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..