GCP guidelines were developed by an accomplished committee set up by CDSCO along with the clinical experts. This article elucidates the. Organization (CDSCO), headed by the Drug Controller General of India (DCGI) Guidelines (ICH-GCP) for clinical trials and follow the recently. The Indian version of GCP is based on the ICH-GCP, but there are key differences between the two. Some of the guidelines found in the Indian.

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

The clinical pharmacological including pharmacodynamic and pharmacokinetic effects. Investigator should ensure that the observations and findings are recorded correctly and completely in the CRFs and signed by the responsible person s crsco in the Protocol.

Categories of Herbal Product. This is especially important when the human subjects are healthy volunteers. Investigator is responsible for the rights, health and welfare of the study subjects. This information should be accurate and adequate to justify the nature, scale and the duration of the Study.

The conditions regulating the use and guidslines of such documents must be honoured as prescribed under Confidentiality. Procedures for managing missing data, unused data and unauthentic data. All amendments should bear amendment number and date s. Summary of the known and potential risks and benefits, if any, to human subjects. The Intensive Care Unit specialist: Preparation of the Study Report. Appropriate storage and dosage handling instructions should also be given.

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

Table 1 Evolution of regulatory changes guidellnes India — as relevant to clinical trials. However, if the drug is bcp value primarily in a disease of children, early trials in the paediatric age group may be allowed. The reports of completed clinical trials shall be submitted by the applicant duly signed by the investigator guidelunes a stipulated period of time.

Study Subjects should be satisfactorily insured against any injury caused by the study. Long term toxicity requirements. Description of the type of the study randomised, comparative, blinded, open, placebo controlledstudy design parallel groups, cross-over techniqueblinding technique double-blind, single-blindrandomisation method and procedure and placebo controlled.

All the general principles of clinical trials described earlier pertain also to herbal remedies. Information to the Study Subjects and the mode of providing it. The academician forms the backbone of any medical college, hospital or university and shoulders the quadruple responsibilities of patient care, teaching, administration and research. The revised ICMR guidelines released in is called the ‘Ethical Guidelines for Biomedical Research on Human Participants’ and remains valid as cdscco today, and a revised version is expected in Preparation and submission of materials to the Ethics Committee, Regulatory Authorities and any other review bodies.


Law Relatings to Drugs & Cosmetics

Precise description of methodology of the proposed research, including intended dosages and routes of administration of drugs, planned duration of treatment and details of invasive procedures if any. Before initiation of multi-centre studies the sponsor should carefully define and document the following: It refers to all records or certified copies of the original clinical and laboratory findings or other activities in a clinical study necessary for the reconstruction and evaluation of the trial.

Selection and recruitment of study subjects: All observations and findings guidflines be verifiable, for the credibility of the data and to assure that the conclusions presented are correctly derived from the Raw Data. However, such trials may be permitted even in the absence of phase I data from other countries if the drug is of special relevance to the health problem of India.

Prerequisites for the study. Compensation for permanent disability: The Investigator should follow the study randomisation procedure, if any, and should ensure bcp the randomisation code is broken only in accordance with the Protocol.

Medical research is only justified if there is a reasonable likelihood that the populations in which the research is carried out stand to benefit from the results of the research.

The Investigator should ensure the accuracy, completeness, legibility, and timeliness of the data reported to the sponsor in the CRFs and in all required reports. 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. Neither would any toxicity study be needed for phase II trial unless there guidelijes reports suggesting toxicity or when the herbal preparation is to be used for more than 3 months.

Bhave A, Menon S.

Since such committees at present do not exist in all institutions, the approval granted to a protocol by the ethical committee of one institution will be applicable to the use of that protocol in other institutions, which do not have an ethical committee. Good research contributes to evidence-based medicine and thus better and improved patient care with the ultimate goal of promoting health.

The nature of the investigational product and the stage of development and the complexity guldelines the study should be considered in determining the nature and extent of the information that should be provided. Safety of proposed intervention and any drug or vaccine to be tested, including results of relevant laboratory and animal research.


Following the SOPs facilitates documentation. A well designed study relies predominantly on a thoroughly considered, well-structured and complete protocol. The subject should be informed of the right to gudelines from participation in the study or to withdraw consent guifelines participate at any time without reprisal. Wherever possible, dose-response relationships and ED 50s should be given.

Safeguarding confidentiality – The investigator must safeguard the confidentiality of research data, which might lead to the identification of the individual subjects. The drugs should be administered throughout the period of organogenesis, using three dose levels. Medical research involving human subjects must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information, and on adequate laboratory and, where appropriate, animal experimentation.

The Schedule Y amendment released on 20 th January, saw dramatic changes that attempted to bring India on par with internationally prevalent regulations.

However, any relevant new information that is considered important should be communicated to the Investigator sEthics Committee and the Regulatory Authorities immediately, even before it can be guidepines included in the IB.

Pharmacokinetics, absorptions, distribution, metabolism, excretion. Principles of totality of responsibility whereby the professional and moral responsibility, for the due observance of all the principles, guidelines or prescriptions laid down generally or in respect of the research or experiment in question, devolves on all those directly or indirectly connected with the research or experiment including the researchers, those responsible for funding or contributing to the funding of the research, the institution or institutions where the research is conducted and the cdssco persons, groups or undertakings who sponsor, use or derive benefit from the research, market the product if any or prescribe its use so that, inter alia, the effect of the research or experiment is duly monitored and constantly subject to review and remedial action at all stages of the research and experiment and its future use.

The phase of these trials differ from drug trials as given below: Research subjects who suffer physical injury as a result of their participation in the Clinical Trial are entitled to financial or other assistance to compensate them equitably for any temporary or permanent impairment or disability subject to confirmation from IEC In case of death, their dependents are entitled to material compensation.

Compensation for birth defect or congenital anomaly: