E-Notes Unit 4-L&T

Chanderprabhu Jain College of Higher Studies
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An ISO 9001:2015 Certified Quality Institute
(Recognized by Govt. of NCT of Delhi, Affiliated to GGS Indraprastha University, Delhi)
E-Notes
Class : BA LLB/ BBA LLB (7th SEMESTER)
Paper Code : LLB 405
Subject : LAW & EMERGING TECHNOLOGY
UNIT – IV
GENETIC AND MEDICAL TECHNOLOGIES

i. Genetic Technologies
A. Environment Effect: Environment Protection Act
What Are GMOs?
A GMOs (genetically modified organism) is the result of a laboratory process where genes from
the DNA of one species are extracted and artificially forced into the genes of an unrelated plant
or animal. The foreign genes may come from bacteria, viruses, insects, animals or even humans.
Because this involves the transfer of genes, organisms.
Genetic Engineering - means the technique by which heritable materials which do not usually
occur or will not occur naturally in the organism or cell concerned generated outside the
organism of the cell is inserted into said cell or organism. It also means the formation of new
combinations of genetic material by incorporation of a cell into a host cell, where they occur
naturally as well as a modification of an organism or in a cell by delegation and removal of parts
of the heritable material.
For centuries crop plants and livestock have been crossbred such that the genetic make-up of
offspring has been altered to select for desired traits and or qualities. Traditional plant and animal
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breeding techniques require that the individual species involved are the same or closely related.
However, the discovery of genetic engineering techniques has made it possible to introduce,
delete or enhance particular traits in an organism either by inserting genes from another organism
or by otherwise altering its genetic make-up. Genetically Modified Organisms are defined in EU
Legislation as those in which the genetic material is altered in a way that does not occur naturally
by mating or natural recombination.
Where GMOs comprise bacteria, viruses, viroid’s and animal and plant cells in culture they are
referred to as Genetically Modified Micro-Organisms or GMMs. Where GMOs comprise GM
plants or GM animals otherwise known as transgenic plants or transgenic animals.
The Environment (Protection) Act, 1986 as an umbrella legislation that provides a holistic
framework for the protection and improvement to the environment. Thereafter a series of rules
were notified to address various problems such as hazardous wastes, hazardous chemicals,
biomedical wastes, municipal solid wastes etc. Along with these, rules were notified for
hazardous microorganisms. The genetically engineered (GE) organisms were included as part of
these rules along with hazardous microorganisms. Hence, these Rules, 1989 are applicable to the
manufacture, import and storage of micro-organisms and Gene-Technological products. These
rules shall also apply to any substances, products and food stuffs, etc., of which such cells,
organisms or tissues hereof form part. New gene technologies apart from genetic engineering
have also been covered.
Environment Protection Act (1986) and Environment (Protection) Rules (1986)
The Act relates to the protection and improvement of environment and the prevention of hazards
to human beings, other living creatures, plants and property. The Act mainly covers the rules to
regulate environmental pollution and the prevention, control, and abatement of environmental
pollution. The Environment (Protection) Rules cover management and handling of hazardous
wastes, manufacture, storage and import of hazardous chemicals and rules for the manufacture,
use, import, export and storage of hazardous micro-organisms, genetically engineered organisms
or cells.
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Rules for the Manufacture, Use/Import/Export and Storage of Hazardous

Microorganisms/Genetically Engineered Organisms or Cells. (notified under the EP Act,
1986) (1989)
These Rules include the rules for pharmaceuticals, transit and contained use of genetically
engineered organism’s micro-organisms and cells and substances/products and food stuffs
of
which such cells, organisms or tissues form a part, LMOs for intentional introduction into the
environment, handling, transport, packaging and identification. These rules are applicable to the
manufacture, import and storage of micro-organisms and gene technology products. The rules
are specifically applicable to: (a) Sale, storage and handling (b) Exportation and importation of
genetically engineered cells or organisms (c) Production, manufacturing, processing, storage,
import, drawing off, packaging and repackaging of genetically engineered products that make
use of genetically engineered microorganisms in any way.
B. Genetic Engineering and Plant Variety Act

The Protection of Plant Varieties and Farmers’ Rights Act 2001 was enacted in India to protect
the new plant varieties. Rules for the same were notified in 2003. The Act has now come into
force. The Protection of Plant Varieties and Farmers’ Rights Authority has been set up and is
responsible to administer the Act. The office of the Registrar has started receiving applications
for registration of twelve notified crops viz. rice, lentil, maize, green gram, kidney bean, black
gram, chickpea, pearl millet, pigeon pea, sorghum, field pea, bread wheat. Under the TRIPS
agreement it is obligatory on part of a Member to provide protection to new plant variety either
through patent or an effective sui generis system or a combination of these two systems. India
was therefore under an obligation to introduce a system for protecting new plant variety. India
opted for sui generis system and enacted The Protection of Plant Varieties and Farmers’ Rights
Act 2001. However, in many countries such plants can be protected through Breeders’ Rights,
patents and UPOV Convention.
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Objectives of Protection of Plant Varieties and Farmers’ Rights Act in India

The objectives of the Protection of Plant Varieties and Farmers’ Rights Act are:
 to stimulate investments for research and development both in the public

and the private sectors for the developments of new plant varieties by ensuring
appropriate returns on such investments;
 to facilitate the growth of the seed industry in the country through
domestic and foreign investment which will ensure the availability of high quality
seeds and planting material to Indian farmers; and
 to recognize the role of farmers as cultivators and conservers and the
contribution of traditional, rural and tribal communities to the country’s agro
biodiversity by rewarding them for their contribution through benefit sharing and
protecting the traditional right of the farmers. More importantly this act provides
safeguards to farmers by giving farmers’ rights while providing for an effective
system of protection of plant breeders’ rights. The Act seeks to safeguard researchers’
rights as well. It also contains provisions for safeguarding the larger public interest.
The farmer’s rights include his traditional rights to save, use, share or sell his farm
produce of a variety protected under this Act provided the sale is not for the purpose
of reproduction under a commercial marketing arrangement.
What kind of varieties are registerable under the plant variety Act?
1. A new variety if it conforms to the criteria of novelty, distinctiveness, uniformity and stability.
2. An extant variety if it conforms to criteria of distinctiveness, uniformity and stability.
“Extant Variety” defined in PPVFR Act, 2001
An “Extant Variety” means a variety, which is–
(i) notified under section 5 of the Seeds Act, 1966 (54 of 1966); or
(ii) a farmers’ variety; or
(iii) a variety about which there is common knowledge; or
any other variety which is in the public domain.
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Farmers’ Variety as per PPVFR Act, 2001

