LAWS REGULATING DRUGS AND COSMETICS IN INDIA AND THE UNITED STATES OF AMERICA
Author: Vanathi Krishna K, IV year of B.B.A.,LL.B.(Hons.) from Sastra Deemed to be University, Thanjavur
Drugs and Cosmetics hold paramount importance in the lives of the earthborn. Drugs are substances that succour the body to be physically and psychologically well balanced. Cosmetics aid to ameliorate or alter the appearance of the countenance and the body which includes personal care, skin care, fragrance, etc. Since drugs and cosmetics serve most of the indispensable necessities of human life, it is inevitable to regulate them. In this research piece, the author has analysed and explored the laws regulating Drugs and Cosmetics in India and the United States of America. Drugs and Cosmetics are regulated by the Drugs and Cosmetics Act of 1940 in India and by the Federal Food, Drug and Cosmetic Act of 1938 in the USA. This paper commences with the legal definitions of drugs and cosmetics under both acts. Further, the regulations of drugs categorised under different schedules and labelling requirements are explored. This paper is shaped to throw light on various offences and penalties and relevant judgments having reference to drugs and cosmetics under the respective acts.
The Drugs and Cosmetics Act of 1940 which regulates drugs and cosmetics in India consists of 5 chapters and 38 sections.[i]
DEFINITION OF DRUGS
Section 3(b) of the Drugs and Cosmetics Act, 1940 defines ‘Drugs’ as
All medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, including preparations applied on the human body for the purpose of repelling insects like mosquitoes.
Such substances (other than food) intended to affect the structure or any function of the human body or intended to be used for the destruction of vermin or insects which cause disease in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette.
All substances intended for use as components of a drug including empty gelatine capsules.
Such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board.[ii]
Section 201(g)(1) of the Federal Food, Drugs and Cosmetics Act, 2004 expounds the meaning of drugs as follows:
Articles recognised in the official United States pharmacopeia, official homeopathic pharmacopeia of the United States or official National Formulary, or any supplement to any of them.
Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.
Articles (other than food) intended to affect the structure or any function of the body of man or other animals.[iii]
Stating simply, drugs are substances or medicines that assist in diagnosing and treating both internal as well as external diseases and disorders of human beings and animals. It includes insect repellents, vaccines, antibiotics, antigens, antitoxins, antibiotics, antiseptic, etc.
DEFINITION OF COSMETICS
Section 201(i) of the Federal Food, Drugs and Cosmetics Act and Section 3(aaa) of the Drugs and Cosmetics Act elucidates Cosmetics as
“Articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance.”
The Federal Food, Drugs and Cosmetics Act of the USA excludes soaps from the category of Cosmetics. In consonance with the FD&C Act, a product may be deemed merely as a drug, merely as a cosmetic and also as both drug and cosmetic.
An anti-dandruff shampoo meets the requirements of both drugs and cosmetics. It is a cosmetic as it cleanses the hair and also a drug since it contains anti-dandruff ingredients to treat dandruff.
LAWS REGULATING DRUGS AND COSMETICS IN INDIA
In India, the Drugs and Cosmetics Act, of 1940 has been enacted to regulate the import, manufacture, sales and distribution of drugs and cosmetics through a valid licence. Subsequently, the Drug Rules were passed in 1945. This act prescribes standards of quality and specific guidelines for the storage, labelling and display of drugs and cosmetics. The main objective of this act is to ensure that the drugs and cosmetics that are sold in India are in consonance with the state quality standards and to ensure that the manufacture, sales and distribution are carried out by qualified persons under this act. Ayurveda, Siddha and Unani drugs are also governed by this act. Furthermore, this act laid down penalties of imprisonment and fine for any offence contravening the provisions of this act. The initial amendment of this act was done in 2008. Recently, the 10th amendment of the Drugs and Cosmetic Rules, 2017 proclaimed that the licence for the manufacture and sale of drugs once issued shall remain perpetually provided that the licensee deposits the retention fee for the licence every five years.[iv]
Regulations of Drugs
As aforementioned, drugs are any substances that are purported to stabilize the physiological and psychological functions of the body. The Drugs and Cosmetics Act, 1940 expounds the terms ‘Misbranded Drugs’, ‘Adulterated Drugs’ and ‘Spurious Drugs’.
