Viveka Roychowdhury – Mumbai
Companies involved in clinical trials in the country could finally have some clarity on the much debated compensation guidelines issued in January this year.
The minutes of the 63rd meeting of the Drug Technical Advisory Board, held on May 16, 2013 in FDA Bhavan, New Delhi, reveal that the DTAB has recommended modifications and clarifications. These are based on the opinions of the Technical Committee, which has been receiving the views of individual industry stakeholders, associations like Indian Society for Clinical Research (ISCR), Federation of Indian Chambers of Commerce and Industry (FICCI), as well as drugs manufacturers associations over the past few months.
In January 2013, the Ministry of Health and Family Welfare (MoH&FW) spelled out guidelines for the grant of compensation in the case of injury or death during clinical trials with the release of a new rule 122 DAB to the Drugs and Cosmetics Rules, 1945 Additionally, an APPENDIX XII was added to Schedule Y laying out the procedures for examination of SAEs and compensations to be paid when clinical trial related injury or death occurred during a clinical trial.
Broadly speaking, the minutes of the May 16, 2013 show that DTAB seems to be trying for a balancing act. Its recommendations have accommodated industry suggestions on some issues, like amending a clause to specify that free medical management is to be provided only in case the injury is due to clinical trial related activities, and dropping sub-rule (5) of rule 122 Clause (c) effectively agreeing to industry’s viewpoint that compensation is not justified in case of death/injury due to failure of investigational product as that there is always a possibility that the investigational product may fail to provide intended therapeutic effect.
Similarly, DTAB agrees to justification for use of a placebo and thus recommends a modification in clause (d) of sub Rule (5) as well as extending timelines for reporting Serious Adverse Events (SAEs) but has stood firm on certain guidelines related to allocation of responsibility by investigators and sponsors.
So also, the Board has not gone along with the Technical Committee’s opinion that a change should be made in sub rule 5 clause (b) and has stood firm that the sponsor has to compensate for injury/death due to violation of approved protocol, scientific misconduct and negligence by the investigator as investigators are identified and are under contract of the sponsor for conduct of the study.
Similarly there was no relaxation in the requirement of sponsors or their representatives to pay compensation within 30 days of receiving the order from Drug Controller General of India (DCGI).
Calling this discussion on compensation in the minutes of the DTAB meeting as “an encouraging development”, Suneela Thatte, President, ISCR says,”ISCR is glad that the regulatory bodies are addressing the concerns of all stakeholders. Collaboration, transparency and open dialogue are important to ensure the progress of the industry, while securing the rights and safety of patients.”
Dr Arun Bhat, President, ClinInvent Research, points out that these are as yet only recommendations of the DTAB and it will take time to actually amend the January notification.
But he points out that the DTAB has not just suggested modifications and clarifications to existing rules and clauses but also recommended inclusion of a new qualifying clause to clause (2) of rule 122 DAB which specifies that “in case there is no permanent injury, the quantum of compensation shall be commensurate with the inconvenience, loss of wages, transportation.” Bhat predicts that this could be a cause for concern as there could be many claims for compensation under this newly proposed sub-rule, should it be passed.
Proving that a temporary injury was not related to the trial could be difficult. Also, there is need for further clarification on how ‘quantum of compensation’ is to be determined as well as maybe a formula to work out what is ‘commensurate with the inconvenience, loss of wages, transportation.’
Released as a new rule 122 DAB to the Drugs and Cosmetics Rules, 1945, in January 2013 the Ministry of Health and Family Welfare (MoH&FW) spelled out guidelines for the grant of compensation in the case of injury or death during clinical trials. Additionally, an APPENDIX XII was added to Schedule Y laying out the procedures for examination of SAEs and compensations to be paid when clinical trial related injury or death occurred during a clinical trial.
Harking back to previous statements by ISCR, Thatte cautioned, “The current compensation rules make the continuing conduct of high quality, scientifically valid clinical trials in India virtually impossible, negatively impacting the availability of scientific data to assess the benefits and risks of medicine for the Indian population. We believe that all of these contentious rules need to be addressed with equal priority and emphasis.”