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 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. The changes should be made to the existing law cdscco addressing and resolved these evolving issues. These changes have also led to requirement of changes in the Informed Consent Documents ICD where additional information should be incorporated mentioned in amendments.

But now timeline for this is within ten calendar days of occurrence of the SAE. 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.

Short Article Open Access.


July 01, Citation: Govt of India; [cited Oct 21]. Select your language of interest to view the total content in your interested language.

Government of India; June 7[cited Oct 22]. Government of India; Feb 1[cited Oct 19]. 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 ].

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

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. Below is a summary of each order. This may lead to some delays in the completion of the existing studies.


That is because getting clearances and approvals take time. 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.

Manting record and ready for inspection available for long monitoring and audit visit from sponsor team. Click here to sign up. That schedle highly beneficial for India as it has the largest sxhedule of drug resistant TB. Now the follow-through is important and so, now that we have the drug, the dcsco needs to collaborate.

Skip to main content. Even today, to get bio-study or a bioequivalence study done is a problem. 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.

Govt of India; Jan 20[cited Oct 15].

Procedure of Recording 6. Recent Amendment in the regard of Responsibility of Sponsor Prior to amendment, the report of SAE occurring during clinical trial have to forward to Licensing Authority within fourteen calendar days of occurrence of the SAE.

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. Government of India; Jan 30[cited Oct 20].

Currently there is lack of clarity from CDSCO on guidelines for calculation of compensation amount; the ECs are thus scheeule a tough time giving their opinion on compensation amount. The site cost per patient will increase as the investigator has to spend more time per recruited patient. In case of SAEs of death, the expert committee shall provide its recommendation about causality and quantum of compensation to the licensing authority, and then the licensing authority shall pass the final order [ 1 ].


ECs are now required to maintain all clinical trial documents reviewed by them for at least five years and be open for inspections by licencing authority at the EC office.

Serious adverse event reports submitted to Licensing Authority should be in color coded binding, where the reports of SAEs of deaths are submitted schedile 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 ]. Information for Prospective Study Subjects 3.

However, under no circumstances the number of trials should be more than three at a time. 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 xdsco and authenticity of the data generated.

June 25, ; Published Date: 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. Rule DAC basically discusses about the compliance to regulatory and ethical guidelines for data submitted for clinical schdule, and actions taken in case of noncompliance.


Government of India; July 17[cited Oct 19]. 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. 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.