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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Additional reforms are in the pipeline.

Clinical research regulation in India-history, development, initiatives, challenges and controversies: Academicians often carry out research that is based on observations in practice or in response to their patient’s needs.

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

Here, the academician raises funds for the study through his efforts from various sources including possibly the pharmaceutical industry. 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.

For trials that involve vulnerable participants children or mentally challenged patients for example and involve a new chemical entity or a new molecular entity, the investigators in addition have to ensure audio visual recording of the informed consent process gazette notification dated 19 th November, Other major provisions included timely reporting of serious adverse events, video recording of the informed consent process, and mandatory registration of ethics committees.

Do clinical trials conducted in India match its healthcare needs? The academician forms the dcvi of any medical college, hospital or university and shoulders the quadruple responsibilities of patient care, teaching, administration and research.

Is it the Answer for Terminally Ill Patients? The Intensive Care Unit specialist: Statement on publishing clinical trials in Indian biomedical journals. 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.

Research, however, is a laborious, time and labour intensive task that can take months or even years to reach fruition. 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. Table 1 Evolution of regulatory changes in India — as relevant to clinical trials. Since clinical trial related injury or gudielines 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.


Clinical research involving human participants remains at the core of the drug development process and clinical trials CTs are an essential ghidelines for finding new cures to unmet medical needs. This article has been cited by other articles in PMC.

In these IISs, he dons the dual mantle of an investigator and ‘sponsor’ and thus directly becomes responsible for ensuring regulatory compliance. In and there was further decline in CTs in India because international sponsors viewed frequent regulatory changes as unpredictable and non-transparent.

It has dcig appendices, formats for clinical trial protocols, informed consent forms, ethics committee EC approval templates and a format for serious adverse event SAE reporting. Obtain informed consent from participants Investigators must ensure that written, informed consent is obtained from all participants in a clinical trial.

Therefore preparedness of the study site at all times must be ensured.

The conduct of CTs in India is currently governed by the following regulations: 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. Evolution of regulatory changes in India — as relevant to clinical trials.

The draft Rules guidflines pending finalization. These mandatory guidelines cover all biomedical research in India at tuidelines stages of drug development, whether prior to or subsequent to product registration in India.

Table 2 covers must know guidelinws good to know aspects of clinical trial research. An example of this would be the intrathecal or epidural route of use of dexmedetomidine.

The clinical pharmacological including pharmacodynamic and pharmacokinetic effects. The CTRI[ 1617 ] is a free, online portal that allows both investigator-initiated and regulatory studies guideilnes be registered. Nov 19, [Last accessed on Feb 26]. Compensation for permanent disability: Ministry of Health and Family Welfare. Central Drugs Standard Control Organization.


This guideline covers two broad aspects of clinical research — the general principles that need to be followed and guidance regarding special areas of research e. While all of these can provide a great measure of satisfaction, a key driver to sating intellectual curiosity remains research. Pre Development Over the past gudelines decades, India has been making efforts to streamline and harmonize its regulations in the biomedical sector to international best practices.

Regulatory environment for clinical ccgi Registration of Ethics Committees. The formulae for compensation for both are described below. The investigator must ensure that clinical trials are conducted as per the rules outlined below[ 13 ].

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.

It has Chapters, Rules and Schedules[ 67 ] and guidelins amended at regular intervals to ensure greater safety, efficacy and guideliens quality. This case is still pending disposition.

Clinical Trials in India

Drug development research, in particular, is long and arduous and bringing a single new drug costs on an average USD 1. Financial support and sponsorship Nil. National Center for Biotechnology InformationU. Subscribe to our mailing list. 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.

A fixed-dose combination of two or more drugs, individually approved earlier for certain claims, which are now proposed to be combined for the first time in a fixed ratio.