Amity Institute of Pharmacy

Amity Institute of Pharmacy

[Link], V Sem

Pharmaceutical Jurisprudence
Module V (Part III)

Medical Termination of Pregnancy Act

Right to Information Act
Intellectual Property Rights
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Medical Termination of Pregnancy Act-1971

• Deliberate termination of pregnancy before the viability of the fetus is called induction of
abortion.

• Induced abortion can be legal or illegal.

• Up until the MTP act was passed, abortion remained punishable under Indian law.

• In case of death due to an abortion procedure, there was a punishment of up to 10 years

imprisonment and a fine.

• In India, abortion was legalized by the medical termination of pregnancy (MTP) act of
1971 and enforced in 1972 and provisions were revised in 1975 and 2021.
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• The Medical Termination of Pregnancy Act was passed by the parliament in 1971 with a
view to provide for the termination of pregnancy by Registered Medical Practitioners for
bonafide medical reasons.

• The Act was framed mainly because legal abortions were difficult at that time and many
were being carried out illegally under unhygienic or unsafe conditions resulting in harm
to health or life of women.

• And as a population control measure since it provided for termination of unwanted

pregnancy resulting from a failure of any device or method used by the married woman
or her husband for limiting the number of children.
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• The act aims to improve the maternal health scenario by preventing a large number of
unsafe abortions and consequent high incidence of maternal mortality & morbidity.

• Legalizes abortion services.

• Promotes access to safe abortion services to women.

• De-criminalizes the abortion seeker.

• According to this Act, no termination of pregnancy shall be made at
any place other than—
a) A hospital established or maintained by Government, or
b) A place for the time being approved for the purpose of this Act by the
Government or a District Level Committee constituted by that
Government with the Chief Medical Officer or District Health Officer as
the Chairperson of the said Committee.
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Provisions of the Act

The Medical Termination of Pregnancy Act provides that, pregnancies of women may be
terminated by RMP under following circumstances:
• Pregnancies of women, 18 years of age or more, with their consent or in case of women
who are less than 18 years of age or are lunatics, with the written consent of their
guardian.

• A pregnancy which is not more than 12 weeks old and the medical practitioner is of
opinion that its continuance is a grave danger to the life of the woman or to her physical
and mental health.

• Or if there is a substantial risk of the child being born with serious mental and physical
abnormalities so as to be handicapped in life.
• For example: Structural, chromosomal, genetic abnormalities in the fetus.
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 Fetus is likely to be deformed due to the action of teratogenic drugs or radiation exposure
in early pregnancy
 Rubella and viral infections in 1st trimester
• A pregnancy which is more than 12 weeks but not more than 20 weeks old, provided that
not less than two registered medical practitioners are of such an opinion.

• A pregnancy of any duration provided that the medical practitioner is of the opinion that
such termination is immediately necessary to save the life of the pregnant woman.

• A pregnancy which is alleged to have been caused due by rape both in the case of a major
and minor girl.

• A pregnancy which is due to the failure of a contraceptive a device used by a woman or

her husband for family planning purposes.
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 Amity Institute of Pharmacy

Key Provisions of the MTP Amendment Act, 2021

 Termination due to Failure of Contraceptive Method or Device:

Under the Act, a pregnancy may be terminated up to 20 weeks by a married woman in the
case of failure of contraceptive method or device. It allows unmarried women to also
terminate a pregnancy for this reason.

 Opinion Needed for Termination of Pregnancy:

• Opinion of one Registered Medical Practitioner (RMP) for termination of pregnancy up
to 20 weeks of gestation.
• Opinion of two RMPs for termination of pregnancy of 20-24 weeks of gestation.
• Opinion of the State-level medical board is essential for a pregnancy to be
terminated after 24 weeks in case of substantial foetal abnormalities.
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Upper Gestation Limit for Special Categories:

• Increases the upper gestation limit from 20 to 24 weeks for special categories of
women, including survivors of rape, victims of incest and other vulnerable
women(differently abled women, minors, among others).

Confidentiality:
• The “name and other particulars of a woman whose pregnancy has been terminated
shall not be revealed”, except to a person authorised in any law that is currently in
force.
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Requirement of experience or training for an RMP to terminate the pregnancy

Any RMP having the following experience/training in the practice of gynecology and
obstetrics can terminate a pregnancy under the Act
(i) If the RMP was registered in a State Medical Register before the commencement of this
Act:
(a) Experience in the practice of gynecology and obstetrics for not less than three years.

(ii) If the RMP was registered on or after the commencement of this Act:
(b) Six months of house surgery in gynecology and obstetrics.

