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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May 26 ; Accepted Date: June 25, ; Published Date: J Bioequiv Availab 5: 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.

Bioequivalence studies are conducted for comparison of two medicinal products containing the same active ingredients, and these studies are mostly conducted in healthy subjects. 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 first gazette notification is G.

The second gazette notification is G. As defined in schedule Y, Scheduls 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 reporting timeline for all serious and unexpected adverse events by principal investigator is now within 24 hours of occurrence schrdule 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 report of SAEs of death, in addition, also needs to be forwarded to the Chairman of expert committee appointed by Licensing Authority [ 1 ]. Prior to the 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. 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 ].


In addition, schedulw or his representative needs to compensate subjects if the injury is clinical trial related, due to adverse effect of investigational product, violation of scheeule 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 ].

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

However, clarity on compensation amount in case of death or injury for healthy volunteer is required from the licensing authority. 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. 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 ].

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. These changes have also led to requirement of changes in the Informed Consent Documents ICD where additional information should be incorporated mentioned in amendments.

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.

The contact details of sponsor representative should be provided in the ICD. Rule DAC basically cdzco about the compliance to regulatory and ethical guidelines for data submitted for clinical trials, and actions taken in case of noncompliance.


Licensing Authority may reject or cancel studies and debar schsdule, sponsors including their employees, subsidiaries and branches, their agents, contractors and subcontractors for conduct of any clinical trials in future [ 3 ]. The registration is given for a period of three years to the committees from the date of issue, unless suspended or cancelled [ 4 ]. Currently there is lack of clarity from Scheduld on guidelines for calculation of compensation amount; the ECs are thus having a tough time giving their opinion on compensation amount.

ECs are now required to maintain all clinical trial documents reviewed by them for at least five years and vdsco open for inspections by licencing authority at the EC office. 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. The regulatory authority may start asking statistical justification for number of subjects in BE study.

Many processes, which earlier only required notification now need approval, schsdule e. 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. This may lead to some delays in the completion of the existing studies. 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.

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