A clinical trial is a scientific process of collecting data.
The given data helps us to come to a conclusion for a drug in respect to its use for a particular dis-ease or a medical condition.
The trials are carried on strict standards to present reliable and safe results. It is used to generate data for discovering or verifying clinical and pharmacological profiles
(including pharmacodynamics & pharmacokinetics)
Pharmacodynamics is the study of how a drug affects an organism, whereas pharmacokinetics is the study of how the organism affects the drug.
Both together influence dosing, benefit, and adverse effects.
(Source: Wikipedia)
or any adverse effects of the drugs on us (Human beings).
A clinical trial is a gateway for a drug to enter the market for human use. It is going under animal trial and the forthcoming effects are observed after which needful steps are taken.
The applicant should have done thorough research on the aim, problems, risks, and benefits of the drug in respect to disease.
The new policy -
The union ministry for health and welfare has made remarkable efforts concerning the clinical trials of new drugs.
This will incredibly boost the clinical research in the country pushing people towards making more efforts on their end. For the enhancement of our nation’s healthcare system.
The new policies would be altering regulatory structures and clinical trial conducts of new drugs in our country.
Its effect would apply to all new drugs and associated official bodies for the clinical trial.
Policy Features -
One of the finest works seen under the new policy is the reduction in time for approving applications. That has gone down to 30 days for the drugs that are manufactured in India. And 90 days for foreign drugs (which are developed abroad).
The Drugs Controller General of India (DCGI) will have the authority for deciding compensation for the subjects (person who participates in the trial) in case of death, partial or permanent disability, injuries, etc. in the process of a clinical trial.
The need for a clinical trial would be abandoned with approval from the government if the drug is approved and runs in the market of nations that are specified by the DCGI. And you can imagine the kind of impact this would make in the process of the approval.
In case of injury to the subject in the process of a clinical trial, medical management will look after the subject as per the guidance of the investigator. There have had been not so concrete take off the bodies on this matter earlier.
The policy has also discarded regulations on animal trials in case of drugs which are in the markets of well-regulated countries for more than 2 years. Eradicating wastage of time.
The new laid policies promote clinical research in the country. It has also made the whole process transparent, structured, and effectively regulated giving the best of healthcare advancements to us the people of India.
Stages of Trials -
The clinical trials are distinguished into 4 phases. And a drug trial goes into all 4 phases giving us a concrete and reliable report.
Phase 1 (clinical pharmacology trials) — In this stage the drugs are taken into account and 2 in- formed volunteers are considered for the trial process. The process is under a doctor’s supervision, and observations are made for the drug components’ behavior in the human body. This point helps us to make a decision for the later stages.
Phase 2 (exploratory trials) — At this stage around 10–15 informed patients are considered to form 2- 5 centers. And the trial is carried out to look for any side effects and effectiveness of the drug.
Phase 3 (confirmatory trials) — At the 3rd stage of the trial the drug is taken to a large scale. Collect sufficient evidence about the effectiveness and safety of the drug. It is carried out within 1000–3000 subjects in different regions. Later if the results are favorable, it is granted for the use of the masses, and licenses are issued from the authorities. And then it is available in the market for mass use.
Phase 4 (post-marketing phase) — The medicines are made available in the markets and are prescribed by the doctors for use. Then its effect is again under scrutiny of the healthcare authorities. For any unforeseen side effects.
These are the phases through which a drug goes for approval.
And after all of these rigorous tests and trials, drugs are issued in the market for our use.
These are the standards that are laid down by the concerned authorities for our health safety.
You would’ve even known all these terms in this time of COVID-19.
Where the nations were trying to find the virus’s vaccine and had made it go through clinical trials. For public use.
Challenges of the Clinical Trials -
Due to the opaque system and rigidity of the regulatory bodies, the process of clinical trials was not so approachable.
There are times where the participants are given the least liberty to present their consent.
The Clinical Research Organisation (CRO) are biased in their nature for the selection process. Their only motive is money.
Due to the three tiers, approval system there used to be great delays in giving approvals for the drugs.
Sometimes there is even conspiracy between the doctors and drug companies. There have been sub- stantial loops concerning regulatory bodies as well.
Conclusion -
India being a country of great populations, around 65–75 million people suffer from diseases that are yet not curable or the treatment is costly and not affordable for the masses.
The new policy has made needed changes into this whole ecosystem with advancements and transparency.
Boosting the process and applications of the clinical trial in the country. Which will help the health ecosystem with faster approvals.
The drugs which are made and developed in the country will be approved with 30 working days for the clinical trial by the Central Licensing Authority (CLA).
And also if there has been no communication on the application from the concerned authority. Then it shall be considered as Granted for the clinical trials.
There also have been a substantial amount of changes concerning the compensation for the subjects.
The effort made by DCGI for collecting data from different countries is highly appreciated and will result in boosting the process immensely.
More importantly, it will reduce the hassle for the drug makers and will also lower the costs of drugs in the country.
