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 12 appendices, formats for clinical trial protocols, informed consent forms, ethics committee EC approval templates and a format for serious adverse event SAE reporting. 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.

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.

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. The CTRI[ 1617 ] is a free, online portal that allows both investigator-initiated and regulatory studies to be registered. Registration of Ethics Committees. Similarly, the new regulations required free medical management for all CT subjects for all medical issues not just those related to the NCE.

The amended Schedule Y provides a checklist of essential elements to be included in the informed consent form as well as the contents of protocols for conducting CTs. Compensation for permanent disability: Therefore preparedness of the study site at all times must be ensured.

Status of ethical review and challenges in India. Please leave this field empty. 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 Schedule Y amendment released on 20 th January, saw dramatic changes that attempted to bring India on par with internationally prevalent regulations.


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

Recent past and expected future. In the past decade, several changes have dotted the regulatory landscape in the country and have changed the way in which academic research is carried out.

Good research contributes to evidence-based medicine and thus better and improved patient care with the guidelinfs goal of promoting health. For institutes that do not have them, this would be a good committee to constitute.

Audio-visual Recording of Informed Consent of Process. In these IISs, he dons the dual mantle of an investigator and ‘sponsor’ and thus directly becomes responsible for ensuring regulatory compliance. That has not been used to a significant extent in the country. The academic investigator needs to be up to speed in reading, understanding and applying regulations and work in tandem with the pharmaceutical industry for greater patient benefit.

The revised ICMR guidelines released in is called the ‘Ethical Guidelines for Biomedical Research on Human Participants’ and remains valid as of today, and a revised version is expected in Table 2 covers must know and good to know aspects of clinical trial research. Its mission is to safeguard and enhance public health by assuring the safety, efficacy and quality of drugs, cosmetics and medical devices.

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

Central Drugs Standard Control Organization. In 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 Indian Council of Medical Research ICMR is the apex body that is responsible for the formulation, coordination and promotion of biomedical research. Feb 08, [Last accessed on Feb 25]. 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.


Addressing problems facing the anesthesiologist. Table 1 Evolution of regulatory changes in India — as relevant to clinical trials. 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.

How to improve R and D productivity: Author information Copyright and License information Disclaimer. Sanders RD, Maze M. The Intensive Care Unit specialist: Drug development research, in particular, is long and arduous and bringing a single new drug costs on an average USD 1. 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 conform to essential quality standards.

What is a ‘new drug’ A ‘new’ drug[ 12 ] is one: 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. The amendments to the DCR provided teeth for the licensing authority, empowering it to, inter alia, suspend or cancel a CT after issuing a warning letter, or ban the sponsor or its representative from conducting any future clinical trial in India, or both.

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 guidlines the country remains variable.

Open in a separate window. The pharmaceutical industry funds or ‘sponsors’ the studies and ensures compliance with the country’s regulatory requirements.

This case is still pending disposition.