JIMS ENGINEERING MANAGEMENT

TECHNICAL CAMPUS School of Law

Assignment
SOCIO ECONOMIC OFFENCES
Topic:
ADULTERATION
CONTROL OF SPURIOUS DRUGS

SUBMITTED TO: -

Mrs. Vijeta Verma

SUBMITTED BY: -

Arun Chopra

BBALLB (2017-2022)

NINETH SEMESTER

Enrolment No. – 00425503517

ADULTERATION
CONTROL OF SPURIOUS DRUGS

Among man’s everyday needs, food plays a major sustaining role. From the simple dish to the most
elaborate haute cuisine, food preparation is as varied and rich as man’s taste. The lure of riches and
general apathy towards mankind has led to adulterants being added to food from the simple stones
in rice to the more harmful brick and boric powder.

What is adulteration
Adulteration of food commonly defined as “the addition or subtraction of any substance to or from
food, so that the natural composition and quality of food substance is affected". Adulteration is either
intentional by either removing substances to food or altering the existing natural properties of food
knowingly. Unintentional adulteration is usually attributed to ignorance’s, carelessness or lack of
facilities for maintaining food quality. Incidental contamination during the period of growth,
harvesting, storage, processing, transport and distribution of foods are also considered.
“Adulterant” means any material which is or could be employed for making the food unsafe or sub-
standard or mis-branded or containing extraneous matter.
Food is declared adulterated if:

 A substance is added which depreciates or injuriously affects it.

 Cheaper or inferior substances are substituted wholly or in part.
 Any valuable or necessary constituent has been wholly or in part abstracted.
 It is an imitation.
 It is colored or otherwise treated, to improve its appearance or if it contains any added
substance injurious to health.
 For whatever reasons its quality is below the Standard

Adulterated food is dangerous because it may be toxic and can affect health and it could deprive
nutrients essential for proper growth and development.
Types of adulterants

Poisonous or Deleterious Substances

Generally, if a food contains a poisonous or deleterious substance that may render it injurious to
health, it is adulterated. For example, apple cider contaminated with E.coli O157:H7 and Brie cheese
contaminated with Listeria monocytogenes are adulterated.
If a food contains a poisonous substance in excess of a tolerance, regulatory limit, or action level,
mixing it with "clean" food to reduce the level of contamination is not allowed. The deliberate mixing
of adulterated food with good food renders the finished product adulterated

Filth and Foreign Matter

Filth and extraneous material include any objectionable substances in foods, such as foreign matter
(for example, glass, metal, plastic, wood, stones, sand, cigarette butts), undesirable parts of the raw
plant material (such as stems, pits in pitted olives, pieces of shell in canned oysters), and filth
(namely, mold, rot, insect and rodent parts, excreta, decomposition.

Economic Adulteration
A food is adulterated if it omits a valuable constituent or substitutes another substance, in whole or in
part, for a valuable constituent (for instance, olive oil diluted with tea tree oil); conceals damage or
inferiority in any manner (such as fresh fruit with food coloring on its surface to conceal defects); or
any substance has been added to it or packed with it to increase its bulk or weight, reduce its quality
or strength, or make it appear bigger or of greater value than it is (for example, scallops to which
water has been added to make them heavier).

Microbiological Contamination and Adulteration

The fact that a food is contaminated with pathogens (harmful microorganisms such as bacteria,
viruses, or protozoa) may, or may not, render it adulterated. Generally, for ready -to-eat foods, the
presence of pathogens will render the food adulterated. For example, the presence of Salmonella on
fresh fruits or vegetables or in ready-to-eat meat or poultry products (such as luncheon meats) will
render those products adulterated.

Ready -to- eat meat and poultry products contaminated with pathogens, such as Salmonella
or Listeria monocytogenes, are adulterated. For raw meat or poultry products, the presence of
pathogens will not always render a product adulterated (because raw meat and poultry products are
intended to be cooked and proper cooking should kill pathogens).
What are drugs?

