In the wake of recent controversies over studies by Cardiff University of UK about the water pollution in Delhi and the following debate over the export of biological samples, the health ministry has decided to implement the guidelines more sternly on transfer of samples outside the country.
As part of enforcing the guidelines, the Ministry has issued direction on transfer of human biological material for research and commercial purposes and asked the domestic and foreign companies to abide by the instructions. The International Health Division of Indian Council of Medical Research has been asked to monitor it, sources said.
The Ministry had constituted a committee in 1997 to consider the cases related to transfer of human biological materials for commercial purpose. The committee evaluated cases where infectious biological material/samples were transferred from foreign research centres to Indian diagnostic laboratories/research centres or vice versa for analysis. It also looked into transfer of human biological waste material or any other cases for commercial purposes.
Based on the recommendations of the committee, some guidelines had been framed and now the government has asked the companies to follow them strictly. The companies have to submit a copy of the duly signed Material Transfer Agreement (MTA) and a copy of the Institutional Ethics Committee (IEC) clearance along with the composition of Ethics committee.
They should give a copy of the patient information sheet and informed consent form (as approved by IEC) giving details on the utilization of samples of the patient for a particular research/R&D study and the kind of benefit (direct/indirect or no benefit - as applicable) for appropriate decision making by the patient.
“They should also include: a copy of the Informed consent/undertaking of individual patient(s) agreeing to the utilization of his/her said biological samples for a particular study/purpose. The undertaking should also clearly state that the patient is willing/not willing (as agreeable to patient) to claim any commercial benefit on the product developed as a result of work carried out on his/her biological samples; a copy of the import certificate as issued by the relevant foreign regulatory authority to the foreign laboratory receiving the Indian biological samples; and a copy of the Memorandum of Understanding signed between Indian laboratory and international agency defining the commercial benefits to each party,” the guidelines said.
Recently a study report by researchers led by Prof Tim Walsh of Cardiff University in the UK has discovered new strains of antibiotic-resistant bacteria in water samples taken from Delhi, creating lots of debate in the country. The Ministry had strongly denied the report as baseless. Last year, some foreign researchers came out with stories about a bacteria named, NDM-1, after New Delhi.
The health ministry said the findings were not backed by clinical and epidemiological evidence. The instances had drawn criticism from many quarters in the country and it was alleged that the biological material for these studies were taken out of the country without due permission.