Registration must for import/export of infectious human biological material from India
Syed Akbar Hyderabad: Waking up from slumber in the wake of Lancet team illegally transferring contaminated water samples containing superbug to the UK for research, theIndian Council of Medical Research has come out with guidelines restricting transfer ofinfectious human biological material from the country. The guidelines make it mandatory for those exporting or importing samples containingdisease-causing organism to seek prior permission from the ICMR. Incidentally, thecontaminated water samples collected from New Delhi were shipped to the UK without theknowledge of the Central government. Unauthorised shipping or airlifting of contaminatedsamples pose severe security risks as any leakage or spillage will spread the infection. If the pathogen is a new mutant or dangerous, the medical consequences will be severe. The ICMR's guidelines are aimed at both curbing unauthorised lifting of infectioussamples from the country for research or commercial purpose, and preventing spread ofdiseases through improper handling of samples. Now such material need to be"triple-packed", its contents disclosed and sent abroad only after ICMR's approval. A committee has been formed to deal with such cases. Even blood samples contaminated withpathogens should not be transferred without prior permission It has also been mandatory to disclose whether the samples involve any unusual risks likeradioactivity, recombinant DNA/genetic engineering work, toxic compounds, communicablediseases for plants, animals and humans, chemicals with long half like accumulating inthe environment and high explosive chemicals. "The ICMR ethical guidelines for biomedical research on human subjects should have to beobserved while sending out of or bringing infectious samples into the country. Issuanceof import certificate issued by the relevant foreign regulatory authority to the foreignlaboratory receiving the Indian biological samples is also a must now," an ICMR statementpointed out. Hundreds of samples of infectious substances are shipped every year from the country fordisease investigations, clinical trials, surveillance studies, antidoping testing and orroutine analyses. Biological materials like blood, blood components, dried blood spots and faecal occultblood, and medical or clinical wastes are covered under "infectious substance category".It should also be disclosed whether the samples pose threat to humans or animals, or tothe health of both.