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Home / IAS Preparation / Ranjit Roy Chaudhury Committee

Dr. Ranjit Roy Chaudhury Committee - Recommendations, Importance, Government Stance & More

Last Updated on Sep 05, 2023
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The Dr Ranjit Roy Chaudhury Body was formed in 2014 as an expert committee to provide rules and policies for approving new pharmaceuticals, clinical trials, and drug prohibition. The key facts concerning the committee’s recommendations and the subsequent steps taken by the government are briefly discussed in this article. 

This article will provide all features and information on Dr. Ranjit Roy Chaudhury Committee. Study major topics of Indian Polity from the perspective of UPSC Exams.

About Ranjit Roy Chaudhury Committee
  • The Dr. Ranjit Roy Chaudhury Committee was formed in 2014 as an expert committee to provide recommendations and policies for approving new pharmaceuticals, clinical studies, and drug bans.
  • To make these decisions, the Indian government organized a committee led by Prime Minister Narendra Modi.
  • The fundamental goal of the Committee is to guarantee that the science underlying producing new pharmaceuticals is supported and authorised by sound scientific evidence.

Recommendations of Ranjit Roy Committee on Clinical Trials

Here are some of the critical recommendations of the committee:

  • Strengthening of regulatory oversight: The committee recommended that the regulatory oversight of clinical trials should be strengthened, emphasizing the safety and well-being of trial participants.
  • Informed consent: The committee recommended that the process of obtaining informed consent from trial participants should be improved, with greater emphasis on ensuring that participants understand the risks and benefits of participating in a trial.
  • Compensation for trial-related injuries: The committee recommended implementing a mechanism to compensate trial participants who suffer from trial-related injuries.
  • Registration of clinical trials: The committee recommended that all clinical trials be registered with a publicly accessible database to promote greater transparency and accountability.
  • Ethical review of clinical trials: The committee recommended that all clinical trials be subject to honest review by an independent institutional ethics committee to ensure they are conducted ethically and socially responsibly.
  • Post-trial access to drugs: The committee recommended that trial participants be provided with continued access to the drugs tested in a trial if they are effective and safe.
  • Monitoring and inspection: The committee recommended that clinical trials should be subject to regular monitoring and check to ensure that ethical and regulatory guidelines are conducting them.
  • These recommendations have helped improve the regulatory framework for clinical trials in India and promote greater transparency, accountability, and ethical conduct in clinical trials.

Check the details on the Economy Notes Here.

Proposed Actions on Recommendations of Ranjit Roy’s Committee

Proposed Actions on Ranjit Roy’s Committee’s Recommendations

Requirement of filing an application
  • If India participates in global clinical trials of such NCEs, it is required to file an application to sell them.
  • The Central Drugs Standard Control Organization (CDSCO) would be the competent authority in India for approving the sale of novel chemical entities.

Timeline for processing of applications
  • CDSCO will set a six-month deadline for the disposition of applications for authorisation of clinical trials and new medications.

Accreditation of Ethics Committee, Investigators and the Clinical Trial Sites:
  • Long-term efforts include an accredited ethics committee and the establishment of centres.
  • Short-term solution – The Quality Council of India will build a system for accrediting investigators, ethics committees, and clinical trial sites.

Computerized database and selection of experts
  • After meeting the selection criteria, the experts will be chosen.

Procedure for review of applications of clinical trials and new drugs
  • New Drug Advisory Committees will be replaced with Subject Expert Committees.
  • These committees will assess clinical trial applications and novel medications.
  • The topic expert committee’s suggestions will be reviewed by the Technical Review Committee.

Other actions
  • The Technical Review Committee will analyse the proposals.
  • Trials with a placebo
  • Investigational product post-trial access
  • Informed Consent Action in the event of a breach of the informed consent processes
  • The number of clinical studies that an investigator can conduct at one time.
  • Utilization of Information Technology
  • Clinical trial monitoring
  • Compensation in the event of harm or death during an academic trial, for example.
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What are Clinical Trials?

