend the laws regarding levying and collection of excise duties of the preparation. The act has undergone amendments to adapt the changes. (10)
OBJECTIVES OF THE ACT
The objectives of the act includes:
Amendments:
Medicinal and. Toilet Preparations (Excise Duties) Amendment Act, 1982: This amendment made changes to the excise duty rates for the different categories of medicinal and toilet preparation.(12)
Amendment of Section 19:
Amendment of Schedule:
OFFENCES AND PENALTIES:(17,18)
Case study (19)
Shree Baidyanath Ayurved Bhawan ... vs State of Bihar & Ors
IN THE HIGH COURT OF JUDICATURE AT PATNA
Petitioner:
Shree Baidyanath Ayurveda Bhawan Pvt. Ltd., Samrat Chemical Industries.
Respondents:
The State of Bihar through the Chief Secretary, Government of Bihar.
The Principal Secretary, Registration, Excise and Prohibition Department, Government of Bihar, Patna.
The Excise Commissioner, Excise and Prohibition, Government of Bihar, Patna.
The Collector of Patna (in Shree Baidyanath Ayurveda Bhawan Pvt. Ltd.'s case) and the Collector of Vaishali (in Samrat Chemical Industries' case).
The Assistant Commissioner of Excise, Patna (in Shree Baidyanath Ayurveda Bhawan Pvt. Ltd.'s case) and the Superintendent of Excise, Vaishali (in Samrat Chemical Industries' case).
Case no: 6415 of 2016, 6404 of 2016
Date: 27 -10-2016
Fact of the case:
The dispute centers on the invalidation of Clause 3 of a Circular dated 17.3.2016, which informs Collectors-cum-District Magistrates in Bihar that licenses granted under The Medicinal and Toilet Preparations (Excise Duties) Act, 1955 (MNTP Act) permits the manufacturing of medications containing alcohol, opium, Indian hemp, and other narcotic drugs; however, licenses for the manufacture of narcotics will not be renewed, and no new licenses will be granted. The MNTP Act grants permits to Shree Baidyanath Ayurveda Bhawan Pvt. Ltd. and Samrat Chemical Industries for the production of ayurvedic medications, some of the preparation which contain alcohol. The petitioners are asking the Excise Commissioner to renew their licenses and to invalidate the circular.
Contention of the case:
According to the petitioners, they have been producing Ayurvedic medications for many years in line with MNTP Act and Ayurvedic principles, some of which contained alcohol and other drugs.
They claimed that the Excise Commissioner's circular, which forbade the renewal of licenses for certain drugs, was illegal and had an impact on their way of life and their enterprises. The petitioners asked for the circular to be overturned and for their manufacturing licenses to be renewed so they could keep making these medications. Clause 3 of the circular was sent to the collectors cum magistrate of the state, was issued by excise commissioner of Bihar on march 17th 2016. It announced a shift in policy by not renewing licenses granted under this act.
SUMMARY:
In conclusion, The petitioners' writ applications were granted by the court. It quashed Clause 3 of the March 17, 2016, Excise Commissioner of Bihar Circular.
The petitioners' licenses must be quickly renewed, according to instructions given to the respondents in Forms L-1 and ND-1.(20)
The judgment clarified that the state could impose reasonable restrictions but could not entirely prohibit the trade or business in such medicines. It emphasized the importance of upholding constitutional principles and rights while regulating these products.
CONCLUSION:
From the above information provided on the case study related to MNTP act, the petitioners claimed that the MNTP Act, 1955, passed by Parliament in accordance with Entry 84 of List I of the Seventh Schedule of the Indian Constitution, granted the central government authority over excise duties related to these preparations. They contended that the State Government, exercising its powers under Entry 8 of List II, cannot prohibit the manufacture and sale of medicinal preparations containing specified substances as they are not equivalent to alcoholic beverages and are used for medicinal purposes. The petitioners emphasized that Article 47 of the Indian Constitution, law promotes the prohibition of harmful intoxicating drinks and drugs, but allows for the exemption of medicinal preparations containing alcohol.
REFERENCES
Spoorthi S., Deeksha K. S., Balamuralidhara V Medicinal And Toilet Preparations Act: An In-Depth Analysis With A Practical Case Study, Int. J. of Pharm. Sci., 2024, Vol 2, Issue 4, 172-177. https://doi.org/10.5281/zenodo.10913184