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Commerce ministry notifies import policy on fruit flies for biotech R&D as free
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Gireesh Babu, New Delhi
March 21 , 2022
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In a major relief to the biotech companies which are into research and development (R&D) by importing organisms, the ministry of commerce and industry has notified the import of fruit flies for the purpose of R&D as free, subject to the approval of Institutional Biosafety Committee (IBSC) in accordance with the revised procedures from the Department of Biotechnology (DBT).
The Ministry, in a notification earlier this month, said that the import of only Drosophila Melanogaster, a species of fly which is used for biological research in genetics, microbial pathogenesis and others, as free subject to IBSC approval. The decision is as per the provisions of the “Revised simplified procedures/guidelines on import, export and exchange of GE organisms and products thereof for R&D purpose” notified by the DBT through a notification on January 17, 2020.
“The import of ‘Drosophila melanogaster’ which does not fall under the provisions of aforesaid Revised Simplified Procedures would require an import authorisation from DGFT,” said the notification. The policy has earlier kept it as restricted for imports.
According to the DBT’s notification in 2020, the revised simplified guidelines mandates that import and export of items including purified nucleic acids, proteins, drug products/drug substances/active pharmaceutical ingredients, and process intermediates and non-genetically engineered microorganisms for biopharma drug development R&D will require IBSC approval. The simplified guidelines under Rules 1989 are for exclusive use in containment for R&D purposes and not meant for release in the environment.
The GE microorganisms, a microorganism that is deliberately modified using rDNA technology and new gene technologies and contains plasmid vector/expression constructs, etc of natural/recombinant/synthetic origin, are also classified under this simplified guidelines with the quantities prescribed.
Such organisms should be developed through Category I/II genetic modification and the host should be routinely used in R&Ds and contain routine and standard mutations or insertions that do not increase the overall risk.
Exchange of regulated items within India for biopharma drug development shall not require approval from the Review Committee on Genetic Manipulation (RCGM) established under the DBT to monitor the safety of on-going research projects and activities including small scale field trials, import, export etc, involving GE organisms.
The exchange of materials may take place with the approval from the respective IBSCs for organisations involved in transfer/receive before commencing the activity.
“For research and development leading to biopharma drug development, IBSC shall approve the import and export of permissible items upto the prescribed quantity(ies) following the approval procedure and conditions as specified…,” said the DBT notification.
According to experts, the fruit fly is one of the most used test beds for R&D in cell biology, physiology and neuroscience. It is also considered to be favourite to researchers, due to its lower cost of maintenance and experimentation, among others.
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