Misbranded Drugs: Section 9 and 17 of the act elucidates Misbranded Drugs as drugs that are coloured, overlaid or laminated to conceal any damages or made it seem to be of possessing greater therapeutic value than the normal standard value of the drug.
Adulterated Drugs: Adulterated drugs are drugs that are incorporated with any decayed, petrified, toxic substances in addition to the essential ingredients which are detrimental to human and animal health as defined under Section 9A and 17A of this act.
Spurious Drugs: Spurious drugs are imitated drugs that lack their own identity and are almost fairly identical to another drug or imported under the name of another drug or manufactured under a name of a fictitious company.
The Drugs and Cosmetics Act categorizes the drugs under Schedules and furnishes guidelines for the storage, labelling and packaging for each schedule respectively. Here are some prime schedules.
Schedule C/C1-Biological drugs
Schedule G- Hormonal preparations
Schedule H- Drugs that are sold only under the prescription of a Registered Medical Practitioner.
Schedule J- Drugs that are not legally claimed to cure diseases such as AIDS, blindness, etc.
Schedule F/F- Blood Products/ Vaccines
Section 10 and 18 of this Act prohibits the import and manufacture & sale of certain drugs respectively which are incorporated by the Central Government by notification in the official gazette i.e. Drugs of non-standard quality, Misbranded, Adulterated, Spurious drugs, etc.,
Section 10A and 26A of this Act empowers the Central Government to prohibit the import and manufacture & sales of any drugs respectively in the public interest or on the ground if the drugs or any ingredient in the drugs do not have any therapeutic value.
Regulation of Cosmetics
Section 9C and 17C of the Drugs and Cosmetics Act, 1940 patently defines Misbranded Cosmetics and 9D and 17D of this act defines Spurious Cosmetics. Adulterated Cosmetics are elucidated under section 17E of this act.
For the manufacture, sale and distribution of cosmetics under this Act, the manufacturer should get hold of a license under Form 31 with a license and inspection fee of Rs. 2500/- and Rs.1000/- respectively. Besides, the manufacturer should possess a premise as prescribed under Schedule MII of this Act.
Prerequisites of Labelling
Name of the drug or cosmetic as prescribed, Net Quantity, Batch Number, Manufacturing License Number, Import License Number, Name and Address of the manufacturer, Manufactured and Expiry date are the labelling requirements of both drugs and cosmetics.
For the drugs of Schedule G -warning and caution; Schedule H- the symbols Rx or NRx with the warning “To be sold under the prescription of the Registered Medical Practitioner Only” should be labelled under this Act. For cosmetics, the direction of use, warning and caution should mandatorily be labelled in the inner and outer container.
Offences and Penalties
Any person who manufactures spurious drugs shall be punished with the imprisonment of 1-3 years with a fine of Rs.500/- and 2-6 years with Rs. 10,000/- on subsequent convictions.
For the manufacturing of Adulterated drugs, the punishment is imprisonment for 1 year with a fine of Rs. 2000/- and 2 years with Rs. 2000/- on subsequent convictions.
Any person who import Spurious drugs and cosmetics and Adulterated drugs and cosmetics that are in contravention to section 10A of this Act shall be punished with the imprisonment of 3 years or a fine of Rs.5000 or both on the first conviction and 5 years or Rs. 10,000/- or both on subsequent convictions.
M/s. Prem Pharmaceuticals and Others. V. State of Madhya Pradesh[v]
In this instant case, the petitioners were prosecuted under the Drugs and Cosmetics Act on the ground that their sodium chloride injection was of sub-standard quality and contained extraneous particles. The Indore Bench of Madhya Pradesh High Court quashed the prosecution and held that in the absence of a proper analysis of the particles in the medicine, it is irrelevant to say that the particles are of extraneous nature and not the ingredient of the medicine that came into existence during the manufacture and storage. Further, the court observed that according to section 19(2)(b) of the Drugs and Cosmetics Act, a drug shall not be deemed to be of sub-standard quality if some extraneous substance has been inexorably intermixed with it.
