DCGI GUIDELINES PDF

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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Registration of Ethics Committees. 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.

Per law, it is mandatory that all clinical research that falls under the ambit of Schedule Y complies with the necessary requirements. Right to Try Act: Table 1 Evolution of regulatory changes in India — as relevant to clinical trials. Please review our privacy policy.

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

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. 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.

Table 2 covers must know and good to know aspects of clinical trial research. 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 Regional Drugs Testing Laboratory as also heading the Indian Pharmacopeia Commission among various other roles, responsibilities and functions. The academician forms the backbone of any medical college, hospital or university and shoulders the quadruple responsibilities of patient care, teaching, administration and research.

Its mission is to safeguard and enhance public health by assuring the safety, efficacy and quality of drugs, cosmetics and medical devices. Table 2 Key rules of the Drugs and Cosmetics Act and what they mean for the researcher. 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.

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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. Clinical Trials Registry — India. Drugs and Cosmetics Act.

Nat Rev Drug Discov. The pharmaceutical industry’s grand challenge.

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

GSR 78 E dated January 31, 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. Financial support and sponsorship Nil. Here, the academician raises funds for the study through his efforts from various sources including possibly the pharmaceutical industry. 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.

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.

Is it the Answer for Terminally Ill Patients?

Research, however, is a laborious, time and labour intensive task that can take months or even years to reach guidelinex. 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.

Pre Development Over the past two decades, India has been making efforts to streamline and harmonize its regulations in the biomedical sector to international best practices. Obtain informed consent from participants Investigators must ensure that written, informed consent is obtained from all participants in a clinical trial. The pharmaceutical industry funds or ‘sponsors’ the studies and ensures compliance with the country’s regulatory requirements. 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.

In addition, several pharmaceutical companies in the country also fund investigator initiated research. Subscribe to our mailing list.

Clinical Trials in India

Academic research, clinical trials, compliance, India, regulations. The Indian Council of Medical Research ICMR is the apex body that is responsible for the formulation, coordination and promotion of biomedical research. Statement on publishing clinical trials in Indian biomedical journals. Report serious adverse events that occur during a clinical trial An SAE is defined as an untoward medical occurrence during a clinical trial that is associated with death, in patient hospitalisation if the study was done on outpatient basisprolongation of hospitalisation if the study was conducted on in-patient basispersistent or significant disability or incapacity, a congenital anomaly or birth defect or is otherwise life-threatening.

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It is recommended that all studies guixelines registered at a public portal. The CTRI[ 1617 ] is a free, online portal that allows both investigator-initiated and regulatory studies to be registered. Dcgo in a clinical trial is needed both when death occurs or when there is clinical trial-related injury.

Of these, research, though long and difficult, is extremely fulfilling. 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. Good research contributes to evidence-based medicine and thus better and improved guidflines care with the ultimate goal of promoting health.

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

The Intensive Care Unit specialist: Similarly, the new regulations required free medical management for all CT subjects for all medical issues not just those related to the NCE. 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.