Clinical trials examine new diagnostic procedures and therapeutic approaches to determine how they impact patient outcomes. Clinical trials enlist volunteers to test a variety of medical interventions, including drugs, cells, and other biological products, surgeries, radiological procedures, equipment, behavioural therapies, and preventative care. Before they can start, clinical investigations must be properly planned, assessed, and completed. All age groups, including children, are welcome to participate in clinical trials.

Study Important Articles of the Constitution of India here.

Significance of Ranjit Roy Chaudhury Committee
  • The Ranjit Roy Chaudhury Committee presented various proposals to help the Indian people.
  • The committee worked hard to create these useful recommendations for conducting clinical studies and approving new medications.
  • The Ranjit Roy Chaudhury Committee was established to guarantee that each medicine is created with what it needs to be and on schedule.
  • The council will authorize clinical studies and oversee testing in India and overseas.
  • The primary goal of this group is to improve people’s quality of life.

Study the Types of majorities in the Indian parliament – Article 249 here.

Government Stance on The Ranjit Roy Committee Report
  • The Union Health Ministry approved the expert group's recommendations chaired by Prof. Ranjit Roy Chaudhury.
  • The government founded the committee in February of this year to establish standards for clinical trials, drug prohibition, and the evaluation of novel drugs.
  • Senior ministry sources assert that the expert committee members recently discussed the committee's recommendations.
  • The committee clarified various recommendations throughout the meeting. Following the meeting, the committee's recommendations were accepted by the ministry.
  • After accepting the expert panel's recommendations for the accreditation of ethics committees, investigators, and clinical trial sites, the ministry decided that clinical trials should be conducted in accredited sites by accredited investigators under the supervision of accredited ethics committees to strengthen the clinical evaluation of new drugs.
  • Given the long-term nature of this strategy, the Quality Council of India (QCI) would be considered for the interim development of a framework for the accreditation of investigators, ethics committees, and clinical trial sites.
  • Although the Drugs and Cosmetics Rules of 1945 now permit the registration of ethical committees, the accreditation of such committees will follow a predetermined procedure.

Read about the Sessions of the Parliament here

New Drugs and Clinical Trials Rules 2019
  • The New Drugs and Clinical Trials Rules 2019 aim to boost clinical research in the country; the health ministry issued the new drugs and clinical trials rules in 2019.
  • These guidelines apply to all new pharmaceuticals, ethical committees, experimental drugs for human use, bioequivalence studies, and clinical trials in India.

Features of Drugs and Clinical Trials Rules 2019

  • Except for Chapter IV, which takes effect 180 days after publication in the Gazette, i.e., 180 days after March 19, 2019, the NDCT Regulations went into force on March 19, 2019.
  • The NDCT Regulations apply to all clinical trials, bioequivalence studies, bioavailability studies, experimental new drugs for human use, and ethics committees.
  • According to what the Medicines Controller General decides constitutes unfavorable injury, death, or disability, compensation is provided.
  • Suppose a novel treatment is licenced and marketed in any nation named by the Medicines Controller General with government approval. In that case, the need for a local clinical investigation for approval may be removed.
  • The ethics committee will oversee the trials and choose how much compensation will be given in the event of a negative event.
  • Drugs tested on Indian patients and found to be effective in other developed markets will automatically receive a licence to be sold in India.
  • Morality Commission: On March 19, 2019, the Indian government published the New Medicines and Clinical Trials Rules 2019 (New Rules). New regulations for the ethics committee (EC) have specified certain criteria.
  • (CLA) Central Licensing Authority The EC must abide by the New Regulations and provide the Central Licensing Authority with reports.

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Dr Ranjit Roy chaudhury Expert Committee- FAQs

Clinical trials are human research studies that try to evaluate a medicinal, surgical, or behavioral intervention.

Clinical trials are becoming an important activity in India since they are an integral component of India's drug research and development agenda.

The Dr Ranjit Roy Chaudhury Committee was formed to provide rules and policies for the approval of new pharmaceuticals, clinical trials, and drug prohibition

The Ranjit Roy Chaudhury Committee suggested that the lead investigator be held accountable for any violations of the participant's rights. The lead investigator will be banned for at least 5 years as a punishment for violating the participants' right to be well-informed.

The Government of India issued the New Drugs and Clinical Trials Rules 2019 (New Rules) on March 19, 2019.

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