The IRBs are one of the most important always find useful information mechanisms for protecting subjects. All efforts must be made to ensure that IRBs across the country are competent. There is urgent need for oversight of IRB functions and the regulators needs to have a division which will have oversight over IRB functions, monitoring them regularly, auditing them sometimes, and help to protect human subjects. To support the regulator, there should be national or regional ethics forums which will work with the IRBs so that subjects are protected better and clinical research gains ground. Footnotes Source of Support: Nil. Conflict of Interest: None declared.
Your attitude, not your aptitude, will determine your altitude??. Zig Ziglar Since Jan 2013, the Indian regulatory authorities have announced a spate of laws and guidelines,[1] which will have a huge impact on the clinical trial sector in India.

REDUCED SPEED OF CLINICAL TRIAL COMPLETION The speed of clinical trial (CT) completion depends on (1) time for regulatory approval and (2) recruitment of clinical trial patients. Regulatory approval The regulatory approval process is slow because of new requirements for submission and review of the CT. The submission requires (a) the sponsor’s undertaking of providing medical treatment and compensation in case of clinical trial related injury/death (b) the sponsor’s commitment that they will market the drug in India after the trial is completed (c) submission of regulatory documents for New Drug Advisory Committee (NDAC) (d) changes in the informed consent form (ICF) to include compensation related clauses and (e) changes in the investigator undertaking to include safety reporting and compensation related clauses and (f) submission of the investigator’s list containing 50% government sites.

The review of CT application is done by the Central Drugs Standard Control Organizations (CDSCO), New Drug Advisory Committees (NDAC), Technical Committee and Apex Committee. Due to these changes, the regulatory approval Carfilzomib takes around 9 months. Recruitment of patients The recruitment of patients depends on the availability of investigator sites and willingness of the patients. The number of investigator sites has reduced as only registered institutional ethics committees (EC) can approve the clinical trial protocols.

In addition, as the regulatory requirements are challenging and stringent, it is becoming increasingly difficult to convince the investigators cell differentiation to conduct the clinical trials. The compensation clauses in ICF-compensation in case of death/injury, details of income, details of nominee-etc., may create anxiety and fear amongst the potential patients about the risk of participation in clinical trial. Further, the patients may be unwilling to undergo audio-visual (AV) recording of the consent process. The investigator will need to devote special time for AV recording of the consent process.