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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RECENT AMENDMENT IN SCHEDULE-Y | Pushpendra Dhanuk –
schedyle Now the follow-through is important and so, now that we have the drug, the government needs to collaborate. Government of India; Jan 30[cited Oct 20]. 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. 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.
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. Once this clarity is received from DCGI, hopefully the current turbulence in the Indian clinical research industry will settle down. The speed 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.
NDAC experts have been requested to evaluate the such applications with these requirements in mind. Even before you start development of a drug, you should start assessing how it will be made accessible to the population.
Since other remedies are usually available, there is no reason to deprive a patient of a drug in such placebo controlled trials. Many processes, which earlier only required notification now need approval, for e. Cdsci now investigator have to send this report to both Sponsor and Ethics Committee within 24 hours.
Govt of India; [cited Oct 21]. Registration of Ethics Committee [Online]. Recent Regulatory Amendment in Schedule Y: June 25, ; Published Date: J Bioequiv Availab 5: 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.
The reporting timeline for all serious and unexpected adverse events by principal investigator is now within 24 hours of occurrence of 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. Information for Prospective Study Subjects 3.
Recent Regulatory Amendment in Schedule Y: Impact on Bioequivalence Studies Conducted In India
Earlier, BE for export studies were approved for the products which are even not approved and marketed g India but it may not be the case now. Agri and Aquaculture Journals Dr. Pharmaceutical Sciences Journals Ann Jose ankara escort.
Compensation in case of cddsco 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 Trial.
Manufacture, distribution, and sale of drug in India.
Recently changes in Schedule Y, then how clinical trial or pharmaceutical industries affected. The final authority for determination of the cause of death or injury and also the quantum of compensation is now the Licensing Authority, cxsco will communicate the compensation amount to sponsor within three months of scedule the report of SAE of death or injury. The regulatory inspections conducted to check good clinical practice GCP compliance have highlighted areas of deficiencies in quality.
Impact on Bioequivalence Studies Conducted in India. 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. Earlier the decision about compensation schevule taken by Ethics Committee but now the Ethics Committee can only give its opinion about compensation to the Licensing Authority.
These changes have also led to requirement of changes in the Csco Consent Documents ICD where additional information should be incorporated mentioned in amendments. Procedure of Recording 6. Bioequivalence studies are conducted for comparison of two medicinal products containing the same active ingredients, and these studies are mostly conducted in healthy subjects.
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