“Farmers’ Variety” means a variety which-
(i) has been traditionally cultivated and evolved by the farmers in their fields; or
(ii) is a wild relative or land race of a variety about which the farmers possess the common
knowledge; where farmer means any person who (i) cultivates crops by cultivating the land
himself; or (ii) cultivates crop by directly supervising the cultivation of land through any other
person; or (iii) conserves and preserves, severely or jointly, with any person any wild species or
traditional varieties or adds value to such wild species or traditional varieties through selection
and identification of their useful properties.
“Essentially Derived Variety” as per PPVFR Act, 2001
“Essentially Derived Variety” is a variety which is predominantly derived from another variety
(protected or otherwise) and conforms to the initial variety in all aspects except for the
differences which result from the act of derivation, and yet is clearly distinguishable from such
initial variety.
The first attempt to bring the biodiversity into the legal framework was made by way of the
biodiversity bill 2000 which was passed by the Lok Sabha on 2nd December 2002 and by Rajya
Sabha on December 2002.
Objectives of the act:
1. To conserve the Biological Diversity.
2. Sustainable use of the components of biodiversity.
3. Fair and equitable sharing of benefits arising out of the use of the B.D.
Novelty, distinctiveness, uniformity & stability have been defined in the Protection of Plant
Varieties and Farmers’ Rights Act
A) Novelty – Plant variety is novel if at the date of filing of the application for registration for
protection, the propagating or harvested material of such variety has not been sold or otherwise
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disposed of by or with the consent of breeder or his successor for the purpose of exploitation of
such variety-
(i) in India earlier than one year or
(ii) outside India, in the case of trees or vines earlier than six years or in any other case, earlier
than four years, before the date of filing such application:
Provided that a trial of a new variety which has not been sold otherwise disposed of shall not
affect the right to protection. Provided further that the fact that on the date of filing the
application for registration, propagating or harvested material of such variety has become a
matter of common knowledge other than through the aforesaid manner shall not affect the
criteria of novelty for such variety.
B) Distinctiveness – New plant variety will be considered distinct if it is clearly distinguishable
by at least one essential characteristic from any other variety whose existence is a matter of
common knowledge in any country at the time of filing of the application.
C) Uniformity – New plant variety will pass uniformity test, if subject to the variation that may
be expected from the particular features of its propagation, it is sufficiently uniform in its
essential characteristics.
D) Stability – New plant variety will be considered stable if its essential characteristics remain
unchanged after repeated propagation or, in the case of a particular cycle of propagation, at the
end of each such cycle. Compulsory Plant Variety denomination: After satisfying the above four
essential criteria every applicant shall assign a single and distinct denomination to a variety with
respect to which he is seeking registration.
What are farmers’ rights?
The farmers’ rights as defined in the Act are:
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(i) a farmer who has bred or developed a new variety shall be entitled for
registration and other protection in like manner as a breeder of a variety under this
Act;
(ii) the farmers’ variety shall be entitled for registration if the application contains
declaration as specified in clause (h) or sub-section (1) of section 18;
(iii) a farmer who is engaged in the conservation of genetic resources of land races
and wild relatives of economic plants and their improvement through selection and
preservation shall be entitled in the prescribed manner for recognition and reward
from the Gene Fund. Provided that material so selected and preserved has been used
as donors of genes in varieties registrable under this Act;
(iv) a farmer shall be deemed to be entitled to save, use, sow, resow, exchange,
share or sell his farm produce including seed of a variety protected under this Act in
the same manner as he was entitled before the coming into force of this Act.
Which plant varieties cannot be protected under this Act?
A plant variety which is: -
 not capable of identifying such variety; or
 consists solely of figures; or
 is liable to mislead or to cause confusion concerning the characteristics, value,
variety, or the identity of breeder of such variety;
 is likely to deceive the public or cause confusion in the public regarding the
identity of such variety;
 is comprised of nay matter likely to hurt the religious sentiments respectively of
any class or section of the citizens of India;
 is prohibited for use as a name or emblem for any of the purposes;
 is comprised of solely or partly of geographical name.
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What is the term of plant variety protection?

 in the case of trees and vines, eighteen years from the date of registration of the
variety;
 in the case of extant varieties, fifteen years from the date of the notification of that
variety by the Central Government under section 5 of the Seeds Act,1966.
 in the other cases, fifteen years from the date of registration of the variety.
Initially the certificate of registration shall be valid for nine years in the case of trees and
vines and six years in the case of other crops and may be revived and renewed for the
remaining period on payment of fees as may be fixed by the rules.
C. Biological Diversity Act, 2002

A national biodiversity authority has been established by the Biodiversity Act, 2002 to regulate
act implementing rules 2004 has been operationalized since coming in to force.
Regulating access well as pushing the officially sponsored, documentation of biological
resources and traditional practices through people’s diversity registers at the local and data bases
at the national levels, respectively. It further probes the extent to which the principles of
conservation have realized.
Provisions of the Act:
1. Prohibition on transfer of Indian genetic material outside the country without specific approval
of the Indian Government.
2. Prohibition of anyone claiming an (IPR) such as a patent over biodiversity or related
knowledge without permission of Indian Government.
3. Regulation of collection and use of biodiversity by Indian national while exempting local
communities from such restrictions.
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4. Measures from sharing of benefits from use of biodiversity including transfer of technology,
monitory returns, joint research and development, joint IPR ownership etc.
5. Measuring to conserve sustainable use of biological resources including habitat and species
protection (EIP) of projects, integration of biodiversity into the plans and policies of various
Departments and Sectors.
6. Provisions for local communities to have a say in the use of their resources and knowledge and
to charge fees for this.
7. Protection of indigenous or tradition laws such as registration of such knowledge.
8. Regulation of the use of the genetically modified organisms.
9. Setting up of National, state and local Biodiversity funds to be used to support conservation
and benefit sharing.
10. Setting up of Biodiversity Management committees (BMC) at local village levels. State
Biodiversity Boards at state level and National Biodiversity Authority.
Functions of Authority:
1. Advise the central Government on any matter concerning conservation of biodiversity
sustainable use of its components and fair and equitable sharing of benefits arising out of the use
of biological resource and knowledge.
2. Coordinate the activities of state biodiversity.
3. Provide the technical assistance and guidance to the state biodiversity boards.
4. Sponsor investigation and research.
5. Engage consultants for a specific period not exceeding 3 years for providing technical
assistance to the Authority in the effective discharges of its functions.
6. Collect, compile and publish technical and statistical data, manuals, codes or guides relating to
conservation of biodiversity, sustainable use of its components and fair and equitable sharing of
benefits arising out of the use of biological resource and knowledge’s.\
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7. Organize through mass media a comprehensive programmer regarding conservation o f

biodiversity, sustainable use of components and fair and equitable sharing of benefits arising out
of the use of biological resources and knowledge.
8. Plan and organize training of personal engaged or likely to be engaged in programmers for the
conservation of biodiversity and sustainable use of its components.
9. Prepare the annual budget of the authority including its own receipts as also the devaluation
from the central Government provided that the allocation by the central government shall be
operated in accordance with budget provisions approved by the central govt.
10. Recommend creation of posts to the central Government for effective discharge of the
functions by the authority.
11. Approve the method of recruitment to the officers and servants of the authority.
12. Take steps to build up data base and to create information and documentation system for
biological resources and associated traditional knowledge through biodiversity register and
electronic data bases to ensure effective management, promotion and sustainable uses.
13. Give directions to state Biodiversity Boards and the Biodiversity Management Committees in
writing for effective implementation of the act.
II. MEDICAL TECHNOLOGIES

