UNIT 2:

1. 2016,2017,2019 What is medical insanity? What are the legal

protections given to mentally ill persons with special reference to
Mental Health Act. U2
2. 2016 Evaluate the provisions for legal control of drugs and cosmetics
under the Drugs and Cosmetics Act, 1940. U2
3. 2017 Exaime product liability for defensive mechanism. U2
4. 2018 Critically analyse the role of regulatory authorities under the
Drugs and Cosmetics Act, 1940. U2

5. . 2018 Distinguish between medical and legal insanity analysing Mc

Naughten Rule. U2

6. 2019 Discuss the salient features of the New Drugs and clinical Trials
Rules 2019 and its relevance in contemporary scenario. U2

7. 2021 Discuss the powers and functions of Inspectors under the Drugs
and Cosmetics Act, 1940. U2
8. 2021 Give an overview of the Mental Healthcare Act, 2017. U2

CONSUMERS UNDER CONSUMER PROTECTION ACT 2019

 1. 2016,2017,2019 What is medical insanity? What are the legal
protections given to mentally ill persons with special reference to
Mental Health Act. U2
2. 2021 Give an overview of the Mental Healthcare Act, 2017. U2

India is a vastly populated country and according to a survey in 2017, one in

seven Indians were affected by mental disorders of varying severity. People
suffering from any sort of mental illness are highly susceptible to finding
themselves in vulnerable positions. Therefore, it is important for developing
countries like India to take this hands-on and make hard and soft laws
concerning mental illness situations.

The term “Mental illness” in this act is defined in Act in Section 2 which consists
of Definitions.

According to this act mental illness indicates a substantial disorder of thinking,

mood, perception, orientation or thought that grossly damages judgment,
behaviour, capacity to recognise reality or ability to meet the usual requirements
of life, mental conditions associated with the degradation of alcohol and drugs,
but does not constitute mental barrier which is a condition of arrested or
inadequate development of mind of a person, particularly characterised by sub-
normality of knowledge.

Mental illness shall be defined in the same style as nationwide or overseas held
medical criteria. Additionally, mental illness cannot be decided by a person’s
political, economic or social status, association in cultural society, racial or
religious group, or non-conformity with a community’s moral, social, cultural,
work or political interpretations and religious opinions.

Major provisions
1) New definition of mental illness

Earlier, Mental illness was defined as any mental disorder and seldom as mental
retardation but the new act provides a broader definition which is stated below:

2) Various rights for persons with mental illness

• Every person has a right to obtain mental health care and its treatment
from mental health services run or financed by the appropriate
government. u/s 18

• Every mental ill person shall have Right to community living u/s19
• Persons with mental illness will also have the right to protection from
barbaric and demeaning treatment. u/s 20

• No discrimination of any basis including gender, sex, religion, culture,

sexual orientation, caste, social, class, disability and political beliefs
should be done against mentally ill people. u/s21

• A person with mental illness and his nominated representative shall have
the rights to the information u/s 22]
• Rights of confidentiality as for mental health, treatment, mental health
care, and physical health care to mentally ill people. u/23

• Forbid the usage of the release of a photograph or any such matter

related to a mentally ill person in the media without the acquiescence of
the person. u/s 24

• All persons with mental illness shall have the right to access their basic
medical records as may be prescribed. u/s 25
 • Right of picking the person who would be answerable for making
decisions with the view to the treatment, his admission into a hospital,
etc. u/s 26

• A person with mental illness shall be entitled to receive free legal

services to exercise any of his rights given under this Act. u/s 27

• Any person with mental illness or his nominated representative, shall

have the right to complain regarding deficiencies in provision of care,
treatment and services in a mental health establishment u/s 28
• Free treatment is provided for the person with mental illness if they are
homeless & fall in Below Poverty Line, even if they don’t own a BPL
card.
• Right to live with dignity is provided for every person with mental
illness.

3) Advance directive

A person with mental illness shall have the right to make an advance directive
that states how he/she wants to be treated for the illness and who his/her
nominated representative shall be. The advance directive should be certified by a
medical practitioner or registered with the Mental Health Board.

4) Mental health authority

The Bill provides power to the government to set-up the Central Mental Health
Authority at national-level and State Mental Health Authority in each State.

Every mental health practitioner and mental health institute including nurses,
clinical psychologists, also psychiatric social workers will be compelled to be
registered with this Authority.
These bodies command to:

1. register, supervise and manage a register of mental health professionals

& establishments,

2. generate quality and service provision norms for such establishments,

3. train law enforcement administrators and mental health experts on the

outlines of the Act,

4. receive complaints about deficiencies in the provision of services, and

5. advise the government upon matters representing mental health.

5) Mental health treatment

The Bill also specifies the process and procedure to be followed for admission,
treatment and discharge of mentally-ill individuals.

A medical practitioner or a mental health professional shall not be held liable for
any unforeseen outcomes on following a valid advance directive.

6) Decriminalization of suicide

As provided in Section 115;

1. Notwithstanding anything contained in Section 309 of the Indian Penal

Code any person who attempts to commit suicide shall be presumed,
unless proved otherwise, to have severe stress and shall not be tried and
punished under the said code.

2. The Appropriate Government shall have a duty to provide care,

treatment and rehabilitation to a person, having severe stress and who
 attempted to commit suicide, to reduce the risk of recurrence of attempt
to commit suicide”.
This is a milestone judgement which annulled Section 309 IPC which stated that
‘Any person attempting to perform suicide shall be punished with simple
imprisonment which may prolong to one year.

7) Abolishment the barbarous treatments

• It also affirms that a person with mental illness shall not be subjected to
electroconvulsive therapy (ECT) therapy without the application of
muscle relaxants and anaesthesia.

