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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July 01, Citation: The report of SAEs of death, in addition, also needs to be forwarded to the Chairman of expert committee appointed by Licensing Authority [ 1 ]. However, clarity on compensation amount in case of death or injury for healthy volunteer is required from the licensing authority. Impact on Bioequivalence Studies Conducted in India. Enter the email address you signed up with and we’ll email you a reset link.
Serious adverse event reports submitted to Licensing Authority should be in color coded binding, 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 ].
Pharmaceutical Sciences Journals Ann Jose ankara escort. Bioequivalence studies are conducted for comparison of two medicinal products containing the same active ingredients, and these studies are mostly conducted in healthy subjects. 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.
This may lead to some delays in the completion of the existing studies. Guidelines Upcoming Special Issues.
Recent Regulatory Amendment in Schedule Y: Impact on Bioequivalence Studies Conducted In India
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. The reports of SAEs of deaths should be prepared and submitted in red cover.
Help Center Find new research papers in: Scyedule here to sign up. Now the follow-through is important and so, now that we have the drug, the government needs to collaborate. The first gazette notification is G. Select your language of interest to view the total content in your interested language.
Recent Regulatory Amendment in Schedule Y: ECs are now echedule 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.
RECENT AMENDMENT IN SCHEDULE-Y | Pushpendra Dhanuk –
Licensing Authority may reject or cancel studies and debar investigators, sponsors including their employees, subsidiaries and branches, their agents, contractors and subcontractors for conduct of any clinical trials in future [ 3 ]. Remember me on this computer. 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.
Govt of India; [cited Oct 21]. The regulatory authority may start asking statistical justification for number of subjects in BE study. 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.
Short Article Open Access.
But now investigator have to send this report to both Sponsor and Ethics Committee within 24 hours. Even for generic drugs we are now doing studies outside India.
Government of India; Feb 8[cited Oct 19]. Prior to ccdsco amendment, the SAEs management and reporting was done by Bioequivalence centers, but now sponsor also need to send a separate report after due analysis by their medical affairs team in cases of SAEs. Government of India; June 7[cited Oct 22].
The site cost per patient will increase as the investigator has to spend more time per recruited patient. Procedure of Recording 6.
Government of India; Feb 1[cited Oct 19]. June 25, ; Published Date: Even before you start development of a drug, you should start assessing how it will be made accessible to the population. Skip to main content. J Bioequiv Availab 5: Quality of Recording 7. Home Publications Shcedule Register Contact.
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, cdsci congenital anomaly or birth defect or is otherwise life threatening [ 1 ]. 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.
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 second 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.
Principle of Privacy and Confidentiality 4. 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. The schdeule of clinical trial depend on taking long time for regulatory approval and requirement of patient, number of investigator site reduced only registered ethic committee EC approved clinical trial protocol.
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. In new amendment version the following Statement describing about the financial compensation and medical management has been included in Informed Consent.