We collaborated with iGEM UNESP Brazil is working on the subject of Engineered Probiotics Around the World.
The goal of the collaboration was to understand about the GMO legislation around the world and if there already is any regulations about engineered probiotics and if there are clinical trials or companies using engineered probiotics in these countries. This work was done in collaboration with teams Chalmers-Gothenburg, IIT Delhi, Jiangnan China, TecCEM and Lambert. We were grateful that they reached out to us. It was really interesting to learn about probiotics marketed in various countries, high tech startups working in the field of probiotics and recent clinical trials across the world that provide critical insight into a topic that has been of much importance recently. The data from the collaboration is given below,
In China, there is no regulation for genetically engineered probiotics, the present tests in the country approach pathogenic potential, and patronized standards for food evaluation. No companies or clinical trials that use engineered probiotics has come to our knowledge.
In India, the ICMR (Indian Council of Medical Research) in partnership with DBT (Department of Biotechnology), created an official guide to evaluate probiotics in the country, so any probiotic product needs to be on this guide´s pattern to be released in the market.
Before being approved and released, food is submitted to standardized tests for identification and characterization of its new chains, such as PCR, in vitro tests mimicking the gut environment, in vivo testing to check the effectiveness in live animals, safety assessment for human use, evaluation of efficacy in humans, also there are standards patterns that need to be followed for the process of food packing and management.
Currently, the probiotic market in India is dominated by multinationals, which mainly commercialize fermented food products. No companies or clinical trials that use engineered probiotics has come to our knowledge.
In Mexico, all food that has been processed or produced by genetically modified organisms are considered transgenic, but food containing GM or transgenic compounds are not identified, even though there are biosecurity laws and norms for regulation, such as SEP, CIBIOGEM, SAGARPA, SEMARNAT, SHCP and the Federal Law for Protection of the Consumer.
In terms of the norm, the Official Mexican, Norm NOM-056-FITO-1995, is in force and regulates everything related to GM mobilization in the country, so all public and private company must fulfill the requirements in the norm to have their food with genetically engineered compounds transit through Mexico. Furthermore, the law of Biosecurity of GMO and the Federal Law for Protection of the Consumer controls the release for consumption and commercialization of pilot projects besides regulating importation and exportation of GM in the country. No companies or clinical trials that use engineered probiotics has come to our knowledge.
In Sweden every substance or combination of substances that is provided under the pretense that it has a preventative or therapeutic effect on diseases in humans or animals states for a pharmaceutical, which is regulated by the Swedish Medical Products Agency (MPA). When this kind of probiotic is been prepared to be released the Swedish Gene Technology Advisory Board and the Swedish National Council of Medical Ethics are often involved and give out statements and input in regards to the applications for clinical trials. There all pharmaceuticals that contain any modified organism need to be labeled with “This product contains (a) genetically modified organism(s)”, and all of the trials regarding GM pharmaceuticals are posted on the Swedish Medical Products Agency’s website. In Europe, the following company working with engineered probiotics has come to our knowledge: ActoBio Therapeutics (part of Intrexon) in Belgium.
Engineered probiotics are not regulated by the US Food and Drug Administration, as they are neither a food nor a drug. As a result, they currently do not require large clinical trials like other drugs in America. The following companies working with engineered probiotics has come to our knowledge: Azitra, Synlogic and ZBiotics.
There exists no law that regulates genetically engineered probiotics, but in 2018 ANVISA, the Brazilian National Health Surveillance Agency, opened up the public consultation and now genetically engineered probiotics were added to the regulation. Besides, there is no companies or clinical trials that use engineered probiotics. With this research, we were able to see that there is a growing movement of engineered probiotics mostly in the U.S., but that there still is a lack of laws and regulation all over the world to regulate these products before they can reach the market and the final consumers.
Genesis, The Life Sciences Department of Shiv Nadar University is interested in setting up an iGEM team for 2019. We are currently mentoring them after they reached out to us through our social media accounts. We had an illuminating mentoring session with them in this aspect where we discussed in detail the prerequisites for participating in iGEM competition as well as a discussion regarding Human Practices, Safety, Funding, iBEC and Track selection. It was a great experience for both the teams. We wish Team Shiv Nadar best of luck for their future endeavors and look forward to work alongside them in the coming year.
During the summers, we had a skype session with iGEM Labpats - a student team from Carroll High School, U.S.A. We talked about our project and exchanged design ideas. We discussed the possible ways in which human practices could be conducted in an impactful manner. The discussion was really stimulating and gave us some great ideas for our human practices. iGEM IIT Delhi being a collegiate team was amazed to see the dedication of these school students. We wish them our best in their future endeavors.
We faced some problems during our InterLab characterization, our absorbance at 600nm for silica beads at high dilutions didn't follow the trend. Upon which, we discussed the problem on All India iGEM group, where the teams gave us multiple suggestions and shared their protocols by which we were able to obtain our results as deisred by iGEM. Hence, we would like to express our gratitude towards the Indian iGEM teams.