India’s pharmaceutical research problem
The recent agitation by scientists, asking for more allocation of funds, underlines the need to focus on science and innovation as a priority area. One of the biggest constraints to advancing scientific research is the lack of sufficient funding and inadequate allocations by the government.
At 0.83% of gross domestic product (GDP), India is among the countries with the lowest investment in scientific research. While India boasts of several innovations in the non-formal sector, breakthrough scientific research, especially in healthcare, has been markedly lacking. New medicines, devices, diagnostics, patient aids and monitoring tools are mostly imported, often coming to India several years after they are available to patients in the developed world.
An industry study of 2016 examined the extent to which public investment, intellectual property rights and drug pricing policies in 56 countries actively contribute to or detract from innovation in global life-sciences. Not surprisingly, India ranked among the lowest (in the bottom five) due to weak intellectual property protection, lack of data protection for biologics, low investment in R&D and price regulations, all of which contribute to reduced revenue and therefore reduced future investment in biopharmaceuticals.
India also ranked No.19 in a 28-nation survey of biomedical investment attractiveness of countries, with an overall score of 59 out of 100. Five metrics were used to determine rankings: scientific capabilities and infrastructure; clinical research conditions and framework; regulatory system; market access and financing; and effective intellectual property protections. India scored low on almost all metrics except for partial step-ups on scientific capabilities and infrastructure, and clinical research conditions and framework.
India’s growing economy, coupled with its changing “epidemiological profile” with cardiovascular problems and other chronic diseases, make it a strong candidate to become a future powerhouse of R&D and manufacturing in pharmaceuticals. In addition, clean water, rising incomes and better health infrastructure for the nation are contributing to an ageing population with a greater demand for different types of pharmaceutical drugs. Some of the leading domestic pharma manufacturers are emerging as innovators, both in-house as well as through external collaborations. Patients are also beginning to benefit from research advancement in the Indian industry. For instance, Biocon’s insulin product that can be consumed orally could provide relief from the burden of daily injections for millions of people with diabetes worldwide, including 67 million in India.
While these are early signs of success, the industry has a long way to travel. The R&D investment as a percentage of sales has been rising for several years and now stands at 6% for some Indian companies. This is still well short of the 20% typical of Western pharma companies. Moreover, innovation in chronic diseases and rare diseases has not yet taken off.
The education system is to blame as well, imparting theoretical knowledge with no emphasis on product development and application of theory. This leads to the deterioration of the knack for problem-solving and innovation. Those who manage to keep their enthusiasm alive for research have to deal with the lack of facilities or face delayed funding issues. Educational and academic institutions should be encouraged to participate in research programmes with funding from both the government as well as the private sector.
An October 2016 PwC report, “Unlocking India’s Potential For Leadership In Pharmaceutical Innovation”, highlights four pillars for strengthening the innovation environment in the biopharmaceutical industry: human resources, finances, infrastructure, and legal and regulatory framework. Each of these pillars needs a concerted focus and a long-term commitment from industry as well as the government. The environment to support the development of these verticals could emerge through our various government-led initiatives such as Skill India, Make in India, Atal Innovation Mission, etc.
However, in order to support consistent innovation, investment has to increase substantially before any tangible outcomes can be envisioned. More regulatory changes are required and Indian pharmaceutical companies need to be supported with more financial and social capital if we are to see meaningful drug research that can address the healthcare needs of India. A strong patent system and robust intellectual property rights environment is required to encourage research and to enable foreign pharma companies to bring new products to the market. Without the requisite investment and enabling policy environment, patients in India will continue to suffer due to lack of access to cutting-edge medicines and new diagnostics.
Short-term populist measures like imposing price ceilings do not contribute to improving patients’ access to innovative life-saving medicines and devices; a more holistic approach is needed. Without building a robust innovation and research platform, a top-notch educational and learning environment, and state-of-the-art research facilities, price control on medicines and devices could lead to serious concerns like delayed or absent access to innovative technology, continued rise in the cost of therapies and quality concerns across the spectrum of healthcare.
Ratna Devi is chief executive officer, DakshamAHealth, and founding member, Indian Alliance of Patient Groups. Comments are welcome at firstname.lastname@example.org
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