• Electro-convulsive therapy for minors is prohibited.

• Chaining in any manner or method whatsoever is banned.

Criticisms of the Act

The Act does not provide for the advance directive to minors, as per Section 5 of
the said Act. All the services are to be ensured by both Central and State
governments. The expenditures estimated will not meet the obligations under the
bill. The Centre and State, both have responsibilities as per the Act; it does not
provide sharing of funds between them. All the States have different financial
conditions; the Central government has to assure funds for meeting the legal
obligations. If a person no longer demands an order of supported admission to the
Mental Health establishment, the Act provides that they may continue to remain
in the mental health establishment as an independent patient and does not clarify
for how long and what procedure is to be adopted to give the person an effective
chance to live in the community. Discussions should be started with the Central
and state governments to recognise the lack of resources and ensure their
availability with proper budgeting to perform the provisions of the MHCB. The
MHCA does propose some timelines, but detailed and precise response plans are
required to prepare the system before the action is executed. Emphasis should be
laid on training for skill development. In the chapter, I of the Act – ‘mental health
professional’ is limited to clinical psychiatrists and specialists containing a
postgraduate degree in Ayurveda, Homeopathy, Siddha, and Unani. Despite the
main worry is psychotherapists and psychoanalysts are omitted from the act as
the current definition. Although the law to punish the person committing suicide
has been prohibited, a lot still needs to be done for the mentally ill people.

Conclusion

The Mental Healthcare Act of 2017 looks alien in nature but impractical in scope.
There is no doubt that in the scope the act is a big leap from its predecessor 1987
Act. However the present healthcare system seems to be incompetent and we
suffer from lack of infrastructure and specialists in the field, resultant of this
causes the degraded quality of living and healthcare of the mentally ill. The Act
has taken a standard shift of rendering “mental healthcare” essentially as
“justiciable rights.”

The new act has set outcome principles that mental health professionals will
embrace and embed in practice. The decriminalization of attempt to suicide is
one of the major highlights of the act, along with the concept of Advance
Directive and ban on all those treatment procedures that gave these mentally ill
person nightmares, also trying to fix the system of institutions by engaging them
and making sure they work at standards which are prescribed by the authorities
in the act. Breaching its stated policies of equality, the act ends up discriminating
against the mentally ill. There is a lack of comprehensive rules and regulations to
include all the settings. The resolve to implement the principles holding the act
appears weak, given the delay of ring‐fenced resources beyond inflationary
arrangements. However, more promotive programs & campaigns should be
promoted on mental health. The government should press more on allocating
more funds in Mental Health Organisations.

3. Evaluate the provisions for legal control of drugs and cosmetics under the
Drugs and Cosmetics Act, 1940
4. 2021 Discuss the powers and functions of Inspectors under the Drugs
and Cosmetics Act, 1940. U2

The Drugs and Cosmetics Act, 1940 (DCA), is one such law that governs the
manufacture, import, and distribution of medicines in the country. It was
followed by the Drug and Cosmetics Rules, 1945, which categorised the drugs
into schedules and provided regulations for the sale, storage, and prescription of
each category. The article seeks to discuss its provisions, as set out in 1940, and
how the legislation has been enhanced in the past two decades and what new
rules and legal provisions have been introduced into the Act.

Objectives of the Drugs and Cosmetics Act

The Drugs and Cosmetics Act aims to hold medical technology and
pharmaceutical companies liable for negligence and sub-standard services
provided by them. A major objective of enacting this legislation was to prevent
adulteration in medicines. Some other objectives have also been discussed
below:

1. Regulation of the sale, import, and distribution of drugs and cosmetics

by means of licensing.

2. Ensuring that only qualified individuals are involved in the import,

distribution, and sale of drugs and cosmetics.
 3. Preventing substandard drug quality, presumably in order to maintain
high medical treatment standards.

4. Regulation of the production and sale of Ayurvedic, Siddha, and Unani

drugs.

5. To form a Drugs Technical Advisory Board (DTAB) and Drugs

Consultative Committees (DCC) for allopathic and allied drugs, as
well as cosmetics.

Relevant definitions in the Drugs and Cosmetics Act

In order to obtain a better understanding of the provisions of the Act, we need to

first familiarise ourselves with certain terms that have been defined within it.
Some of the terms used throughout the Act have been defined hereunder.

Drug

Under the Act, ‘drug’ has been defined in Section 3 by categorising the term to
include 4 categories, which are as follows:

1. All the medicines which are meant for internal or external use on
humans or animals, and the “substances used for or in the diagnosis,
treatment, mitigation or prevention of any disease in human beings or
animals.” This also includes preparations that are applied to the human
body as repellents for insects like mosquitoes.

2. Substances other than food that may affect the structure or function of
the human body or that are used to destroy insects or vermin that cause
disease in humans or animals, as the Central Government specifies
through a notification in the Official Gazette from time to time.
 3. It also includes the substances that are used as components of a drug,
including empty gelatin capsules.

4. The devices that are used internally or externally on the human body
or on animals for the purpose of diagnosing, treating, mitigating, or
preventing any disease or disorder, as may be specified by the central
government in the Official Gazette from time to time after consulting
the Drugs Technical Advisory Board (DTAB).

Cosmetic

It has also been defined under Section 3 and refers to any item that is “intended
to be sprayed, poured, rubbed, or sprinkled on, introduced into, or applied” to
the human body or any part of it for cleansing, beautifying, promoting
attractiveness, or altering appearance. It also includes any items intended for use
as a cosmetic component.

