Domestic manufacturing of key ingredients must be ramped up to reduce dependence on other countries: Sudarshan Jain, IPA

Published on 11 March, 2022 / Published by Financial Express

According to an IBEF report, the Indian pharmaceutical market is set to grow at a CAGR of 37% from 2020-2025 and is expected to reach US$ 50 billion. Also, India is the world’s largest producer of generic drugs globally and supplies over 50% of world’s demand for various vaccines. India ranked 3rd in terms of pharmaceutical production by volume and 14th by value. India’s position is getting strengthened in the global pharmaceuticals sector. The government of India has recognized the vital role of the pharma sector in realizing India’s vision of ‘Atma Nirbhar Bharat’. In an exclusive interaction with, Sudarshan Jain, Secretary General, Indian Pharmaceutical Alliance said that the Indian pharma industry is ready to expand in terms of innovation, research and development capabilities to offer cutting-edge products at competitive prices.

What are the urgent interventions needed to fuel innovation and R&D in the sector?

Today India has a strong starting position in generic drugs, but India will need to move up the value chain and get into the innovation space which accounts for 2/3rds of the total global market. The key interventions that are critical are:

Creating an enabling regulatory environment in the country that encourages and enables innovation and research in the drug discovery and development of the pharma sector. For instance, having a ‘single window system’, elimination of multiple regulatory bodies, establishing detailed guidelines, ongoing dialogue between the regulator and the industry , among others.

Incentivizing and funding research: Explore mechanisms to incentivize private sector investment in research and evaluate various funding mechanisms – research-linked incentives Budgetary support, Venture capital, fiscal and non-fiscal incentives

Enabling Industry-academia collaboration to promote industry-oriented research. Strong policy framework for collaboration for moving academic discoveries into the commercial. Setup of strong governance framework to build accountability through strong program management; Development of conducive external ecosystem through setup of independent bodies to catalyze collaboration. It will require infrastructure support such as technology transfer offices, centers of excellence to harness academic talent and development, incubation centers, provision for exclusive licensing deals and more

Monitoring progress and impact: An “Innovation index” can be a holistic yardstick to track progress across the building blocks, course correct as required and assessing the deliverables

What are the key growth drivers for the Indian Pharma sector post the pandemic?

The Government of India has also recognized the vital role of the pharma sector in realizing India’s vision of an ‘Atma Nirbhar Bharat’. The sector is now ready to expand its innovation, research and development capabilities to offer cutting-edge products at competitive, affordable prices. If we talk of key growth drivers – the industry needs to build capacities across business functions to help India achieve its vision of growing its pharmaceutical industry to $130 bn by 2030. Consolidating extant export markets and exploring newer markets thereby expanding global footprint will be important. More and more pharmaceutical companies need to venture into specialty and innovation-areas such as biosimilars, complex generics, novel biologics, customized medicines, preventive medication and in addressing unmet patient needs to expand our market.

As the industry’s product portfolio shifts towards more complex products, the demand for operations and highly skilled personnel for the manufacture of these products will also increase. Expanding and upskilling the talent pool to handle complex technologies will become crucial. An enabling policy environment is required that encourages drug discovery and new research, streamline drug development processes by avoiding multiple levels of regulatory approval, facilitating fast-track approvals and new funding sources to encourage private sector investment in R&D and innovation. An overarching core multi-sectoral committee involving key stakeholders should be created to enable thought leadership, cross-stakeholder dialogue, collaborations, partnership models and integrated initiatives.

What are your views on FTA with Australia? What are the new markets India can look at?

India and Australia have signed a Comprehensive Economic Cooperation Agreement (CECA) with the aim of increasing bilateral merchandise trade. It will further cement the already deep, close and strategic relations between the two countries. This agreement contains scope for enhancement in bilateral trade through improved access.

One of the major positive steps forward provided by the Agreement is that the Therapeutic Goods Administration (TGA) of Australia will utilize reports from a comparable regulator as recognised by it in relation to the pre-market evaluation of products. Further, the TGA may utilize Good Manufacturing Practice (GMP) inspection reports from regulatory authorities recognised by it as a comparable regulator in relation to the quality assessment of manufacturing facilities in India. This opens the pathways for fast-track approvals for Indian pharmaceutical products and manufacturing facilities having approvals from at least one of the Regulatory Authorities/ reference countries. This is an important milestone as Indian companies approved by Comparable Overseas Regulators (COR) will have expeditious approvals, and thereby, rapid market access in the Australian pharmaceutical market.

