CDSCO GCP GUIDELINES PDF

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Let us try to find answers to some of these questions starting with Indian GCP. The much talked about launch of Indian GCP guidelines in by many; did not prove potential thereafter. According to Dr. This futuristic view for cleaning the system hardly seems to be satisfying now, just because of the fact that Indian version is practically difficult to follow.

Some of these guidelines in the Indian version lead towards a difficult methodology which is a juggernaut for sponsors, investigators and Ethics Committees. Few of these differences as cited by Dr. The investigator along with his research staff has to acknowledge and comply with the SOPs. This is practically impossible, as it will be a huge burden for the sponsor to get SOPs signed by of all its investigators on a trial.

Besides this, maintaining and managing hundreds of SOPs along with their revisions will create a lot of complexity in the whole process. This will certainly increase the workload of already too busy investigators as well as Ethics Committee. Further this will lead to multiple study reports for multiple sites for the same study. Indian GCP offers latitude to the patients of right to preventing the use of such samples collected during the trial for possible current and future uses; considering its sharing or secondary uses is anytime likely.

Such mandates create complexities in the ICF informed Consent Process and may discourage the patient from getting enrolled in a clinical trial. This is hardly possible as monitor is never in direct contact with Ethics Committees. Finally after all these considerations, we can state that, the perception behind the creation of Indian version of Good Clinical Practices was to anticipate good deeds which is worth appreciating, but will be stupendous only if it had its practical implications that are easy to comply with.

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Indian GCP: Do we really need 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. Of these, research, though long and difficult, is extremely fulfilling. Academicians often carry out research that is based on observations in practice or in response to their patient's needs. 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.

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Clinical Trials: Changing Regulations in India

The importance of drug trials in promoting health services cannot be overemphasized. New drugs and therapies can improve the quality and lifespan of patients. While it is imperative that the number of clinical trials increase, the Government is also trying to ensure that the rights and safety of the subjects are protected and the quality of the trials performed in India improve to international standards. The regulatory guidelines in terms of serious adverse events SAEs reporting, informed consent, compensation in case of injury or death in clinical trials have been recently modified.

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