Misbranded drug

A drug will be considered a misbranded drug under the following 3 conditions:

1. If the drug has not been labelled in the manner as it has been
prescribed.

2. If it is coloured, coated, powdered, or polished in order to conceal any

damage, or if it is made as such, it appears to be of better or greater
therapeutic value than it actually is.

3. If the label or container coming with the drug bears any statement,
design, or device making a false claim about the drug or giving any
misleading information.
Ayurvedic, Siddha or Unani drugs

This term, defined under Section 3(a) encompasses all medicines which are
used for internal and external purposes in diagnosis, treatment, prevention or
mitigation of disorder or disease in humans or animals. These medicines have to
be manufactured exclusively in accordance with the formulae laid down in the
authoritative texts of Ayurvedic, Siddha, and Unani Tibbi Systems of Medicines
provided under the First Schedule to the DCA.

Patent or proprietary medicine

The meaning of this term, as defined under Section 3(h), can be derived as
follows:

1. In relation to the Ayurvedic, Siddha, or Unani systems of medicine,

“all formulations containing only the ingredients mentioned in the
formulae described in the authoritative books of the Ayurvedic,
Siddha, or Unani systems of medicine specified in the First Schedule
to the Act,” but excluding the medicine in which parenteral
administration is used.

2. In relation to any other system of medicine, including allopathy, a drug

is introduced in a form “ready for internal or external administration”
of humans or animals that is not currently included within the editions
of the Indian Pharmacopoeia or any other Pharmacopoeia.

Adulterated drug

According to Section 9A, a drug will be treated as adulterated if it falls into one
of the below categories:
 1. Whole or part of it consists of “any filthy, putrid, or decomposed
substance”, or

2. It has been “prepared, packed, or stored under poor sanitary

conditions” due to which it may have been exposed to contamination
and hence rendered injurious to health, or

3. The whole or part of the composition of the container of the drug was
“of any poisonous substance which may render the contents injurious
to health,” or

4. The drug contains a colour that is not prescribed, or

5. The drug contains a harmful or toxic substance that renders it injurious

to health, or

6. It is mixed with a substance that may reduce the drug’s quality or

strength.

Manufacture in relation to drugs or cosmetics

Although the term ‘manufacture’ has not been explicitly mentioned in the Act,
it refers to any process that is fully or partially used for “making, altering,
ornamenting, finishing, packing, labelling, breaking up, or otherwise treating or
adopting any drug/cosmetic with a view to its distribution or sale, but does not
include the compounding or dispensing of any drug or cosmetic in the ordinary
course of retail business.”

Spurious drug

As per Section 17B of the Act, a drug will be treated as spurious under the
following situations:
 1. If the drug has been imported under a name that belongs to another
drug, or

2. If it is an imitation or substitute for another drug or it has a

resemblance with some other drug in a way that it will likely deceive
or happens to bear on itself or its label the name of another drug, or

3. If the name of a person or business claiming to be the drug’s producer

appears on the label or container but that person or business is fictional
or nonexistent, or

4. If the drug has been substituted in whole or in part by another drug

substance, or

5. If it claims to be the product of a manufacturer or company by which it

isn’t actually produced.

Misbranded cosmetic

A cosmetic will be deemed misbranded, according to Section 17C, if it falls

under one of the following categories:

1. When it contains an unprescribed colour, or

2. When the cosmetic is not labelled as it was prescribed to be, or

3. When the label or container of the cosmetic or anything that

accompanies the cosmetic happens to bear any statement that is false
or misleading in nature.

Spurious cosmetic

According to Section 17D, a cosmetic will be termed a spurious cosmetic:

 1. If it has been imported under a name belonging to some other
cosmetic, or

2. If the cosmetic is an imitation of or a substitute for another cosmetic,

or happens to resemble another cosmetic in a “manner likely to
deceive”, or bears on it or on its label or container the name of some
other cosmetic, or

3. If the label or container of the cosmetic bears the name of any

fictitious person or company claiming to be the manufacturer of the
cosmetic, or

4. If the cosmetic claims to be the product of a manufacturer who hasn’t

really produced the cosmetic.

Salient features of the Drugs and Cosmetics Act

The Act has made a significant effort toward regulating the pharmaceutical
industry in India and hence ensuring the protection of the health and safety of
the public. Some of the salient features of the Act can be summed up as follows:

1. The maximum penalty is life imprisonment and a fine of Rs. 10 lakhs

or three times the confiscated goods’ value, whichever is greater.

2. Other gazette officers, in addition to officers from the Drug

Controller’s Office, are authorised to initiate prosecution under the
Act; some of the offences are cognizable and non-bailable;

3. Specialised courts for the trial of offences covered by the Act;

4. Provision for the aggregation of minor offences.

Wings under the Drugs and Cosmetics Act, 1940

The Drugs and Cosmetics Act established 3 wings with proper authorities to
ensure proper regulation and administration of the Indian pharmaceutical
industry. These wings are:

Advisory wing

This wing consists of two bodies.:

1. Drugs Technical Advisory Board (DTAB)

2. Drugs Consultative Committee (DCC)

Analytical wing

This wing consists of the following bodies and individuals

1. Central Drug Laboratory

2. Government analysts

3. Drug Testing Laboratories for the states

Administrative wing

The following individuals are responsible for the administration of drugs and
cosmetics regulations:

1. Drugs Controller General of lndia

2. Drugs Control and Licensing Authorities of States

3. Drug Inspectors of central and state governments

The functions and features of the significant authorities have been discussed in
the following sections of the article.
Drugs Technical Advisory Board (DTAB)

It is a statutory board established by the Central Government under

the provisions of this Act to advise the Central Government and State
Governments on all technical matters pertaining to the Act, as well as to
establish guidelines for types of formulations as and when requested by the
Central Government. It is a technical advisory body composed of members who
are ex-officio, nominated, and elected. The DTAB has a total of 18 members
who represent various aspects of the pharmacy and medical professions in the
country. The Chairman of the DTAB is the Director General of Medical and
Health Services, Government of India, and the Member Secretary is the Drugs
Controller General of India. The DTAB’s headquarters are located at
the Ministry of Health and Family Welfare, Government of India, Nirman
Bhavan, New Delhi.

