The Compound Eye

Policy Focus

Guidelines for Evaluation of Nano-Agri Input and Nano-Agri Products! 

The Department of Biotechnology invites comments on ‘Guidelines for Evaluation of Nano-Agri Input and Nano-Agri Products in India" from all the stakeholders- government agencies, institutions, industry/researchers engaged in research & development in Nanobiotechnology. It is requested that comments/observations pertaining to the same may be conveyed positively by 31st August, 2019 to Dr. Suchita Ninawe, Adviser, DBT only through email at policy[at]dbt[dot]nic[dot]in

Hundreds of nano-agriinproducts (NAIPs) and nano-agriproducts (NAPs) using nanotechnology are already on the market even though there are no specific policies regulations for their control. Therefore, there is a need to develop the policy and regulations in place.

A NAIP is defined as an agricultural input preparation containing nanomaterials intended for external and internal applications (through soil, seed, foliar, and drip in crops as well as by other means) on crop for the purpose of agricultural farming. 

A NAP is defined as an agricultural preparation containing nanomaterials intended for consumption or applications in food/feed and their supplements as well as nutraceutical delivery. These are the products that contain materials with any of the dimensions (zero, one or two) falling under the size range of >100 nm and <1000 nm, provided the particle size has altered the agriproduct characteristics associated with the application of nanotechnology compared with the active ingredient.

The guidelines categorise the products and lay out criteria for stability, safety, residue analysis, hazard characterisation and uncertainty analysis. There are also suggestions for inclusion in the existing regulatory act by FSSAI to smoothen the protocol for approving nanofeed. 

You can access the detailed guidelines here - do send in your comments by 31st August. 

It's Controversial

Fighting Ebola.. Continued

In a previous edition, The Compound Eye covered the on-going Ebola outbreak in the Democratic Republic of Congo. The chief challenge in curbing the outbreak has been mistrust in the healthcare system, including misinformation spread about the Ebola vaccine. 

However, in a new turn of events, two drug candidates have shown promising results against Ebola. Preliminary results, of 499 of the participants, show that two of the candidates, REGN-EB3 and mAb114, were highly effective in treating people infected with the virus. 

The overall mortality among patients randomly chosen to receive REGN-EB3 and mAb114 was 29% and 34% respectively. The striking difference in efficacy was in patients who were recently infected (and so had a low viral load). REGN-EB3 cured the disease in 94% of such patients, while, in the case of mAb114, it was 89%.

REGN-EB3 is a cocktail of three antibodies generated by injecting Ebola virus into a mice model that has a human-like immune system, while mAb114’s development goes back to the Ebola outbreak in 1995 in Congo.

A drug for Ebola is perceived very differently from the vaccine and the expectation is that once Ebola is thought of as a curable disease, there will be less resistance to accessing treatment. The current network of healthcare practitioners already engaged in fighting Ebola can be rechannelised to screen and identify Ebola victims early enough for the drugs to be effective. 

Final trial results are still awaited, but if the results so far hold, the combination of a vaccine and drugs would help stop Ebola in its deadly tracks.  

 

Science in India

Vaccines in India: 

The Indian Council of Medical Research (ICMR) has launched India’s first large-scale trial for two new TB vaccines. This is the first time a large preventive TB vaccine trial involving more than 12,000 healthy household contacts of newly diagnosed TB patients from across six states of India are set to be enrolled.

For these trials, the six states including Delhi, Maharashtra, Odisha, Telangana and Karnataka, with two thousand participants from each state are to be enrolled over the next seven to eight months. Further, seven main centres will have six sub-sites, where these trials will be conducted.

The existing TB vaccine Bacille Calmette-Guerin (BCG) is now more than a hundred years old and is known to be immunoprotective against TB and TB meningitis in children, but its protection provided for pulmonary TB in adults is variable, as per ICMR. 

In addition to new vaccines in India, US FDA has approved a Pretomanid, a new medicine for treating deadly, drug-resistant forms of tuberculosis (TB) that makes the treatment regimen shorter and simpler.

A vaccine and drug for TB as well; let us hope we can tackle our in-house TB outbreak as we have our fingers crossed for our friends in Africa tackle their Ebola outbreak.

Meanwhile, in some non-vaccine news:

A vaccine for Chlamydia: Ha! There is no escaping vaccine news this fortnight. The first vaccine against chlamydia has passed its first test in humans.Chlamydia, caused by the bacterium Chlamydia trachomatis, is one of the most common sexually transmitted diseases, with around 131 million women and men newly infected worldwide each year. 

CRISPR enters its first human clinical trials: In an upcoming trial, people with an inherited blindness will have the molecular scissors injected into their eyes. Those tests, if successful, could spur future trials for Duchenne muscular dystrophy, cystic fibrosis and a wide variety of other genetic diseases, affecting millions of people worldwide.

Goodbye to Kary Mullis: And finally, as we welcome in gene therapies, we bid adieu to Kary Mullis, the noted biochemist who pioneered the PCR, a technique so central to the way we now analyse DNA. Dr Mullis passed away at the age of 74 on August 7. 

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