DEFENCES UNDER IPC

Section 80 of Indian Penal Code – Anything which is done by accident or misfortune and without any criminal
intention or knowledge in the doing of a lawful act in a lawful manner by lawful means and with proper care and
caution is not an offense.

Section 81 of Indian Penal Code – Anything which is done merely by reason of it is being done with the knowledge
that it is likely to cause the harm, if it is done without any criminal intention to cause harm, and in good faith for the
purpose of preventing or avoiding other harm to person or property is not an offense.

Section 88 of Indian Penal Code – No person can be accused of an offense if he/she performs an act in good faith for
the benefit of the other person, does not intend to cause harm even if there is a risk and the patient has explicitly or
implicitly given consent.

Section 92 of Indian Penal Code – Nothing is an offence by using cause of any harm which it will intent to a person
for whose improvement it’s finished in just right faith, even without that character’s consent, if the instances are
such that it’s not possible for that individual to suggest consent, or if that character is incapable of giving consent,
and has no guardian or a different man or woman in lawful charge of him from whom it’s possible to receive consent
in time for the object to be done with advantage.

 First of all, this exception shall not prolong to the intentional causing of loss of life, or the making an attempt
to motive dying.
 Secondly, that this exception shall now not extend to the doing of something which the man or woman
doing it knows to be more likely to reason death, for any motive rather than the stopping of death or
grievous damage, or the curing of any grievous sickness or infirmity.
 Thirdly, that this exception shall no longer extend to the voluntary inflicting of hurt, or to the making an
attempt to cause harm, for any reason as opposed to the stopping of dying or hurt.
 Fourthly, that this exception shall no longer lengthen to the abetment of any offense, to the committing of
which offense it would now not extend.

Features of Drugs, Medical Devices and Cosmetic Bills, 2002

The Ministry of Health and Family Welfare released a draft of the Drugs, Medical Devices and Cosmetics Bill, 2022 (“the
bill”) with an aim of reviewing, replacing and modernizing the obsolescent Drugs and Cosmetics Act, 1940 where the
ministry has been persistently reviewing and streamlining the rules to further accommodate the changes and to adopt the
new technology.

OBJECTIVE OF THE BILL

The aim of the bill is to ensure and provide comprehensive legislation to regulate that the medical products sold in India
are safe, effective and conform to prescribed quality standards to the individuals. The other objectives are enumerated as
under:

 To amend and consolidate the law relating to the import, manufacture, distribution and sale of drugs, medical
devices and cosmetics
 To ensure the quality, safety, efficacy, performance and clinical trial of new drugs and clinical investigation of
investigational medical devices
 To ensure that drugs, cosmetics and medical devices sold in India are reliable, efficient, and conform to quality
requirements
 To adapt to the modern-day technological and medicinal breakthroughs
 To boost domestic manufacturing of medical devices and attract huge investments in India in healthcare center.

FEATURES OF THE BILL

 ONLINE PHARMACIES: The Bill has for the first time introduced a regulatory mechanism for online sale of drugs
and cosmetics, making it mandatory for every person who stocks, exhibits, sells or distributes any drugs through
online mode to obtain a license or permission from the Authority, though there are no clear guidelines on the
 procedures for acquiring license, nonetheless Section 83(2)(l) mentions that Central government would makes
rules prescribing the manner for regulation and restriction for online mode of sale of medicines.
 MEDICAL DEVICES:
 Today millions of patients depend on medical device based treatment for the management and diagnose
of several diseases. Quality and safety of device is depends upon the regulatory guidelines.
 The Bill establishes a distinct definition for medical devices. The Bill also proposes to constitute a
separate Medical Devices Technical Advisory Board to advise the government on technical matters
pertaining to medical devices, which shall include officials from the various Government Departments
and experts nominated by the government from the field of medical devices industry.
 The Bill prohibits the manufacture, import, or distribution of medical devices that are not in conformity
with the prescribed standards of quality, safety, and performance. And makes it mandatory to obtain
permission from the Central Licensing Authority for conducting any clinical investigation of medical
devices on human participants.
 Furthermore, provisions relating to compensation and medical treatment in case of injury or death of a
person participating in clinical investigation of any investigational medical device have been provided. It
also allows the Central Licensing Authority to waive the requirement of conducting clinical investigation
for manufacture or import of a new medical device in public interest.
 AYUSH PRODUCTS: The current Drugs and Cosmetics Act only regulates Ayurveda, Unani, and Siddha drugs and
cosmetics, the bill proposes to include and regulate Sowa Rigpa, Homeopathy, and Traditional Medicines as Ayush
Products.
The Bill proposes to constitute an Ayurveda, Siddha, Sowa-Rigpa, Unani, and Homeopathy Drugs, Medical Devices,
and Cosmetics Consultative Committee to advice both the State and Central Government with the aim of securing
uniformity throughout India for regulation of AYUSH Drugs, Medical Devices, and Cosmetics.
 CLINICAL TRIALS AND INVESTIGATIONS: For the first-time provisions relating to the clinical trials have been
included under the Bill, which prohibits the conduct of a clinical trial of a new drug, investigational new drug,
bioavailability or bioequivalence study of any new drug in human participants without obtaining permission from
the Central Licensing Authority. Furthermore, provisions relating to compensation and medical treatment in case
of injury or death of a person participating in a clinical trial or study of such a drug are also included.

PENALTY PROVISIONS

The proposed bill has replicated next to all the offences of the existing Drugs and Cosmetics Act; however, in order to make
the punishments more stringent the bill enhances the period of imprisonment between 1-10 years which may extend to life
imprisonment and amount of fine up to Rs. 15 lakhs for any contravention of provisions of the bill.