An Introduction to Clinical Trial Regulatory Agencies in India

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What is a Regulatory Agency?

A regulatory agency can be defined as the government agency which will take responsibility for exercising some autonomous activities over some areas of human activity. As such, the regulatory agencies would deal with the administrative laws in forms of regulations and rulemaking. Most generally, the regulatory agencies will be a part of the executive branch of a nation's government. In some cases, these agencies will have the statutory authority for performing their functions with the oversight from legislative branches. Some of the famous regulatory agencies are:

- U.S. Food and Drug Administration

- Ofcom


- Interstate Commerce Commission

Like with other activities, there is a requirement for regulatory agencies for the clinical trial research also. And, we all know about the most famous agency in this arena, the U.S. FDA. (7)

Status of Clinical Trials in India:

As you may look at the status of clinical trials in India, you will be shocked to know about the fact that the number of deaths resulting from clinical trials has increased in the past few years. The number of deaths from clinical trials in India is threatening when on the other hand; the decrease in the number of clinical trials as well as approval given for the clinical trials is equally shocking. When we want to look at the reasons and causes for all these, we are in need to know about the clinical trial regulatory agencies in India. (10)

Regulatory Agencies of India:

There are three main regulatory agencies for clinical trials in India:

- Ministry of Health and Family Welfare

- Central Drug Standards Control Organization

- Indian Council of Medical Research

- Ministry of Chemicals and Fertilizers (13)

Ministry of Health and Family Welfare:

This is the regulatory agency which is primarily dealing with healthcare. This government body has several bodies under its administrative control. Some of them are:

- Medical Council of India

- Dental Council of India

- Pharmacy Council of India

- Central Drug Standards Control Organization

- Hospital Services Consultancy Corporation Limited

This regulatory agency acts by prescribing the standards in order to ensure the safety, efficacy as well as the quality of the following products:

- Drugs

- Cosmetics

- Diagnostics

- Devices

In addition, this regulatory agency is also regulating the following aspects of clinical trial:

- Market authorization of new drugs

- Clinical trials standards

The role of Ministry of Health and Family Welfare in a clinical trial does not stop with this alone. This body will also supervise the drug imports. Furthermore, it is this regulatory agency which will approve the license to drug manufacture. (14)

Central Drug Standards Control Organization:

This is the national regulatory authority that is being operated under the 'Ministry of Health and Family Welfare'. This is the primary regulatory authority for the pharmaceuticals as well as medical devices in the nation. The Central Drug Standards Control Organization is serving the parallel function to the U.S. FDA, Japan's PMDA and European Union's EMA.

With this regulatory agency, it is the Drug Controller General of India who is regulating all the pharmaceuticals and medical devices. As such, the DCGI is being advised by two other bodies which are:

- Drug Technical Advisory Board

- Drug Consultative Committee (5), (9)

As such, the whole regulatory agency has been divided into zonal offices to perform the following functions:

- Pre-licensing inspections

- Post-licensing inspections

- Post-market surveillance

- Recalls (if required)

The Central Drug Standards Control Organization is maintaining a good track record with 'World Health Organization'. At present, this agency is planning open its international offices in China. (9)

Indian Council of Medical Research:

This is one among the oldest research bodies of the country. This agency is being funded by the Indian Government. The governing body of this organization is presided by the Union Health Minister. And, this regulatory agency is being assisted by the scientific advisory board. Various eminent experts in biomedical disciplines will assist ICMR in both scientific and technical matters. This regulatory agency is acting to promote biomedical research in the country and is considered as the apex body for the following activities:

- Formulation of biomedical research

- Coordination of biomedical research

- Promotion of biomedical research (8)

ICMR is the regulatory body which has formulated guidelines for several aspects that are relating to national health. Treatments for conditions like malaria, cancer, type 2 - diabetes and retinoblastoma have been covered by various guidelines by Indian Council of Medical Research. (2)

The ICMR guidelines that are pertaining to the clinical trial research in the country are:

- Ethics guidelines for biomedical research: This includes the following information:

o General research principles for the research works that involve human subjects.

o Specific research principles for the research works that involve human subjects in specific areas. (4)

- Guidelines for Good Clinical Laboratory Practices: These guidelines are aiming to elucidate the step-wise procedures that are to be followed by the laboratories for the purpose of strengthening the quality of all the test results. In India, these guidelines must be taken up by all the ICMR labs which are engaging in clinical trial research. A checklist will be prepared in order to monitor all these ICMR laboratories for compliance with ICMR guidelines. (3)

Ministry of Chemicals and Fertilizers:

This ministry in India is the primary administrative unit of the following departments:

- Department of Chemical and Petrochemicals

- Department of Fertilizers

- Department of Pharmaceuticals (1)

The Department of Chemicals and Petrochemicals is involved in the following activities:

- Setting and revising the drug prices

- Maintaining the data on production/export/import

- Enforcing and monitoring the availability of medicines

- Giving options to the parliament

This government body is regulating the industrial policy on drugs in the country. (11)


In general, the clinical trials are being governed by the guidelines as well as directives in addition to the national laws. The regulatory agencies and their guidelines are not legally binding yet are playing an important role in the clinical trial regulations.

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About the Author

Tharani Rajamanickam's picture

I am Tharani. I have Bachelors degree in Biotechnology. I am passionate about the healthcare and medical industry and continue to explore, learn and share and I bring in a wealth of knowledge and expertise to help you keep updated with current trends and developments. I have gained a lot of experience in clinical field by working in clinical trials arena. Stay tuned..

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