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Approach Paper on Draft National Pharmaceuticals

Policy 2023

he Department of Pharmaceuti- several renowned pharma educational (PTUAS), National Policy on Research &
cals, Ministry of Chemicals and and research institutes and the robust Development & Innovation in Pharma-
TFertilisers, recently released support of allied industries. MedTech Sector, and Scheme for
an Approach Paper on Draft National Promotion of Research & Innovation
Pharmaceuticals Policy 2023 (NPP The Indian pharma industry has in Pharma MedTech Sector(3), aim to
2023). played a key role in driving better health create an ecosystem for innovation and
outcomes across the world by being a drive better health outcomes.
The process undertaken for the large and reliable supplier of affordable
drafting was end-user and stakeholder and high-quality generics. The vaccine One of the key drivers for growth
led. Individuals with distinct roles and industry in India has proven its capa- of the Indian pharmaceuticals indus-
responsibilities in the pharmaceuti- city for manufacturing at scale (catering try would be expansion of the indus-
cal ecosystem were consulted for their to more than 60% of global vaccine try’s presence in the innovation space.
thoughts on the current state of play, demand)(2). With a potential to grow up Building this presence would gene-
key challenges and priority areas fol- to US$120-130 bn over the next decade, rate substantial health benefit for India
lowed by possible interventions and the Indian pharma ecosystem needs by enabling development of innovator
recommendations to address the chal- holistic set of policy interventions to drugs, New Chemical Entities (NCEs),
lenges and progress towards a desired help leapfrog and radically strengthen New Biological Entities (NBEs),
end-state. These consultations saw partici- its position in the world market. strengthening response to Anti-Micro-
pation from diverse groups consisting bial Resistance (AMR), create a large
of industry/academic experts and re- Armed with the triple advantage of pool of white-collar jobs and increase
search professionals, Senior Govern- cost, quality, and scale in the pharma industry’s contribution to the Indian
ment officials and other stakeholders sector today, the Government of India economy and enhance India’s differen-
who act as catalysts in the interplay of is placing greater than ever emphasis tiation versus other developing eco-
various public and private bodies for on both strengthening the industry’s nomies.
nurturing a vibrant pharmaceutical reputation as a supplier of good quality
ecosystem. generic medicines at high production In an era of rapid technological
scale and at affordable prices, as well advancements, evolving global standards,
Comments on the policy are invited as to extend our capabilities beyond and burgeoning healthcare demands,
until November 30, 2023 and may be volume to value, which will depend the National Pharma Policy (2023)
sent to vaibhavraina.dop@govcontrac- largely on our ability to differentiate (NPP 2023) serves as a comprehensive
tor.in. through innovation in the next 25 years. framework to address the challenges
Over the last few years, recognising faced by Indian pharma industries and
INTRODUCTION the need to ensure drug security, reduce provides definitive policy interventions
import dependence and build domestic to enhance the collective ecosystem.
Background manufacturing capacities, the Depart-
Indian pharma industry is the 3rd ment of Pharmaceuticals (DoP) has The Vision for the NPP 2023
largest in the world by volume with been implementing three PLI schemes encompasses five key pillars:
a current market sise of ~US$50-bn. for pharmaceuticals, medical devices, 1. Fostering global pharma leadership;
The country exports pharmaceuticals and APIs/KSMs/bulk drugs. Further, to 2. Promoting self-reliance;
to around 200 countries, including build infrastructure, to enable enhanced 3. Advancing health equity and accessi-
highly regulated markets such as USA, competitiveness of APIs, financial sup- bility;
UK, European Union, Canada, etc. port has been extended to States for 4. Enhancing regulatory efficiency;
and is widely known as ‘Pharmacy of setting up of three Bulk Drug Parks and
the World’(1). Besides largest number and four Medical Devices Parks. Other 5. Attracting investments.
of USFDA-approved manufacturing schemes including the Pharma Techno-
plants outside of the US, India also has logy Upgradation Assistance Scheme The policy aims to support this

Chemical Weekly November 21, 2023 177

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