Composition of DTAB

The DTAB comprises ex-officio, nominated, and elected members. The

following are the members under each head:

Ex-officio members

There are 8 ex-officio members, namely:

1. “Director General of Medical and Health Services, Government of

India (Chairman)

2. Drugs-Controller General of India (Member Secretary)

3. Director, Central Drug Research Institute (CDRI), Lucknow, U.P.

4. Director, Central Drug Laboratory (CDL), Kolkata

 5. Director, Indian Veterinary Research Institute (IVRI), Izzatnagar, U.P.

6. Director, Central Research Institute (CRI), Kasauli, H.P.

7. President, Pharmacy Council of India (PCI)

8. President, Medical Council of India (MCI)”

Elected members

There are five positions where members have to be elected:

1. One professor in pharmaceutics or pharmaceutical chemistry or

pharmacognosy is elected by the Executive Committee of
the Pharmacy Council of India (PCI) from any university or affiliated
pharmacy college.

2. One professor in medicine or therapeutics in any of the government or

affiliated medical colleges is elected by the Executive Committee of
the Medical Executive Committee of Medical Council of India.

3. One professor in pharmacology and toxicology is to be elected by the

governing body of the Indian Council of Medical Research (ICMR).

4. One member is to be elected by the Central Council of the Indian

Pharmaceutical Association (IPA).

5. One member is to be elected by the Indian Medical

Association (IMA).

Nominated members

The remaining 5 members will be nominated by different bodies. They are:

 1. Two members will be nominated by the central government who are in
charge of the Drugs Control Department of the state or union territory.

2. Two government analysts will be nominated by the central government

anywhere from the country.

3. One industrialist representing the pharmaceutical industry is to be

nominated by the central government.

Term of office

The term of office for elected and nominated members is three years. Ex-officio
members hold office so long as they are in that specific position. Even if they
are not members of the DTAB, they can form sub-committees and co-opt
member experts for specific assignments. The DTAB makes policy decisions on
technical aspects of the Drugs and Cosmetics Act and Rules and forwards its
recommendations to the Ministry of Health and Family Welfare for approval.
DTAB meets twice a year. DTAB can be summoned with one week’s notice for
certain urgent matters. The Ministry of Health and Family Welfare may decide
on very urgent matters on a priority basis at times. However, such government
decisions must be ratified by DTAB within 6 months.

Drugs Consultative Committee (DCC)

It is the Advisory Body appointed by the central government under Section 7 to

advise the central and state governments, as well as the DTAB, on matters
pertaining to the uniform implementation of DCA and Rules provisions. The
DCC is made up of two representatives nominated by the central government
and one representative each from the state government and the union territory.
The state government or union territory usually appoints the Director of Drug
Control Administration or Drug Controller of State to this Council.
Central Drug Laboratory (CDL)

The Act directed the establishment of a Central Drug Laboratory (CDL)

under Section 6 in Kolkata, and it will be headed by a director appointed by the
central government. It is the “Statutory Analytical Laboratory for drugs and
cosmetics under DCA whose decision with regards to analysis is final in the
court of law.”

Functions of the Central Drug Laboratory

The CDL is responsible for performing various functions, which are:

1. It analyses drug and cosmetic samples sent by customs collectors and

different courts.

2. As directed by the central government, it advises the central

government, state governments, and union territories on drug and
cosmetic analysis aspects, and it also undertakes analytical work of a
particular nature for samples sent by the central government and state
governments.

3. It may accept samples for analysis in exchange for a fee from private
parties, consumer organisations, and so on.

4. It is involved in research for the development of newer drug and

cosmetic analysis techniques.

Powers of the Director of the Central Drug Laboratory

In order to carry out an effective analysis of the items, the director of the
concerned laboratory is vested with the powers of the Director of the CDL as
per the Act. The following are the powers:
“1. Director, Central Research Institute (CRI), Kasauli, H.P: for biological
preparations such as vaccines, sera, toxins, toxoids, etc., and also
bacteriophages, surgical sutures, and ligatures.

2. Director, Indian Venterinary Research Institute (IVRI), Izzatnagar,

U.P: for all biological products and other veterinary products meant for
animals.

3. Director, Central Indian Pharmacopoeia Laboratory (CIPL),

Ghaziabad, U.P: for all homeopathic medicines and condoms.

4. Director, National Institute of Communicable Diseases: Oral Polio

Vaccine”

The sample for analysis must be sent under sealed cover via registered mail to
the Director of the relevant laboratory. A memorandum filled out by the person
posting the sample for analysis in accordance with the procedure should be
accompanied separately on the same registered post. A separate copy of this
memorandum with the impression of the seal must be sent to the Director via
registered mail. The officer delegated on behalf of the Director or the Director
himself receives the registered post of sample and memorandum. The
impression of the seal in both cases is compared, and its authenticity is
confirmed before the seal is opened. The sample must be kept in the custody of
the Director or an officer designated by him until the analysis is completed and
then for a period of one year. Following the completion of the analysis, the
protocol used for the analysis, analytical results, and other pertinent information
are sent to the appropriate party via registered mail. Priority for analysis is
determined by the importance of the matter. The analysis decision made by
CDL is final and cannot be challenged in court.
Drug inspectors

Drug inspectors are appointed under Section 3(e) by both the state and federal
governments for specific areas or categories of activity. A separate set of
inspectors could be assigned to the manufacturing of drug formulations. Drug
Inspectors work for the Drug Controlling Authority of the state or central
government, depending on the circumstances. An inspector has been tasked
with ensuring that the Drugs and Cosmetics Act is strictly enforced in his or her
jurisdiction.

