The Role of Clinical Research Services in India In Regulatory Expectations

The Role of Clinical Research Services in India in Meeting Regulatory Expectations

Introduction

In the field of clinical research, where novel findings and transformative medical breakthroughs emerge, regulatory compliance is a crucial cornerstone. In regulatory expectations meeting clinical research provides global Clinical trial approval, safety reporting, test license services, etc. Clinical research organizations in India have become leaders in maintaining adherence to complex regulatory frameworks among the several centers of excellence for research.

Why are clinical trials necessary in India?

As a vital part of India’s commitment to drug discovery and development, clinical studies are becoming a more significant activity in the country. Clinical trials provide numerous advantages to participants in addition to furthering knowledge.

Conducting carefully planned clinical trials is the only reliable method of assessing a novel medication. This emphasizes the necessity of making sure that regulatory standards are followed and that relevant staff members are properly trained in good clinical practice (GCP). This would guarantee that clinical trials continue to benefit India and position the country as a global leader in this area.

Understanding the roles of the regulatory bodies

The key documents in clinical research include the Drugs and Cosmetics Act (1940) and Drugs and Cosmetics Rules (1945), the Indian Council of Medical Research (ICMR), 2017 (National Ethical Guidelines for Biomedical and Health Research involving human participants), and Indian Good Clinical Practice Guideline (2001).

A complicated network of laws, regulations, and guidelines governs the field of clinical research. It is both an ethical obligation and a need for the validity and acceptability of research findings to ensure adherence to these principles.² The basic regulations in India and the main documents followed include:

Regulations in India	Key Documents Followed
Law	Drugs and Cosmetics Act (1940) and Drugs and Cosmetics Rules (1945)
Regulations	The New Drugs and Clinical Trial Rules, 2019⁵
Guidelines	Indian Council of Medical Research (ICMR) guidelines Good Clinical Practice (GCP) guidelines, 2017

The roles and responsibilities of the regulatory bodies include:

Clinical studies (trials) for both newly approved indications of registered medications and non-registered medications must be reviewed by regulatory bodies.
It is legally required of regulatory authorities to make sure that the medications that are sold in the nation meet the standards for efficacy, quality, and safety.
In the event of significant violations of good clinical practice, it is the duty of regulatory authorities to terminate an ongoing trial.
It is the duty of regulatory authorities to put in place a system of regulations requiring registration from all clinical trials planned to be carried out in the nation.
The regulatory authorities shall bear the primary responsibility of promoting, guaranteeing, and overseeing adherence by authorized ethical committees in a nation that has pertinent laws, rules, and directives, including guidelines.

Sponsors and CROs

A sponsor is an individual, business, institution, or other group that assumes accountability for the planning, execution, and/or funding of clinical studies or trials.

An organization hired by a different business or research facility to manage particular facets of a clinical study is known as a clinical research organization or contract research organization. The company may organize, supervise, and design the trial in addition to assessing the results.

How do Clinical Research Organizations in India meet Regulatory Expectations

A CRO in India is a blessing for both pharmaceutical and research needs, as they can multitask within a set timetable.

The services provided by CRO include:

