Bill drawn up to regulate research on humans

Proposes regulator to enforce ethical practices.

The government has drawn up a Bill to regulate research on humans, an industry which at times allegedly stretch the boundaries of what is ethical. The Bill is likely to be introduced in the next session of Parliament.

Christened the BioMedical Research on Human Subjects (Promotion & Regulation) Bill, it proposes a regulator to enforce ethical practices in scientific research on humans.

At present, the Drug Controller-General of India regulates clinical trials, but only the part that has a commercial motive.

The Bill will cover all clinical trials, commercial and academic, as well as the entire range of research, including genomics, gene mapping, foetal tissue transplant, stem cell research and clinical trials.

"When every other thing pertaining to human health is regulated, how can this be ignored?" said an official of the health and family welfare ministry. The Bill draws heavily upon the "ethical guidelines for biomedical research on human subjects" issued by the Indian Council of Medical Research (ICMR).

Five of the Bill's schedules specify general principles on ethical considerations, ethical review procedures, clinical trials, clinical evaluation of devices, diagnostics, vaccines and epidemiological studies. Three others cover stem cell research, including human genetics research, transplant research and assisted reproductive technologies.

In research on humans, stem cells are a particularly sensitive area. Scientists have not yet been able to fully control the development of embryonic stem cells, which are undifferentiated and can develop into any adult cell. US President George Bush has criticised stem cell research, since studies derive inputs mostly from embryos that have the potential to create life.

There is a fear that lack of formal guidelines and constructive opposition to stem cell research in India may lead to unfettered abortions and leave Indian doctors free to conduct such research without following established scientific principles and medical ethics.

Instances have been reported of clinical research organisations obtaining consent from human subjects without sufficiently briefing them about the implications. In many cases, the subjects are semi-literate and poor.

The Bill prescribes fines up to Rs 1 lakh and imprisonment of up to a year for norm violations. The ethics committee of ICMR is to be cast as the national ethics committee, which will also be the technical adviser to the biomedical regulator.

"It is a very positive step. We need adequate checks and balances," said Ajay Bharadwaj, president (group marketing) of biotechnology company Biocon.

Disagrees Brijesh Regal, chairman and managing director of Rx Apothecaries Clinical Research. "We already have the Drugs and Cosmetics Act. Clinical trials are already being well regulated (by DCGI). One more Act regulating somewhat the same area will kill the clinical trials market,"he said.