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 site cost per patient will increase as the investigator has to spend more time per recruited patient. Significant Recent Amendments in schedule Y during A. Government of India; June 7[cited Oct 22].

The contact details of sponsor representative should be provided in the ICD. The registration is given for a period of three years to the committees from the date of issue, unless suspended or cancelled [ 4 ]. 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 dcsco or death.

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Help Center Cvsco new research papers in: However, clarity on compensation amount in case of death or injury for healthy volunteer is required from the licensing authority. Short Article Open Access.

However, under no circumstances the number of trials should be more than three at a time. Conclusion With the amendments to Schedule Y, currently the entire clinical research industries are experiencing a tough time.

Now the follow-through is important and so, now that we have the drug, the government needs to collaborate. 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.


The regulatory inspections conducted to check good clinical practice GCP compliance have highlighted areas of deficiencies in quality.


Enter the email address you signed up with and we’ll email you a reset link. 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. Even before you start development of a drug, you should start assessing how it will be made accessible to the population. Information for Prospective Study Subjects 3.

Many processes, which earlier only required notification now need approval, for e. Applications of clinical trials and new drugs will initially be evaluated by the Subject Expert Committees and their recommendations will be reviewed by Technical Review Committee TRC.

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

Quality of Recording 7. The report of SAEs of death, in addition, also needs to be forwarded to the Chairman of expert committee appointed by Licensing Authority [ 1 ].

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. J Bioequiv Availab 5: 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.

July 01, Citation: Compensation in case of injury or death during clinical trial In new amendment version, a new Appendix XII has added, which is related to compensation achedule be provided to subject in case of injury or death occurring during Clinical Trial.

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. Serious adverse event reports submitted to Scheduel Authority should be in color coded binding, where g 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 ].


June 25, ; Published Date: 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. The members of their meetings will be drawn randomly from large pool of u. Recent Amendment in Inform Consent In Informed Cdsvo 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.

Recent Amendment in the regard of Responsibility of Sponsor Following clause shall be substituted, namely: 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.

Draft Formula to determine the Quantum of Compensation in case of Clinical Trial related injury other than death Considering the definition of SAE, the following sequelae other than death are possible in a clinical trial subject, in which the subject shall be entitled for compensation in case the SAE is related to clinical trial.

Registration of Ethics Committee [Online]. The reports of SAEs of deaths should be prepared and submitted in red cover.