A. Medical Technologies and Forensic Science
i. DNA Profiling
DNA profiling is a technique by which individuals can be identified and compared via their
respective DNA profiles.
 Within the non-coding regions of an individual’s genome there exists satellite
DNA – long stretches of DNA made up of repeating elements called short tandem repeats
(STRs).
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 As individuals will likely have different numbers of repeats at a given satellite

DNA locus, they will generate unique DNA profiles.
DNA profiling is a forensic technique in criminal investigations, comparing criminal suspects'
profiles to DNA evidence so as to assess the likelihood of their involvement in the crime. It is
also used in parentage testing, to establish immigration eligibility, and in genealogical and
medical research. DNA profiling has also been used in the study of animal and plant populations
in the fields of zoology, botany, and agriculture.
DNA profiling can be used in old or unsolved crimes or to identify human remains. The
availability of parental DNA samples might allow identification of a body when conventional
means (physical appearances, dermatoglyphic fingerprints, dental charts) have been
unsuccessful. Dissimilar DNA profiles will exclude a relationship. Teeth are important
evidentiary material in forensic cases, since they are more resistant to post-mortem degradation
and extreme environmental conditions. Teeth are also easy to transport and serve as a good
source of DNA.
ii. Brain Mapping

Brain mapping attempts to relate the brain's structure to its function, or finding what parts give us
certain abilities. For example, what aspect of our brain allows us to be creative or logical? This is
called localization of function.
It examines how our environment changes our brain's structure by studying, for instance, how
the brain changes physically through the learning and aging processes. Brain mapping also
examines what goes wrong physically in the brain during mental illnesses and other brain
diseases.
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Finally, brain mapping aims to give us a thorough picture of our brain's structure. Google Earth
shows us satellite images of our planet and zooms in to continents, countries, states, cities,
highways, streets and buildings. A complete structural map of our brain might be similar.
The Brain Mapping Test is also known as P-300 test. In this test of Brain Mapping the suspect is
first interviewed and interrogated find out whether he is concealing any information. The
activation of brain for the associated memory is carried out by presenting list of words to the
subjects. There are three types of words in the list used for Brain Mapping Test,
Part I consisted of neutral words, which have no direct relationship with the case.
Part II consists of probe words directly related to the case and suspects to elicit concealed
information, which all suspects have had opportunity to come to know during the course of
events related to the case.
Part III consists of target, which are not part of the first two parts. The words in this part are
based on confidential findings which suspect does not know.
The recording of this test is done by acquiring the response through 32 channel EEG-ERP Neuro
Scan cording system. It is carried out by asking the suspect to sit down and close his eyes. The
32 channel electrodes are placed over the scalp directly while conducting this test twice by
presenting each word in three parts randomly. the suspect is instructed to relax and listen to the
words presented in the auditory mode. This test does not expect any oral response from the
witness. The conclusion drawn by the experts after the conduct of the test to indicate the
possession of the knowledge about the relevant subject which is helpful in the investigation and
collecting of evidence. After the administration of the test, what comes out is that, the person
undergoing the test has the knowledge of the crime about which he was questioned (brain
mapping). In the said test there is no way to find out what the lie is or what is the information
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stored in the brain of the person concerned. It can be called the information received of taken out
from the witness.
Performing Brain Mapping Test
Merely conducting of or performing of the Brain Mapping Test on the accused would not take
away the protection guaranteed under Article 20(3) of the Constitution of India and the said
aspect is not required to be considered at the time of performing or conducting the Brain
Mapping Test and only when the statement which has been recorded during the course of the
Narco Analysis test, if it is used against the person as evidence at that stage, the same is required
to be considered. Therefore, the question of consent at the stage of conducting/ performing the
Brain Mapping Test is not required to be considered. As stated hereinabove, conducting
/performing of the Brain Mapping Test is a part of investigation and for the investigation by the
Investigating Agency the consent of the accused is not required, otherwise the Investigating
Agency will not be in a position to further investigate the case, if the consent of the accused is
required. At this stage, it is also required to be noted that the accused has not allegedly come
forward with the truth and therefore, scientific tests are resorted to by the Investigating Agency.
When the accused/person has not told the truth during the investigation, naturally, that accused/
person would not be voluntarily giving consent for the Brain Mapping Tests as he is always
apprehensive that if the Brain Mapping Test is conducted then the same might go against him
therefore, he is bound to not give consent. Even it is not expected from a person/ accused to give
consent for the Brain Mapping Test when he has not come forward with the truth. As stated
above the Brain Mapping Test is a scientific methods of investigation and is the part of
investigation. There is no provision under the Criminal Procedure Code to have the consent of
the accused before or during the investigation. It is also to be noted that before subjecting the
accused to Narco Analysis Test his/her mental fitness will be ascertained and thereafter only
accused will be subjected to Narco Analysis Test. The dosage level required to take a person to
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the hypnotic stage is found to be 3-4 times smaller than those required for stages beyond. Under
the circumstances, the contention on behalf of the petitioner accused that before
conducting/performing the Brain Mapping Test, the consent of the accused person who will be
subjected to the Brain Mapping Tests is required cannot be accepted and the answer to such
question is in negative. (Santokben Sharmanbhai ]adeja v. State of Gujarat, 2009 Cri LJ 68
(Cuj).)
However, certainly he cannot defer hearing of the bail application and the learned Judge has to
take an appropriate decision on the bail application one way or the other on merits, and he might
in appropriate case if satisfied that as the investigation is: pending it is not desirable at that stage
to grant bail, even consider not to grant bail and or even he may consider granting of bail on
certain conditions as he may have deemed fit. However, he is not justified in deferring hearing of
the bail application. Bail. Applications are required to be heard and decided as early as possible.
Under the circumstances, the learned Trial Court was not justified in deferring hearing of the bail
application till Narco Analysis Test and Brain Mapping Tests are performed the petitioner.
What does "compelled testimony" Mean- The phrase 'compelled testimony' must be read as
evidence procured not merely by physical threats or violence but by psychic torture, atmospheric
pressure, environmental coercion, tiring interrogative prolixity, overbearing and intimidatory
methods and the like not legal penalty for violation. So, the legal perils following upon refusal to
answer, or answer: • truthfully, cannot be regarded as compulsion within the meaning of Article
20(3). (Nandini Satpathy v. P. L. Dani, AIR 1978 SC 1025).
Powers of High Court in Conducting Brain Mapping Test-
The Court adjourned the matter at the instance of the learned Senior Advocate appearing on
behalf of the petitioner so as to enable the petitioner to move an appropriate application before
the Hon'ble Supreme Court for transfer of the present proceedings and on the last occasion it was
also agreed by the learned counsel appearing on behalf of the petitioner that if no orders are
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obtained he will proceed further with the matter and make submissions on merits. The petitioner
is not desirous of submitting an appropriate application for transfer before the Hon'ble Supreme
Court and that is how this Court has taken up the matter and considered the same on merits. It is
also required to be noted that conducting/performing of the aforesaid two tests are timely
requirement, more particularly during the course of the investigation and even if after the period
of 6 months or so and/ or after a long time, the said test is permitted to be performed, the purpose
for which the said tests are required would be frustrated. If the said tests are not permitted to be
performed at an appropriate time and stage, the same would defeat the purpose for which the
said test is required to be performed i.e. to find out the truth to reach the real culpritand to further
investigate the case. There are so many proceedings pending in the State involving serious
offences like Saurabuddin encounter case and the murder of his wife Kausharbibi and others.
Where the questions with regard to conducting/ performing of the Brain Mapping Test is
involved and in some cases the Investigating Agency have found themselves in dark and
clueless, there is necessity of conducting the Brain Mapping Tests and the proceedings are
pending at different stages before the different Courts i.e. either at the stage of learned
Magistrate and/ or Revisional Court and or before this Court and therefore, this Court has
considered the case on merits. (Santokben Sharmanbhai] adeja v. State of Gujarat, 2009 Cri L]
68 (Guj)).
The right to direct the accused to undergo scientific tests has been finally determined by the