(b) An experience by way of assistance given by the person to an RMP in the performance
of twenty-five cases of medical termination of pregnancy in a hospital established or
maintained, or a training institute approved for this purpose, by the Government.
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Maintenance of Records
• Records pertaining to the admissions of women for termination of pregnancy shall be
maintained by the head of the hospital or the owner of the approved place, in special
registers kept for the purpose.

• The entries in the register shall be made serially year-wise.

• The admission register shall be a secret document and the information contained therein
shall not be disclosed to any person except as provided under the Act.

• However, in the case of an employed woman whose pregnancy has been terminated, the
RMP shall grant a certificate on demand in order to enable her to obtain leave from the
employer.
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• The employer shall however not disclose this information to any other person.

• No entry regarding the name or identity of the woman shall be made in any case sheet,
operation theatre register, follow-up card or any other document or register (except the
admission register).

• Any reference to the pregnant woman shall be made on the basis of the serial number
assigned to the woman in the admission register.

• Every admission register shall be destroyed on the lapse of five years from the date of
last in the register.
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• Other papers shall be destroyed on the lapse of three years from the date of termination of
the pregnancy concerned unless otherwise directed.

• The consent given by the pregnant woman regarding the termination of her pregnancy
together with the certified opinion of the RMP shall be sealed in an envelope by the RMP.

• The envelope shall bear the serial number assigned to the pregnant woman, the name of
the RMP by whom the pregnancy was terminated and shall be marked SECRET.

• The envelope shall be kept in safe custody by the head of the hospital or the owner of the
approved place.
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Right To Information (RTI) Act

• In a democratic Republic, it is expedient to provide for furnishing certain information to
citizens who desire to have it.
• Democracy requires an informed citizenry and transparency of information which are
vital to its functioning and also to contain corruption and to hold Governments and their
instrumentalities.
• Right to information is guaranteed to every citizen of India under section 3 of the Right
to Information Act, 2005.

• The term “information” which means any material in any form, including records,
documents, memos, e-mails, opinions, advices, press releases, circulars, orders,
logbooks, contracts, reports, papers, samples, models, data material held in any
electronic form and also include information relating to any private body which can be
accessed by a public authority under any other law for the time being in force.
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The objectives for the attainment of which the Act was enacted are:
• To enable the citizen to get access to information which is under the control of the
government and its authorities.

• To promote accountability and transparency in the administrative functioning of the

government and public bodies and thereby curbing corruption.

• To establish a central information commission and a state information commission for the
proper implementation and monitoring of the Act and Rules.

• To impose a paramount duty on the public authorities to make available to the public as
much information as possible.
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Right to Information and Obligations of Public Authorities

• Every public authority shall maintain all its records duly catalogued manner which
facilitates the right to information.

• It has to be ensured that all records that are computerized and connected through a network
all over the country on different systems so that access to such records is facilitated.

• Every public authority shall designate as many officers as the Central Public Information of
this Act, Officers or State Public Information Officers in all administrative units or offices
to provide information to persons requesting for the information under this Act.

• Under this act, a duty is cast on the public authority to provide information regarding any
occurrence, event or matter that has happened 20 years before the date of the request for the
supply of information.
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• This implies that authorities are under obligation to maintain the information or records
of the last and for the next 20 years in such a manner as facilitate the enforcement of the
RTI Act.

• A person, who desires to obtain any information under this Act, shall make a request in
writing or through electronic means in English or Hindi or in the official language of the
area in which the application is being made, accompanied by fees to (a) the Central
Public Information Officer or State Public Information Officer (b) the Central Assistant
Public Information Officer or State Assistant Public Information Officer, specifying the
particulars of the information sought by him/her.

• An applicant making request for information shall not be required to give any reason for
requesting the information or any other personal details except those that may be
necessary for contacting him. Information shall ordinarily be provided in the form.
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• Bodies applicable under RTI: Constitutional bodies at the centre and State (Legislature,
Executive, Judiciary), bodies / NGOs owned/financed by the government, and privatized
public utility companies.
• Bodies excluded under RTI: Central Intelligence and Security Agencies

• The law shows that the information requested may be denied under the following two
circumstances –

 Where the information requested is of a personal nature and as such has apparently no
relationship to any public activity or interest.

 Where the information requested is of a personal nature and the disclosure of the said
information would cause an unwarranted invasion of the privacy of the individual.
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• If the applicant doesn’t get a proper response or requested information from the public
authority or from its public information officer within 30 calendar days, the applicant can
file a complaint with Information Commission or file an appeal with the first appellate
authority.

• If the concerned officer does not provide information in time, a penalty of Rs 250 per day
of delay can be imposed by the Information Commissioner.

