Details on volunteers, registration of ethics panels on the cards.
The Union health ministry is planning a set of amendments to the country’s drug rules to make monitoring of drug clinical trials more stringent.
Mandatory registration of institutional ethics committees, empowering drug regulatory officials to inspect clinical trial sites and trial sponsors (pharmaceutical companies) are among the changes proposed. So is revising the clinical trial consent form to capture the exact socio-economic status of the trial recruits.
The move comes after Parliament’s Committee on Government Assurances — headed by Bharatiya Janata Party MP and ex-Union minister, Maneka Gandhi -– pulled up the ministry for maintaining no records of the socio-economic status and contact details of clinical trial volunteers.
The committee had found the government was not in a position to say how many of the 671 deaths reported during clinical trials in 2010 had been compensated. Under the panel’s directive, the ministry has already sought clarifications from 44 pharmaceutical companies on the compensation given.
Unlike the current consent form, which does not seek details of the clinical trial volunteers but only ensures - through thumb impression or signature – the person’s willingness to participate in the trial, the new form will seek details of the socio-economic status, occupation, address, etc.
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While the present consent form allows the volunteer to have his legal representative as a signatory, the new form will limit that option to specified occasions. It is expected the move would minimise the chance of exploiting illiterate patients or volunteers.
The changes will also make ethics committees, investigators and sponsors more responsible. “The rights and safety of the clinical trial volunteers will be assured and they will get adequate compensation in case of serious adverse reactions through these amendments,” an official said.
Other changes
The amendments will also give statutory backing to some administrative reforms already initiated by the office of the Drugs Controller General of India (DCGI). Registration of ethics committees, clinical trial site inspections, mandatory registration of clinical trials, etc, will all get legal backing. The responsibility of the sponsors will also be redefined, it is learnt.
The office of the DCGI will constitute a special cell to monitor clinical trials. The proposed amendment will arm drug inspectors with the powers to visit clinical trial sites, sites of the sponsors or even offices of pharmaceutical companies as part of its investigation. It will also provide detailed guidelines on how such investigations should be conducted and what action can be taken in case of proof of misconduct. This could include barring clinical trial investigators from taking up future assignments or suspending the licences of contract research organisations.
Registration of ethics committees is another change expected to make such committee members more accountable. “Currently, the law mandates the formation of an ethics committee. However, it does not spell out specific measures needed to ensure the quality of such committees. The responsibilities of ethics committees are immense and we want them to be accountable,” the official said.
According to him, the amendments would allow the ministry to specify the requirements of an ethics committee and do periodic monitoring of the functioning of such committees.