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Regulations & Guidelines Specific to. Ethics. Schedule Y & CDSCO-GCP. Dr. K. Bangarurajan M Pharm, PhD. Deputy Drugs Controller (India). CDSCO – West. Drugs and Cosmetics Act and Schedule ‘Y’Mr. NAGENDRAPPA. The Central Drugs Standard Control Organisation (CDSCO), headed by the Drugs Controller . Recently there have been three amendments in Schedule Y of the Drugs and . Currently there is lack of clarity from CDSCO on guidelines for calculation of.

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NDAC experts have been requested to evaluate the such applications with these requirements in mind. The reports of SAE of injury other than deaths should be g and submitted in blue cover. The registration of independent ECs has been initiated after a long waiting period and many of them got query letter due to stringent scrutiny of their applications.

Help Schefule Find new research papers in: Many processes, which earlier only required notification now need approval, for e.

This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. The second gazette notification is G.

The report of the serious adverse event, after due analysis shall be forwarded by the investigator to the Licensing Authority as referred to in clause b of rule 21, chairman of the Ethics Committee and the Head of the Institution where the trial has been conducted within fourteen calendar days of the Occurrence of the serious adverse event. However, clarity on compensation amount in case of death or injury for healthy volunteer is required from the licensing authority.

Home Publications Conferences Register Contact. The changes should be made to the existing law to addressing and resolved these evolving issues. In addition, sponsor or his representative needs to compensate subjects if the injury is clinical trial related, due to adverse effect of investigational product, violation of the approved protocol, scientific misconduct or negligence by the sponsor or his representative or by investigator, failure of investigational product to provide intended therapeutic effect, use of placebo in a placebo controlled trial, adverse effects due to concomitant medications, injury to a child in-utero due to participation of parents, or due to any clinical trial procedures [ 1 ].

Significant Recent Amendments in schedule Y during A. The final authority for determination of the cause of death or injury and also the quantum of compensation is now the Licensing Authority, who will communicate the compensation amount to sponsor within three months of receiving the report of SAE of death or injury. May 26 ; Accepted Date: There is more clarity expected from the DCGI on the definition of injury, reasons which are included in clinical trial related injury, calculation of compensation amount and compensation in cases where the injury or death is not related to clinical trial.


Looking at the current regulatory environment of clinical trial in India, it is important that all information related to 4 major domains of CT are captured through online in an organized manner. That is highly beneficial for India as it has the largest burden of drug resistant TB. Recent Amendment in Inform Consent In Informed Consent process a new point have included that an audio-video recording of inform consent process of individual subject, including the procedure of providing information to the subject and his understanding on such consent shall be maintained by investigator for record.

But now timeline ccdsco this is within ten calendar days of occurrence of the SAE. Manting record and ready for inspection available for long monitoring and audit visit from sponsor team.

The regulatory guidelines in terms of serious adverse events SAEs reporting, informed consent, compensation in case of injury or death for bioequivalence studies are similar as in clinical trials.

This is based on the report’s observation that placebo controlled trials are fairly uncommon these days, although there will always be a case for them in special circumstances. Quality of Recording 7. As defined in schedule Y, SAE is an untoward medical occurrence during clinical trial that is associated with death, in patient hospitalization in case the study was being conducted on out-patientprolongation of hospitalization in case the study was being conducted on in-patientpersistent or significant disability or incapacity, a congenital anomaly or birth defect or is otherwise life threatening [ 1 ].

The sponsor has to pay the compensation in case of clinical trial schedulr injury or death within thirty days of the receipt of order from Licensing Authority. The first gazette notification is G. Govt of India; Jan 20[cited Oct 15]. Rule DAC basically discusses about the compliance to regulatory and ethical guidelines for data submitted for clinical trials, and actions taken in case of noncompliance. Recent Regulatory Amendments in Schedule Y: However, under no circumstances the number of trials should be more than three at a time.

Information for Prospective Study Subjects 3. Earlier, BE for export studies were approved for the products which are even not approved and marketed in India but it may not be the case now. Manufacture, distribution, and sale of drug in India. The regulatory scbedule conducted to check good clinical practice GCP sdhedule have highlighted areas of deficiencies in quality. Government of India; [cited Oct 21].


That is because getting clearances and approvals take time.

In this Appendix whole complete process are given about that how will be reporting of injury or SAEs or death to the Licensing Authority and what is the process of analyzing SAEs or cause of death and the timeline for reporting SAEs, providing compensation also have amended as compare to prior version.

Earlier the decision about compensation was taken by Ethics Committee but now the Ethics Committee can only give its opinion about compensation to the Licensing Authority. Impact on Bioequivalence Studies Conducted in India.

The site cost per patient will increase as the investigator has to spend more time per recruited patient. Recent Amendment in the regard of Responsibilities of the Ethics Committee Prior to amendment there was no such provision that Ethics Committee have to send the report of SAE to Licensing Authority within 21 calendar days. Remember me on this computer. Click here to sign up. Can’t read the image? As the regulatory world is dynamic and the flow of new schedjle from clinical trial is arising at rapid rate and issues related to clinical trial involving more and more.


Need for changes in Schedule Y a To frame guidelines for the current scenario of clinical research. July 01, Citation: Government of India ; April In new amendment version the following Statement describing about the financial compensation and medical management has been included in Informed Consent.

Serious adverse event reports submitted to Licensing Authority should be in color coded binding, where the reports of SAEs of deaths are submitted ccsco red cover, the reports of SAEs of injury other than deaths in blue cover and the remaining scheduel of SAE reports in white cover [ 2 ]. Even before you start development of a drug, cxsco should start assessing how it will be made accessible to the population. Currently there is lack of clarity from CDSCO on guidelines for calculation of compensation amount; the ECs are thus having a tough time giving their opinion on compensation amount.

Recent Regulatory Amendment in Schedule Y: Impact on Bioequivalence Studies Conducted In India

Guidelines Upcoming Special Issues. Government of India; Feb 1[cited Oct 19]. This may lead to some delays in the completion of the existing studies.


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