Drugs affect the way your body and mind function; they can change how you feel, think
and behave. People take drugs for different reasons and in different ways

Drugs affect your mind and body

Drugs are substances that change a person’s mental or physical state. They can affect
the way your brain works, how you feel and behave, your understanding and your
senses. This makes them unpredictable and dangerous, especially for young people.

The effects of drugs are different for each person and drug. Learn more about
the effects of drugs and the different types of drugs.

Why do people use drugs?

Drugs change the way your body or brain works. 

People take drugs because:

 they are curious and want to see what happens

 they want to fit in or feel pressured by their peers
 they enjoy the effect on their body — for example, feeling excited and energetic, or
relaxed and calm
 they help them cope with situations — for example, reducing pain or relieving stress
 they’ve have a drug dependency and need to keep taking them to avoid withdrawal
symptoms

How are drugs made?

Drugs come from different sources:

 plants — for example, cannabis, mushrooms, or tobacco

 processed plant products — for example, alcohol, or heroin
 synthetic chemicals — for example, ecstasy or amphetamines

The processes used to make drugs varies widely, but drug products have 2 main types
of ingredients:

 active ingredients — the ingredients that biologically affect your body

 inactive ingredients — these generally have no biological effect. They include binding
agents, capsules, dyes, preservatives, flavourings and other ingredient
Legal and illegal drugs

Drugs can be:

 legal — for example, alcohol, caffeine, and tobacco

 illegal — for example, cocaine or heroin

Legal drugs

Some drugs — such as alcohol, caffeine, and nicotine — are legal but may be subject to
restrictions based on age, location of use, driving and point of sale regulations.

We regulate and control the active ingredients in legal drugs:

 the alcohol content of drinks

 the milligrams of nicotine in cigarettes

Illegal drugs

Other drugs such as cannabis, amphetamines, ecstasy, cocaine and heroin, are illegal.
They are not subject to quality or price controls and the amount of active ingredient
varies. A person using illegal drugs can never be sure of how strong the drug is, or what
is actually in it.

Different batches of an illegally manufactured drug may have different amounts of the
drug and other unidentified additives.

It is against the law to possess, use, make, import or sell illegal drugs. The penalties for
drug offences vary depending on the age of the offender (adult or minor), type of drug,
quantities involved, previous offences, and the state or territory in which the offence
happened.

Concept of Adulterated, Misbranded and Spurious

Drugs/Devices explained by Drugs and Cosmetic Act 1940

The Drug and Cosmetic act 1940 is an Act of the Parliament which regulates the import,
manufacturing and distribution of drugs in India.
The Primary objective of the act is to ensure the drugs and cosmetics sold in India are
safe , effective and follow quality standards.

In 1964 the act was amended to include Ayurveda and Unani drugs as well.

Section 16 of the act defines the standards of quality for drugs.

Section 17 defines misbranding. A drug is considered misbranded if it claims to be of

more therapeutic value than it actually is. The manufacturer of such drugs may be
asked to suspend manufacture of the drug under section 18.

Section 27 deals with fake and adulterated drugs. The act requires that ingredients of
the drugs should be printed on the label.

Section 22 defines the powers of the drug inspectors.

Section 23 defines the strict procedure which should be followed by the inspector
during any raids.

The manufacture and sale of drugs is a licensed activity under the Drugs and Cosmetics
Act 1940 and Drug and Cosmetic Rules 1945.

The licenses are required to comply with the provisions of the act, rules and condition
of the license granted to them by the licensing authorities for manufacture and sale of
drugs.

The Drugs and Cosmetics Act 1940 have elaborate provisions to check the production of
spurious and substandard drugs in the country.

The act provides elaborate definitions of the terms spurious, adulterated and
misbranded drugs for the purpose of taking penal actions against the offenders.

Spurious Drugs and Devices:

A drug shall be deemed spurious;

(i) id it is manufactured under a name which belongs to another drug.

(ii) if it is an imitation of another drug or resembles another drug in a manner likely to
device or bears upon its label or container the name of another drug unless it is plainly
and conspicuously marked so as to reveal its true character and its lack of identity with
such other drug.

