July 17, 2013

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How safe are Indians as subjects of clinical trials?

In 2005, India amended the intellectual property rights (IPR) law and emerged as a global destination for clinical trials.  The Government of India upgraded Schedule Y of the Drugs and Cosmetics Act of India, which is equivalent to the Code of Federal regulations applicable to the FDA. Today, India is a global hub for clinical trials, drawing companies because of its ethnically diverse pool of potential test subjects and potential to reduce research and development (R&D) costs by nearly 60%. The availability of a large drug naïve patient population, qualified doctors fluent in English, skilled medical professionals trained in ICH-GCP and a new IPR law make India one of the best grounds for clinical research. In addition, India has a large network of global quality hospitals and easy to access trial sites. A highly developed IT and data collection capability, and improving infrastructure and technology are some of the other factors in favor of India.

But there is a flipside to this sudden clinical trial boom. India is struggling to protect the millions of poor and illiterate patients who are being used as guinea pigs. Unregulated trials, malpractices, and non-compliance to regulations have become everyday news. A large number of the participants are unaware of the benefits and risks of participating in a trial, cannot distinguish between treatment and research, do not understand the concept of informed consent, and are lured into trials by offers of free health care and financial benefits. Some of the information published by the media is listed below:

  • There were 16 deaths related to the adverse impact of clinical trials in 2012
  •  Between 2005 and 2012, 2,644 people died during the clinical trials  for 475 new drugs
  • About 99 per cent of clinical trial subjects are poor and are unaware of their enrolment
  • With 25% of India's population living below the poverty line, it is likely that many of these drugs will remain unaffordable to the subjects participating in clinical trials
  • In order to meet targets, doctors will sometimes manipulate data and recruit patients who do not qualify. In an Indore case, doctors entered into contracts with clinical trial companies in their individual capacity but recruited patients from the government hospital
  •  In one case, doctors recruited 150 children to participate in a trial within three hours without any counselling
  • Hundreds of tribal girls had also been recruited for an immunisation study without parental consent and only with permission from the warden of their government hostel. Several of these girls subsequently died.
  • Drug companies have used survivors of the world's worst poisonous gas disaster in Bhopal for at least 11 trials without proper consent; 14 participants died during the course of these trials

Are the above allegations true? The industry, however, argues that the clinical trial protocols are audited regularly by the world’s best regulators like USFDA. The claim is that clinical trials in India follow best practices such as preserving documents, recruiting healthy volunteers where none is allowed to participate in more than one trial at a time, educating and counseling subjects, and site audits. Kiran Mazumdar Shaw, CMD of Biocon also believes that these allegations of improper clinical trials are blown out of proportion and that the entire industry cannot be judged basis a few cases. Some argue that the cause of deaths may not be the clinical trial and that many of the subjects may have already been severely ill.

Despite the debate, there is a growing urgency to take steps to bring in more transparency and improve the way clinical trials subjects are recruited and managed. Experts say that clinical trials need to be regulated. Public announcement and awareness camps could be the first step in educating the local community and doctors regarding ongoing trials. Adequate counseling and information regarding the trials should also be provided, in addition to getting informed consent and providing the right compensation. The government has already taken steps by creating ethics committees and leveraging digital (audio-visually recorded) informed consent. Since June 2009 it has become mandatory to register all clinical trials that will be conducted in India. In fact, the Drugs Controller General of India (DCGI) mandates that trials should be registered before the enrolment of the first patient. In August 2012, the DCGI also made it mandatory to register the ethics committee associated with CROs. Ethics committees must ensure that clinical trials are being conducted as per Schedule Y, GCP guidelines and that the rights and safety of trial subjects are protected. On 30th January 2013, the government made amendments to Schedule Y of the rules relating to the conduct of clinical trials especially in terms of taking informed consents from the trial subjects and providing them or their legal representatives compensation in case of any trial related injury or death. It also mandates GCP compliance and adverse event reporting.

Have these amendments improved the condition of Indians as subjects of clinical trials? Due to the increasing awareness, media attention and activism, and strict regulatory control and government intervention, we are definitely in a much better situation today. The question now is, “Will these changes impact the number of trials and subsequently the business and future of the clinical trial sector in India?” The next blog will discuss some of the other issues related to clinical trials.