Qualifications necessary for the position of drug inspector

In order to hold the position of drug inspector, one must meet the following
criteria:

• The individual should not have a direct or indirect financial interest in

any of the activities related to drug import and export, manufacturing,
sale, or distribution.

• A graduate in pharmacy, pharmaceutical sciences, or medicine with a

specialty in clinical pharmacology or microbiology from an Indian
university is eligible for the position of Inspector.

• For the purpose of “Schedules C and C (1) drugs”,

(i) a drug inspector with at least 18 months of experience manufacturing at least
one substance specified in Schedules C and C(1) or

(ii) a drug inspector with at least 3 years of experience inspecting firms

manufacturing Schedules C and C(1) drugs or
(iii) a drug inspector with at least 18 months of experience testing at least one of
the substances in Schedules C and C (1) in a laboratory approved for the
purpose.

However, these qualifications may not be needed for those who were appointed
as an inspector on or before October 18, 1993. Every drug inspector will be
deemed to be a public servant as per the definition provided under Section 21 of
the Indian Penal Code, 1860.

Duties of inspectors of premises licensed for sale

Subject to instructions issued by the controlling authority, an inspector

authorised to inspect premises licensed for the sale of drugs has the following
duties under Section 51 of the Drugs and Cosmetics Rules of 1945:

• To inspect all establishments for sale at least once a year.

• To ensure that licensing conditions are being followed.

• To obtain and send the drug for testing or analysis if he has reason to
suspect that the drug is being sold or stocked in violation of the Act or
Rules.

• To conduct a worded investigation into the complaint.

• To keep a record of inspections.

• To conduct the necessary research.

• To initiate prosecutions for violations of the Act and Rules.

• When authorised by the State Government, detain imported packages

containing drugs, the import of which is prohibited.
Duties of inspectors specially authorised to inspect the manufacture of
drugs or cosmetics

The duties to be performed by an inspector are mentioned below. These duties

are subject to the instructions issued by the Controlling Authority.

• To inspect, at least once a year, all premises licenced for the

manufacture of drugs or cosmetics.

• To ensure that licence conditions are met.

• To inspect the plant, manufacturing process and standardisation,

storage, technical qualifications, and other details for Schedules C and
C (1) drugs.

• To submit a thorough inspection report to the Controlling Authority.

• To collect samples for testing or analysis in accordance with the rules.

The inspector is restricted from disclosing any information that he acquires
except for official purposes or when the law requires him to do so. He also has
the authority to seize records or to prevent the manufacturer from selling the
drugs for a period of 20 days if he has reason to believe that they are violating
provisions of the Drugs and Cosmetics Act. If needed, he may take xerox copies
of the seized documents signed by the owner of the documents.

A drug inspector is required to conduct a routine inspection of a shop or

manufacturing unit within his jurisdiction at least once a year. In general, the
inspection should be performed at a reasonable time, preferably during working
hours. However, if he or she has reasonable grounds to believe that a violation
of the DCA is happening, he or she may raid the premises and seize the
documents, records, or medicines, as the case may be.
The sample taken from the drug store should be divided into four parts. The
seizure of medicine should be done according to the provisions of the Code of
Criminal Procedure, 1973, and in the presence of witnesses. The samples must
be sealed, and the drug store owner’s seal should be permitted. In the case of
injectables, four different ampoules from the same batch are confiscated. The
drug inspector pays the drug store owner the fair price of the seized material, or
if the owner refuses to accept money, the receipt is prepared separately and the
form is filled out. Any seizure or raid must be immediately reported to the
Judicial Magistrate of that area. One of the four samples confiscated is kept by
the inspector; one is sent to a government analyst; one is returned to the drug
store owner; and the fourth is sent to the manufacturer.

An inspector shall send the sample to the government analyst by registered mail
or hand in a sealed packet enclosed with a memorandum on Form 18 in an outer
cover addressed to the government analyst. A copy of the memorandum and a
specimen impression of the seal are sent separately by registered mail to the
government analyst.

In the event of a raid or seizure of medicine at a manufacturing facility, three

seized samples are prepared using the same procedure. The Inspector keeps one
sample to present in court. The second sample is given to the manufacturer, and
the third sample is sent to the government analyst for analysis.

Following receipt of the analysis report, appropriate action is taken. Regular

sales are permitted if the report is satisfactory. If it is not satisfactory, legal
action will be taken.

Any physical assault or threat made in writing or over the phone to an inspector
while he is performing his duties is considered an offence punishable by
imprisonment for up to three years, a fine, or both.
Government analyst

Government analysts are appointed under Section 3(c) by the central

government and state governments to test or analyse drugs and cosmetics. They
work in Central Drugs Laboratories and the state and Union Territory’s drug
testing laboratories.

Duties of a government analyst

A government analyst has to perform the following duties:

• To analyse samples sent by the Inspector, Custom Officer, or other

person in accordance with the provisions of Chapter IV of the Act and
to prepare a detailed analysis report in triplicate. The entire protocol of
the analysis test should be provided. The report should be sent in a
sealed envelope to the Customs Department or the Drug Inspector,
depending on the situation.

