Committee recommends restarting clinical trials in Madhya Pradesh

Says is in interest of people

By Ankur Paliwal
Published: Tuesday 20 December 2011

The committee constituted by the Madhya Pradesh government to prepare guidelines to regulate drug trials in the state has recommended restarting the trials.

The state government had put a ban on any new clinical trials in October last year following reports of unethical drug trials. The medical education department of the government had asked the committee to give recommendations on how to effectively regulate clinical trials. The committee submitted its report last month but did not suggest any punishment for those responsible for conducting unethical trials. 

What the committee recommends 

  • Videographing the informed consent process
  • The principal investigator should not be allowed to take more than 30 per cent of the total trial amount given by the sponsor company
  • Give trial related information on the website of the department of medical education of the state government
  • Make the trial drug available to the patient till it comes in the market
  • Constitution of all ethics committee in the state should be done under the supervision of medical education department
  • Make provision for grievance redressal by the subject or his relatives
  • No doctor should be involved in more than one trial at one time
Meanwhile, many other state-level agencies including Lokayukta and Economic Offence Wing (EOW) have also initiated inquiries into the unethical clinical trials in the state. While the report of Lokayukta is awaited, EOW submitted its report in August this year. It found that doctors violated ethical guidelines in conducting clinical trials and pocketed millions of rupees from multinational pharmaceutical companies. It found that the doctors subjected 3,307 individuals, majority of them children, to experimental drugs and vaccine trials between 2006 and 2010.

“No action has been taken against any of the culprit doctor, sponsor pharmaceutical company or contract organisations so far,” says Anand Rai, a health activist based in Indore. 

Objections are being raised on the constitution of the state level committee also. “Some of the members have themselves conducted clinical trials in the past,” alleges Rai.

One of them was removed from the committee four months ago so that no one can cast aspersions on the committee,” adds Rai. “Minutes of the meetings show how the member favoured clinical trials,” he adds.

Unethical trials continue

Meanwhile, reports of unethical clinical trials in Madhya Pradesh are pouring in. Around 233 mentally ill patients were subjected to clinical trials in Indore for checking efficacy of various drugs, including 42 patients for dapoxetine, a drug used to cure premature ejaculation. These trials were conducted by doctors of Mahatma Gandhi Medical College in private clinics between January 2008 and December 2010 after taking permission from independent ethics committee.

“The mental hospital, a branch of Mahatma Gandhi Medical College, has its own ethics committee. Then why the approval was taken from the independent ethics committee,” asks Rai. According to the guidelines of Indian Council of Medical Research, approval is taken from independent ethics committee only if the institution does not have its own ethics committee.   

Abhay Paliwal, associate professor with the Mental Hospital at Indore who conducted some of these trials says, “We have not violated any norms, all of these trials were approved by the Drugs Controller General of India.”

In its recommendations, the state level committee has said that the state should open clinical trials as it is in the interest of people. Its recommendations broadly sum up what is already present in the schedule Y of Drugs and Cosmetics Act 1940 and Ethical guidelines for Biomedical Research on human participants. It also calls for making the trial drug available to the patient till it comes in the market. But public health experts argue they say the drug should be made available life long as after coming in the market it will be expensive for the patient to buy.       

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