Court below and thereby the criminal proceedings taken to demystify the grey area of
investigation has culminated. Therefore, the Court finds that the present order impugned which
substantially determines the rights of the parties is a final order challengeable under Section 397
of the Code of Criminal Procedure by way of revision. (Dinesh Dalmia v. State, 2006 Cri LJ
2401 (Mad).
iii. Narco-analysis
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The term Narco-analysis is derived from the Greek word narkç (meaning "anesthesia" or
"torpor") and is used to describe a diagnostic and psychotherapeutic technique that uses
psychotropic drugs, particularly barbiturates, to induce a stupor in which mental elements with
strong associated affects come to the surface, where they can be exploited by the therapist. The
term Narco-analysis was coined by Horseley. Narco-analysis poses several questions at the
intersection of law, medicine and ethics. Is the procedure for Narco-analysis is violative of the
rights against self-incrimination, guaranteed under Article 20 (3) of Constitution? It figured
prominently in the news recently when it became eye of storm and sparked off the debate when
media played the role of Unnao rape case2, in utter Pradesh. Accused subjected to Narco-
analysistest when he demanded Narco test for justice and for the faith in criminal justice system.
Constitutional & Legal Provisions on Narco-analysis in India
Like confessions, Narco-analysis tests generally don’t have legal validity as it is made by a semi-
conscious person are not admissible in court. The court may, however, grant limited
admissibility after considering the circumstances under which the test was obtained. Narco-
analysis, brain mapping and lie detector tests against the will of the accused would be violative
of Article 20 (3) of the Constitution. The main provision regarding crime investigation and trial
in the Indian Constitution is Art. 20(3). It deals with the privilege against self-incrimination. The
privilege against `self-incrimination is a fundamental canon of Common law criminal
jurisprudence. Art. 20(3) which embodies this privilege says, “No person accused of any offence
shall be compelled to be a witness against himself”. Subjecting the accused to undergo the test,
as has been done by the investigative agencies in India, is considered by many as a blatant
violation of Art.20 (3) of Constitution. The application of Narco-analysis test involves the
fundamental question pertaining to judicial matters and also to Human Rights. The legal position
of applying this technique as an investigative aid raises genuine issues like encroachment of an
individual’s rights, liberties and freedom. In case of State Bombay v. Kathikalu, it was held that
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it must be shown that the accused was compelled to make statement likely to be incriminative of
himself. Compulsion means duress, which includes threatening, beating or imprisonment of wife,
parent or child of person. Thus where the accused makes a confession without any inducement,
threat or promise art 20(3) does not apply. Thus, the privilege against self-incrimination enables
the maintenance of human privacy and observance of civilized standards in the enforcement of
criminal justice.
Admissibility of Narco-analysis in the court
While Narco-analysis yielded an immense amount of information, it also triggered off many
questions as several critics shared profound sense of skepticism over the administration of serum
on the witness to extract truth. Narco-analysis is considered as a tool or aid in collecting and
supporting evidence. However, doubts are raised whether it amounted to testimonial compulsion
in judiciary and violation of human right, individual liberty and freedom. Lawyers are divided on
whether the results of Narco-analysis and P300 tests are admissible as evidence in courts, as they
claim that confessions made by a semiconscious person is not admissible in court. A Narco-
analysis test report has some validity but is not totally admissible in court, which considers the
circumstances under which it was obtained and assessed its admissibility. Results of such tests
can be used to get admissible evidence, can be collaborated with other evidence or to support
other evidence. But if the result of this test is not admitted in a court, it cannot be used to support
any other evidence obtained the course of routine investigation.
In India, Narco-analysis was first used in 2002 in the Godhra carnage case. It was also in the
news after the famous Arun Bhatt kidnapping case in Gujarat wherein the accused had appeared
before NHRC and the Supreme Court of India against undergoing the Narco-analysis. It was
again in the news in the Telgi stamp paper scam when Abdul Karim Telgi was taken to the test in
December 2003. Though in the case of Telgi, immense amount of information was yielded, but
doubts were raised about its value as evidence. Narco-analysis was in the limelight in the context
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of infamous Nithari village (Noida) serial killings. The two main accused in the Nithari serial
killings Mohinder Singh Pandher and Surendra Kohli have undergone Narco-analysis tests in
Gandhinagar in Gujarat.
Criticism of Narco-analysis test
Narco-analysis has been criticized on the ground that it is not 100% accurate. It has been found
that certain subjects made totally false statements. It is often unsuccessful in eliciting truth as
such it should not been used to compare the statement already given to the police before use of
drug. It has been found that a person who has given false information even after administration
of drug. It is not much help in case of malingers or evasive, untruthful person.9 It is very difficult
to suggest a correct dose of drug for a particular person. The dose of drug will differ according to
will power, mental attitude and physique of the subject. Successful Narco-analysis test is not
dependent on injection. For its success a competent and skilled interviewer is required who is
trained in putting recent and successful questions. Narco-analysis test is a restoration of memory
which the suspect had forgotten. This test result may be doubtful if the test is used for the
purposes of confession of crimes. Suspects of crimes may, under the influence of drugs,
deliberately withhold information or may give untrue account of incident persistely.10Narco-
analysis is not recommended as an aid to criminal investigation. In medical uses like in treatment
of psychiatric disorder the Narco-analysis may be useful. Unless the test is conducted with the
consent of the suspect it should not be used in criminal investigation.
iv. Handwriting
A forensic document examiner conducts an examination of a document to determine its
authenticity and/or its relationship to a person, thing, event or time. A questioned document is
any document about which some issue has been raised or that is the subject of an investigation.
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This can be anything from written letters, drivers' licenses, contracts, wills, passports or lottery
tickets! An examiner tries to answer the following questions about the document:
Is the document genuine?
Has the document been changed in anyway and how was it changed?
Which person or machine wrote or produced the document?
The majority of cases that document examiners deal with are fraud related; fraud (65%),
robbery/breaking and entering (8%), threats (8%), mischief (7%), homicide (2%), and other
types of cases (10%).
Before we discuss how the documents are examined, there are five different conclusions that an
examiner can reach that we must learn about.
Positive Identification - suspect's sample matches the evidence found. Excludes all other possible
writers.
Probable Identification - still a strong conclusion, combination of similarities points strongly to
one writer with no fundamental differences, leaves only theoretical possibility of another writer.
Unable to Determine - there is not enough of a writing sample to make any sort of determination.
Probable Elimination - the writing samples most likely to not match, but the suspect cannot be
excluded with extreme certainty.
Positive Elimination - the suspect's sample and the evidence do not match at all, thus excluding
the suspect as the writer.
Handwriting analysis falls into the questioned documents section of forensic science. These
documents are examined by expert questioned documents examiners or QDEs. QDEs look for
forgeries and alterations and make comparisons if there is an original sample of handwriting
available.
Handwriting is an individual characteristic. This means that handwriting is unique for each
person. Each person has their own style. Handwriting analysts say that people could have a few
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writing characteristics that are the same but the likelihood of having any more than that is
impossible. The similarity in handwriting would be due to the style characteristics that we were
taught when we were learning handwriting in school out of a book. Thus, handwriting is as
unique as a fingerprint.
Handwriting analysis is looking for small differences between the writing of a sample where the
writer is known and a writing sample where the writer is unknown. Instead of beginning to look
for similarities in the handwriting a QDE begins to search for differences since it’s the
differences that determine if the document is a forgery. A QDE is looking at three things: letter
form, line form and formatting.
• Letter form– This includes curves, slants, the proportional size of letters (relationship between
size of short and tall letters and between the height and width of a single letter), the slope of
writing and the use and appearance of connecting lines (links) between letters. A person may
form a letter differently depending on where the letter falls in a word – beginning, middle or end.
So an analyst will try to find examples of each letter in each placement.
• Line form– This includes how smooth and dark the lines are, which indicates how much
pressure the writer applies while writing and the speed of the writing.
• Formatting– This includes the spacing between letters, the spacing between words, the
placement of words on a line and the margins a writer leaves empty on a page. It also considers
spacing between lines.
b. Medical Technologies and Drugs

