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.

Author: Fenrishakar Akinokasa
Country: El Salvador
Language: English (Spanish)
Genre: Finance
Published (Last): 18 January 2018
Pages: 254
PDF File Size: 12.29 Mb
ePub File Size: 8.40 Mb
ISBN: 962-3-14944-801-9
Downloads: 18565
Price: Free* [*Free Regsitration Required]
Uploader: Kejas

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 cddsco fourteen calendar days of occurrence of the SAE. Enter the email address you signed up with and we’ll email scheedule a reset link. Compensation in case of injury or death during clinical trial [Online]. Government of India; Jan 30[cited Oct 20]. Now the follow-through is important and so, now that we have the drug, the government needs cdco collaborate.

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.


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. 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.

But now investigator have to send this report to both Sponsor and Ethics Committee within 24 hours. 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.

Ethics Committee EC 4. NDAC experts have been requested to evaluate the such applications with these requirements in mind. Once this clarity is received from DCGI, hopefully the current turbulence in the Indian clinical research industry will settle down.


The members of their meetings will be drawn randomly from large pool of experts. These changes have also led to requirement of changes in the Informed Consent Documents ICD where additional information should be incorporated mentioned in amendments. However, under no circumstances the number of trials should be more than three at a time.

Government of India ; April 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.

Since other remedies are usually available, there is no reason to deprive a patient of a drug in such placebo controlled trials. Recently changes in Schedule Y, then how clinical trial or pharmaceutical industries affected. Need for changes in Schedule Y a To frame guidelines for the current scenario of clinical research. The reports of SAE of injury other than deaths should be prepared and submitted in blue cover.

Information for Prospective Study Subjects 3. 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, cdso congenital anomaly or birth defect or is otherwise life threatening [ 1 ].

J Bioequiv Availab 5: Even for generic drugs we are now doing studies outside India. Registration of Ethics Committee [Online]. Pharmaceutical Sciences Journals Ann Jose ankara escort.

Agri and Aquaculture Journals Dr. Significant Recent Amendments in schedule Y during A.

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

But now timeline for this is within ten calendar days of occurrence of the SAE. The regulatory authority may start asking statistical justification for number of subjects in BE study.

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


The investigator has to devote time and effort to become aware of new regulatory compliance processes. ECs cdso 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.

Home Publications Conferences Register Contact. Govt of India; [cited Oct 21]. Govt of India; Jan 20[cited Oct 15].

The act and Rules are binding on allopathic and other system of medicine and regulate imports. Principle of Privacy and Confidentiality 4. Recent Amendment in the regard of Responsibilities of the Ethics Committee Prior to amendment there was no scbedule provision that Ethics Committee have to send the report of SAE to Licensing Authority within 21 calendar days.

This may lead to some delays in the completion of the existing studies. Remember me on this computer.

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

Draft Formula to determine the Quantum of Schedyle 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. 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.

Manting record and ready for inspection available for long monitoring and audit visit from sponsor schefule. The regulatory inspections conducted to check good clinical practice GCP compliance have highlighted areas of deficiencies in quality.