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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Careful consideration should be given to ensuring the freedom of consent obtained from members of a group with a hierarchical structure- such as medical, pharmacy and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, and members of the armed forces.

Y, Item 5 is to determine the maximum tolerated dose in humans; pharmacodynamic effects, adverse reactions, if any, with their nature and intensity; and pharmacokinetic behaviors or the drug as far as possible. Data on ADRs observed during clinical use of the drug should be reported along with a report on its efficacy in the prescribed format.

This audit should be conducted with the purpose of being independent and separate from routine monitoring or quality control functions.

It includes description of experimental and statistical methods and materials, presentation and evaluation of the results, statistical analyses and a critical ethical, statistical and clinical appraisal.

Feb 08, [Last accessed on Feb 25]. QC activities concern everybody involved with planning, conducting, monitoring, evaluating, data handling and reporting.

Most of the data under this heading See Appendix I to Sch.

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

To assist in the development and the education of a research community responsive to local health care requirements. The process of assigning study subjects to either the treatment or the control group. In case any significant formulation changes are made in the Investigational Product during the course of the Study – hcp results of any additional studies of the new formulation e.


Labelling developed specifically for products involved in the study.

Recent past and expected future. Trials in phase IV are carried out on the basis of the product characteristics on which the marketing authorization was granted and are normally in the form of post-marketing surveillance, assessment of therapeutic value, treatment strategies used and safety profile.

Every precaution should be taken to respect the privacy of the subject, the confidentiality of the patient’s information and to minimize the impact of the study on the subject’s physical and mental integrity and on the personality of the subject.

The agreement should define the relationship between the investigator and the sponsor guidelies matters such as financial support, fees, honorarium, fuidelines in kind etc. All documentation and communication of an IEC are to be dated, filed and preserved according to written procedures.

There should be guidelinss data to justify the nature, scale and duration of the proposed trial and to evaluate the potential safety and need for special precautions. Adequate backup of the data should be maintained. Original documents or their verified and certified copies necessary for evaluation of the Clinical Trial. The herbal products can belong to any of the three categories given below: Investigator should ensure that all persons involved in the study are adequately informed about the protocol, Cdso, the investigational product s and their study related duties and functions.

Law Relatings to Drugs & Cosmetics

Status of ethical review and challenges in India. The protocol should include the following: Persons with incurable diseases, in nursing homes, in detention, unemployed or impoverished, in emergency rooms, homeless persons, nomads, refugees and any ethnic or racial minority groups should be considered as vulnerable population whose mode of consent should be carefully considered and approved by the Ethics Committee.


If the drug is a new drug substance discovered in India and guidelinex marketed in any other country, phase III data should be obtained on at least patients distributed over centers. Since multicentre studies are conducted simultaneously by several investigators at different institutions following the same protocol, the sponsor should make special administrative arrangements for their conduct.

Chemical and pharmaceutical information. Summary of the known cgp potential risks and benefits, if any, to human subjects. Aims and objectives of the study, indicating the Phase to which the study corresponds. Documentation of any decoding that may occur during the study. A pharmaceutical product including placebo used as a reference in a clinical trial. Any change in the regulatory requirements should be brought to their attention and they should be kept abreast of all national and international developments in this regard.

The academician forms the backbone of any medical college, hospital or university and shoulders the quadruple responsibilities of patient care, teaching, administration and research. In case of a Non-Therapeutic Study the consent must always be given by the subject.

However, it needs to be emphasized that since the substance to be tested is already in used in Indian Systems of Medicine or guidleines been described in their texts, the need for testing its toxicity in animals has been considerably reduced. These trials may be carried out by clinicians in the concerned therapeutic areas, having facilities appropriate to the protocol.

Type cdsdo duration of the follow-up of the subjects after adverse events. Good research contributes to evidence-based cdscl and thus better and improved patient care with the ultimate goal of promoting health.