The Union health ministry is taking initiatives to push a Bill during the next session of Parliament to regulate booming human genetic research in the country and thereby setting up a Biomedical Research Authority to govern the sector.
The Biomedical Research on Human Participants (promotion and regulation) Bill has been nearly finalized by the ministry after consultations with the different stakeholders. The ministry wants to place the same in the next session of the Parliament itself. "There are no specific legislations to regulate Human Genetic Research, although the Pre-conception and Pre-natal Diagnostic Techniques (PC&PNDT) (Regulation and Prevention of Misuse) Act covers some aspects of human genetic research. So, the Bill is finalized as a priority now," a senior official said.
The new law will cover entire activities related to the sector and there will be a provision for biomedical research authority for the purpose. There are no direct provisions for protection of medical data and genetic material. However, guidelines have been issued by the Ministry, for exchange of Biological Material in 1997 for protection of genetic material in case the biological material is to be transferred to another country, he said.
India has increased its focus on genetic research in the recent years, in view of the potential ahead. The ministry of science and technology has also programmes to boost the genetic research. A task force was set up by the Department of Biotechnology to study the scope of the sector and chart out programmes to spread the availability of prenatal diagnosis of genetic disorders across the country. Based on the report of the task force, the government is also in the process of setting up research groups capable of delivering gene therapy.