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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There should not be any restriction on subject’s right to ask any questions related to the study as any restriction on this undermines the validity of informed consent. A pharmaceutical product including placebo used as a reference in a clinical ccdsco.

Format for submission of Pre-clinical and clinical data for r-DNA based vaccines, diagnostics and other biologicals. Subject experts may be invited to offer their views, but should not take part in the decision making process. A meticulous and specified plan for the various steps and procedures for the purpose cdssco controlling and monitoring the study most effectively.

However, such trials may be permitted even in the absence of phase I data from other countries if the drug is of special relevance guidleines the health problem of India. Author information Copyright and License information Disclaimer. The physician may combine medical research with medical care, only to the extent that the research is justified by its potential prophylactic, diagnostic or therapeutic value.

In any research on human beings, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail. Good Clinical Practice Guidelines. None of the oral and written information concerning the Study, including the written informed consent form, should contain any language that causes the Subject s or their legal representatives or guardians to waive or to appear to waive their legal rights, or that releases or appears to release the Investigator, the Institution, the Sponsor or their representatives from their liabilities for any negligence.

Signature or thumb impression.

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

For electronic data processing only authorised person should be allowed to enter or modify the data in the computer and there should be a recorded trail of the changes and deletions made. Allocation of duties and responsibilities. A person legally qualified to be an investigator, to whom the Gujdelines delegates a part of his responsibilities. Exclude the possibility of unjustified deception, undue influence and intimidation.


The operational techniques and activities undertaken within the system of QA to verify that the requirements for quality of the trial related activities have been fulfilled. This is especially gyidelines when the human subjects are healthy volunteers.

If the drug is a new drug substance discovered in India and not marketed in any other country, phase Guiidelines data should be obtained on at least patients distributed over centers.

Any structural similarities to other known compounds should be mentioned. Good Clinical Practices GCP is an ethical and fcp quality standard for designing, conducting and recording trials that involve the participation of human subjects. Special studies to elucidate mode of action may also be described.

There should be adequate representation of age, gender, community; etc. The Study should use the maximum degree of blindness that is possible.

It includes hospital files, consultation records or special subject files allowing the authenticity of the information presented in CRF to be verified and where necessary allowing it to be completed or corrected.

The drugs should be administered throughout the period of organogenesis, using three dose levels. Principles of professional competence whereby, the research is conducted at all times by competent and qualified persons, who act with total integrity and impartiality and who have been made aware of, and mindful of, the ethical considerations to be borne in mind in respect of such Study.

In publication of the results of research, the investigators are obliged to preserve the accuracy of the results. This does not pertain to guidelines issued for clinical evaluation of Ayurveda, Siddha or Unani drugs by experts in those systems of medicine which may be used later in their own hospitals and clinics.

If clinical trials have been carried out with the FDC in other countries, reports of such trials should be submitted. 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.

An individual participating in a clinical trial as a recipient of the Investigational Product. Chemical and pharmaceutical information.

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

All such omissions must be documented to enable review. Ocular or Otic or Nasal. A noxious and guidelinws response at doses normally used or tested in humans. The sponsor must appoint adequately trained monitors or CRO to supervise an ongoing study. A document designed in consonance with the Protocol, to record data and other information on each trial subject. The highest dose used should not affect general health or growth of the animals. After ensuring that the subject has understood the information, the physician should then obtain the subject’s freely given informed consent, preferably in writing.


Categories of Herbal Product. The IB should provide a description of the possible risks and adverse drug reactions to be anticipated on the basis of prior experiences with the product under investigation and with related products. Other pharmacokinetic data eg. Product-product interactions and effects of food.

The Declaration of Geneva of the World Medical Association binds the physician with guidelijes words, “The health of my patient will be my first consideration,” and the International Code of Medical Ethics declares that, “A physician shall act only in the patient’s interest when providing medical care which might have the effect of weakening the physical and mental condition of the patient.

The researcher has the obligation to provide monitoring information to the committee, especially any serious adverse events.

Information on establishment of the study-code, where it will be kept and when, how and by whom it can be broken in the event of an emergency.

Any Study related duty, function or responsibility transferred to and assumed by a local representative or a CRO should be specified in writing. Even the best proven prophylactic, diagnostic, and therapeutic methods must continuously be challenged through research for their effectiveness, efficiency, accessibility and quality. Adequate justification is required for the involvement of subjects such as prisoners, students, subordinates, employees, service personnel etc.

It ensures that the studies are implemented and reported in such a manner that there is public assurance that the data are credible, accurate and that the rights, integrity and confidentiality of the subjects are protected. The variables to be monitored and recorded in long-term toxicity studies include behavioral, physiological, biochemical and microscopic observations. A file containing demographic and medical information about a study subject.

For permission to carry out clinical trials with such FDC, a summary of available pharmacological, toxicological and clinical data on the individual ingredients should be submitted, along with the rationale for combining them in the proposed ratio. The drug should be administered throughout the last third of pregnancy and then through lactation and weaning.