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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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. The conduct of CTs in India guiedlines currently governed by the following regulations: Additional reforms are in the pipeline.

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

Over the past two decades, India has been making efforts to streamline and harmonize its regulations in the biomedical sector to international vcgi practices. These mandatory guidelines cover all biomedical research in India at all stages of drug development, whether prior to or subsequent to product registration in India.

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. These issues were highly publicized by NGOs and the media and involved parliamentary hearings.


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

This case is still pending disposition. In and there was further decline in CTs in India because international sponsors viewed frequent regulatory changes as unpredictable and guideliines.

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.

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

The amendments to the DCR provided teeth for the licensing authority, empowering it to, inter gudelines, 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.

Some of these notifications and guidelines were subsequently modified. 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 revoked, and the requirement for institutional ethics committee IEC permission for the addition of new trial sites or investigators was also eliminated.


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. The draft CT Rules seek to address the healthcare landscape in India guidelinfs 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, guideines include postmarketing trials to validate the anticipated clinical benefit.

The draft Rules are pending finalization.

Please leave this field empty. Pre Development Over the past two decades, India has been making efforts to streamline and guidelinss its regulations in the biomedical sector to international best practices.

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