New Delhi: The Ministry of Health has drawn up ethical guidelines for the commercial use of leftover, anonymous or de-identified biomedical samples such as blood and tissues. They also apply to samples whose identification is withheld.
Hospitals generate large amounts of biomedical waste that may not be of use to them. However, companies can use these leftover samples for research and development.
The guidelines specify that companies will have to maintain transparent and open communication with hospitals for the development of commercial kits and technologies, which must be affordable and accessible to patients and healthcare providers.
The guidelines jointly prepared by the Directorate General of Health Services (DGHS) and the Indian Council of Medical Research (ICMR) only address ethical issues.
“…For use of unidentified/anonymized leftover samples, use may be permitted with a ‘waiver of informed consent.’ Patient rights and autonomy would not be lost in cases where leftover samples are identified and cannot be traced back to the patient,” the guidelines state.
The Central Pollution Control Board (CPCB) report for 2022-23 stated that 764 tonnes of biomedical waste is generated every day in India’s 375,256 healthcare facilities, of which 721 tonnes are treated and disposed of.
Biomedical waste is regulated under the Environment (Protection) Act, 1986 to improve the practices of collection, segregation, processing, treatment and disposal of biomedical waste in environmentally sound management to avoid its adverse effects on the environment and health. human health.
What does the guideline say…?
The guidelines state that hospitals should request periodic progress reports from companies to ensure compliance with signed agreements regarding the use of leftover samples provided.
Companies must provide information on the intended use of the sample, declare the nature of the product development, and display transparent policies that indicate the source, purpose of handling, financial interests and sound scientific methods, security, and destruction of the samples. samples when they complete the process. intended purpose.
Queries sent to the spokesperson for the Ministry of Health remained unanswered.
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