• Send reports to the government about work done, research done,

publications, if any, and keeping drug and pharmaceutical information
up to date.
Before beginning analysis, the government analyst should verify the seal and
ensure proper custody of the sample sent for analysis. The analytical report
should be submitted in triplicate to the inspector or the appropriate person on
Form 13. Form 14-A is used for a purchaser’s request for testing or analysis,
and Form 14-B is used for the analysis report.

Licensing authority

This authority is concerned with the issuance of licences for the sale and import
of drugs and cosmetics within a particular jurisdiction. Each member of such an
authority must be a graduate in pharmacy or pharmaceutical chemistry or in
medicine with a specialisation in clinical pharmacology or microbiology. They
also must have five years of experience in the manufacturing or testing of drugs.

The duties to be performed by the licensing authority are as follows:

• To inspect all drug-selling establishments within the area assigned to

him.

• To ensure that the licence conditions are followed.

• To obtain and, if necessary, send imported packages for testing or

analysis.

• To look into any complaints.

• To keep a record of all inspections performed and actions taken in the

performance of his duties.

• To conduct such inquiries and inspections as may be necessary to

detect drug sales in violation of the Act.

Regulating the import of drugs

In order to regulate the import of drugs, certain conditions must be met for all
types of drugs. The following sections deal with the conditions for each type.

Import of drugs for personal use

1. If the drugs are a part of the passenger’s luggage, up to 100 doses of

the drug may be imported without any permit.

2. If the number of doses exceeds 100, a licence has to be issued for

import, the application for which can be filled out on Forms 12-A and
12-B.

3. The drugs must be for bona fide personal use.

 4. If the custom collector directs, the drugs must be declared to them.

Import of drugs for examination, test, or analysis

1. In order to import drugs for the purpose of examination, test, or

analysis, license is needed under Form-11.

2. The imported drugs must be used only for the purpose stated and at the
specific place mentioned in the licence.

3. The record with respect to quantities, the name of the manufacturer,

and the date of import must accompany the drugs.

4. An inspector must be allowed to inspect the premises and check

records.

Import of drugs without licence

Some drugs are eligible to be imported without a licence. These are:

1. Those substances which are not used for medicinal purposes.

2. Drugs under Schedule C, which are required for manufacturing

purposes.

3. Substances like powdered milk and cereal oats, which are both drugs
and foods.

4. Pre-digested foods.

Prohibition on the import of certain drugs

A number of drugs are completely prohibited from being imported. Given

below is a list of the same:
 1. Substandard drugs or cosmetics.

2. Misbranded, counterfeit, or adulterated drugs or cosmetics.

3. Importing those drugs or cosmetics which require a licence.

4. Any patent or proprietary medicine that does not have a true formula
or a list of active ingredients and their amounts.

5. Any drug or formulation which claims to prevent or cure diseases

mentioned in Schedule J.

6. Any drug or cosmetic whose manufacture, sale, or distribution is

illegal in the country of origin.

7. Any drug that is not packed or labelled in accordance with the

provisions of the Act.

8. Any cosmetic that contains an ingredient that may make it unsafe or

harmful.

9. Any drug or cosmetic whose import is prohibited by the Act.

Penalties under the Drugs and Cosmetics Act, 1940

The offences and penalties under the Act can be summed up as follows:

• Any adulterated or counterfeit drug or cosmetic imported into the

nation in contravention of the Act’s requirements is punishable by up
to three years in prison and a fine of up to 5,000 rupees.

• Any medicine or cosmetic other than the one mentioned in the above
point that is illegally imported is subject to a six-month prison
sentence, a fine of Rs. 500.00, or both.
• Any medication or cosmetic imported in violation of the terms of a
notification issued under Section 10A is punished by up to three years
in prison or a fine of Rs. 5000.00.
 5. 2019 Discuss the salient features of the New Drugs and clinical Trials
Rules 2019 and its relevance in contemporary scenario. U2

Deficiencies in regulation of clinical trials had been observed in the 59th Report
of the Parliamentary Standing Committee on Health and Family Welfare on the
functioning of the Central Drugs Standard Control Organisation (CDSCO)[6],
and in the report of an expert committee set up by the MoHFW under the
chairmanship of Prof. Ranjit Roy Chaudhury. The New Rules comprise 13
chapters (including 107 rules), 8 Schedules, and 27 Forms. These rules
supersede Part XA and Schedule Y of the Drugs and Cosmetics Rules, 1945
Earlier regulations and schedule Y will still be applicable for veterinary use
drugs. In the New Rules 2019, the timeline of the lengthy regulatory process for
approval is significantly reduced. The definition of the 'new drugs' has been
revised.

Salient Features of the NDCT Rules

1. The NDCT Rules have come into force from March 19, 2019
onwards, except for Chapter IV, which shall come into effect 180
days after publication in the Gazette, i.e. 180 days after March 19,
2019.

2. The NDCT Rules are applicable to, and regulate, all new drugs,
investigational new drugs for human use, clinical trials,
bioequivalence studies, bioavailability studies and Ethics
Committees.

3. Rule 2(w) defines a “new drug” to include, inter alia, ‘a drug,

including active pharmaceutical ingredient or phytopharmaceutical
drug, which has not been used in the country to any significant
extent’, ‘a drug approved by the Central Licensing Authority for
 certain claims and proposed to be marketed with modified or new
claims’, ‘a fixed dose combination of two or more drugs, approved
separately for certain claims and proposed to be combined for the
first time in a fixed ratio’, ‘a modified or sustained release form of a
drug or novel drug delivery system of any drug approved by the
Central Licensing Authority’, or ‘a vaccine, recombinant
Deoxyribonucleic Acid (r-DNA) derived product, living modified
organism, monoclonal anti-body, stem cell derived product, gene
therapeutic product or xenografts, intended to be used as drug’.
Stem cell based products are, therefore, also deemed to be “new
drugs” under the NDCT Rules.

