Last week Piramal Group came out with a stunning announcement of stopping its new molecular research in India, an activity the Group actively pursued without much success for the last several years. Piramal Group, one of the strong advocates of new drug research along with half a dozen other leading Indian pharmaceutical companies, had boasted for some years that they could bring out new drug molecules much faster and cheaper than multinational drug companies. None has so far succeeded in achieving this goal after spending thousands of crores of rupees since nineties. One after another almost all of them exited from this high risk but a highly responsible activity. The Piramal Group converted its R&D establishment into a separate company sometime in 2007 as it had a pipeline of early-stage discovery projects. The research company was then merged back with the Group in 2011 after the sale of its domestic formulations business to Abbott in 2010. The company’s most promising late-stage biological drug for cancer then failed in phase II clinical trials in 2012. Since then, it could not take any other strong drug candidates forward to the advanced stages. Like Piramal Group, Dr Reddy’s Labs and Ranbaxy also tried to build drug discovery as a core business but faced setbacks. Dr Reddy’s had formed a separate company, Perlecan Pharma Ltd, for drug discovery, but closed down after its two lead diabetes molecules failed in late-stage trials, although these drug candidates were licensed to Novo Nordisc. Ranbaxy Laboratories, which developed a malaria drug in partnership with the Indian government at its R&D centre but could not market until the company was taken over by Japanese buyer Daiichi Sankyo Co. Ltd. Glenmark Pharmaceuticals, Sun Pharma and Lupin are the three other companies still pursuing discovery research in the country but without any big breakthroughs.
Like Indian companies, most of the research based international drug companies in the US and Europe are also gradually coming out of new drug research and getting into marketing of generics in a big way. Probably one reason for this trend is the difficulty the drug companies are finding to get new drug approved for marketing from the US FDA and European drug regulators. These leading regulatory authorities have, no doubt, intensified their scrutiny of adverse reactions of new chemical entities during clinical trials for more than a decade now making drug approval process very difficult. Thus, very few new drugs are getting into the market for the existing and new diseases. It is a fact that for TB and malaria no new drugs have come out from the research labs of international pharma companies for the last several decades although these two ailments continue to kill several millions of people in Asia and Africa. What is disturbing the governments of developing nations, therefore, is not only the prospects of a drop in the availability of new drugs for infectious and lifestyle diseases but the growing resistance of old drugs to treat prevailing diseases. This should be a matter of serious concern for World Health Organization and governments of poor nations.