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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The reports of SAE of injury other than deaths should be prepared and submitted in blue cover. 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.

Procedure of Recording 6. However, under no circumstances the number of trials should be more than three at a time. 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. As per the new requirements in Appendix V of Schedule Y, now, the ICD should clearly state that the subject is entitled to free medical management as long as required in case of injury, and financial compensation in case of clinical trial related injury or death.

But now timeline for this is within ten calendar days of occurrence of the SAE. Ann Jose ankara escort. The sponsor has to pay the compensation in case of clinical trial related injury or death within thirty days of the receipt of order from Licensing Authority. Recent Amendment in the regard Responsibilities of the Investigator s Prior to amendment the Investigator send report of all unexpected SAE to Sponsor within 24 hours and to the Ethics Committee that accorded approval to the study protocol within 7 working days their occurrence.

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. As the regulatory world is dynamic and the flow of new information from clinical trial is arising at rapid rate and issues related to clinical trial involving more and more.

Government of India ; April Recent Regulatory Amendments in Fdsco Y: Log In Sign Up. 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.


Recent Amendment in the regard of Responsibility of Sponsor Following clause shall be substituted, namely: Registration of Ethics Committee [Online].


Click here to sign sxhedule. 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.

Compensation in case of injury or death during clinical trial [Online]. 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.

Below is a summary of each order. Home Publications Conferences Register Contact. 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.

The reporting timeline for all serious and unexpected adverse events by principal investigator is now within 24 hours of occurrence of event to the Licensing Authority, sponsor and the EC; whereas, prior to this amendment, the 24 hours reporting was limited to sponsor by the investigator.

The contact details of sponsor representative should be provided in the ICD.

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. The investigator has to devote time and effort to become aware of new regulatory compliance processes. But now investigator have to send this report to both Sponsor and Ethics Committee within 24 hours.

Govt of India; [cited Oct 21]. Guidelines Upcoming Special Issues. Now the follow-through is important and so, now that we have the drug, the government needs to collaborate.

Manting record and ready for inspection available for long monitoring and audit visit from sponsor team.

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

This is based on the report’s observation that placebo controlled trials are fairly uncommon these days, although there will always be a vdsco for them in special circumstances. Recently changes in Schedule Y, then how clinical trial or pharmaceutical industries affected. May 26 ; Accepted Date: However, clarity on compensation amount in case of death or injury for healthy volunteer is required from the licensing authority.


Once this clarity is received from DCGI, hopefully sschedule current turbulence in the Indian clinical research industry will settle down.

The regulatory authority may start asking statistical justification for number of subjects in BE study. Compensation in case of injury or death cfsco clinical trial In new amendment version, a new Appendix XII has added, which is related to compensation to be provided to subject in case of injury or sschedule occurring during Clinical Trial.

Government of India; Feb 8[cited Oct 19]. The first gazette notification is G. 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. Serious adverse event reports submitted to Licensing Authority should be in color coded cdscp, where the reports of SAEs of deaths are submitted in red cover, the reports of SAEs of injury other than deaths in blue cover and the remaining cases of SAE reports in white cover [ 2 ].

NDAC experts have been requested to evaluate the such applications with these requirements in mind. Even today, to get bio-study or schedlue bioequivalence study done is a problem.

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 ].

In new amendment version the following Statement describing about the financial compensation and medical management has been included in Informed Consent. Proposal for creation of IT enabled system for Clinical Trials CDSCO proposes to create an IT enabled system for online submission of various information on clinical trials to streamline the process of approval, maintaining comprehensive database and monitoring of clinical trials for ensuring the protection of rights, safety and well beings of trial subjects and authenticity of the data generated.