i. Patent Protection
Patent protection is often essential to ensure a successful return on the investments made in an
invention. Therefore, pending or existing patents is one of the key components a potential
investor will look for before investing in a company.
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A patent is the legal protection offered to an invention. A patent gives the proprietor the
exclusive right to produce, sell or import the invention. This means that the holder of a patent
can prohibit others from using the invention. Patentable inventions are not limited to products.
On the contrary, patents can be granted to other inventions as well, such as manufacturing
processes, measuring methods or, in some cases, the use of a certain substance in a specific
manufacturing process. It is therefore important to analyze all aspects of an invention. For
example, a new product often requires a new manufacturing method. Protection can in such
situations be granted for both the product and the method.
The protection offered by a patent is defined by the patent claims, i.e. the wording used in the
patent application to define the invention. It is therefore very important that the patent claims are
worded with care. As mentioned above, patent protection can be granted for many aspects of an
invention. Therefore, it is not unusual for a patent to include several independent patent claims.
The exact wording of the patent claims is something an IP counsel can assist with.
A patent is generally valid for 20 years from the day of the patent application, as long as the
yearly fees are paid. In relation to certain products, for example pharmaceutical products, an
additional five years can be added to the protection. A patent is always limited to the
jurisdiction(s) where it is registered.
ii. Life Saving Drugs

Emergency drugs/life-saving drugs require immediate administration within minutes’ post or
during a medical emergency or medicines which have the potential to sustain life or prevent
further complications.
Life-saving drugs are emergency drugs that require immediate administration in medical
emergency. Medicines which have the potential to sustain life and / or prevent further
complications.
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List of Drugs are as follows:

(A) Drugs used in Anaphylactic shock: -
(1) Inj. Epinephrine Hydrochloride (Adrenaline)
(2) Inj. Sodabicarb,
(3) Inj. Dexamethasone Sodium phosphate.
(B) Drugs used in Myocardial infarction and cardiogenic shock: -

(4) Inj. Isoprinosine.
(5) Inj. Amino Caproic Acid.
(6) Inj. Streptokinase.
(7) Inj. Morphine sulphate.
(8) Inj. Meperidine Hydrocloride (Pethidine)
(9) Inj. Calcium Chloride
(10) Inj. Dopamine Hydrochloride
(11) Inj. Heparin
(12) Inj. Nitroglycerine
(13) Inj. Propranolol.
(14) Inj. Digoxin.
(15) Inj. Protamine Sulphate.
(16) Inj. Lignocaine Hydrochloride 2 percent
(17) Cap. Nifedipine.
(C) Drugs used in peripheral circulatory collapse:

(18) Inj. Dopamine Hydrochloride.
(19) Inj. Glucose 25 percent.
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(20) Oxygen gas I.P/B.P.

(21) I.V. Ringer Lactate
(22) I.V. Normal Saline
(D) Drugs used in status eplipticus:

(23) Inj. Phenytoin Sodium
(24) Inj. Diazepam.
(25) Inj. Phenobarbitone.
(E) Drugs used in acute respiratory failure: -

(26) Inj. Nikenamide.
(27) Oxygen gas I.P./B. P
A generic drug
A generic drug is a medication that has exactly the same active ingredient as the brand name
drug and yields the same therapeutic effect. It is the same in dosing, safety, strength, quality, the
way it works, the way it is taken, and the way it should be used. Generic drugs do not need to
contain the same inactive ingredients as the brand name product.
The generic drug is bioequivalent to the branded product, meaning there is either no significant
difference between the two drugs in terms of the rate and extent of absorption or if there is a
difference, it is either intended or not medically significant.
So long as the FDA criteria are met, a generic drug may be marketed when the patent protections
end or the patent owner waives its rights. The competitive nature of the drug market means that
once the generic drug is available, the cost of the drug is substantially lowered for both the
original brand name product and the generic drug.
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However, a generic drug can only be marketed after the brand name drug's patent has expired
and are usually much less expensive than brand name drugs once they reach the market. They
have exactly the same dosage, intended use, effects, side effects, route of administration, risks,
safety, and strength as the original drug. In other words, their pharmacological effects are exactly
the same as those of their brand-name counterparts.
An example of a generic drug, one used for diabetes, is metformin. A brand name for metformin
is Glucophage. (Brand names are usually capitalized while generic names are not.) A generic
drug, one used for hypertension, is metoprolol, whereas a brand name for the same drug is
Lopressor.
Many people become concerned because generic drugs are often substantially cheaper than the
brand-name versions. Although generic drug active ingredients are chemically identical to their
branded counterparts, they are typically sold at a cheaper price than the brand name drug.
Generics are less expensive because the drug manufacturer does not have to duplicate the
original clinical trials for effectiveness and safety, which lowers the cost to bring the drug to
market. Generics are not less expensive because they are lower in quality.
India: The Indian government began encouraging more drug manufacturing by Indian
companies in the early 1960s, and with the Patents Act in 1970. The Patents Act removed
composition patents for foods and drugs, and though it kept process patents, these were
shortened to a period of five to seven years. The resulting lack of patent protection created a
niche in both the Indian and global markets that Indian companies filled by reverse-engineering
new processes for manufacturing low-cost drugs. The code of ethics issued by the Medical
Council of India in 2002 calls for physicians to prescribe drugs by their generic names only.
India is a leading country in the world's generic drugs market, with Sun Pharmaceuticals being
the largest pharmaceutical company in India.
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iv. National Drugs Policies

