The expert panel was set up soon after the Supreme Court slammed the Union Ministry of Health and Family Welfare for the uncontrolled clinical trials going on in the country, resulting in the deaths of over 2,000 people between 2008 and 2011. In its report, the committee has recommended that the principal investigator of a drug trial should be an accredited clinical investigator and other measures …
The expert committee set up by the government to formulate policy guidelines for approval of new drugs has proposed major changes in the existing guidelines for clinical drug trials in the country. The committee headed by Ranjit Roy Choudhury, advisor to the Department of Health and Family Welfare, has recommended that clinical drug trials should be held only at centres which are accredited for the purpose.
The expert committee was constituted in February to formulate policy and guidelines for approval of new drugs, clinical trials and banning drugs. The panel was set up soon after the Supreme Court slammed the Union Ministry of Health and Family Welfare for the uncontrolled clinical trials going on in the country, resulting in deaths of over 2,000 people between 2008 and 2011.
In its report, the committee has recommended that the principal investigator of a drug trial should be an accredited clinical investigator. The ethics committee of the institute where the trials are held must also have accreditation, the committee has said. Only trials conducted at accredited centres and meeting these stipulations should be accepted by the Drugs Controller General of India (DCGI), the panel has recommended. The panel report has recommended the setting up of a central accreditation council to oversee the accreditation of institutes, clinical investigators and institute ethics committees.
The report has recommended selection of assessors for accreditation and of experts to review new drug applications and other purposes through a blind randomised procedure from a roster of experts. This roster will be prepared after a nationwide search of appropriate experts and approval by the technical review committee, which will replace drug advisory committees, for approval of applications. The selection will have built-in safeguards for gender sensitivity and geographical representation.
On the process of taking consent of subjects for trials, the committee has said that informed consent from each participant should be made a mandatory prerequisite for a clinical trial. In circumstances where informed consent has to be obtained from special groups of people who have diminished capacity to protect their interests or give consent for themselves, the consent given by the guardian should be witnessed by an independent person who also has to sign the informed consent document.
The panel has also suggested audiovisual recording of the informed consent process, which should be undertaken and the documentation preserved while adhering to the principles of confidentiality. As per its recommendation, if any adverse effect (AE) or serious adverse effect (SAE) occurs during a clinical trial, the sponsor investigator should be responsible for providing medical treatment and care to the patient at his/their cost till the resolution of AE/SAE. This is to be given irrespective of whether the patient is in the control group, placebo group, standard drug treatment group or the test drug administered group.
Who gets compensation?
The recommendations also deal with the matter of compensation. “Compensation need not be paid for injury or death due to totally proven unrelated causes. In all other cases of death or injury/disability, compensation should be paid to the participant or his or her legal heirs.” Compensation should be paid to the trial participant if any drug-related anomaly is discerned at a later stage and accepted to be drug-related by a competent authority whether in India or abroad, the report says. It suggests that any SAE arising in the group receiving the placebo in place of the standard treatment should also be compensable if the SAE is related to the use of placebo.
The committee suggests that no compensation needs to be paid for therapeutic inefficiency, since the very purpose of a clinical trial is to determine the efficacy and safety of a given drug, vaccine or device. It says that the government of India, State governments and institutions should create a fund in order to encourage academic and clinical research (non-pharmaceutical company related) in institutions. This fund will be available to the institution for paying compensation.
Indore-based activist Anand Rai, who has has been vocal about unethical practices in drug trials said there are still a few problems with the recommendations. For example, the committee recommends no compensation for patients in the case of therapeutic inefficiency. “It is beyond our understanding that you administer drug during trial on a patient who has come to you for treatment, and later you tell them that it was drug trial and the drug was inefficient. In such case, the patient suffered but he/she will not get compensation.” Another recommendation of providing compensation to drug trial subject by State and Central government is also illogical, he says, adding that the profit of drug trial will go to private firm so why, the government will pay the compensation; it means the public in the country will be paying for it.
Will Loopholes Now Be Plugged?
In the past eight years, 2,868 deaths have occurred during clinical drug trials across India. But only 89 have been attributed to such trials and compensation has been paid in 45 cases, said the Union Health Minister on 5 March in Parliament. Considering the Supreme Court’s recent observation that uncontrolled clinical trials “are causing havoc to human life”, Ghulam Nabi Azad’s speech only highlighted the poor state of regulations for clinical drug trials.
To tighten guidelines for conducting these trials, the Health Minstry had amended the Drugs and Cosmetics Rules by passing three notifications between January and February. The notifications specified procedures for compensation and functioning of the ethics committee, which is constituted by an institution conducting the trial.
Health activists said the notifications were rife with loopholes. The first one deals with compensation in case of injury or death during clinical trial but the onus of deciding the injury continued to be with those carrying out the trial. S Srinivasan of All India Drug Action Network said, “The notification does not define injury. How does one prove that an injury is related to the trial? Who is the appellate body in case the compensation is not satisfactory?” Amar Jesani, editor of the ‘Indian Journal of Medical Ethics’, said it is important that arbitration boards are created at local and regional levels to arbitrate on the quantum of compensation a provision that was present in the draft but is missing in the notification. Will these and other loopholes be plugged now that the expert panel has come up with several recommendation?
Main recommendations of expert committee
- Clinical drug trials should be held only at centres which are accredited for the purpose
- Principal investigator of a drug trial should be an accredited clinical investigator
- Ethics committee of the institute where the trials are held must also have accreditation
- There should be a central accreditation council to oversee the accreditation of institutes, clinical investigators and institute ethics committees
- Informed consent from each participant should be made a mandatory prerequisite for a clinical trial
- In cases of death or injury/disability related to trial, compensation should be paid to the participant or his or her legal heir
- If any adverse effect (AE) or serious adverse effect (SAE) occurs during a clinical trial, the sponsor investigator should be responsible for providing medical treatment and care to the patient.