(Namita Pradhan, Intern Journalist) The world affected with the Coronavirus is eagerly waiting for the vaccine it might not affect where but when and what it takes to work out an approved new drug and whether it has the right parameters to held the clinical tests. It raised many legal issues applicable to the fundamental rights of individuals.
Globally thousands of people are dying due to the pandemic hoping for a vaccine to be discovered soon which will recover them.
We have been hearing many drugs are being prepared which are ready for Phase 1, Phase 2, Phase 3 testing, or to complete the clinical test.
Scientist are working hard on the vaccine from various corner of the world.
Now here lead the question not where but when and what does it need to avail the new drug and what parameters are needed to conduct the clinical trials.
Whenever there is formed a new combination of chemicals to form new drug clinical testing is important before providing it to the actual patient. During a clinical test, the lowest version of the disease germ is injected in healthy persons to train their immune system to prepare antibodies in the case of exposure to the disease germs. Several times the test is held on humans and thus it occurs in four phases, with an increase of subjects in each phase.
Clinical testing is necessary and also beneficial for some reasons, as it has raised many legal issues in the fundamental rights of individuals.
As without a test providing the vaccine to the patient is dangerous so it has to be pass through various test, then only after its success it can pass to the patient.
The court has observed many legal issues that that it was not objected to clinical trial, the pain of the disease germ on the trial subjects without their permission could not be held. It led to the first ethical code which is called as the Prussian Code, which need the permission of the subjects.
During the end of World War II, Clinical testing was considered as an cruel act by war criminals in Russia.
Nuremberg Doctors Trial were 16 doctors were accused of guilty and 7 were sentenced to death. Which held the concept of informed agreement and the right to the subject to withdraw the agreement anytime till the end of the test.
Later the Helsinki Declaration held forward the necessary guidelines on Countries during the clinical testing with the resistance to conduct tests among vulnerable groups.
In 1976, the United Nations International Covenant of Civil and Political Rights recognized that the essential equality and absolute rights of all members of the family as the foundation of freedom, justice and peace in the world”, and dealing with the clinical test involve the participation of human, provides with three nondelegable rights provided to individuals- rights to life, nondiscrimination and freedom from non agreed on medical experimentation on humans.
With the increase in the laws and guidelines for the clinical trial provided by many doctors and countries, several guidelines were provided by The Council for International Organisations of Medical Sciences (CIOMS), established by the World Health Organisation (WHO) and the United Nations Educational, Scientific and Cultural Organisation (UNESCO).
India has always in favor of conducting human trails as the subjects are available for the testing at a cheaper rate due to poverty and illiteracy.
On 5th June 2020, the Government of India has released the draft rules, 2020, doe to the growth of Covid-19, as the amendment was proposed to Rule 96 of the Original rules, 2019. Under this, the procedure of given approval to manufacture or import a new drug was added for use as empathizing.
The compassionate use has suggested that the dying patient can make a declaration to the Central Licencing Authority to import or manufacture the unapproved drug in a limited quantity for that patient use only through a medical officer. This suggests that providing of the drugs which haven’t passed through the four phases of the trials, to the patient who has not included trial subjects or post-trial subjects.
The growth in the Covid-19 infected people makes the whole population subject for a trial and error method with no responsibility of the sponsors or the doctors and ensuring the administration of” on request drugs” which are not free.
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