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Remarkable Phases of Clinical Trials in India in 2023

Clinical Trails in India

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Do you want to have a career in Clinical Research or Clinical Trials? Are you a research enthusiast and want to become a clinical research associate? 

If this is the case, you should know about the clinical trial market in India. So, here it is:

The size of the Indian clinical trial market is expected to reach $3.88 billion by 2030. The Indian clinical trials market is expected to expand by an 8.2% compounded annual growth rate from 2020 to 2030. Clinical Trials globalization, the growing rate of diseases with variations, and prevalence of Clinical trials in India with new technology adoption in clinical research, and increasing research and development promotion outsourcing are the specific key factors that have driven the Indian clinical trials market. 

The increase in research and development investments by biopharmaceutical or pharmaceutical companies has led to an increase in demand for CROs (Contract research organisations) and outsourcing to curb the cost in the Indian market. Moreover, outsourcing the process of clinical trials enables drug companies to specifically focus on their core competencies and improve their productivity while facilitating outsourcing clinical trials in India. In this blog, we will discuss clinical trials, why we need clinical trials and their phases. By the end of the blog, you will understand the clinical trial development process for new medical treatments to make informed decisions about whether or not to participate.

Clinical Trials and its Importance

Clinical trials are basically the studies specifically to test new drugs, approved drugs, treatments and medical devices. Many clinical trials in India look for multiple ways to diagnose, detect or measure the extent of disease. However, some even look at different ways to prevent patients from diseases before it will happen. Clinical Researchers still human volunteers to specifically test these methods and they apply the same rule. 

Even Clinical trials are used by doctors to learn whether a treatment, a new drug, or a combination of these two works for the safety of people. Clinical trials are essential to develop new treatments for specific and serious diseases such as cancer. In fact, all new treatments should go through clinical trial research in India before getting approval from the Food and Drug Administration (FDA). When it comes to cancer clinical trials, it can take months or years to see if a cancer treatment does what it is meant to do. 

Why do Clinical Researchers need Clinical trials?

Clinical trials always show what is working and what is not working in the medical and healthcare sector. Clinical trials are the best way to learn what is working for treatments of diseases such as cancer. Why clinical researchers need clinical trials in India is typically based on the research studies to test the behavioural, surgical, or medical intervention in the people. Clinical trials are specifically designed to learn new treatments if it is effective and have fewer side effects or are less harmful than the existing drug. 

The Investigational New Drug (IND) Applications in India

Currently, Federal law requires a drug to be subject before the approval of marketing applications so the transportation or distribution of drugs over state lines. If the sponsor of an investigational new drug application in India in the market is seeking privilege from the legal requirements, and technically they obtain this exemption from the Food and Drug Administration. However, during preclinical development, the primary goal of a sponsor is to determine whether the product is reasonably safe for human use if the sponsors find that the compound demonstrates pharmacological activity to justify commercial development. 

A clinical researcher investigating new drug

The sponsor focuses on the data collection and information that is necessary for product identification. If the product is identified as a most viable candidate for the advancements and establishment of a product that will not expose unreasonable risks to humans when they use it in limit. The IND application contains information in three broad categories:

  • Animal Pharmacology and Toxicology Studies
  • Manufacturing Information 
  • Clinical Protocol and Investigator information. 

Once the investigational new drug application in India is submitted, the sponsor should wait for 30 days after that they can initiate clinical trials. During the initial 30 calendar days, the Food and Drug Administration has an opportunity to review the investigational new drug for safety and research without unreasonable risk. 

Phases of Clinical Trials in India

In the healthcare industry, researchers usually conduct clinical trials in phases to build on one another. The phases of clinical trials in India are specifically designed to answer specific questions. You must know the clinical trial phase so that you will get the overall idea of the studied treatments. However, there are risks and benefits to taking part in clinical trial phases. 

Phase 0: Clinical Trails

In phase 0, the clinical researchers do a study of new drugs in humans. It is a study which is not like other clinical trial phases. The main purpose of phase 0 is to streamline and speed up the approval process of the drugs. Phase 0 studies help the clinical researchers to find out the drugs that they are expecting from it. The study of drugs helps the researchers save time and money for later clinical trial phases. 

Phase 1: Safe Treatment

The researchers study new drugs which usually involve people first in phase 1 of clinical trials. From phase 1 of the clinical trials study, the researchers do find the highest dose for new treatments which can be given with safe and without any side effects. However, the treatments in clinical trials tested in lab and animal studies where the researchers cannot be able to find the side effects on the people. Phase 1 clinical trial studies will help people find new treatments that are working or not working for them. 

Phase 2: Treatment Work

If the researchers find that the treatment is safe in phase 1 of clinical trials, they do phase 2 clinical trials to see specifically if the treatment works or not for cancer. The doctors look for the benefits and that depends on the treatment goal. If the new drug treatment works, then it may mean cancer disappear. In a few clinical trials in India, the benefit is the improved quality of patients\’ lives. However, many clinical trials look at the situation if people get the new treatments and live longer than most people can do without the treatment. 

Phase 3: New Drug vs. Old Drug

In phase 2 clinical trial research, the specific treatments have been shown that work must be successful in phase 3 before the approval for general use of drugs. When it comes to phase 3, clinical trial research in India compares the safety and effectiveness of new treatments with current treatment standards. 

Phase 4: 

The studies are imperative and after the approval of drugs by the Food and Drug Administration, the drugs are often watched over a long time. After the medicine is available to doctors as they prescribe, the drugs are monitored based on thousands of patients to identify the same. 


In conclusion, you have gone through the Indian clinical trial market analysis, the importance of clinical trials in India, the process of clinical trials, and the phases of clinical trials. To get more knowledge about clinical trials and clinical research, you need to go for one of the best resources given below. 

CliniLaunch Research Institute is one of the best clinical research training institutes in India offers training and education with massive careers in healthcare industry and medical sectors for students and working professionals. They are also providing medical coding, and clinical SAS courses to students who want to grow their careers in the healthcare industry. To know more about the courses, visit our website

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