The Indian pharma sector occupies an important position in the global arena. If the right steps are taken and nurtured in the right way, India can become a leader in the global pharmaceutical market. The next achievement of the Indian pharma area should be focused on innovation.
However, to move beyond generics and bring innovation, the pharma industry will need policy support in the form of R&D tax breaks, patent law changes, and research talent.
Status of Indian Pharma Sector
India is the largest provider of generic drugs globally. It accounts for 50% of the global demand for various vaccines, the US has 40% for generics and the UK supplies 25% of all drug demand in India.
The Indian pharmaceutical market is worth around US$ 40 billion and pharma companies export an additional US$ 20 billion. However, this is only a small part of the US$1.27 trillion global pharmaceutical markets.
Globally, India ranks third in drug production by volume and 14 by value. India’s share of the global generics market is over 30%, but less than 1% in the new molecular unit space.
According to the Economic Survey 2021, the domestic market is expected to grow three times over the next decade. India’s domestic pharmaceutical market is estimated to be worth US$ 42 billion in 2021, which is expected to reach US$ 65 billion by 2024 and US$ 120 to 130 billion by 2030.
Problems associated with the Indian pharma sector
Lack of capabilities in the field of innovation: India is rich in manpower and talent, but still lags behind in the area of ​​innovation infrastructure. The government needs to invest in research initiatives and talent to develop India’s innovation. The government should support clinical trials and ‘subjectivity’ in some regulatory decisions.
Influence of External Markets: As per reports, India is heavily dependent on other countries for Active Pharmaceutical Ingredients (APIs) and other intermediates. 80% of APIs are imported from China. Hence India is prone to supply disruptions and unpredictable price fluctuations. In order to stabilize the supply, it is necessary to improve the infrastructure in the area of ​​internal facilities.
Quality Compliance Checks: India is under maximum Food and Drug Administration (FDA) monitoring since 2009; Therefore, continuous investment for up-gradation of quality standards will divert capital away from other areas of development and slow down the pace of development.
Lack of stable pricing and policy environment: A challenge has arisen from unpredictable and frequent domestic pricing policy changes in India, which have created a questionable environment for investment and innovations.
Need for innovation in indian pharma sector
The need of the hour was to bring a change in attitude and increase the use of technology. But now it is imperative that innovation is at the core of this business, and there is a critical need to embrace innovation if India wants to remain relevant in the global pharmaceutical sector.
India’s wider engagement in innovation will not only help the country but also create a sustainable source of revenue and lead to innovative solutions for healthcare needs.
This would result in a reduction in the disease burden in India (India-specific concerns such as the development of drugs for tuberculosis and leprosy do not receive global attention), new high-skilled jobs would be created, and by 2030, about 10 billion Americans There will be a situation of export in addition to the dollar.
Countries like China have already made considerable progress, leaving behind generic drug-based development.
challenges in the way of innovation
Innovation advancement in India faces various challenges, the main ones being: Complicated and lengthy approval processes (New drugs development in India takes 33-63 months, while in developed countries it takes 11-18 months for approval).
Lack of sound process guidelines (India lists only 24 guidelines compared to over 600 guidelines listed in USFDA).
Lack of transparency (the US has a well-established pre-submission process and a time-bound step-gate There is a process.
Inadequate capacity/capacity (the capacity of regulatory bodies in India needs to be substantially increased).
Limited governance (Indian authorities currently only track the number of applications and approvals).
A limited innovation mindset (Clinical India is at risk as compared to most global bodies in matters like acceptance of tests).
way ahead
Robust Regulation: To create an efficient regulatory framework with simplified procedures, sound guidelines, predictability, adequate capacity, and sound governance. India needs to reduce the approval time by 60% to remain competitive.
To provide sound financial support for industrial investment with government support through policies/incentives, direct government investment, and significant private investment.
India offers an attractive array of benefits where progressive policies for weighted R&D reduction, additional patent box benefits, and growth of innovation funding can attract more investment.
Industry-Academic Linkages: The need to build strong links between academia and industry with high-quality academic talent and infrastructure, industry-oriented research, and sound governance.
The US has passed the Beh-Dole Act to encourage academics to set up independent companies. India needs to establish world-class centers of excellence to attract global talent and support cutting-edge research.
Coherent Policies: There is a need to create a conducive policy landscape through coherent policies in disciplines such as research, technology commercialization, and Intellectual Property (IP).
Need for Innovation Centers to accelerate collaboration: Developing a suitable number of Innovation Hubs There is a need where academia, public R&D centers, industry, start-ups, and incubators are co-located.
Investment in other modern sectors: India should also focus on biotechnology and invest in it. India’s biotechnology industry (which includes biopharmaceuticals, bio-services, bio-agriculture, bio-industry, and bio-informatics) is expected to grow at an average rate of about 30% per year and reach US$ 100 billion by 2025.
FAQ
India is the largest provider of generic drugs globally.
