The Drugs Controller General of India (DCGI) is an official of the CDSCO who is the final The revised ICMR guidelines released in is called the ‘Ethical. Guidelines (ICH-GCP) for clinical trials and follow the recently amended Schedule Y . Currently, the Drug Controller General of India (DCGI). o Office of Drugs Control General (“DCGI”) (India’s licensing authority) o Indian Council of Medical Research (“ICMR”) guidelines; Indian.

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Several governmental and non-governmental organisations within the country fund academic research and the academician needs to make an application to them with application formats and timelines being available on their home pages.

Registration must be done before the first participant is enrolled. The Indian Council of Medical Research ICMR is the apex body that is responsible for guidelinss formulation, coordination and promotion of biomedical research. An example of this would be the intrathecal guideljnes epidural route of use of dexmedetomidine. This guideline covers two broad aspects of clinical research — the general principles that need to be followed and guidance regarding special areas of research e.

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Recent past and expected future. The present article details these requirements giving their historical evolution, the key bodies in India that govern or oversee research along with ‘must know’ and ‘good to know’ for the conduct of clinical trials in the country. The Intensive Care Unit specialist: The investigator must ensure that clinical trials are conducted as per the rules outlined below[ 13 ].

Status of ethical review and challenges in India. Therefore preparedness of the study site at all times must be ensured.

Clinical Trials in India

Nov 19, [Last accessed on Feb 26]. Registration of Ethics Committees that approve studies Rule DD [ 15 ] Investigators and Administrators of Academic Institutes should ensure that their Institutional Ethics Committees IECs are registered with the central licensing authority and the registration renewed at the end of 3 years. Of these, research, though long and difficult, is extremely fulfilling. Report serious adverse events that occur during a clinical trial An SAE is defined as an untoward medical occurrence during a clinical trial that is associated with death, in patient hospitalisation if the study guidelinea done on outpatient basisprolongation of hospitalisation if the study was conducted on in-patient basispersistent or significant disability or incapacity, a congenital anomaly ddgi birth defect or is otherwise life-threatening.


Central Drugs Standard Control Organization. It has 12 appendices, formats for clinical trial protocols, informed consent forms, ethics committee EC approval templates and dcg format for serious adverse event SAE reporting.

Compensation in a clinical trial is needed both when death occurs or when there is clinical trial-related injury. Similarly, the new regulations required free medical management for all CT subjects for all medical issues not just those related to the NCE.

Other major provisions included timely reporting of serious adverse events, video recording of the informed consent process, and mandatory registration of ethics committees. The conduct of CTs in India is currently governed by the following regulations: For institutes that do not have them, this would be a good committee to constitute. Projects submitted essentially undergo two broad types of review- Full board or full committee review [for all projects that present more than minimal risk] or expedited review [for projects that pose no more than minimal risk; e.

Good research contributes to evidence-based medicine and thus better and improved patient care with the ultimate goal of promoting health. Understand that compensation for trial related death and injury is now required and the implications of compensation particularly when academic studies with ‘new drugs’ are carried out Compensation in a clinical trial is needed both when death occurs or when there is clinical trial-related injury.

Medical care to be provided as long as required and a lumpsum amount to be kept in a fixed deposit that would bring in a monthly interest equal to half of the minimum wage of an unskilled worker in Delhi.

Here, the academician raises funds for the study through his efforts from various sources including possibly the pharmaceutical industry. Addressing SAEs and compensation: Registration of the clinical trial with the Clinical Trials Registry of India The CTRI[ 1617 ] is a free, online portal that allows both investigator-initiated and regulatory studies to be registered.


Compensation for permanent disability: Table 1 Evolution of regulatory changes in India — as relevant to clinical trials.

Global Focus: Clinical Trials in India – Food and Drug Law Institute (FDLI)

Audio-visual Recording of Informed Consent of Process. The formulae for compensation for both are described below. Still long way to go. Right to Try Act: This act first came into being in and regulates the import, manufacture and distribution of drugs in the country to ensure that drugs and cosmetics sold in the country are safe, effective and gudielines to essential quality standards.

For example, a requirement to obtain video-recorded consent from all human subjects was modified to apply only to vulnerable populations, 3 the rule limiting investigators to huidelines three trials was revoked, and the requirement for institutional ethics committee IEC permission for the addition of new trial sites or investigators was also eliminated.

Studies that involve a collaborator from outside India need an additional approval from the Health Ministry Screening Committee, a committee that works out of ICMR and meets quarterly to assess these projects for collaborative merit. Pre Development Guiselines the past two decades, India has been making efforts to streamline and harmonize its regulations in the biomedical sector to international best practices.

While all of these can provide a great measure of satisfaction, a key driver to sating intellectual curiosity remains research. The draft CT Rules seek to address the healthcare landscape in India by providing accelerated approval for new drugs intended to treat serious or life-threatening conditions or diseases of special relevance to the country, address unmet medical needs, and include postmarketing trials to validate the anticipated clinical benefit.

A recent regulatory change with respect to IISs is that academicians who carry out trials with ‘new drugs’ no longer need approval from the DCGI for the conduct of the trial and IEC approval would suffice. The CTRI[ 1617 ] is a free, online portal that allows both investigator-initiated and regulatory studies to be registered.