Introduction:
In the outbreak of the COVID-19, the whole world is trying to invent vaccines to combat coronavirus. Likewise, India is also conducting various researches to invent a vaccine of COVID-19 to prevent the spread of COVID-19 and cure. The people who are affect due to deadly COVID-19. To held the researches of medicines and drugs, the process is prescribe in India; through which all the researches must go called clinical trials.
“A clinical trial is a systematic study to generate data for discovering or verifying the clinical and pharmacological profile (including pharmacodynamic and pharmacokinetic) or adverse effects of a new drug on humans.”[1] Clinical trials evaluate the effectiveness and safety of medicines or medical devices, gene therapy or blood product by monitoring their effects on a group of people and certify that new drug is efficacious for use on a large group of people. The clinical trials are risky and may face problems and that’s why the medicines or other treatment must be tried in the animal laboratory first to know its effects before they can be applied to people.
Laws Regulating Clinical Trials in India
In India, there are several laws and regulations to conduct and carry out the clinical trials. These are as follows:
- Drugs and Cosmetics Act, 1940
- Medical council of India, 1956 (Amended in 2002)
- Guidelines for Exchange of Biological material (MOH order, 1997)
- Central Council for Indian Medicine Act, 1970
Drugs and Cosmetics Act 1940, has powers for regulating and ensuring quality, safety and efficacy of drugs and framed guidelines for clinical trials in India. The guidelines from an application for a clinical trial to its marketing are in the act.[2]
Schedule Y of the Drugs and Cosmetics act 1940 delivers proper guidelines for conducting clinical trials in India. Also, the drugs and clinical trials rule, 2019 has altered the controlling scenery for the endorsement of new drugs and conduct of clinical trials in India. The Drugs Controller General of India is the in-charge of administrative endorsements of clinical trials in India.
Clinical trials are only conducted when there is good reason to be certain that new drugs or treatment may cure or progress the health of patients.[3] Conducting trials involve many risks and have to face many problems.
Process of Clinical Trials
To conduct a clinical trial, one must have to go through established protocols. Under the New Drugs and Clinical Trial rules, the Ethics Committee has set up and whoever wants to conduct clinical trials or research/studies must be registered. The trial or study can be conduct only when approve by the ethics committee. Also, the permission to conduct trials must take from Central License Authority. The application for permission must be accompanied with the documents and information as prescribed the rules.[4]
There are four phases of clinical trials through which each and every clinical trial has to undergo in India. These phases are as follows:[5]
PHASE-I (first in man study)
In phase one of the trial, the new drug is administer to a small number of people (minimum two) first time. Under the strict supervision of doctors, the dose of the new drug is to volunteer people. The intent of this trial is to whether the new drug is tolerate by a human body and behaves in a predict manner.
PHASE-II (exploratory trials)
In the second phase of the trial, the drug is administered to a group of around 10-12 informed people in around 3-4 clinical/research centre to know its effects and also check for any unpredictable side effects.
PHASE-III (confirmatory trial)
In the third phase of the trial, the group of people increased between 1000-3000 and the purpose of this trial is to get the sufficient evidence of drug’s efficacy and safety of the drug in a larger number of people. If the result of the drug is favourable and satisfactory in a large number of people then the report is sent to licensing authorities for a commercial license to sell the drug in the market.
PHASE-IV (post marketing phase)
In the fourth and final phase of a clinical trial, it made available to doctors to prescribe it on certain specified and approved symptoms to patients. The effects are monitored on thousands of patients to help to identify any unforeseen side effects.
Ethics in Clinical Trials
The ethical conduct of clinical trials includes the protection of rights of the persons participated in clinical trials. The safety of participated subjects is the responsibility of various groups of investigators and researchers. Informed consent of the participant is an important part of ethical research. Participant must be informed about his rights, risk and benefits associated with the trials.
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials.[6] It also serves to protect the rights, integrity and confidentiality of trial subjects. GCP guidelines are key elements to carry out ethical clinical trials.
Conclusion
In recent times, India has emerged as a global hub to conduct clinical trials and conducting clinical trials are very important for discovering new treatments for diseases. Also, new ways to invent drugs and devices are crucial with the changing nature of the environment and diseases. It is also important in the sense to advance the medical knowledge which may help in many types of research.
The process of clinical trials are controlled by various legislation and provisions. Laws are there to check the legality of process at each stage of the clinical trial.
References:
[1] Pikee Saxena and Rohit Saxena, Clinical trials: Changing Regulations in India, Indian Journal of Community Medicine (Oct. 2014), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4215498/#:~:text=No%20trial%20shall%20begin%20without,sites%20of%20sponsors%20and%20investigators.
[2] Drugs and Cosmetics Act, 1940, http://naco.gov.in/sites/default/files/Drug%20%26%20Cosmetic%20Act%201940_1.pdf
[3] Phases of Clinical Trials, https://www.nccn.org/patients/resources/clinical_trials/phases.aspx
[4] Sapra, Lenin & Jain, New Drugs and Clinical Trials rules, 2019- A Regulatory Overview, Indian Corporate Law (July 31, 2019), https://corporate.cyrilamarchandblogs.com/2019/07/new-drugs-clinical-trials-rules-2019-regulations-india/
[5] Supra 1
[6] Vijaynathan & Nawawi, The importance of good clinical practice guidelines and its role in clinical trials, Biomedical Imaging and Intervention Journal (Jan-march 2008), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3097692/#:~:text=international%2C%20ethical%2C%20historical-,DEFINITION,and%20reporting%20of%20clinical%20trials.
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