• If the information provided is false, a penalty of a maximum of Rs 25,000/- can be

imposed.

• A penalty can also be imposed for providing incomplete or for rejecting your application
for malafide reasons. This fine is deducted from the officer’s personal salary.
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Information that may be Refused:

• Information, disclosure of which would prejudicially affect the integrity of India, the
security, strategic, scientific or economic interests of the State, relation with foreign State
or lead to incitement of an offence.

• The information which has been expressly forbidden to be published by any court of law
constitutes contempt of court; or the tribunal or the disclosure of which may constitute
contempt of court.

• Information including commercial confidence, trade secrets or intellectual property, the

disclosure of which would harm the competitive position of a third party.
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• Information, the disclosure of which would cause a breach of the privilege of Parliament
or the State Legislature.

• The information available to a person in his fiduciary relationship, unless the competent
authority is satisfied that the larger public interest warrants the disclosure of such
information.

• The information which would impede the process of investigation or apprehension

prosecution of offenders.

• The disclosure of information which would endanger the life or physical safety of any
person.
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• Information received in confidence from foreign Governments.

• Cabinet papers including records of deliberations of the Council of Ministers, Secretaries

and other officers.

• The information which relates to personal information, the disclosure of which has no
relationship to any public activity or interest, or which would cause unwarranted invasion
of the privacy of the individual unless the Central Public Information Officer or the State
Public Information Officer or the appellate authority, as the case may be, is satisfied that
the larger public interest justifies the disclosure of such information.
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Intellectual Property Rights

• Intellectual property refers to creations of the mind: inventions; literary and artistic
works; and symbols, names, and images used in commerce.

• Intellectual property rights (IPR) refers to the legal rights given to the inventor or creator
to protect his invention or creation for a certain period of time.

• These legal rights confer an exclusive right to the inventor/creator or his assignee to
fully utilize his invention/creation for a given period of time.
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 Amity Institute of Pharmacy

The Patent Act

A patent in relation to inventions is an exclusive right granted by the Government to the
patentee, in exchange of full disclosure of his invention, for excluding others from making,
using, selling, importing the patented product or process producing that product for those
purposes.
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What Is Patentable?
• Processes: Like an assembly line process or online ordering system.
• Machines: Any machine with parts.
• Articles of manufacture: Inventions that are manufactured and achieve a result, such as
a tool or a machine.
• Composition of matter: Inventions that are chemical compositions, like a drug with a
new chemical structure.
• Devising an improvement to an already-known invention can also be patented.
Patent Idea Requirements
• Novel: Your invention must be new and different in some way from previous inventions.
• Useful: It must provide a practical benefit and help accomplish something.
• Non-obvious: Someone skilled in the invention's field would not consider it obvious
when compared to inventions that are already on the market.
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Inventions not patentable

• An invention which is which claims anything obviously contrary to well-established
natural laws.

• An invention, the primary or intended use or commercial exploitation of which would be

contrary to which causes serious prejudice to human, animal or plant life or health or to
the environment.

• The mere discovery of a scientific principle or formulation of or discovery of any living

thing or non-living substance occurring in nature.

• The mere discovery of a new form of a known substance which does not result in the
enhancement of any known efficacy of that substance.
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• The mere discovery of any new property or new use for a known substance or of the mere
use of a known process, machine, or apparatus, unless such known process results in a
new product or employs at least one new reactant.

• The mere arrangement or rearrangement or duplication of known devices, each

functioning independently of one another in a known way.

• A method of agriculture or horticulture.

• An invention which in effect is traditional knowledge or is based on the properties of

traditional knowledge.

• Any process for the medicinal, surgical, curative, prophylactic, or any other type of
treatment.
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• Biological processes for production or propagation of plants and animals.

• A mathematical or business method or a computer programme per se or algorithms.

• Likewise, a literary, dramatic, musical, or artistic work or any other aesthetic creation
whatsoever including cinematographic works and television productions.

• A mere scheme or rule or method of performing a mental act or method of playing a

game.

• Topography of integrated circuits.

• Inventions relating to atomic energy.

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 Amity Institute of Pharmacy

• Every application for a patent should be for one invention only and should be made in the
prescribed form and filed in the Patent Office (Head Office at Calcutta and Branch
Offices at Chennai, Mumbai, and Delhi).
• Every application must be accompanied by a provisional or a complete specification. A
complete specification contains the following:
(i) A full description of the invention and its operation or use and the method of
performance.
(ii) Disclosure of the best method of performing the invention known to the applicant and
for which he is entitled to claim protection.
(iii) A statement of claim or claims defining the scope of the invention for which protection
is sought.