4. “Adverse event” has been defined under Rule 2(d) to mean any
untoward medical occurrence (including a symptom or disease or an
abnormal laboratory finding) during treatment with an
investigational drug or a pharmaceutical product in a patient or a
trial subject. In cases of adverse events, compensation is payable to
the trial subject/ patient.

5. 2(j) “clinical trial” in relation to a new drug or investigational new

drug means any systematic study of such new drug or
investigational new drug in human subjects to generate data for
discovering or verifying its,- (i) (ii) (iii) clinical or;
pharmacological including pharmacodynamics, pharmacokinetics
or; adverse effects, with the objective of determining the safety,
efficacy or tolerance of such new drug or investigational new drug

6. The Drugs Controller, India, appointed by the Central Government

in the MoHFW has been designated as the Central Licensing
Authority under the NDCT Rules, to act as the nodal entity for
licensing and approvals under these rules (Section 3).
7. Ethics Committee: Under the NDCT Rules, an Ethics Committee is
required to be set up and registered by whoever intends to conduct
clinical trials on humans or bioavailability studies or bioequivalence
studies. The study/ trial can be conducted only with the approval of
this Committee, whose registration with the Central Licensing
Authority will be valid for a period of five years. In case of any
serious adverse event during a clinical trial or bioavailability or
bioequivalence study, the Ethics Committee is required to analyse
the relevant documents pertaining to such event and forward its
report to the Central Licensing Authority (Chapter III).

8. The Application for permission to conduct clinical trials is required

to be submitted to the Central Licensing Authority in Form CT-04.
Further, the application has to be accompanied with information and
documents as specified in the Second Schedule and Fee as specified
in the Sixth Schedule (Rule 21).

9. Deemed Approval: Under Rule 23, when a drug is discovered in

India, or research and development of the drug are being done in
India and also the drug is proposed to be manufactured and
marketed in India, the application for permission to conduct clinical
trials in respect of such drugs shall be disposed off by the Central
Licensing Authority within 30 working days of receipt of such
application, and if the applicant does not receive any
communication during this period, the permission to conduct the
clinical trial shall be deemed to have been granted by the Central
Licensing Authority.

10.Compensation: The most important changes brought in by the

NDCT Rules, are the provisions related to compensation. Chapter
VI of the NDCT Rules, deals with compensation in case of injury or
 death in clinical trial or bioavailability or bioequivalence studies of
new drugs or investigational new drugs. The quantum of
compensation is required to be calculated on the basis of the formula
specified in the Seventh Schedule of the NDCT Rules[9].

11.Manufacture of New Drugs for Clinical Trial: Permission of the

Central Licensing Authority must be obtained to manufacture a new
drug for conducting a clinical trial or bioavailability or
bioequivalence study or for examination, test and analysis. The
permission, if granted, is valid for a period of three years. The
labelling requirements and other conditions for grant of permission
have also been laid down in the NDCT Rules (Chapter VIII).

12.Import of New Drugs for Clinical Trial: A licence from the

Central Licensing Authority must be obtained to import a new drug
for conducting a clinical trial or bioavailability or bioequivalence
study or for examination, test and analysis. The licence, if granted,
is valid for a period of three years. The labelling requirements and
other conditions for grant of the licence have also been laid down in
the NDCT Rules (Chapter IX).
13.AMENDEMENTS OF DRUGS AND COSMETICS RULES,
1945 : “122DAA. Non-application of certain rules for new drugs
and investigational new drugs for human use.― Part XA and
Schedule Y shall not be applicable in respect of new drugs and
investigational new drugs for human use from the date of coming
into force of the New Drugs and Clinical Trials Rules, 2019, and the
references in respect of human use made in the these rules shall
respectively be omitted, and the construction thereof shall be
construed accordingly and shall stand amended with all cogent
meaning of the grammar”. CHAPTER XII.
 14.Post-trial access of investigational new drug: Post-trial access of
investigational new drug is to be provided by the sponsor to the trial
participant after the completion of the clinical trial. The drug will be
provided free of cost by the sponsor, if it is found to be beneficial
and there is no alternative available.
15.Post-marketing surveillance studies (PMS): Requirements for carrying out
the PMS for a new drug have been laid out. As a part of requirement,
Periodic Safety Update reports (PSUR) are required to be submitted every
six months for the first two years after the approval for a drug is granted.
Pediatric and geriatric populations are required to be included in the clinical
trial study if the drug is intended to treat conditions that specifically affects
such populations.
16.Increase in fee: The application fee for conducting phase I to phase IV trials
has been increased about six to eight times.
 6. Distinguish between medical and legal insanity analysing Mc

Naughten Rule

The Indian Penal Code considers insanity as a general exception under section
84. Criminal intent is necessary to make a person legally liable for a crime. And
therefore, a person’s mental capacity to form a criminal intent is significant in
determining the criminal liability of that person. A person may lack enough
mental ability to form a criminal intent due to some defect of the mental faculty.

The defence of insanity can be pleaded where the unsoundness of mind of the
offender is to such an extent that he cannot understand the nature of the act or
distinguish between what he is doing is right or wrong.

