Saturday, July 9, 2011

500 clinical trials take place in India at any point of time: WHO says only 40 ethics committees are properly constituted in India

By Syed Akbar
Hyderabad: At any given point of time as many as 500 clinical trials take place in India, but the World Health Organisation points out that less than 40 ethics committees in the country are properly constituted and functioning. A large number of pharma companies, medical colleges and reputed hospitals including those under government's control in Andhra Pradesh are known to flout rules on ethics committee.
Every clinical trial needs to be cleared by the locally-constituted ethics committee before it is approved by the Central Drugs Standards Control Organisation. Moreover, the trial should be registered with the Clinical Trials Registry of India, managed by the Indian Council of Medical Research.
Clinical trials are not illegal but most of the organisations including reputed hospitals take advantage of the poverty in rural areas and recruit people from poor sections of society. Taking strong exception to the practice of recruiting volunteers for clinical trials from among the poor, the World Health Organisation in its health bulletin noted 
that fewer than 40 ethics committees in India are properly constituted and functioning. This in other words means, more than 90 per cent of clinical trials conducted in the 
country are "unethical", though not illegal.
Ironically there's no legal requirement for investigators or members of the ethics committees to declare a conflict of interest. "There's the need for ensuring that guidelines for constitution and functioning of ethics committee are implemented. Review of the documents submitted to Clinical Trials Registry reveals the extent of improper functioning of several ethics committees," regrets Dr Arvind Pandey of Clinical Trials 
Registry of India. Dr Pandey and his team including Dr SD Seth delved into clinical trials records to find out if they are according to procedures.
In many cases it has been noticed that the trial’s contact person for scientific and public query, is also the member secretary of the ethics committee and signing authority of the EC approval. "Many academic institutions might not have a proper ethics committee for reviewing and approving clinical trials that are being conducted as a part of the postgraduate medical courses not realising the fact that principles of ethics remain the same for the global trial or for just a dissertation for academic purpose," he added.
According to ICMR records, there have been instances of many principal investigators involved in multiple trials - as many as 25 clinical trials. Another modus operandi adopted by companies is to declare their research as "global multicentre trials", but actually a majority of patients are recruited from India. This is unethical.
"Global trials registered in the CTRI, are required to declare the number of patients proposed to be recruited from India. Based on the information through CTRI, there have been certain instances where there has been a bias in allocation of recruitment of subjects for the Indian arm in global clinical trials. In these instances it was observed that more than 80 per cent of the recruitment took place from India as against the planned equal allocation," according to Dr SD Seth of National Institute of Medical Statistics.
Senior oncologist Dr P Raghuram points out that since cancer drugs are highly expensive, doctors are paid money to recruit patients and conduct trials. "The huge pool of innocent patients and unethical principles are a lethal combination in India. The manner in which some doctors recruit patients using 'humans as guinea pigs' without any informed consent leaves a lot to be desired," he adds.

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