Antibiotics have saved millions of human lives from infectious diseases throughout the world since the discovery of penicillin in the first half of the 20th century. A number of new antibiotics were launched subsequently by the large pharma companies to treat TB, malaria, diarrhoea and other infections. Once the infectious diseases came under control somewhere around seventies, the focus of pharma companies turned to drugs to treat life style diseases. Now, with the emergence of microorganisms which developed antibiotic resistance, humanity is once again facing a major threat of many incurable infectious diseases. Drug resistant infections are difficult to treat and have resulted in an increase in medical costs and mortality in recent years. In fact, drug resistance has turned out to be one of the world's most pressing public health problems of today. Confirming a bacterial infection, selecting the right antibiotic for the infection and educating patients about the need for taking therapy as prescribed by physicians are considered critical in treating infectious diseases. Bacteria can become resistant in several ways and all of which involve changes in their genetic material. These altered genes enable the bacteria to either destroy the antibiotic or block its ability to inhibit bacterial growth. Repeated and improper use of antibiotics are two main causes for increase in resistant bacteria world over. It is estimated that up to 50 per cent of antibiotic prescriptions given in the community settings are not actually needed.
Now the issue is how the governments of countries and the global pharmaceutical industry have taken this new medical challenge. The pharmaceutical giants have given up research to find new molecules for infectious diseases long back as they found that it is much more profitable to bring out new drugs for life style diseases like diabetes, cancer, hypertension, mental disorders, etc. And these diseases are spreading fast among all sections of people across the continents. No new drugs were developed by pharmaceutical industry for drug resistant TB, malaria and many other infections for several decades. This is causing serious concern to the governments and patient communities of several nations. While no national governments have taken any bold initiatives to counter this new global threat, the US government has launched a major initiative in this regard by framing a new legislation namely Generating Antibiotic Incentives Now (GAIN) Act. The GAIN Act has outlined various incentives meant to spur antibiotic drug discovery and approval which can influence the pharmaceutical industry in the US. The companies developing a new antibiotic will be eligible for a fast track status. This will increase the level of communication between the US FDA and the company, reducing the time required for filing a New Drug Application. The new antibiotic application will be qualify for priority review, thereby shortening the FDA review period from ten to six months. Once approved, the new antibiotics would receive five additional years of market exclusivity. These incentives may not be sufficient incentives to attract large pharma companies to revive its antibiotic R&D but they certainly increase interest among smaller companies with new antibiotic pipelines. The focus of drug research among Indian companies also need to be changed as India is facing the problem of antibiotic resistance. Currently the top ten Indian pharma companies are spending Rs. 3000 crore or more every year on new drug research but it is mostly to find new molecules for treating life style diseases. Unless a shift in the focus of drug research is brought in now, people in India may have to depend on the US and European drug companies once again to get new generation antibiotics in future.