Narcotic Drugs and Psychotropic Substances Act, 1985
India is a party to the three United Nations drug conventions – the 1961 Single Convention on
Narcotic Drugs (1961 Convention), the 1971 Convention on Psychotropic Substances (1971
Convention) and the 1988 Convention against Illicit Traffic in Narcotic Drugs and Psychotropic
Substances (1988 Convention). Domestic legislation to give effect to these treaties was
introduced only in the 1980s when the ‘grace period’ for abolishing non-medical use of cannabis
and opium under the 1961 Convention expired. Exercising its powers to make law for the
country for implementing “any treaty, agreement or convention or decision made at international
conference”, the Indian Parliament passed the Narcotic Drugs and Psychotropic Substances Act,
1985 (NDPS Act) hastily, without much debate. The NDPS Act came into force on 14 November
1985, replacing the Opium Acts and the Dangerous Drugs Act. The 1940 Drugs and Cosmetics
Act, 1940, however, continues to apply. The official record states that the NDPS Act was
enacted in order to provide adequate penalties for drug trafficking, strengthen enforcement
powers, implement international conventions to which India was a party, and enforce controls
over psychotropic substances. The Act was amended in 1989, 2001 and more recently in 2014.
The NDPS Act prohibits cultivation, production, possession, sale, purchase, trade, import,
export, use and consumption of narcotic drugs and psychotropic substances except for medical
and scientific purposes in accordance with the law. Preparation to commit certain offences is
punishable as is attempt. Accessory crimes of aiding and abetting and criminal conspiracy attract
the same punishment as the principal offence. The Act covers three broad classes of substances:
1) narcotic drugs, that is, those covered under the 1961 Convention;
2) psychotropic substances or those covered under the 1971 Convention as well as other
psychoactive substances such as ketamine which are not yet classified under 3 international
conventions; and
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3) “controlled substances” that are used to manufacture narcotic drugs or psychotropic

substances, for example precursor chemicals such as acetic anhydride, ephedrine and
pseudoephedrine.
Narcotic drugs include:
• Cannabis: plant; resin or charas and its concentrated variant called hashish; dried flowering or
fruiting tops of the plant, that is, ganja and any mixture of charas or ganja. Importantly, bhang or
the cannabis leaf is excluded (in accordance with the 1961 Convention) and regulated through
state excise laws
• Coca: plant: leaf; derivatives include cocaine and any preparation containing 0.1% of cocaine
• Opium: poppy plant; poppy straw; concentrated poppy straw; juice of opium poppy; mixture of
opium poppy juice; preparations with 0.2% morphine; derivatives include heroin, morphine,
codeine, the baine, etc.
NDPS amendments 1989, 2001&2014.
In 1988, the NDPS Act was supplemented by the Prevention of Illicit Traffic in Narcotic
Drugs and Psychotropic Substances Act to provide for preventive detention of people
suspected or accused of involvement in drug trafficking. The Prevention of Illicit Trafficking in
Narcotic Drugs and Psychotropic Substances Act is a drug control law passed in 1988 by the
Parliament of India. It was established to enable the full implementation and enforcement of the
Narcotic Drugs and Psychotropic Substances Act of 1985.
organ Transplantation
Organ transplants include kidney, pancreas, liver, heart, lung, and intestine. Vascularized
composite allografts (VCAs), are now also possible, including face and hand transplantation.
Sometimes, "double" transplants are done, such as kidney/pancreas or heart/lung. Kidney
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transplants are the most common type of transplant surgery; the least common single-organ
transplants are the intestines. Depending on the organ needed, organs are matched using several
characteristics, including blood type and size of the organ needed. Also taken into account is how
long someone has been on the waiting list, how sick they are, and the distance between the donor
and the potential recipient.
Types of organ transplants:
1. Heart transplant
A healthy heart from a donor who has suffered brain death is used to replace a patient’s damaged
or diseased heart. Due to the complexity of this procedure, strict medical criteria is imposed in
assessing whether a donor’s heart is suitable for transplant, and whether a potential recipient is
suitable to receive the transplant.
2. Lung transplant
One lung or both lungs from a recently deceased donor are used to replace a patient’s diseased
lung or lungs.
3. Liver transplant
A patient’s diseased liver is replaced with a healthy liver graft from a donor. Donor livers can be
obtained from deceased donors, or a family member may choose to donate a portion of his liver to
the patient.
4. Pancreas transplant
This type of transplant is commonly done on type 1 diabetics whose pancreas don’t work properly.
5. Cornea transplant
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Corneal donation restores vision to those blinded by corneal disease. A damaged or cloudy cornea
can be replaced surgically with a healthy, normal cornea, donated by another individual, during a
corneal transplantation.
6. Trachea transplant
The windpipe or trachea is a cartilaginous tube descending from the larynx to the bronchi and into
the lungs. A trachea transplant can help patients who suffer from hardening and narrowing of their
windpipe.
7. Kidney transplant
A kidney for transplant can be taken from a living or dead donor.
8. Skin transplant
Donor skin has been found to be an effective treatment option for patients suffering from severe
burn injuries, acting as a temporary dressing and allowing and promote healing until a patient is
ready for grafting using his own skin.
9. Vascular tissues transplant
Transplanting vascular tissues that circulate blood around the body can help relieve symptoms of
breathlessness, tiredness and dizzy spells in patients with severe cardiovascular conditions.
Vascular tissues can be donated up to 24 hours after death.
In India Transplantation of Human Organs Act was passed in 1994. It provides a system to
regulate removal, storage and transplantation of human organs for therapeutic purposes and for
prevention of commercial dealings in human organs. Consequently, this act was amended in 2011.
In pursuance to the amendment Act 2011, Transplantation of Human Organs and Tissues Rules
2014 have been notified in March 2014.
ii. Experiment on Human Beings

