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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Compensation for an SAE leading to life-threatening disease: Obtain informed consent from participants Investigators must ensure that written, informed consent is obtained from all participants in a clinical trial. In addition, send to Chairman of IEC and the Head of the institution where dcyi trial has been conducted within 14 calendar days of occurrence of the event.

Clinical Trials in India

Evolution of regulatory changes in India — as relevant to clinical trials. In the past decade, several changes have dotted the regulatory landscape in the country and have guuidelines the way in which academic research is carried out. This is provided that these studies are not intended for generating data to make a regulatory submission. National Center for Biotechnology InformationU. The clinical pharmacological including pharmacodynamic and pharmacokinetic effects.

For the first time, there guidelunes a proposal to include provisions on post-trial access to be provided by the sponsor to CT subjects cost-free if the Guudelines 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.

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.

If the IEC does not hear from the DCGI within dgci days, it should be presumed that no permission is needed from the licensing authority. In the event that the IEC feels that there could be a potential overlap between the academic and regulatory purposes of the trial, they should notify the office of the DCGI.

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

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Do clinical trials conducted in India match its healthcare needs? The double burden of communicable and non-communicable diseases in developing countries. Subscribe to our mailing list. Feb 08, [Last accessed on Feb 25].

In these IISs, he dons the dual mantle of an investigator and ‘sponsor’ and thus directly becomes responsible for ensuring regulatory compliance.

Anaesthesiologists are uniquely positioned to carry out translational research given the data-rich environment in which they practice[ 2 ] and this research can be used successfully to guide evidence-based practice of the discipline as also public health policy.

The Intensive Care Unit specialist: The CTRI[ 1617 ] is a free, online portal that allows both investigator-initiated and regulatory studies to be registered. His ambit, in addition, also extends to inspections of trial sites, inspections of sponsors of clinical research and manufacturing facilities in the country, oversight of the Central Drugs Testing Laboratory Mumbai and the Guieelines Drugs Testing Laboratory as also heading the Indian Pharmacopeia Commission among various other roles, responsibilities and functions.

GSR 78 E dated January 31, The amended Schedule Y provides a checklist of essential elements to be included in the informed consent form as well guidelknes the contents of protocols for conducting CTs.

Anaesthesia as a speciality straddles several diverse disciplines that include various branches guidelinds surgery and medicine as well as critical care and pain management among others.

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

Clinical research involving human participants remains at the core of the drug development process and clinical trials CTs are an essential component for finding new cures to unmet medical needs.

Open in a separate window. The Indian Council of Medical Research ICMR is the apex body that is responsible for the formulation, coordination and promotion of biomedical research.

Registration is important from a publication standpoint point as editors of many Biomedical Journals will not accept papers that have interventional studies not registered with a Clinical Trials Registry. Still long way to go. This case is still pending disposition. Please review our privacy policy.

The Guideline 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 buidelines variable. 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.


Academic research, clinical trials, compliance, India, regulations. These issues were highly publicized by NGOs and the media and involved parliamentary hearings. That has not been used to a significant extent in the country. Regulatory environment for clinical 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.

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. Clinical research regulation in India-history, development, initiatives, challenges and controversies: Compensation in a clinical trial is needed both when death occurs or when there is clinical trial-related injury.

Conflicts of interest There are no conflicts of interest. In and there was further decline in CTs in India because international sponsors viewed frequent regulatory changes as unpredictable and non-transparent.

Since clinical trial related injury or death is equally possible both with pharmaceutical industry and investigator-initiated academic studies, budgetary provisions need to be in place at the institutional level for the medical management of adverse events [AEs], SAEs and provision of insurance to trial participants.

Drugs and Cosmetics Act. 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.

The funding from the industry could be by way of provision of drug supplies or monetary support or both.