India’s Pharma Vision 2020 — Are We There Yet?
With 2020 upon us , there is global anticipation as to how many of India’s Pharma Vision 2020 targets have been fulfilled. Pharma Vision 2020 was the Indian government’s commitment to make India a global leader in end-to-end drug discovery & development as well as production of low-cost generic medicines. The aim was to drastically grow the pharma industry this decade to meet the increasing demands brought about by — aging population, rise in chronic diseases & our changing lifestyle and increased incomes
Through the decade the pharma sector has seen continuous growth with turnover at US$37.2 billion, exports contributing US$19.14 billion — both in 2019 — and the domestic market in 2018 standing at US$18.12 billion. As of 2019 (Dept. of Pharmaceuticals, Govt of India) the total size of the industry (including drugs & medical devices) is around US$43 billion (Rs.3,01,000 crore) and is currently having a growth rate of 7–8% in drug sector and 15–16% in medical device sector. According to Pharma Vision 2020, the Indian pharmaceutical industry is pegged at US$50 billion mark by end of 2020 with expectations of a CAGR of 22%.
Imitation to Innovation
Although there has been continuous growth , the pharmaceutical industry is now fraught with challenges and opportunities .The production of generic drugs remains India’s bread and butter . India supplies affordable generic drugs to millions of people around the globe and operates more than 250 US Food and Drug Administration (FDA) and UK Medicine and Healthcare products Regulatory Agency (MHRA) approved plants. While generics continue to be the key driver in India’s pharma growth there is a dire need for Innovation. If Indian pharma is to help propel the country towards economic development it needs to be producing a lot more value than it does now and slowly shift its focus towards growing an innovative bio-pharmaceutical sector. The country’s relatively liberal regulations make it a promising destination for stem cell research and therapeutic R&D.
India’s well established base in Information Technology & Computer Sciences can help it emerge as a leader in transforming pharmaceutical innovation &large-scale manufacturing . As digital devices integrate our lives, there is a fundamental shift in the patient-doctor relationship. Patients are more informed about their diseases and treatment options as compared to 5 years ago. This signifies how the profile of the average Indian patient is changing and how we need to adapt to the demands of the new age patient.
The role of Big Data in bio-pharma will play a major role in the transition to innovation for patient-centricity. Analytics can heavily drive innovation &value to optimize and improve the efficacy of clinical trials. The importance of having more inclusive clinical trials has been a pressing matter as lack of diversity & inclusion leads to a faulty representation of the population. Big Data can effectively help identify niche patient populations &significantly reduce costs and speed up trials.
Vaccine Diplomacy — Immunity to War ?
In an article this month Kiran Mazumdar Shaw, Chairperson of Biocon said ‘Vaccine Diplomacy could be a game changer of India’s foreign policy’. India is already known as the pharmacy of the world . Indian manufacturers account for 60% of vaccines supplied to UNICEF’s global immunization programs. The multinational race for a Covid-19 Vaccine might not only save lives but also prevent conflict.
At the peak of this pandemic in Europe, both Italy and Spain accused Germany of denying ventilators to them during their times of need. US was also accused by a few countries of diverting supplies . Eventually over these 4 months the global focus has shifted to controlling this pandemic through vaccine development and ensuring its availability globally at the earliest.
The idea of vaccine diplomacy isn’t new but is as old as vaccines themselves. In 1798 Edward Jenner published his research on the use of the cowpox virus to vaccinate against the human smallpox virus. A decade later Napoleon ordered for vaccine departments to be established in all major cities of France. Jenner observed in a letter to the National Institute of France — “The sciences are never at war”. India can commit its critical resources to accelerate the development of a new vaccine . Along the way to vaccine diplomacy, we might just acquire an immunity to war.
India’s API Dependence on China
India’s import dependence on China for APIs has become a significant threat to its healthcare supply chain. It’s over dependence on China poses threats to the nation’s health security as some of these APIs are critical to reducing India’s communicable disease burden. Over 63% of India’s pharmaceutical imports are API and intermediates and almost 70 per cent of it comes from China . Intermediaries and APIs are crucial chemical compounds (raw materials) required to manufacture formulations or medicines.
In the early 90’s, India was completely self sufficient to formulate and produce APIs. But in the last two decades it was considered viable to import APIs from China owing to low profit margins. With this over-dependence on China for bulk drugs and intermediates , the government’s aim to achieve Pharma Vision 2020 seems bleak. Given the unstable political relationship with China globally, the risk of being dependent on China is more than ever & requires the Pharma Industry to be self-sufficient.
In response to the COVID-19 crisis and the increased emphasis on ‘Make In India’ and ‘Vocal for Local’ , India’s Union Cabinet has approved an investment package worth $1.3 billion to boost the country’s pharma and API production and cut dependence on China. This is a major step in the journey to a self-sufficient healthcare ecosystem in the country.
Even though the Indian pharma industry growth has been impressive over the decade, it has fallen short of fulfilling Pharma Vision 2020. True innovation focusing on end-to-end drug delivery and development infrastructure is missing. The Indian academic system is in place and has commendable talent but there are not enough incentives to enter the R&D space. The Indian Pharmaceutical Alliance (IPA), which submitted its Vision 2030 in July 2019 underlining plans to make India into an innovation leader by building a strong innovation pipeline, has urged the government to set up a large fund to boost technological innovation in pharma, biotech and healthcare start-ups. But given the high risk associated with the current domestic and global economic climate , India’s growth towards a bio-pharma innovation leader is likely to be slow.
