Drug development and trials: Spare 2 minutes to know the whole process
If someone tells you today that the corona vaccine has been
developed, then after a few days tells that all the clinical trials have been
successful, then you will be confused as to what is going on and what is yet to
happen.
In order to come out of this puzzle, you need to devote just
2 minutes hre and know the whole process of drug development.
Let's refresh our
basics before starting this discussion.
Corona-borne disease ie Covid-19 is a viral disease. If it
was a bacteria-borne disease, , like typhoid, cholera etc, the disease could be
overcome by giving anti-biotic to the patients, killing the bacteria that
entered their body.
But the virus cannot be killed, so for a viral disease such as as hepatitis B,
smallpox, polio etc., what we can make is only a vaccine.
The person who takes the vaccine for a particular disease, if not
yet affected with that disease, will not get affected with a that disease in
future. disease has not happened yet, will not be further, such
The process of giving vaccine is called Vaccination. The vaccine, after
entering the person’s body, develops IMMUNITY
) against that virus in the body, by which the body can resist that virus and
prevent it from causing disease. This process, which takes place inside the
body due to the effects of vaccination, is called immunization.
In fact, there is already some immunity present in the body, which keeps fighting with many bacteria
and viruses every day. Some people have very high immunity , others have not so
high immunity. . Those having high immunity are least affected by any disease,
even by the effect of corona, and they become healthy without much suffering.
This ability can also be increased by the consumption of certain substances and
by sticking to regular routine, exercise etc.
Baba Ramdev was developing a similar medicine which would
increase immunity( Immunity Booster). It would be helpful in not only Kovid-19
but in many other diseases. But since it was not going to create immunity
against Covid-19, it would be wrong to call it a vaccine.
But whatever be the medicine, you cannot sell it by making
it directly, taking advantage of people's trust over you. Even if that medicine
is not harmful, even if it has the ability to cure the disease, it has to be given
approval by the concerned government institution before giving it to the
patient.
In India, the name of the competent government organization is
CDSCO ie Central Drugs Standard Control Organization (Central Organization for
the Control of Drug Standards).
CDSCO is called FDA of India.
The FDA (US Food and Drug Administration) is a US body that
determines, among other things, what the stages of a drug's development will
be, how they are tested first on cells, then
on small animals,followed by testing on
humans, under their consent.
Let us introduce you to these steps of Drug Development
Process prescribed by FDA. The names of these steps are as follows:
1. Discovery and development-
During discovery, the pharmaceutical company understands the
mechanism of the disease in a new way and develops the medicine to prevent or
reverse its effect. The test is only between the chemicals that are associated with the disease
and the drug. . If a new technology has come up, then new methods are thought .
They also study pthe methods tried in past but proved unsuccessful. Thousands
of chemicals are taken as initial options and through systematic tests,some are
selected for development. During development, it is decided what the dosage of
the medicine will be, how it will be administered, how much its absorption will
be in the body, etc. Also its harmful effects, reaction with other drugs
etc. are ascertained.
2. Preclinical research
Under this, experiments are done on cells and animals. Their
purpose is to see that this medicine cures the cells and organisms affected by
that disease, as well as to find out the extent of toxicity and damage that drug can cause,just to ensure that these
things are within acceptable limits.
3. Clinical research:
In this phase the drug is used on humans. This research
takes place in 5 phases..
a. In the first phase a
group of 20 to 100 people is selected, everyone is given this medicine and it is checked whether the medicine is safe and
the Dose is correct. Approximately 70% of the drugs are passed in this phase.
b. In the second phase, 200
to 400 people are given this medicine for a few months., it is seen that this
medicine is effective in curing the disease and its side effect is not much. In
this, about 33% of the drugs pass.
c. In the third phase, 1000
to 2000 people are given this medicine for a few years .It is seen that the
drug has no adverse effect. In this, about 25% of medicines are passed.
d. In the 4th phase,
thousands of people are given these medicines to see that t the medicine is safe and
effective. About 25% of the drugs pass in it.
4. FDA review: Now, details of all the above steps are placed
before the FDA and the FDA decides whether to approve the drug or not.
5. FDA Post-market safety Monitoring: Once FDA has
approved, the drug starts being sold in the market and people start using it.
At that time., FDA keeps monitoring the dose being given,the advertisement being made, whether it is being
used for the intended purpose only ,etc. FDA also monitors the complaints received
against it.
Now come to the process prevalent in India. CDSCO also
adopts a similar, or slightly more flexible, simplified procedure, but the
sequence of procedures remains the same. For example, here the sub-clinical
trials are not written separately. Human trial sequence is also flexible.
By now ,you must have understood that if the news comes in
the newspaper that a particular company has developed the C-19 vaccine, then it
will only mean that simply the Discovery
And Development is done. If sub- clinical or clinical trials are in news,
it should be understood that the second or third phase is going on.
The latest news in India is that Bharat Biotech and Zydus Cadila have
received approval to do a clinical trial of the Corona vaccine in India. Also,
Zydus Cadila has started clinical trials. This means that in Phase 1 of FDA, is
on.
How much time will be taken, will mostly depend on the
results of further tests. It may take 3-4 months or even more.
Till the time this vaccine comes, what will be the level of
corona in India ? Please don’t get bothered ! Just make sure it doesn't happen
to you.
For this, do what you have been doing till date, ie, washing
hands, putting on masks and maintaining distance.
Now the destination may be far away but at least is clearly visible..
Comments
Post a Comment