Skip to main content

ROLE OF ETHICS COMMITTEES

The most costly part of new drug discovery is the three phase clinical research lasting for three to four years involving thousands of human volunteers and investigators in multi locations. Any of these potential drug candidates can be abandoned during the trial period if their adverse drug events are beyond the acceptable limits. 

It is certainly a high risk activity involving millions of dollars and pharmaceutical companies usually make sure that trial reports reaching the regulatory authorities are favourable. No new drug can be approved for marketing without submission of trial reports and their scrutiny by the regulatory authorities. Because of these reasons, the whole operation  of clinical research is highly secretive. 

Apart from top MNCs like Pfizer, GSK, Novartis and Novo Nordisk, there are a large number of contract research organizations engaged in clinical trials in India for the last ten years.


As thousands of human subjects are recruited for each drug trial, the regulatory authorities have a responsibility to monitor the trial locations. And it is for this purpose, the Schedule Y of the Drugs & Cosmetics Act stipulates the existence of an ethics committee at each  trial site.  

But for many years, ethics committees have not been existing or non functional in India. It is this ineffectiveness of ethics committees that embolden the CROs and MNCs to carry out trials illegally endangering the lives of illiterate and  ignorant volunteers.

The decision of the Drug Technical Advisory Board to make registration of ethics committees mandatory at its meeting early last month is in consideration of this state of affairs. There has been several complaints about the non functioning of ethics committees at most of the trial sites. It is this situation that has led to a sharp rise in the number of cases of trial related deaths and injuries in the country during the last five years. 

Currently, ethics committees are constituted by the pharma companies or CROs intending to conduct trials but they are not required to be registered. For starting any clinical trial, the approval of the ethics committee is necessary as without which the DCGI do not permit the study in the country. But the ethics committees are not found to be responsible once the approval is given. No periodic meetings with investigators are called and no critical assessment of data is made. And there is no monitoring of the functioning of the ethics committee by the office of DCGI. 

The need to streamline activities of ethics committees is extremely urgent considering the growing  number of clinical trials taking place in the country. Making registration of ethics committees is an extremely critical step and needs to be strictly enforced without any delay.
Labels:

Comments

Post a Comment

Popular posts from this blog

ICH GCP requires EC members to be independent of investigator and sponsor to avoid conflicts of interest

Can an Ethics Committee member e.g. layman/chairman or anyone in the committee participate in the trial as a subject? Vidya If an Ethics Committee member becomes a trial subject on a trial that he/she was involved in approving then there has been a major conflict of interest. The following situations need to be considered: ● IEC member reviews study without any prior knowledge of the study, votes, and then afterwards is approached by clinical research team to participate. Possibly this is OK but the member should no longer be part of the IEC that reviews that study. This will be difficult in practice, so therefore it is not advisable. ● IEC member already knows about the study and is voting in order to be able to participate. This is clearly not acceptable and made worse if there is additional financial incentive for the study (e.g. volunteer study). ICH GCP requires Ethics Committee members to be independent of the investigator and the sponsor to avoid confl...
Post a Comment
Read more

Indian government outlines policies on drug pricing to favor poorer patients, and increase clinical trials

The Indian government is looking to review the existing drug price control measures in order to make medicines more affordable in the country, and at increasing the number of clinical trials taking place in the country, reports The Pharma Letter's India correspondent. In a parallel move, the Health Ministry is also preparing a framework for public private partnership to tackle the menace of non-communicable diseases in the country, In a move that could potentially result in affordable Medicare and health security moving to a larger section of the population, the government is considering a rash of policy measures in favor of poor patients. Talks are also on in government circles to abolish clinical trials on proven drugs that have been approved and marketed for at least two years in the European Union, United States, UK, Australia, Canada and Japan. A draft proposal in this regard has been prepared by the Health Ministry. If instituted, it would reduce the time taken to introduce n...
Post a Comment
Read more

How drugs work

Prescription Drugs Special Report Ever wonder how the medications you take act in your body? This brief guide explains how several classes of popular drugs work. Thousands of medications are in use today. Here are some of the most common mechanisms by which these drugs achieve their effects: Antibiotic Drugs -- The development of safe and effective drugs to cure infections was arguably the most significant advance in drug development of the 20th century. Perhaps the most famous example is penicillin, which is derived from a toxin produced by the fungus Penicillium notatum that contaminated a laboratory experiment. The Scottish scientist Alexander Fleming noticed that the Penicillium fungus had done something to kill the bacterium Staphylococcus, which is responsible for many human infections. Antibiotics have several modes of action. Penicillin disrupts the cell walls of bacteria, causing them to die. Some other antibiotics interfere with the ability of microorganisms to ...
Post a Comment
Read more