Last month, Pharmabiz came out with a study of R&D expenditures of India’s top 25 pharmaceutical companies during 2014-15. It shows that there has been a 28.8 per cent growth in R&D spending at Rs.9,250 crore by these companies during the last year which is almost 7 per cent of their combined turnovers. The research spending of Indian pharmaceutical companies has been steadily growing over the last 20 years. In terms of percentage of R&D spending to sales of these companies, it is not that impressive when compared to the R&D spending of 15 per cent on sales of international companies. The research spending of Indian companies has been mainly targeted at developing cost effective generics, biosimilars and novel drug delivery system products. And they have been successful at that considering the growth in the number of filings of ANDAs and DMFs in the US and other developed countries. For the nine months ended September 2015, Indian companies received final approvals for 113 ANDAs from US FDA as against 122 final ANDAs approval during the year ended December 2014. The companies which received a good number of ANDAs this year are Aurobindo Pharma, Lupin, Glenmark Pharmaceuticals, Alembic Pharmaceuticals, Jubilant Life Sciences, Natco Pharma, Sun Pharmaceuticals and Hetero Labs.
Among all companies, Sun Pharma remained on top in R&D spending during 2014-15 with its consolidated research expenditure increasing by almost 87 per cent to Rs 1,856 crore from Rs 993 crore in the previous year. Dr. Reddy’s and Lupin are the other two major Indian companies which have been spending heavily on R&D. Despite such huge spending on research every year, Indian companies have been successful only in filing ANDAs and DMFs in the US and not been able to bring out any new molecule into the market so far. Some of the new molecular entities of these companies are in pre clinical or in clinical trial stages. They will be incurring much more expenditure for the clinical trials of these drugs and still may not get them to launch in the market. The focus of new drug research of these companies has been mainly in areas like diabetes, cancer, skin diseases, etc. where quite a few effective drugs are already there in the market. At the same time, there has been no serious attempt by Indian pharmaceutical companies to direct their research spending for finding new drugs for treating TB, malaria and many orphan diseases. TB and malaria continue to kill several lakhs of people in India and many Asian and African countries every year as the existing drugs are ineffective to treat these ailments. And there are no drugs for treating many of the rare diseases across the world. Indian pharmaceutical companies need to consider these priorities also in drug research while they claim to spend such huge amounts for research & development activity.