• Every specification, whether provisional or complete shall describe the invention and
begin with a title sufficiently indicating the subject-matter to which the invention relates.
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• Where an application is accompanied by a provisional specification, a complete

specification must be filed within 12 months from the date of filing of the application.
• On receiving the application for a patent along with complete specification, the
Controller shall refer it to an examiner for making a report to him in respect of:
(i) Whether the application and specification are in accordance with the requirements of
this Act.
(ii) Whether there is any lawful ground of objection to the grant of a patent.
(iii) The result of the investigation made by him regarding anticipation of the invention by
virtue of a previous publication or prior claim.

• The examiner to whom the application and specification have been referred should make
the report to the Controller within a period of 18 months from the date of such reference.
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• After the first examination report is issued, the applicant is given an opportunity to meet
the objections raised in the report.

• The applicant has to comply with the requirements within 6 months from the issuance of
the first examination report which may be extended for further 3 months on the request of
the applicant.

• If the requirements of the first examination report are not complied with within the
prescribed period of 9 months, then the application is treated to have been abandoned by
the applicant.

• After the removal of objections and compliance of requirements, the patent is granted and
notified in the Patent Office Journal.
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Trademarks

• It is covered under the Act called Trade Marks Act, 1999.

• The Act came into effect on September 15, 2003.

• It replaced the Trade and Merchandise Marks Act, 1958.

• Trademark: A symbol, logo, word, sound, color, design, or other device that is used to
identify a business or a product in commerce.
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• A trademark is a distinctive sign that identifies certain goods or services as those

produced or provided by a specific person or enterprise.

• It may be one or a combination of words, letters, and numerals.

• They may consist of drawings, symbols, 3D signs such as the shape and packaging of
goods, audible signs such as music or vocal sounds, fragrances, or colours used as
distinguishing features.

• It provides protection to the owner of the mark by ensuring the exclusive right to use it to
identify goods or services or to authorize another to use it in return for payment.
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• It helps consumers identify and purchase a product or service because its nature and
quality, indicated by its unique trademark, meets their needs.

• Registration of a trademark is proof of its ownership giving a statutory right to the

proprietor. Trademark rights may be held in perpetuity.

• The initial term of registration is for 10 years; thereafter it may be renewed from time to
time.
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Amity Institute of Pharmacy
Amity Institute of Pharmacy
 Amity Institute of Pharmacy

Steps To Register A Trademark

Step 1: Trademark Search
Conducting a detailed search will help a trademark owner to know whether their trademark
is unique and distinct in nature and also check whether there is any similar or identical
mark already existing or not.

Step 2: Filing an Application

The application must be filed in Form TM-A either online from the IP India's official
website or physically at the Trademark Registry Office according to one's jurisdiction.

The application must be backed up with the required documents, along with complete
details of the trademark.
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Step 3: Examination Process

Once the application is filed, it will be thoroughly examined by the Registrar and they will
prepare an examination in writing and will send a copy of it to the applicant with 30 days
to let them know whether the Registry wants to refuse or conditionally accept the
application.

If there is objection then the applicant within 30 days from receiving the examination
report, must file a reply, stating all the defenses along with evidences against the objection
raised by the trademark office.

Step 4: Post-Examination Procedures

Once the applicant files the reply to the examination report, the Examiner, if wants, can
arrange a hearing if due to any reason he/she is not satisfied with the reply sent by the
applicant. After the hearing process, if the examiner is fully satisfied, can accept the mark
and forward it for publication in the Trademark Journal or can refuse the application if any
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Step 5: Publication of the Trademark Application

After the examiner has accepted the application, it is published in the Trademark Journal for
4 months so that any third party can see it and if they want can file an opposition against the
applicant.
Step 6: Notice of Opposition
Within 4 months from the date of publication of the application, any aggrieved party can file
a notice of opposition in Form TM-O.
Notice of opposition will halt the registration process and the opposed mark of the applicant.
The applicant have to go through certain legal procedures, which includes filing a counter-
statement, submitting evidence.

Step 7: Registration
After the mark goes through all the legal processes related to the opposition, and if the
opposition is cleared, the applicant will receive the certificate.
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REFERENCES

• Agarwal SP and Khanna R., Pharmaceutical Jurisprudence and Ethics, 5th ed, reprint.
New Delhi: Birla Publications Pvt. Ltd., 2005.

• Jain NK, A text book of Forensic Pharmacy, 8th ed, reprint. Delhi: Vallabh Prakashan;
2014.

• Mithal BM, A text book of Forensic Pharmacy, 10th ed, reprint. Delhi: Vallabh
Prakashan; 1998.