R&D in Pharma

Context:
  • Issues which are halting the progress of Pharmaceutical Sector in India
Biggest Challenge
  • Lack of sufficient funding and inadequate allocations by the government
  • At 0.83% of GDP, India is among the countries with the lowest investment in scientific research
An industry study of 2016
  • It examined the extent to which public investment, IPRs and drug pricing policies in 56 countries actively contribute to or detract from innovation in global life-sciences.
  • India ranked among the lowest (in the bottom five) due to weak IP protection, lack of data protection for biologics, low investment in R&D and price regulations
  • All of these contribute to reduced revenue and therefore reduced future investment in biopharmaceuticals
Investment Attractiveness:
  • India ranked No.19 in this 28-nation survey
  • Five metrics were used to determine these rankings
(1) scientific capabilities and infrastructure
(2) clinical research conditions and framework
(3) regulatory system
(4)  market access and financing
(5) 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
Chances ahead:
  • Rising cardiovascular problems and other chronic diseases, make India 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
  • This population will cause a greater demand for different types of pharmaceutical drugs
Low R&D investment:
  • The R&D investment as a percentage of sales has been rising for several years and now stands at 6% for some Indian companies
  • But it 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
Issues with Indian Education System
  • 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(capability) 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
Need of the hour:
  • Four pillars for strengthening the innovation environment in the biopharmaceutical industry
(1) human resources
(2) finances
(3) infrastructure
(4) 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.
Way Forward:
  • In order to support consistent innovation, investment has to increase substantially before any tangible outcomes can be envisioned
  • A strong patent system and robust IPRs 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