Clinical Research Services Provided	Meeting Regulatory Expectations
Global Clinical Trials Approval (GCT)	Helps to complete the application for a GCT approval which includes Form CT-04 (Application for grant of permission to conduct clinical trial of new drug or investigational new drug), Form CT-10 (Application for grant of permission to manufacture new drug or investigational new drug to conduct clinical trial), Form CT-12 (Application for grant of permission to manufacture formulation of unapproved active pharmaceutical ingredient for clinical trial), Form CT-13 (Application for grant of permission to manufacture of unapproved active pharmaceutical ingredient for development of formulation for clinical trial), and/or Form CT-16 (Application for grant of license to import new drug or investigational new drug for clinical trial).
Safety reporting	As per the New Drugs and Clinical Trial Rules, 2019, , periodic safety update reports (PSURs), are submitted once every six months for the first two years and annually for the subsequent two years.
Test license	By the 2019 new drug and clinical trial regulations, CDSCO accepts applications in Form CT-11/CT-14/CT-15/CT-17 for the granting of a license for the manufacturing or import of new pharmaceuticals for testing, analysis, or clinical trial study. Form CT-11: After reviewing the documents submitted with the application in Form CT-10 and conducting any additional investigations as deemed necessary, the Central Licensing Authority may permit the manufacture of the new drug or investigational new drug for use in clinical trials, bioavailability or bioequivalence studies, or for the purpose of examination, testing, and analysis of the new drug or investigational new drug.
Clinical Trial Registry India (CTRI) Registration	Ensures trial registration in the CTRI. Provides a registration number for every trial in each publication. Provides details of the target sample size, trial locations, enrollment date, and investigator details. Following registration, they update the trial status on a regular basis with any modifications.
Ethics Committee Registration	Ensures submission of ethics committee registration application as per rule 8. Assists in submitting Form CT-01 (application for grant of registration to the central licensing authority). Registration is granted via Form CT-02.

The Role Of Clinical Research Services

Fig 1: Services provided by CROs

Conclusion

Cliniexperts is a full-service provider of clinical trial solutions with over a decade of experience in the market. The team’s expertise and wide industry networks make it easy to procure the licenses and approvals your products need. Cliniexperts is a one-stop shop for clinical research services in India, capable of handling a variety of regulatory issues, ensuring complete client satisfaction.

Performing clinical trials not only advances science but also offers numerous advantages to the individuals involved. With sufficient regulations in place to guarantee participant safety, clinical trials have made India a major global center. India will continue to gain from clinical trials as long as regulatory standards are followed and relevant personnel are properly trained in GCP.

References

Poongothai S, Unnikrishnan R, Balasubramanian J, Nair MD, Mohan V. Why are clinical trials necessary in India? Perspectives in Clinical Research [Internet]. 2014;5(2):55–9.
Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3980544/
Gogtay NJ, Ravi R, Thatte UM. Regulatory requirements for clinical trials in India: What academicians need to know. Indian Journal of Anaesthesia [Internet]. 2017 Mar 1;61(3):192–9. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5372399/
INDIAN COUNCIL OF MEDICAL RESEARCH 2017 NATIONAL ETHICAL GUIDELINES FOR BIOMEDICAL AND HEALTH RESEARCH INVOLVING HUMAN PARTICIPANTS [Internet].
Available from: https://main.icmr.nic.in/sites/default/files/guidelines/ICMR_Ethical_Guidelines_2017.pdf
K. Kamnoore, M P Venkatesh, Balamuralidhara V, T M Pramod Kumar. Regulatory requirements for conducting Clinical Trials in India. Research J. Pharm. and Tech 2020; 13(3):1517-1522.
Available from: https://rjptonline.org/HTMLPaper.aspx?Journal=Research%20Journal%20of%20Pharmacy%20and%20Technology;PID=2020-13-3-81
The New Drugs and Clinical Trials Rules, 2019 [Internet]. Cdsco.gov.in. 2023.
Available from: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=OTIzMA==
Roles and Responsibilities of the Regulatory authority CHAPTER-II [Internet].
Available from: https://webstor.srmist.edu.in/web_assets/srm_mainsite/files/downloads/Responsibilities_of_Regulatory_authority.pdf
Clinical study sponsor [Internet]. Toolkit.
Available from: https://toolkit.ncats.nih.gov/glossary/clinical-study-sponsor/
Definition – Contract Research Organization [Internet]. National Cancer Institute. 2011.
Available from: https://www.cancer.gov/publications/dictionaries/cancer-terms/def/contract-research-organization
CRO Support, Clinical Trials, Research & Approval -CliniExperts [Internet]. cliniexperts.com. Available from: https://cliniexperts.com/india-regulatory-services/cro/
Application For Global Clinical Trial [Internet].
Available from: https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/GCT_PDFs/GCT_Checklist.pdf
Notice [Internet]. Cdsco.gov.in. 2024
Available from: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTYyMQ==

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