Health Ministry issues ethical guidelines for commercial use of leftover biomedical samples

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.

Key Guidelines:

Transparency and Communication: Companies must maintain open communication with hospitals, ensuring that any developed commercial kits and technologies are affordable and accessible to patients and healthcare providers.

Ethical Use: Jointly prepared by the Directorate General of Health Services (DGHS) and Indian Council of Medical Research (ICMR), the guidelines focus solely on ethical issues.

Waiver of Informed Consent: For deidentified 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.

Compliance and Reporting:

Hospitals are required to seek regular progress reports from companies to ensure compliance with the agreements regarding the use of leftover samples.

Information Disclosure:

Companies must provide details on the intended use of the samples.

Declare the nature of the product development.

Display transparent policies covering the source, handling purpose, financial interests, scientific methods, safety, and sample destruction once the intended purpose is completed.

Biomedical Waste Management:

According to the Central Pollution Control Board (CPCB) report for 2022-23, India's 375,256 healthcare facilities generate 764 tonnes of biomedical waste daily, with 721 tonnes being treated and disposed of. Biomedical waste management in India is regulated under the Environment (Protection) Act, 1986, to ensure environmentally sound practices that protect human health and the environment.

Additional Resources:

Govt drafts SoP to regulate clinical research organizations

By establishing these guidelines, the Health Ministry aims to balance the advancement of medical research with ethical considerations, ensuring that the use of biomedical waste contributes positively to healthcare without compromising patient rights.