India struggles to regulate biomedical research
[MUMBAI] India is struggling to regulate its stem-cell research and clinical trials despite aiming to become a world leader in these fields, said specialists last week.
The comments were made at India's first national bioethics conference, which took place in Mumbai on 25-27 November.
Stem cells are unspecialised cells that can turn into other types of tissue such as bone or heart muscle. Researchers are looking at whether they could be used to help cure a number of diseases.
The week before the meeting, a private infertility clinic in Delhi claimed in a press conference attended by India's health secretary that it had used stem cells from embryos to treat 100 patients for a range of conditions.
The clinic, NuTech MediWorld, needed no permission to give the treatment to patients. In fact, India currently has no national authority to issue such permission. Nor has the clinic published details of its findings in a peer-reviewed journal.
Other senior officials, at the Indian Council of Medical Research (ICMR), are calling for stiffer controls over this kind of research.
Both ICMR and the Department of Biotechnology have published guidelines on conducting stem cell research, but they carry no legal weight.
"We have to stop such cases," says ICMR’s deputy director-general Vasantha Muthuswamy.
Sangeeta Udgaonkar, a Bangalore-based lawyer who helped draft the ICMR guidelines, says there are inconsistencies both within and between different sets of guidelines, and adds that India should address this by adopting a comprehensive national policy on stem-cell research.
In parallel to the disagreement over the need to regulate stem cell research, there is growing unease at ICMR over the rapid increase in the number of organisations that recruit patients for clinical trials.
India has no central database of its clinical trials and no system for regulating and monitoring them.
"We have no idea how many clinical research organisations there are, what they are doing, or who is reviewing their procedures," Muthuswamy points out. The results are not made public so nobody knows what the findings are.
ICMR announced this month that, working with the World Health Organization, it would set up a registry of clinical trials in 2006 (see India plans tighter scrutiny of clinical trials).
In addition, ICMR intends to encourage editors of key Indian journals to only publish results from trials that are given official approval.