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In any field affecting man, research is necessary as it provides data to improve situations for
human beings and this laudable objective demands encouragement and motivation at all levels o f
participation. In the healthcare field, research has added complexities as it calls for
experimentation on humans which may expose them to risk. Society permits such experimental
research but demands that members of society who participate in such experiments are protected
from undue harm. However low the degree of risk, society agrees that it cannot be dismissed or
ignored.
In any country, developed or developing, where research involving humans is conducted, the
ethical issue of prime importance is how to achieve fullest protection of clinical trial participants.
Ideally, clinical trials should be associated with altruism and trust- society expects that 1) people
will participate in a clinical trial through altruism and 2) that the other stakeholders in the clinical
trial will be trustworthy enough to ensure that the agreeing participants are treated with dignity,
their wellbeing and rights preserved and safety protected.
Good Clinical Practice norms which contribute to these objectives have evolved and guidelines for
clinical trial professionals have been issued by countries including India. Regulators in all
countries where clinical trials are conducted recognize the importance of these guidelines and their
implementation. That such clinical studies should be transparent is now considered important.
Clinical trials form an integral part of the drug discovery process worldwide. Clinical trials are the
set of practices required to certify a new drug molecule as safe and efficacious for the market.
Medical research, in general, is a good thing and absolutely necessary to cure number of chronic
diseases. At present in India we have 40 million asthmatic patients, about 34 million diabetic
patients, 8-10 million people with HIV, 8 million epileptic patients, 3 million cancer patients,
more than 2 million cardiac-related deaths, 1.5 million people with Alzheimer's disease; 15% of
the population is hypertensive, and 1% suffers from schizophrenia in order to give best treatment
to above diseases research on humans is both necessary and desirable.
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A clinical trial is defined as "any research study that prospectively assigns human participants or
groups of humans to one or more health-related interventions to evaluate the effects on health
outcomes." Interventions include not only drugs but also cells and other biological products,
surgical procedures, radiological procedures, devices, behavioral treatments, process-of-care
changes, preventive care, etc. A set of guidelines are already in place in India for the ethical
conduct of studies to safeguard the interests of patients or volunteers participating in the study.
Global clinical research is exploring India. Yet, it is certainly not the West that is introducing
clinical research to India. Two ancient scripts, Charaka Samhita (a textbook of medicine) and
Sushruta Samhita (a textbook of surgery), compiled as early as 200 B.C. and 200 A. D.
respectively, show India's age-old proficiency in medical research. However, a lot has changed in
the clinical research scenario since then. Today, clinical trials are conducted through a regulated
approach following certain guidelines laid down by the International Conference on
Harmonization (ICH), which is spearheaded by U.S.A., Europe and Japan. There are number of
laws governing clinical research in India.
Indian Acts/Orders related to Clinical Trials is:

Drugs and Cosmetics Act - 1940
Medical Council of India Act - 1956, (amended in the year2002)
Central Council for Indian Medicine Act - 1970
Guidelines for Exchange of Biological Material (MOH order, 1997)
Right to Information Act - 2005,
The Biomedical Research on Human Subjects (regulation, control and safeguards) Bill – 2005.
Even though we have number of legislations the important one for clinical trials is The Indian
Council of Medical Research (ICMR) - 1947(amended in the year2002), which was set up in
order to foster a research culture in India, improve and develop infrastructure and foster
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community support. The Drugs and Cosmetics Act, The Medical Council of India (MCI) Act
states that all clinical trials in India should follow the ICMR guidelines of 2000. The ICMR has a
mechanism of review for its own institutions, and so do other government agencies. Every doctor
is governed by the MCI Act. Any doctor doing wrong in a trial or in practice can be prosecuted
and the hospital can be closed. The MCI Act is very strong; the MCI has the power to take
punitive measures.
The Drugs Controller General of India (DCGI) is responsible for regulatory approvals of clinical
trials in India. The DCGI's office depends on external experts and other government agencies for
advice. Additional permissions are required for the export of blood samples to foreign central
laboratories. The ICMR has a Central Ethics Committee on Human Research (CECHR). This
committee audits the functioning of this Institutional Ethics Committee (IEC). The recently
amended Schedule Y of Drugs and Cosmetic Rules order the composition of the IEC as per the
ICMR guidelines. The DCGI's office in collaboration with WHO ICMR and many committed
research professionals, has been conducting training programs for members of the Ethics
Committees across the country.
Regulatory changes in India regarding clinical trials:

Schedule Y of the Drugs and Cosmetics Act -1940 was amended in the year 2005. Earlier, we
required that all foreign drugs be retested at one phase below the highest phase of testing abroad.
Now parallel global clinical trials have come. Schedule Y now permits concomitant phase 2 and
phase 3 trials. India can become part of global trials. But even then phase 1 has to be repeated for
safety. The advantage is that, if we become part of a global trial, a part of a global movement to
develop drugs, we can demand an affordable price. For example, if a new anti-malarial drug is
developed by a multinational company, India is part of the global trial; India can have a claim on
it. ICMR should not approve drugs which are not relevant to India.
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iii. Sex Determination Test

Sex determination refers to prenatal or testing the gender of the fetus before birth. With the
centuries-old preference being given to male children in the traditionally patriarchal Indian
society, the birth of a girl child isn’t much of a cause for celebration in most parts of India. Studies
have shown that female infanticide has been an ongoing practice in most parts of the country,
especially the north.
To check this situation of women being pressurized by the family to abort female fetuses, the
Indian Parliament in 1994 passed the ‘Prenatal Diagnostic Techniques (Regulation and Prevention
of Misuse) Act. This Act bans the determination of the gender of the fetus before birth and was
enacted in an effort to narrow down the growing gender gap in numerous states within the country.
The Act was further upgraded in 2003 and called the PC-PNDT Act [Pre-conception and Prenatal
Diagnostic Techniques (Prohibition of Sex Selection)]. This also bans sex determination,
advertisements related to preconception and prenatal determination of sex as well as the use of sex
selection technologies on the unborn child.
Though it has been many years since the Act was put forth, the history of discrimination against
the girl child and women in general still carries on. The good news, however, is that it has reduced
to varying levels in most of the states. According to the Indian Ministry of Health and Welfare, the
sex-selective abortion prevalent illegally in India even today has its roots in the country’s long
history of patriarchal dominance in all aspects of life. Everyone wants a son in India irrespective
of their class, caste or socioeconomic status in life.
However, the Act has been declared to be a sloppy one by radiologists as only about 5% of
ultrasound scans are carried out on pregnant women, the remaining 95% is used for other,
sometimes critical situations; as the Act further dictates that the scanning machines including the
ECG machine cannot be transported out of the diagnostic center – this poses a big problem as
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some critical patients aren’t ambulant and need these machines to be brought to them for
emergency diagnostic purposes.
The flip side of the coin, however, shows that there are still many fraudulent doctors around who
transport these scanning machines to rural locations for conducting banned prenatal sex
determination, thus making things difficult when formulating laws. But everything said and done,
murder in the womb of innocent females is still going on. According to a study in 2011, around
1.5 lac unborn girls are killed every year in UP alone. The rate of conviction of the culprits is very
low – with only 206 doctors being convicted from 2003-2014; Maharashtra leads the way,
followed by Rajasthan, Punjab and Haryana. More efforts are needed to prevent the murder of the
girl child while in the womb.
iv. Designer Baby