What are the new funding avenues that can be explored to encourage private sector investment in R&D?

The Government has a key role in facilitating funding access to enable India to elevate R&D to the level of advanced countries. Firstly, the regulatory bottlenecks to funding must be dealt with; and a focused strategy is important. Also, the risks associated with investing in R&D are high and many organizations do not have the capacity to garner funds on their own. An ecosystem view is necessary for funding as well, because after the early-stage, pharma companies, investors, and the equity market need to support late-stage funding. The Government can also provide direct support through tax deduction, subsidies and research grants similar to what is being initiated in other countries. Research-Linked Incentive Schemes can also be beneficial to drive increased investment in innovation. A recent example is a statement by our Health Minister, on how amid the pandemic, the PLI scheme by the Government helped India reduce imports and initiate production of more than 35 drugs in India.

Also, financial markets could be supported in offering incentives for investing in innovation such as private equity, innovation bonds, crowdfunding and P2P lending, among others. Further, as an indirect enabler, it is critical to enhance the credibility of Indian talent to encourage investors to fund innovation in India. It is important to leverage our skills in data and digital and move from classical research to new technology platforms and digital analysis.

What kind of policy changes will help in the growth of domestic manufacturers?

A fundamental enabler for a vibrant innovation ecosystem is a strong and efficient regulatory setup which facilitates a ‘single window system’, eliminates multiple regulatory bodies, establishes detailed guidelines and fosters dialogue between regulators and the industry. The Government could create immediate and direct impetus through initiatives such as research-linked incentives, grants, subsidies as well as higher tax aids for R&D. Further, financial markets could be supported in offering incentives for investing in innovation through varied, non-traditional pathways. In addition, there is a need to strengthen academic industry linkages, collaborating across institutions and sectors and building supporting infrastructure.
API requirements must be given top priority – Domestic manufacturing of key ingredients for vaccines and medicines must be ramped up to reduce dependence on other countries. Investors and innovators are keen to work together to overcome this challenge. The Government has also taken some important steps to fulfil India’s domestic healthcare needs and help the industry to be self-reliant, utilize technology and boost volumes through production-linked incentive schemes for APIs, Key Starting Materials (KSM) and intermediaries, among others, with a sizeable financial outlay of 6940 crores.

Involvement of the Department of Biotechnology (DBT), Department of Science and Technology, Council for Scientific and Industrial Research (CSIR) to foster ‘Make in India’ is of critical significance. Continuation of the national Bio-pharma Mission, and Mission Covid-Suraksha, conceptualized by DBT, is necessary, as it turned out to be a great facilitator for innovation in vaccines. Sustained focus on National Biotechnology Development Strategy (2021-25) which will also be one of the catalysts for change, going forward. The formation of innovation and API clusters should help to catalyse these areas going forward.

How important is it for the Indian pharma sector today to match global quality standards and benchmarks?

Driving excellence in pharma quality through capability building, global benchmarking and sharing best practices is one of the focus areas of IPA. The IPA has had a focused Quality Forum since 2015. IPA is driving several initiatives around quality standards in pharma manufacturing. This includes helping Indian pharma manufacturers to be the global benchmark in quality, be the conduit of change in the industry through leadership, knowledge development, best practice sharing and engagement across the industry. We engage in benchmarking activity with companies, share best practices on pertinent topics of quality and conduct capability building programmes such as advanced GMP workshops every year.

We have come out with several guidelines and best practices documents – such as Best Practices on Cleaning Methodology and Validation, Best Practices in Media Fills, Focus on First Cycle Approvals of ANDAs and Visual Inspection of Sterile Products. Our Quality Conference is held every year where regulators from developed countries and India along with company representatives exchange knowledge on the latest developments and standards. While the industry is moving towards complex products, driving automation and integrating new technologies, the current good manufacturing standards (cGMP) are evolving rapidly across the globe. IPA is committed to quality. The thrust is to position India being recognized as the Pharmacy of the World, providing affordable and quality medicines. We want to move up the value chain from “Make in India” to “Make and Discover in India”.

This article was originally published on Financial Express