(iii) if the label or container bears the name of an individual or company purporting to
be the manufacturer of the drug, which individual or company is fictitious or does not
exist.

(iv) If it has been substituted wholly or in part by another drug or substance

(v) If it purports to be the product of a manufacturer of whom it is not truly a product.

Offenses and Punishments:

The drugs and cosmetic act 1940 has been recently amended under the Drugs and
Cosmetics Amendment Act 2008 providing very strict penalties for manufacture of
spurious and adulterated drugs.

It is provided that any drug deemed to be spurious or adulterated when used by any
person for or in the diagnosis, treatment,, mitigation or prevention of any disease or
disorder is likely to cause his death or is likely to cause such harm on his body as would
amount to grievous shall be punishable with imprisonment for a term which shall not
be less than 10 years but which may extend to life imprisonment and shall also be
liable to fine which shall not be less than 10 lakh rupees or 3 times value of the drugs
confiscated whichever is more.The fines realized in such cases will be paid to the
relative of the deceased or aggrieved person.

Any drug deemed to be spurious but not likely to cause death shall be punishable with
imprisonment of a term which shall not be less than 7 years but which may extend to
life imprisonment with fine which shall not be less than 3 lakh rupees or 3 times the
value of the drugs confiscated, which ever is more.

Offense related to sale, manufacture of spurious and adulterated drugs have now been
made cognizable and non bailable.
It has been provided that besides an Drug Inspector appointed under the act; the
person aggrieved or consumer associations, a gazetted officer authorized by
Government of India have also been authorized to launch prosecution under the act.

Low conviction hinders fight against

spurious drugs
Spurious drugs can have harmful side-effects and can even kill. Yet India has
been able to decide only 35 cases of the 606 prosecutions launched against
the manufacture, sale and distribution of spurious or adulterated drugs from
2015 to 2018, according to figures provided by the Drug Controller.

During this time, 328 arrests were made. 15,749 samples were declared not of
standard quality and 593 samples were declared spurious or adulterated, while
a total of 2,33,906 drug samples were tested during the three-year period.

‘Sample size inadequate’

The 54th Parliamentary Standing Committee on Chemicals and Fertilizers
noted that “considering the size of the country and the huge quantum of
medicines being distributed and sold in the country, this sample size is not
adequate to measure the actual problem of spurious and non-standard quality
drugs in the country.

Special courts sought

“We are dismayed to note that the decision is pending in most cases. There is
an urgent need for time-bound decisions on prosecutions launched against
manufacture, sale and distribution of spurious and non-standard quality drugs.
Special courts should be opened in all states/UT and these courts may also
impressed upon the need for timely disposal of cases,” the Committee noted.

Under the Drugs and Cosmetics (Amendment) Act 2008, any drug is deemed
to be adulterated or spurious when used by any person for or in the diagnosis,
 treatment, mitigation or prevention of any disease or disorder is likely to
cause his death or is likely to cause such harm on his body.

Drugs and Cosmetics Act, 1940

17B. Spurious drugs

For the purposes of this Chapter, a drug shall be deemed to be spurious,-

(a) if it is manufactured under a name which belongs to another drug; or

(b) if it is an imitation of, or is a substitute for, another drug or resembles another drug in a manner likely to deceive or
bears upon it or upon its label or container the name of another drug unless it is plainly and. conspicuously marked so
as to reveal its true character and its lack of identity with such other drug; or

(c) if the label or container bears the name of an individual or company purporting to be the manufacturer of the drug,
which individual or company is fictitious or does not exist; or

(d) if it has been substituted wholly or in part by another drug or substance., or

(e) if it purports to be the product of a manufacturer of whom it is not truly a product.