A designer baby is a baby whose genetic makeup has been selected or altered, often to include a
particular gene or to remove genes associated with a disease. [1] This process usually involves
analyzing a wide range of human embryos to identify genes associated with particular diseases
and characteristics, and selecting embryos that have the desired genetic makeup; a process known
as preimplantation genetic diagnosis. Other potential methods by which a baby's genetic
information can be altered involve directly editing the genome before birth.
Genetically altered embryos can be achieved by introducing the desired genetic material into the
embryo itself, or into the sperm and/or egg cells of the parents; either by delivering the desired
genes directly into the cell or using the gene-editing technology. This process is known as
germline engineering and performing this on embryos that will be brought to term is not typically
permitted by law. Editing embryos in this manner means that the genetic changes can be carried
down to future generations, and since the technology concerns editing the genes of an unborn
baby, it is considered controversial and is subject to ethical debate. While some scientists condone
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the use of this technology to treat disease, some have raised concerns that this could be translated
into using the technology for cosmetic means and enhancement of human traits, with implications
for the wider society.
In many ways, designer babies—sometimes called genetically modified babies—are the obvious
result of decades of advancing IVF technology. Once scientists discovered how to create babies in
the lab, embryo editing to produce a healthy GMO baby (also referred to as GM baby) was
perhaps a natural next step. Scientists saw the potential to not just optimize genes for disease
prevention, but also to choose aesthetics and personality traits.
There are various technologies involved in the creation of a GM baby. One protocol is
Preimplantation Genetic Diagnosis (PGD), where embryotic genetic defects are identified
preimplantation and only embryos devoid of certain genetic disorders are implanted. Most recently
in the news is CRISPR genetic engineering, which was originally created in the 1980’s. An
evolution of the genetic technology is known as CRISPR-CAS9. CRISPR designer babies are
created by modifying DNA fragments to prevent and correct disease-causing genetic errors. CAS9
is a special technology which can remove or add certain types of genes from a DNA molecule, and
most recently has been used after fertilization for gene-edited embryos.
Abortion
An abortion is a procedure to end a pregnancy. It uses medicine or surgery to remove the embryo
or foetus and placenta from the uterus. The procedure is done by a licensed health care
professional.
Every woman has the recognized human right to decide freely and responsibly without coercion
and violence the number, spacing and timing of their children and to have the information and
means to do so, and the right to attain the highest standard of sexual and reproductive health
(ICPD 1994). Access to legal and safe abortion is essential for the realization of these rights. One
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in four pregnancies ends in abortion. Abortions include various clinical conditions such as
spontaneous and induced abortion (both viable and non-viable pregnancies), incomplete abortion
and intrauterine fetal demise.
Abortions are safe if they are done with a method recommended by WHO that is appropriate to the
pregnancy duration and if the person providing or supporting the abortion is trained. Such
abortions can be done using tablets (medical abortion) or a simple outpatient procedure.
Unsafe abortion occurs when a pregnancy is terminated either by persons lacking the necessary
skills or in an environment that does not conform to minimal medical standards or both. Unsafe
abortion procedures may involve the insertion of an object or substance (root, twig, or catheter or
traditional concoction) into the uterus; dilatation and curettage performed incorrectly by an
unskilled provider; ingestion of harmful substances; and application of external force. In some
settings, traditional practitioners vigorously pummel the woman's lower abdomen to disrupt the
pregnancy, which can cause the uterus to rupture, killing the woman.
Women, including adolescents, with unwanted pregnancies, often resort to unsafe abortion when
they cannot access safe abortion. Barriers to accessing safe abortion include:
 restrictive laws
 poor availability of services
 high cost
 stigma
 the conscientious objection of health-care providers and
 Unnecessary requirements, such as mandatory waiting periods, mandatory counselling, provision
of misleading information, third-party authorization, and medically unnecessary tests that delay
care.
vi. Cloning
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Cloning, the process of generating a genetically identical copy of a cell or an organism. Cloning
happens often in nature—for example, when a cell replicates itself asexually without any genetic
alteration or recombination. Prokaryotic organisms (organisms lacking a cell nucleus) such as
bacteria create genetically identical duplicates of themselves using binary fission or budding. In
eukaryotic organisms (organisms possessing a cell nucleus) such as humans, all the cells that
undergo mitosis, such as skin cells and cells lining the gastrointestinal tract, are clones; the only
exceptions are gametes (eggs and sperm), which undergo meiosis and genetic recombination.
Reproductive cloning is defined as the deliberate production of genetically identical individuals.
Each newly produced individual is a clone of the original. Monozygotic (identical) twins are
natural clones. Clones contain identical sets of genetic material in the nucleus—the compartment
that contains the chromosomes—of every cell in their bodies. Thus, cells from two clones have the
same DNA and the same genes in their nuclei.
All cells, including eggs, also contain some DNA in the energy-generating “factories” called
mitochondria. These structures are in the cytoplasm, the region of a cell outside the nucleus.
Mitochondria contain their own DNA and reproduce independently. True clones have identical
DNA in both the nuclei and mitochondria, although the term clones are also used to refer to
individuals that have identical nuclear DNA but different mitochondrial DNA.
vii. Artificial Reproductive Technologies

Assisted reproductive technology (ART) is used to treat infertility. It includes fertility treatments
that handle both a woman's egg and a man's sperm. It works by removing eggs from a woman's
body. The eggs are then mixed with sperm to make embryos. The embryos are then put back in the
woman's body. In vitro fertilization (IVF) is the most common and effective type of ART.
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ART procedures sometimes use donor eggs, donor sperm, or previously frozen embryos. It may
also involve a surrogate or gestational carrier. A surrogate is a woman who becomes pregnant with
sperm from the male partner of the couple. A gestational carrier becomes pregnant with an egg
from the female partner and the sperm from the male partner. The most common complication of
ART is a multiple pregnancy. It can be prevented or minimized by limiting the number of embryos
that are put into the woman's body.
Types of ART:
 Show Ovulation induction (OI)
 Show Artificial insemination or IUI
 Show In-vitro fertilization (IVF)
 Show Intracytoplasmic sperm injection (ICSI)
 Show Intracytoplasmic morphologically selected sperm injection (IMSI)
 Show Donor conception
 Show Preimplantation genetic testing (PGT)
 Show Surrogacy

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Chanderprabhu Jain College of Higher Studies

Class : BA LLB/ BBA LLB (7th SEMESTER)

Paper Code : LLB 405

Subject : LAW & EMERGING TECHNOLOGY

GENETIC AND MEDICAL TECHNOLOGIES

Rules for the Manufacture, Use/Import/Export and Storage of Hazardous

B. Genetic Engineering and Plant Variety Act

Objectives of Protection of Plant Varieties and Farmers’ Rights Act in India

 to stimulate investments for research and development both in the public

Farmers’ Variety as per PPVFR Act, 2001

What is the term of plant variety protection?

C. Biological Diversity Act, 2002

7. Organize through mass media a comprehensive programmer regarding conservation o f

II. MEDICAL TECHNOLOGIES

 As individuals will likely have different numbers of repeats at a given satellite

ii. Brain Mapping

b. Medical Technologies and Drugs

ii. Life Saving Drugs

List of Drugs are as follows:

(B) Drugs used in Myocardial infarction and cardiogenic shock: -

(C) Drugs used in peripheral circulatory collapse:

(20) Oxygen gas I.P/B.P.

(D) Drugs used in status eplipticus:

(E) Drugs used in acute respiratory failure: -

iv. National Drugs Policies

3) “controlled substances” that are used to manufacture narcotic drugs or psychotropic

Types of organ transplants:

ii. Experiment on Human Beings

Indian Acts/Orders related to Clinical Trials is:

Regulatory changes in India regarding clinical trials:

iii. Sex Determination Test

iv. Designer Baby

vii. Artificial Reproductive Technologies

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