New Delhi: The Ministry of Health & Family Welfare (Mohfw) has issued guidelines “Guidelines for Ethical use of Leftover de-identified/Anonymous Samples for Commercial Purpose” for ethical use of leftover, de-identified and anonymous samples caused by diagnostic or surgical procedures for commercial usage. These samples include organs, parts of organ, cells, tissues, cell products such as blood, blood products, urine, saliva, DNA/RNA, hair, nail clippings, or any other cells and body fluids. The health ministry pointed out that the source of the samples may be patients, autopsy specimens, abandoned wastes, tissue banks, IVF clinics and organ donation centers and other possible sources. The ministry pointed out that after the samples undergo the requisite clinical and laboratory test, these samples become leftovers and are referred to as biomedical waste or biohazard and are disposed of as per the regulatory norms.
Read also: PMJAY Fraud: Pediatric hospital fined Rs.6.54 crores for manipulating medical records
As per the Mohfw guidelines these leftover samples which are considered waste can serve as a precious resource for research and development activities to develop diagnostics, advance innovations or for the development kits, identify specific disease makers or determine health parameters and other such purposes which are extremely valuable. The guidelines said that there has been keen interest from commercial companies for procuring these leftovers which they utilize for various therapeutic advancement which are beneficial for the society as a whole. The guidelines cautioned the hospitals that they should consider only those leftover which are going to be discarded after clinical diagnostic or care. Effectively only those leftovers which are considered waste can be considered for commercial usage as per the guidelines. The hospitals have to maintain the privacy and identity of the patient whose sample has been offered for commercial usage. Robust data security measures must be in place to protect any residual information associated with the samples. The guidelines also warns the companies to maintain transparency and open communication with the hospital that will source the sample for them. The guidelines has bifurcated the samples into two; if the sample is from the patient whose identity is known to the hospital then informed consent should be taken from the patient before handing over the sample to company and in second class of samples, the samples are anonymous or de-identified irreversibly or left over after clinical care, then such sample lose their identity and in such case consent is not required. The guidelines further added that the companies must adhere to local, national and international regulations governing the collection, storage and secondary use of biological samples.
The Guidelines issued by Ministry of Health & Family Welfare (Mohfw) is attached herewith
