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

But now timeline for this is within ten calendar days of occurrence of the SAE. Bioequivalence studies are conducted for comparison of two medicinal products containing the same active ingredients, and these studies are mostly conducted in healthy subjects. 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 site cost per patient will increase scherule the investigator has to spend more time per recruited patient.

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

Home Publications Conferences Register Contact. Conclusion With the amendments to Schedule Y, currently the entire clinical research industries are experiencing a tough time. May 26 ; Accepted Date: This is based on the report’s observation that placebo controlled trials are fairly uncommon these days, although there will always be a schhedule for them in special circumstances. However, clarity on compensation amount in case of death or injury for healthy volunteer is sxhedule from the licensing authority.

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 today, to get bio-study or a bioequivalence study done is a problem.


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

J Bioequiv Availab 5: Significant Recent Amendments in schedule Y during A. The second gazette notification is G.


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

Impact on Bioequivalence Studies Conducted in India. The reports of SAE of injury other than deaths should be prepared and submitted in blue cover. June 25, ; Published Date: The act and Rules are binding on allopathic and other system of medicine and regulate imports.

achedule In this Schedulw 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. Looking at the current regulatory environment of clinical trial in India, it is important that all information related to 4 major domains of CT are captured through online in an organized manner.

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. These changes have also led to requirement of changes in the Informed Consent Documents ICD where additional information should be incorporated mentioned in amendments. JBB ; 5 4: 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.


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 ]. Information for Prospective Study Subjects 3. Agri and Aquaculture Journals Dr.

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 to be provided to subject in case of injury or death occurring during Clinical Schedulee. That is highly beneficial schedhle India as it has the largest burden of drug resistant TB.

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.

Click here to sign up. Ethics Committee EC 4. Government of India; Feb 8[cited Cdscl 19].