LAWS REGULATING DRUGS AND COSMETICS IN THE USA
The Federal Food, Drug and Cosmetic Act (1938) is a Federal law that was enacted to establish, oversee and enforce the quality standards of food, drugs, cosmetics and medical devices manufactured and sold in the United States of America. The Pure Drug and Food Act, the first law enacted in 1906 for the federal regulation of food and pharmaceutical industries, was replaced by the Federal Food, Drug and Cosmetic Act of 1938 owing to the Elixir Sulfanilamide disaster. The FD&C Act has several times been amended since 1938. The main objective of amending the act was to ameliorate the efficacy of the established drugs since 1938. The Human Resources (HR) introduced the Safe Cosmetics Act of 2010 to expand the regulation of cosmetics.[vi]
Chapter V of the act deals with Drugs and Devices. Section 501 and 502 of the FD&C Actinterpret the terms ‘Adulterated drugs and devices’ and ‘Misbranded drugs and devices’ respectively. These definitions look much more natural in both the Drugs and Cosmetics Act of India and the FD&C Act of the USA. Chapter VI of the FD&C Act deals with Cosmetics. The FDA under FD&C Act does not approve cosmetics whereas it inspects and prohibits the manufacture and marketing of misbranded or adulterated cosmetics. In the USA, it is not imperative for any company to avail premarket approval or registration for the manufacture of cosmetics. However, they can submit the information of the products of their own volition through Voluntary Cosmetic Registration Program (VCRP) and Food & Drug Administration (FDA)to avoid any predicaments in future.
Prerequisites of labelling
Drugs - Name of the drug as prescribed, Name and the net quantity of each component, Name and Address of the manufacturer, packer and distributor, Lot number and Batch number should be labelled. Further, the manufactured and Expiry date should be labelled both on the inner container and outer package. For Over Counter (OTC) drugs (i.e.) the drugs that can be sold without a prescription from a medical practitioner, the warning about the usage of the drug during pregnancy or breastfeeding should be labelled.
Cosmetic - In the USA, cosmetic labelling is regulated by both the FD&C Act and FPLA (Fair Packaging and Labelling Act). An explicit declaration of the ingredients in the package is required for the products manufactured for retail sale as suggested by the Cosmetics, Toiletries and Fragrances Association (CTFA). For imported cosmetic products, the country of origin should be labelled.
Offences and Penalties
‘Mens rea’ or intention is not a predominant element under the FD&C Act. The three main elements for a criminal conviction under this act is
(i) Whether the article is a food or drug or medical device or cosmetic.
(ii) Whether the article is adulterated or misbranded.
(iii) Whether the article is introduced into interstate commerce.
Section 303(a) of this act establishes penalties for any criminal infringement of the act (misdemeanours) and for any criminal act with an intention to defraud or mislead (Felonies). For simple violations of the act, the accused shall be punished with imprisonment which may extend to 1 year or a fine of $1,000 or both. Any person who has a guilty mind to defraud or mislead shall be punished with imprisonment for up to 3 years or a fine up to $10,000 or both. The current maximum fine for an individual for misdemeanours not resulting in death is $100,000 and for misdemeanours resulting in death is $250,000. In the case of an organisation, the maximum fine for misdemeanours not resulting in death is $200,000 and misdemeanours resulting in death are $500,000.[vii]
The United States. V. Park[viii]
The defendant Park, CEO of Acme International had failed to comply with the conditions laid down by the Food, Drug and Cosmetic Act for warehouse sanitation. The Supreme Court of the United States held that Park was strictly liable for the unhygienic condition that his company had created. Further, the court held that the FD&C Act being a welfare statute, its chief purpose is to avert appalling harm in the society and also held that the Food and Drug Administration(FDA) under FD&C Act could penetrate the corporate veil.
Safety and efficacy are the two prime elements for the enactment of the laws regulating drugs and cosmetics. Drugs and cosmetics are regulated by various bodies under the Drugs and Cosmetics and the FD&C Act. These acts ensure that the drugs and cosmetics sold in the nation meet the prescribed quality standards. These acts are enacted for the welfare of the mortals and guarantee that the drugs and cosmetics that are manufactured, sold and distributed in the nations meet the indispensable necessities of humankind.