Dr Ranjit Roy Chaudhury Committee was an expert committee constituted in 2014 to develop the guidelines and policy for the approval of new drugs, clinical trials, and also regarding the banning of drugs. The relevant facts about the suggestions of the committee and the actions taken by the government thereafter; are mentioned in this article in brief. The information provided here is helpful for the IAS Exam (GS 1, GS 2 and Essay) preparation.
Aspirants can read about various other committees and their findings for UPSC Mains preparation, linked below:
|Shekatkar Committee||Shyam Benegal Committee|
|PJ Nayak Committee||Sundar Committee|
|Malimath Committee||Hari Gautam Committee|
Recommendations of Ranjit Roy Committee on Clinical Trials
- Accredited Centres for Clinical Trials – The committee recommended that clinical trials should be carried away only in the accredited centres.
- Accreditation Council – The recommendation of a central accreditation council was proposed that is responsible for the selection process of the experts who further are responsible for new drug applications’ review.
- Compulsory Obligations – The Ranjit Roy Chaudhury Committee recommended holding the principal investigator responsible for any violation done to the rights of the participant. As a punishment to violate the participant’s right to be highly informed; the principal investigator to be blacklisted for at least 5 years.
- Technical Review Committee – The committee to set up a technical review committee that will replace drug advisory committees to catalyse the clearance process for clinical trials.
- Compensation – The committee recommended that the sponsor investigator take on the responsibilities for any adverse effects on the participant during the clinical trial. The committee report mentioned that the compensation must be provided irrespective of whether the patient is in control group, placebo group, standard drug treatment group or test drug administered group.
- Special Expert Committee – A committee other than the Drug Technical Advisory Board to be set up to review the drug formulations in the market and identify potentially hazardous drugs.
Proposed Actions on Ranjit Roy’s Committee’s Recommendations
- Accreditation of Ethics Committee, Investigators and the Clinical Trial Sites:
- Long term measures – Accredited Ethics Committee, centres to be established.
- Short term measure – System for accreditation of Investigators, Ethics Committee and Clinical Trial Sites to be established by Quality Council of India.
- Procedure for review of applications of clinical trials and new drugs
- Subject Expert Committees to replace New Drug Advisory Committees.
- These committees will evaluate the applications of clinical trials and new drugs. Technical Review Committee to review the recommendations of the subject expert committee.
- Computerized database and selection of experts
- The experts will be selected after they meet the selection criteria.
- Requirement of filing an application to market New Chemical Entities (NCEs) if India participated in Global clinical trials of those NCEs
- Central Drugs Standard Control Organisation(CDSCO) to be the responsible authority to approve the marketing of new chemical entities in India.
- Specifying a timeline for processing of applications
- A timeline of six months to be fixed by CDSCO for disposal of applications for approval of clinical trials and new drugs.
- The other actions are proposed related to the following:
- Proposals that will be evaluated by the Technical Review Committee.
- Placebo-controlled trials
- Post-trial access of investigational product
- Informed Consent
- Action in case of violation of the informed consent processes
- Number of clinical trials an Investigator can undertake at a time
- Use of Information Technology
- Monitoring of clinical trials
- Compensation in case of injury or death in an academic trial, etc.
|Aspirants can cover the topics mentioned in the UPSC Syllabus by following the below-mentioned links:|
New Drugs and Clinical Trials Rules 2019
- To promote clinical research in the country, the new drugs and clinical trials rules were notified by the health ministry in 2019.
- The applicability of these rules extends from all new drugs, ethics committee to investigational drugs for human use, bioequivalence studies and clinical trial in India.
What are the salient features of drugs and clinical trials rules 2019?
- Promotion of Clinical Research.
- Catalysing the application approval process.
- 30 days for drugs manufactured in India
- 90 days for those developed outside the country
- The application will be deemed to be approved if, within the stipulated time, Drugs Controller General of India don’t communicate the approval.
- Compensation provided against any adverse injury, death, or disability to be decided by the Drugs Controller General.
- The requirement of a local clinical trial may be waived for approval of a new drug if it is approved and marketed in any of the countries specified by the Drugs Controller General with the approval of the government.
- The ethics committee will monitor the trials and decide on the amount of compensation in cases of adverse events.
- If the trials of drugs include Indian patients and the same are approved in select developed markets; these will have the automatic approval to be marketed in India.
What are clinical trials?
To add to medical knowledge, a research study is conducted on human volunteers which are also called participants; and is referred to as clinical trials. The safety and efficacy of a new drug are evaluated using clinical trials. Once the drug gets approved post clinical trials, they are approved for marketing.
There are various phases in clinical trials:
- Clinical pharmacology trials are called the Phase-I trials. The other name of the phase-I trials is the ‘first in man’ study.
- Exploratory trials are the phase-II trials.
- Confirmatory trials are the phase-III trials.
- Post-marketing is the phase-IV trials.
In India, clinical trials are governed by the following acts:
- Drugs and Cosmetics Act, 1940
- Medical Council of India Act, 1956 and
- Central Council for Indian Medicine Act, 1970