THE ORIGIN OF INSANITY AS A DEFENCE:

‘Insanity’ as a defence marked its inception from the case of R v Arnold (1724).
This case led to the development of the ‘Wild Beast Test’ which examined the
mental capacity of the accused in understanding the nature of his act and his
ability to distinguish between ‘good’ and ‘bad’. In addition to this, the case of R
v Hadfield (1800), created another test known as ‘Insane Delusion Test’ to
prove the same.But both these tests turned out to be arbitrary and ineffective in
establishing insanity.

Unsoundness of a person’s mind as a defence is given under Chapter IV, section

84 of IPC. And, it is based on M’Naghten’s Rule.
What Is M’Naghten Rule?

Daniel M’Naghten was a Scotsman, and he was tried for the murder of Edmund
Drummond, Private Secretary of Sir Robert Peel, the then Prime Minister. He
was under an insane delusion that Sir Robert Peel had injured him, and
mistaking Drummond for Sir Robert Peel, he shot and killed him.

The accused pleaded for insanity in his defence. The medical evidence that
produced showed he was suffering from a morbid delusion, due to which he lost
his power of control. And therefore, he was acquitted on the ground of insanity.

As his acquittal caused a great sensation, it became the subject matter for debate
in the House of Lords. Therefore, the House of Lords referred this matter to a
bench of fifteen judges who were ordered to lay down the law relating to
criminal responsibility in case of lunacy. The bench was asked to answer some
questions, and these questions and answers are known as M’Naghten Rules.
These M’Naghten Rules form the basis of the modern law of insanity.

The following proposition can be drawn from the answers given by the
judges:-

1. Every person is believed to be of sound mind and to have a reasonable extent

of justification to held liable for the crime committed by him until it is proved to
the jury’s satisfaction or the court that the man committing an offence was of
unsound mind at the time of the commission of the offence.

2. To plead for a defence of insanity, it must be proved that the person was
suffering from such a mental disease at the time of the commission of the act,
which made him unable to understand the nature of the act he was doing or
what he was doing was right or wrong.
3. If the accused was aware of the fact that the act he was doing was not ought
to be done and that act was at the same time opposite to the law, he will be
punishable.

4. A medical witness who has not seen the accused before the trial should not be
asked for his viewpoint on evidence about what he thinks that the accused is
insane or not.

5. Where the criminal act is committed by a man under some insane delusion as
to the surrounding facts, which conceals from him the true nature of the act he is
doing, he will be under the same degree of responsibility as he would have been
on the facts as he imagined them to be.

Criticism of M’Naghten Rule

M’Naghten Rule has been criticized for various reasons. Some major reasons
are as follows:

1. The rule evolved that a person is insane if he is unable to differentiate

between right or wrong. But there may be some medical conditions where a
person knows of ‘what is right’ but is irresistible in doing wrong. It is often
termed ‘irresistible impulse’ where a person can’t prevent themselves from
doing wrong. For example, people suffering from manias and paraphilias.

2. The rule has been criticized for making an easy way to escape for the
defendant. He can easily escape from criminal liability if affected with severe
mental disorder irrespective of the fact that to what extent this disorder aided in
the accomplishment of crime.
3. Some situations have been seen where the legal definition of insanity does
not conjoint with the medical criteria laid down for insanity.

4. It is also criticised because only a legal definition for insanity is given and a
medical definition for insanity is not given under the M’Naghten rule. The
M’Naghten rule will be adequate if it contains both.

5. The rule does not explain or give details about terms like temporary or
permanent insanity. There may be an illness that is temporary in nature and rises
at different intervals in a person’s lifetime.

6. The rule does not explain the situation, whether the insanity or unsoundness
of mind of the person affects the public at large. Will it pose a threat to the
public or not is not discussed in the rule.

In Dulal Naik v State (1987) the McNaughton’s rule was interpretedalong

withSection 105 of the Indian Evidence Actstating that courts presume a person
to be sane and in full control of his faculties unless otherwise proven. Moreover,
the burden of proof too lied with the accused.Also, the unsoundness of mind
before or after the conduct of offence does not attract insanity as a defence. It
has to be present during the offence.

The law that relates itself to unsoundness/insanity of mind has been discussed
thoroughly in current judgments of the Supreme Court in the case of Surendra
Mishra vs. State of Jharkhand AIR 2011 SC 627.

The things those were highlighted in this are elaborated below:

i. The accused has to prove legal insanity and not the medical insanity
 ii. Every person who is suffering from mental disease is not ipso facto
exempted from criminal liability.

iii. The onus of proving insanity or unsoundness of mind which is one of the
exceptions mentioned in Chapter IV of the CrPC, lies on the accused on
preponderance of probabilities. To discharge the onus, the accused must
prove his conduct prior to offence, at the time or immediately after the
offence, with reference to his medical condition. Whether the accused
knew that what he was doing was wrong or it was contrary to law is of
great importance and may attract culpability despite mental unsoundness
having been established.

iv. The accused has to prove legal insanity beyond all reasonable doubt.

The Supreme Court in HARI SINGH GOND VERSUS STATE OF M.P.

[2008 (8) TMI 1012- SUPREME COURT] has held that Section 84 lays down
the legal test of responsibility in cases of alleged unsoundness of mind. There is
no definition of 'unsoundness of mind' in I.P.C. The courts have, however,
mainly treated this expression as equivalent to insanity. But the term 'insanity'
itself has no precise definition. It is a term used to describe varying degrees of
mental disorder. So, every person, who is mentally diseased, is not ipso facto
exempted from criminal responsibility. A distinction is to be made between
legal insanity and medical insanity. A court is concerned with legal insanity,
and not with medical insanity. The burden of proof rests on an accused to prove
his insanity, which arises by virtue of Section 105 of the Evidence Act, 1872
and is not so onerous as that upon the prosecution to prove that the accused
committed the act with which he is charged.