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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It has Chapters, Rules and Schedules[ 67 ] and is amended at regular intervals to ensure greater safety, efficacy and drug quality. The clinical pharmacological including pharmacodynamic and pharmacokinetic effects. Regulatory environment for clinical research: Compensation in a clinical trial is needed both when death occurs or when there is clinical trial-related injury.

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

B – Conduct of the clinical trial Conduct of the clinical trial The investigator must ensure that clinical trials are conducted as per the rules outlined below[ 13 ] In compliance with an EC and a DCGI approved protocol. The academic investigator needs to be up to speed in guidelnies, understanding and applying regulations and work in tandem with the pharmaceutical industry for greater patient benefit. Some of these notifications and guidelines were subsequently modified. 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.

Still long way to go.

Institutional Ethics Committees function according to standard operating procedures [SOPS] that are usually available on their websites. Compensation for birth defect or congenital anomaly: Feb 08, [Last accessed on Feb 25]. Right to Try Act: An example of this would be the intrathecal or epidural route of use of dexmedetomidine.

Regulatory requirements for clinical trials in India: What academicians need to know

Academicians, however, also carry out their own research and these studies are called as ‘Investigator initiated studies’ IISs. Pre Development Over the past two decades, India has been making efforts to streamline and harmonize its regulations in the biomedical sector to international best practices.

Over the past two decades, India has been making efforts to streamline and harmonize its regulations in the biomedical sector to international best guuidelines. 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.


Central Drugs Standard Control Organization. Report serious guidwlines 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 was done on outpatient basisprolongation of hospitalisation if the study was conducted cdgi in-patient basispersistent or significant disability or incapacity, a congenital anomaly or birth defect or gidelines otherwise life-threatening.

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.

Other major provisions included timely reporting of serious adverse events, video recording of the informed consent process, and mandatory registration of ethics committees.

Open in a separate window. Sanders RD, Maze M. The Intensive Care Unit specialist: Good research contributes to evidence-based medicine and thus better and improved patient care with the ultimate goal of promoting health.

It has 12 appendices, formats for clinical trial protocols, informed consent forms, ethics committee EC approval templates and a format for serious adverse event Guidelijes reporting. These mandatory guidelines cover all biomedical research in India at all stages of cdgi development, whether prior to or subsequent to dcig registration in India. Site preparedness rule DAC Understand that the regulator can inspect the site at any time and that he can cancel the trial permission and discontinue the study.

GSR 78 E dated January 31, The CTRI[ 1617 ] is a free, online portal that allows both investigator-initiated and regulatory studies to be registered.

Table 1 Evolution of regulatory changes in India — as relevant to clinical trials. Registration must be done before the first participant is enrolled.

Chapter VII of this notification states that clinical trials with the former need both IEC and DCGI approval, while academic studies [studies not intended for manufacturing or marketing the device] with the latter, guidelones only IEC approval. These issues were highly publicized by NGOs and the media and involved parliamentary hearings. Per this notification, medical devices are broadly classified as investigational medical devices and registered or approved medical devices. This is provided that these studies are not intended for generating data to make a regulatory submission.

Anaesthesia as a speciality straddles several diverse disciplines that include various branches of surgery and medicine as well as critical care and pain management among others. The double burden of communicable and non-communicable diseases in guidekines countries. The draft Rules are pending finalization. The ECs now have a larger than ever onus need to appreciate and understand risk — benefit and to empower themselves through repeated training and use of standard operating procedures given that it is known that the quality of IEC review across the country remains variable.

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The academician forms the backbone of any medical college, hospital or university and shoulders the quadruple responsibilities guideljnes patient care, teaching, administration and research. That has not been used to a significant extent in the country. Compensation for an SAE leading to life-threatening disease: This guideline covers two broad aspects guideoines clinical research — the general principles that need to be followed and guidance regarding special areas of research e.

The control of the study including its conception, conduct and analysis remains exclusively with the investigator in these studies and would need a clear memorandum of understanding with the industry funder. A recent regulatory change with respect to IISs is that academicians who guidelins out trials with ‘new drugs’ no longer need approval from the DCGI for the conduct of the trial and IEC approval would suffice.

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 guiidelines, address unmet medical needs, and include postmarketing trials to validate the anticipated clinical benefit. Do clinical trials conducted in India match its healthcare needs?

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Clinical Trials in India

If the IEC does not hear from the DCGI within 30 days, it should be presumed that no permission is needed from the licensing authority. In the guide,ines decade, several changes have dotted the regulatory guidleines in the country and have changed the way in which academic research is carried out.

J Pharm Bioallied Sci. How to improve R and D productivity: Table 2 covers must know and good to know aspects of clinical trial research. Nat Rev Drug Discov.