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Multi-drug resistant bacteria (MDR) in humans and animals have become a pandemic. Antibiotic resistance occurs when a few bacteria mutate in a given population that enables them to survive antibiotics. Scientists and public health officials have been constantly raising alarm about it but to no avail.

Antibiotics, when discovered in the early 1900s, were, without a doubt, a miracle cure that saved millions of lives around the world during the two world wars and beyond. But clinicians started using it recklessly as a cure-all for all infections, resulting in the evolution of resistant strains of microbes that could not be controlled effectively in due course of time. Even to this day, doctors in India are still prescribing antibiotics at the drop of a hat without much monitoring or follow-up with patients to see if the therapy was conducted scientifically.

Another vicious practice in India and many other developing countries is the total lack of drug controls. Pharmacists themselves prescribe antibiotics and they do not do any follow-up as it is not their responsibility. This pernicious practice of dispensing scheduled drugs without a valid physician’s prescription is really killing antibiotic therapy itself. Patients, in order to save a few rupees in doctor’s fees, go directly to the pharmacy and get whatever they want. The state governments are sleeping over this raging corrupt practice.

India is one of the countries that is now the epicentre of multi-drug resistant tuberculosis (MDR-TB). China, Russia, and South Africa are the other countries. Nearly 450,000 new cases of MDR-TB are reported every year. US pharma giant Eli Lilly, maker of two about-to-be-phased-out antibiotics, cycloserine and capreomycin, re-inducted them to the therapeutic regime after a study carried out in 1996 by a non-profit organization called Partners In Health (PIH).

PIH showed that cycloserine and capreomycin, as part of a multi-drug therapy, could treat TB successfully in 80% of the cases in resource-poor country settings. Lilly did not have the capacity to produce sufficient quantities. It launched the Lilly MDR-TB Partnership in 2003 and brought manufacturing close to all the target countries. Lilly committed $70 million to support discounted pricing. So far, Lilly has committed $170 million with multiple stakeholders to deliver the antibiotics to the needy. Lilly helped local manufacturing facilities acquire world-class standards, certified by the World Health Organization.

JSC BIOCOM was the first Russian company to obtain pre-qualification from WHO to manufacture the critical antibiotics. In China, Zhejiang Hisun Pharmaceutical Co. is another facility that is certified by WHO to manufacture the same antibiotics. Patents for cycloserine were obtained in 1956 and for capreomycin in 1962. However, since they were so old, there was a critical need for upgrading the chemistry and manufacturing processes which Lilly undertook with heavy investment.

Global Drug Facility (GDR) is one of the international drug procurement agencies for distribution in small countries that has helped the marketing. However, there are innumerable technical, logistical and marketing issues that need to be worked out in each country’s marketing conditions. Technology transfer is hard work. Pricing is still a key challenge; for Lilly it might be philanthropy, but for its partners, it is a business to make money. Health systems are broken in most TB-affected countries. If the problems are not detected sufficiently ahead of time, it will be difficult to design therapies. Treatment of MDR-TB takes 18 to 24 months, drug cocktails are highly toxic with vicious side-effects. Heavy investments in the public healthcare system are still woefully lacking, and no one needs to explain its condition in India. If the infrastructure to detect, diagnose and treat patients does not happen in time, the MDR problem will be compounded. A Lilly publication, “Seeking Solutions to a Global Health Crisis", on its website can serve as a guide to tackle future health crises.

Alternative antibiotic discovery slowed down in the last couple of decades, but is now picking up. Thanks to the functional genomics platform created by modern biotechnology, there is renewed hope of discovering new antibiotics. The first Antibiotic Summit was convened by the White House this year, underscoring the importance of the public health crisis. Resistance is largely caused by overuse. In 2014, the US FDA (Food and Drug Administration) approved three new antibiotics to control methicillin-resistant Staphylococcus aureus (the staph infection). NovoBiotic Pharmaceuticals, using a novel method developed by scientists to grow non-culturable bacteria from the soil, a hunting ground for new microbes, has identified 25 new drug candidates. Teixobactin seems to be a promising candidate. University of California-San Diego scientists are developing methods through genomics to overcome the problem of cultivating the huge cache of microbes from the oceans to discover potential new candidate drugs. This method is called meta-genomics, a huge field of biological oceanography.

Tel Aviv University and MIT scientists are using gene editing techniques called CRISPR/Cas9 to target bacterially encoded antibiotic-resistance genes and eliminate them. The beauty of this technique is that it can precisely target the specific resistant bacteria and not kill useful bacteria as usually happens with antibiotics. Without pussy-footing, India needs to target this public health crisis on a war footing.

Shanthu Shantharam teaches plant biotechnology and biotechnology innovation management at Iowa State University and was formerly executive director of the agricultural group of India’s Association of Biotechnology-led Enterprises. He is a former biotechnology regulator with the US department of agriculture.

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