New Delhi: The Health Ministry has introduced ethical guidelines for the commercial use of leftover, anonymous, or unidentified biomedical samples, such as blood and tissue. These guidelines also cover samples where identification has been withheld. Hospitals generate significant quantities of biomedical waste that may no longer be useful to them but can be valuable for research and development by companies. The guidelines has been jointly prepared by the Directorate General of Health Services (DGHS) and Indian Council of Medical Research (ICMR) and only address ethical issues.
The guidelines specifies that these companies must be transparent and must maintain open communication with hospitals, ensuring that any developed commercial kits and technologies are affordable and accessible to patients and healthcare providers. The guidelines says that for de-identified or anonymous leftover samples, usage may be permitted without informed consent, as these samples cannot be traced back to patients, thereby not infringing on patient rights or autonomy. The guidelines states that hospitals need to seek regular progress reports from companies to ensure compliance with the signed agreements regarding the use of provided leftover samples. Companies have to provide information on the intended use of the sample, declare the nature of the product development, and display transparent policies that indicate the source, handling purpose, financial interests, and robust scientific methods, safety and destruction of samples when they complete the intended purpose.
The Central Pollution Control Board (CPCB) report 2022-23 stated 764 tonnes of bio-medical waste is generated by India’s 375,256 healthcare facilities every day, 721 tonnes of which are treated and disposed of. Biomedical Waste is regulated as per Environment (Protection) Act, 1986 to improve the collection, segregation, processing, treatment and disposal practices for bio-medical wastes in an environmentally sound management to prevent from its adverse effect on the environment and human health.
