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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GSR 78 E dated January 31, These issues were highly publicized by NGOs and the media and involved parliamentary hearings. Central Drugs Standard Control Organization.

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

Drugs and Cosmetics Act. Guirelines addition, send to Chairman of IEC and the Head of the institution where the trial has been conducted within 14 calendar days of occurrence of the event.

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. This guideline covers two broad aspects of clinical research — scgi general principles that need to be followed and guidance regarding special areas of guideliens e.

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 was done on outpatient basisprolongation of hospitalisation if the study was conducted on in-patient basispersistent or significant disability or incapacity, a congenital anomaly or gyidelines defect or is otherwise life-threatening.

Obtain informed consent from participants Investigators must ensure that written, informed consent is obtained from all participants in a clinical trial. Nat Rev Drug Discov. Please review our privacy policy.

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 practices. 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.


While all of these can provide a great measure of satisfaction, a key driver to sating intellectual curiosity remains research. For the first time, there is a proposal to include provisions on post-trial access to be provided by the sponsor to CT subjects cost-free if the CT is for an indication for which no alternative therapy exists and the investigational new drug or new drug has been found to be beneficial to the trial subject by the investigator.

In and there was further decline in CTs in India because international sponsors viewed frequent regulatory changes as unpredictable and non-transparent. 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.

Status of ethical review and challenges in India. Evolution of regulatory changes in India — as relevant to clinical trials. Academicians, however, also carry out their own research and these studies are called as ‘Investigator initiated studies’ IISs.

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

Registration must be done before the first participant is enrolled. Academic research, clinical trials, compliance, India, regulations. 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.

The clinical pharmacological including pharmacodynamic and pharmacokinetic effects. The Indian Council of Medical Guidelinee ICMR is the apex body that is responsible for the formulation, coordination and promotion of biomedical research. Compensation for an SAE leading to life-threatening disease: Abstract The academician forms the backbone of any medical college, hospital or university and shoulders the quadruple responsibilities of patient care, teaching, administration and research.

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

Bhave A, Menon S. The pharmaceutical industry’s grand challenge. 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 only three trials was guidelijes, and the requirement for institutional ethics committee IEC permission for the addition of new trial sites or guixelines was also eliminated.


Guidelinws past and expected future. It has Chapters, Rules and Schedules[ 67 ] and is amended at regular intervals to ensure greater safety, efficacy and drug quality. 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.

National Center for Biotechnology InformationU.

B guideines 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.

Its mission is to safeguard and enhance public health by assuring the safety, efficacy and quality of drugs, cosmetics and medical devices. Sanders RD, Maze M. Per this notification, medical devices are broadly classified as investigational medical devices and registered or approved medical devices. In addition, several pharmaceutical companies in the country also fund investigator initiated research.

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. Ministry of Health and Family Welfare.

Clinical Trials in India

Financial support and sponsorship Nil. Author information Copyright and License information Disclaimer. Therefore preparedness of the study site at all times must be ensured. Conflicts of interest There dci no conflicts of interest.

The pharmaceutical industry funds or ‘sponsors’ the studies and ensures compliance with the country’s regulatory requirements. Statement on publishing clinical trials in Indian biomedical journals. Some of these notifications and guidelines were subsequently modified. The funding from the industry could be by way of provision of drug dcgl or monetary support or both. Addressing problems facing the anesthesiologist.

The Schedule Y amendment released on 20 th January, saw dramatic changes that attempted to bring India on par with internationally prevalent regulations.