By Nikkhil K Masurkar
India exports pharmaceuticals to around 206 countries all over the world, with the US ranking as the top market followed by Africa and Europe. Over 60% of the world’s vaccination demand is met by the Indian pharmaceutical industry. The goods of the Indian pharmaceutical sector continue to enhance patient health outcomes globally, with an export value of $24.44 billion (2020–21). This has been made feasible by the government of India’s policy measures and the entrepreneurial spirit of the Indian industry.
The potential for further raising its exports is significant since the industry has the skills to produce high volumes and meet stringent quality standards and norms in key global markets. However, the government should also immediately initiate steps to boost R&D efforts in the pharmaceutical sector which in turn will help increase India’s exports.
Current Initiatives by the Government
The Government of India has recently introduced several steps for the advancement of R&D in the pharma sector, including the Umbrella Scheme of the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Government of India (DoP) namely ‘Scheme for Development of Pharmaceutical Industry’. This initiative aims to boost the effectiveness and competitiveness of the domestic pharmaceutical industry to help India’s position in the global market and ensure accessibility. This Scheme is comprised of sub-schemes, including, amongst others: (a) Production Linked Incentive (PLI) Scheme; (b) Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS); and (c) Assistance to Pharmaceutical Industry for Common Facilities (API-CF).
The PLI Scheme for Promotion of Domestic Manufacturing of Critical KSMs, DIs, and APIs in India seeks to increase domestic production and investment in the sector while promoting product diversification into high-value items in the pharmaceutical industry. The DoP also recently unveiled a Draft Policy to catalyse R&D and innovation in the pharma-medtech Sector with the aim of enabling an accommodating regulatory environment to speed up R&D and drive targeted funding, develop strong industry-academia collaboration in accordance with global best practices and create top-class infrastructure for innovation in the pharma-medtech sectors.
While these are certainly laudable efforts by the government, further thrust needs to be provided to accelerate R&D innovation, nurture valuable collaborations and foster policy reforms to shift from ‘Make in India’ to ‘Discover and Make in India’.
Moving towards Innovation in R&D in the Pharmaceutical Sector
Effective collaboration (between academics and industry specialists) and funding will be needed for innovation in the pharmaceutical industry. The following essential elements may be kept in mind to drive this:
Focus on innovation and R&D: To capture the global pharmaceutical market, the Indian pharmaceutical industry must climb up the value chain and concentrate more on innovation. The Indian pharmaceutical business must create a robust pipeline for innovation (with 5-7 new molecular entities and ten to twelve innovation launches per year by 2047). In order to achieve this, the industry is increasingly branching out into specialised pharmaceuticals and complicated generics. The goal is to increase Indian pharma’s importance in biologics, new drug development, and innovations, as well as its capacity in biological sciences, IT use, cell and gene therapy and other areas that are patient-focused.
Policy Reforms: A strong and effective regulatory framework, such as a “single window system,” the reduction of various regulatory bodies and the establishment of specific norms, are the keys to facilitating a thriving innovation environment. A key lesson from the pandemic is that it is essential to make sure that the regulator and the industry are in constant communication such as through more frequent industry meetings, pre-approval meetings and rolling reviews.
Initiating Valuable Collaborations: The key to advancing research activities during COVID 19 epidemic has been an effective collaboration between the government, academia and industry. During the pandemic, regular feedback, coordinated activities, sharing and persistent interaction between industry stakeholders and government agencies worked out successfully. This dialogue should continue in the future as well.
Road Ahead
Going forward, the sector will need to consolidate the current significant export markets and look into new ones in the future. In this situation, Indian missions abroad could be very helpful intermediaries. The policies in India would also need to concentrate on helping the industry to be competitive in the export market through the use of policy instruments like the Remission of Duties and Taxes on Exported Products (RoDTEP), PLIs and incentives for R&D and innovation in the pharmaceutical business.
Additionally, the Indian pharmaceutical industry should also pursue an aggressive collaboration strategy for growth, increase its investment in research and take the initiative in setting the pace for innovation, while the Indian government should provide the necessary incentives to encourage innovation and finance development.
(The author is a CEO, Entod Pharmaceuticals. Views expressed are personal and do not reflect the official position or policy of the FinancialExpress.com.)
