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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National Center for Biotechnology InformationU. 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.

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.

An already approved drug that is now proposed to be used in a different dosage, different dosage form, a new route or a new indication.

Drug development research, in particular, is long and arduous and bringing a single new drug costs on an average USD 1. 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.

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

This article has been cited by other articles in PMC. The investigator must ensure that clinical trials are conducted as per the rules outlined below[ 13 ]. Research, however, is a laborious, time and labour intensive task that can take months or even years to reach fruition. While guideines of these can provide a great measure of satisfaction, a key driver guidslines sating intellectual curiosity remains research. For institutes that do not have them, this would be a good committee to constitute.

Addressing problems facing the anesthesiologist. 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. Similarly, the new regulations required free medical management for all CT subjects for all medical issues not just those related to the NCE. The funding from the industry could be by way of provision of drug supplies or monetary support or both.


Do clinical trials conducted in India match its healthcare needs? Author information Copyright and License information Disclaimer. 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.

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. Over the past two decades, India has been making efforts to streamline and harmonize its regulations in the biomedical sector to international best practices.

In these IISs, he dons the dual mantle of an investigator and ‘sponsor’ and thus directly becomes responsible for ensuring regulatory compliance. Academicians often carry out research that is based on observations in practice or in response to their patient’s needs.

What is a ‘new drug’ A ‘new’ drug[ 12 ] is one: Ministry of Health and Family Welfare. 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. Please review our privacy policy. An example of this would be the intrathecal or epidural route of use of dexmedetomidine.

Please leave this field empty. 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. It is recommended that all studies are registered at a public portal. Academic research, clinical trials, compliance, India, regulations.

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. The past three decades have also seen remarkable advances in the field of anaesthesia, some of which include pulse oximetry, end-tidal gas monitoring, introduction of propofol and the laryngeal mask airway.


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.

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

Some of these notifications and guidelines were subsequently modified. 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.

Status of ethical review and challenges in India.

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.

Table 2 Key rules of the Drugs and Cosmetics Act and what they mean for the researcher. The formulae for compensation for both are described below.

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

The conduct of CTs in India is currently governed by the following regulations: 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. Compensation in a clinical trial is needed both when death occurs or when there is clinical trial-related injury. Recent past and expected future. How to improve R and D productivity: