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Quality accreditation to be made mandatory for new clinical trials

New Delhi: In a move to tighten noose and ensure quality standard of clinical trials in India, the government is planning to make quality accreditation mandatory for new clinical trials in the country soon.

In this regard, the National Accreditation Board for Hospitals and Healthcare Providers (NABH) has already issued draft accreditation standards for clinical trial sites, ethics committees and investigators.

The accreditation, when implemented, will be mandatory only for new clinical trials, however, the ongoing trials are also expected to be brought under accreditation sooner or later.

The proposed quality accreditation, under which pharma companies or sponsors keen to conduct new clinical trials in India would have to seek accreditation for their sites, ethics committees and investigators before they applying for CDSCO (Central Drugs Standard Control Organization)’s clearance, could be implemented within a month.

Dr K K Kalra, CEO, NABH told India Medical Times, “The NABH will help ensure that all the stakeholders in the process of new clinical trials follow a mandatory procedure in order to conduct transparent and foolproof trials. We have divided it into three components i.e. the criteria to be followed for accreditation of the ethics committee, the investigators and the sites where clinical trials are to be carried out. Clinical trials have been proving challenging for quite some time, the guidelines for new clinical trials will ensure adherence to certain quality standards, hence, instilling confidence in both patients and the industry by more safer and transparent clinical trials. In order to take all the stakeholders into confidence, we have put up the draft for suggestions and we welcome constructive suggestions.”

“We will increase the personnel size of the board in order to effectively implement the whole purpose of quality accreditation. I would like to add that our work will be just to ensure the quality, CDSCO would continue to grant permissions for testing new pharmaceutical products,” he said.

According to the draft document, some of the mandatory procedures to be followed for accreditation of the ethics committee are — composition, procedures for new induction and resignation of members; frequency of ethics committee meetings, receipt, review and decision making of proposals; review of protocol amendments, procedure for deliberations and maintaining minutes; periodic review and oversight; procedure to be followed for vulnerable population; review of informed consent document and informed consent process etc.

The investigators would be accredited on the following procedures – investigator’s role and responsibilities; investigator’s education, qualification and experience; investigators to follow site SOPs (standard operating procedures) and study protocol for all essential trial activities and if there is a contradiction, study protocol requirements would take a upper hand.

Similarly, the procedure for accreditation of clinical trial sites are — subject protection policy, informed consent, including procedures for audio-visual recording of consent; medical management of adverse events; adverse events and serious adverse events reporting (including emergency care); roles and responsibilities of the study team; site research team training; research pharmacy (investigational product management); protocol compliance and protocol deviations etc.

Lately, clinical trials have been a matter of concern in the country for its opaque practices and the shady procedure it follows to conduct trials. After reports of several flaws while testing experimental drugs emerged into the scene, clinical trial permissions were stalled for months by the Supreme Court last year. The court is currently hearing a public interest litigation (PIL) on the matter.

It should be noted that the Dr Ranjit Roy Chowdhury Committee also proposed a new regulatory model that would take several aspects of clinical trials away from the CDSCO. The current move is touted as the fallout of its recommendation to introduce a transparent accreditation process at all levels right from the investigator who conducts the trials, the centre where it is done and the ethics committee that clears it.

The draft document has been put up by the NABH on its website for comments which could be submitted before December 15. While, the quality accreditation at first appears to be a move to increase accountability of much criticized clinical trials in India, on a positive side it is expected to give a push to clinical trial industry which has been suffering due to uncertain regulatory environment for long.

by Vidhi Rathee

2 Comments

  1. K.Gowrinath K.Gowrinath Monday, December 8, 2014

    I support the central government move to have audio-visual consent process during clinical trials.How about having the same audio-visual arrangements during central government interviews,MD and DNB exams for verification in case of any complaint.All clinical drug trials are under review of institutional ethics committees even after approval and patient can approach them in case of doubt or can complain against the principle investigator and get out of the drug trial without even informing the reason.A copy of the signed informed consent document is given to the patient for verification. In the name of protecting the interests of patients,central government is ignoring the sufferings of countless patients in many government hospitals,private medical colleges where surgeries are done by taking signature or left thumb impression of the patient or legal representative with only two or three handwritten sentences written by the nurse without involvement of doctor in most of the cases.Can anybody say that an informed consent for procedure or surgery need not have the signature and seal of the doctor-in-charge ?. Let central government check the informed consent forms of procedures or surgeries in different state and central government run hospitals and implement same policy of informed consent process under TV camera and let patient get one soft copy of informed consent process for his records.

  2. Dr Mahesh Sinha Dr Mahesh Sinha Thursday, December 4, 2014

    It seems that in Government one arm doesn’t knows what other is doing. How many Ethics committee guidelines ICMR, CDSCO and now NABH.

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