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 placein India, but the World Health Organisation points out that less than 40 ethicscommittees in the country are properly constituted and functioning. A large number ofpharma companies, medical colleges and reputed hospitals including those undergovernment'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 committeebefore it is approved by the Central Drugs Standards Control Organisation. Moreover, thetrial should be registered with the Clinical Trials Registry of India, managed by theIndian Council of Medical Research. Clinical trials are not illegal but most of the organisations including reputed hospitalstake advantage of the poverty in rural areas and recruit people from poor sections ofsociety. Taking strong exception to the practice of recruiting volunteers for clinicaltrials from among the poor, the World Health Organisation in its health bulletin notedthat 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 ethicscommittees to declare a conflict of interest. "There's the need for ensuring thatguidelines for constitution and functioning of ethics committee are implemented. Reviewof the documents submitted to Clinical Trials Registry reveals the extent of improperfunctioning 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 clinicaltrials 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 andpublic query, is also the member secretary of the ethics committee and signing authorityof the EC approval. "Many academic institutions might not have a proper ethics committeefor reviewing and approving clinical trials that are being conducted as a part of thepostgraduate medical courses not realising the fact that principles of ethics remain thesame 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 investigatorsinvolved in multiple trials - as many as 25 clinical trials. Another modus operandiadopted by companies is to declare their research as "global multicentre trials", butactually a majority of patients are recruited from India. This is unethical. "Global trials registered in the CTRI, are required to declare the number of patientsproposed to be recruited from India. Based on the information through CTRI, there havebeen certain instances where there has been a bias in allocation of recruitment ofsubjects for the Indian arm in global clinical trials. In these instances it was observedthat more than 80 per cent of the recruitment took place from India as against theplanned equal allocation," according to Dr SD Seth of National Institute of MedicalStatistics. 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 innocentpatients and unethical principles are a lethal combination in India. The manner in whichsome doctors recruit patients using 'humans as guinea pigs' without any informed consentleaves a lot to be desired," he adds.