Sunday, May 1, 2011

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, the Indian Council of Medical Research has come out with guidelines restricting transfer of infectious human biological material from the country.
The guidelines make it mandatory for those exporting or importing samples containing disease-causing organism to seek prior permission from the ICMR. Incidentally, the contaminated water samples collected from New Delhi were shipped to the UK without the knowledge of the Central government. Unauthorised shipping or airlifting of contaminated samples 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 infectious samples from the country for research or commercial purpose, and preventing spread of diseases 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 with pathogens should not be transferred without prior permission
It has also been mandatory to disclose whether the samples involve any unusual risks like radioactivity, recombinant DNA/genetic engineering work, toxic compounds, communicable diseases for plants, animals and humans, chemicals with long half like accumulating in the environment and high explosive chemicals.
"The ICMR ethical guidelines for biomedical research on human subjects should have to be observed while sending out of or bringing infectious samples into the country. Issuance of import certificate issued by the relevant foreign regulatory authority to the foreign laboratory receiving the Indian biological samples is also a must now," an ICMR statement pointed out.
Hundreds of samples of infectious substances are shipped every year from the country for disease investigations, clinical trials, surveillance studies, antidoping testing and or routine analyses.
Biological materials like blood, blood components, dried blood spots and faecal occult blood, 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 to the health of both.

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