The Drugs and Cosmetics Rules, 1940 are the rules which the government of India established
through the Drugs and Cosmetics Act, 1940. These rules classify drugs under given schedules and
present guidelines for the storage, sale, display and prescription of each schedul

In India, as per Drug and Cosmetic (D and C) act, 1940, under section 17, 17A and 17B poor
quality drug comprises of misbranded, spurious and adulterated drugs, respectively[13]. With the
2008 amendment of D and C act, Indian drug regulatory authority that is Central Drugs Standard
Control Organization (CDSCO) has categorised not of standard quality (NSQ) products in three
categories A, B and C that is helpful in categorising the products during quality evaluation[14].
Category A incorporates spurious and adulterated drug products; which conceal the real identity
of the product or formulation and be similar to some well-known brand. These products may or
may not contain active ingredients and generally manufactured by unlicensed antisocial people
or sometimes by licensed manufacturers. Products that consist of adulterant/substituted product
or incorporate some filth material are known as adulterated drugs.
Category B include grossly substandard drugs in which product fails the disintegration or
dissolution test and where active ingredient assay get below 70% and 5% of permitted limit for
thermolabile and thermostable product, respectively for tablets or capsules. In case of parenteral
preparation, failing sterility, pyrogen/endotoxin test or inappropriate toxicity, and fungus
presence in any liquid preparation hold such products in this substandard category. Category C
involved products with minor defects like emulsion cracking, change in formulation colour,
small variation in net content, sedimentation in clear liquid preparation, failing of weight
variation test, spot or discolouration on product, uneven coating, presence of foreign matter and
labelling errors.
In this evaluative review, an attempt has been made to know the correct extent of the SFFC or
NSQ drugs in India and to make awareness among the public, medical practitioners and
pharmacists. Data was acquired from governmental and non-governmental studies, literature,
news, journals and authentic web sites. All the data was compared and interpreted to reveal the
real story of poor quality drugs in India.

Schedules
The Drugs and Cosmetics Rules, 1945 contains provisions for classification of drugs under given
schedules and there are guidelines for the storage, sale, display and prescription of each
schedule. The Rule 67 details the conditions of licenses. The Rule 97 contains the labeling
regulations.
The notable Schedules and their summary:

 Schedule G: Most of these drugs are hormonal preparations.[4] The drug label must

display the text "Caution: It is dangerous to take this preparation except under medical
supervision" prominently. Examples of substances under this
schedule: Testolactone, Hydroxyurea, Carbutamide, Primidone etc.[3]
 Schedule H: The drug label must display the texts "Rx" and "Schedule H drug.
Warning : "Not to be sold by Retail without the prescription of a Registered Medical
Practitioner" prominently. It can only be supplied to licensed parties. It cannot be sold
without a prescription and only the amount specified in the prescription should be sold.
The time and date of prescription must be noted.
Examples: androgenic, anabolic, oestrogenic and progestational substances; Alprazolam 
(Xanax), Hepatitis B vaccine, Ibuprofen, Vasopressin etc.[3]
o If a Schedule H drug also comes under the purview of Narcotic Drugs and
Psychotropic Substances Act, 1985, it must carry the
texts "NRx" and "Schedule H drug. Warning: To be sold by retail on the
prescription of a Registered Medical Practitioner only." on the label
prominently.
 Schedule X: All the regulations of Schedule H apply. The retailer must keep a copy of
the prescription for two years. The drugs must be kept under lock and key.
Examples: Secobarbital, Glutethimide etc.
 Schedule J: Contains a list of various diseases and conditions that cannot be treated
under any drug currently in market. No drug may legally claim to treat these diseases
Conclusion
Globally, every country is the victim of substandard or spurious drugs, which result in life threatening
issues, financial loss of consumer and manufacturer and loss in trust on health system. The aim of this
enumerative review was to probe the extent on poor quality drugs with their consequences on public
health and the preventive measures taken by the Indian pharmaceutical regulatory system. Government
and non-government studies, literature and news were gathered from journals and authentic websites.
All data from 2000 to 2013 were compiled and interpreted to reveal the real story of poor quality drugs
in India. For minimizing spurious/falsely-labelled/falsified/counterfeit drugs or not of standard quality
drugs, there is urgent requirement of more stringent regulation and legal action against the problem.
However, India has taken some preventive steps in the country to fight against the poor quality drugs for
protecting and promoting the public health.