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vision by focus on proposed thematic pharmaceuticals in all its dimensions, By streamlining regulatory processes
areas outlined in the policy priorities including, investments, access to tech- and encouraging research-driven in-
and interventions. The policy acknow- nology, research and development, novation, this policy not only ensures
ledges the need for greater emphasis development of human resources, and the availability of safe and affordable
on encouraging R&D and innovation strengthen regulation and policy by medicines, but also bolsters India’s
in emerging trends, harmonisation in indicating a list of time-bound quantita- position as a global pharma leader. It paves
regulatory approvals and strengthening tive and qualitative goals aligned with the way for a more resilient and equita-
manufacturing capacities for Atmanirbhar the Hon’ble Prime Minister’s vision of ble healthcare system, where every citi-
Bharat and supply chain to sustain Amrit Kaal. zen, regardless of their socioeconomic
global competitiveness while meeting background, can access cutting-edge
health goals. By focusing on research- Need for the policy pharmaceuticals, ultimately fostering a
driven innovation, collaboration, and India, often referred to as the ‘Phar- healthier and more prosperous India for
adherence to global standards, the in- macy of the World,’ boasts a thriving all. This policy rekindles the vital need
dustry can maintain its reputation as pharma industry known for its cost- to prioritise sustainable innovation that
a reliable supplier of affordable and effective generic drug production and aligns with global standards while plac-
high-quality medicines. robust export capabilities. As the coun- ing a paramount focus on the quality
try aspires to secure its place as a global and safety of pharma products.
NPP 2023 aims to provide a sup- leader in healthcare, it is imperative to
portive framework for the industry to have a comprehensive policy frame- The industry operates in a complex
flourish, setting the stage for a promis- work that can effectively address the and dynamic environment, marked by
ing future where India remains a global multifaceted challenges plaguing the rapidly evolving technologies, global
leader in pharmaceuticals. The policy pharma sector. This policy serves as a regulatory standards, and increasing
aims to make substantial contributions guiding light towards achieving health- quality expectations. The COVID-19
to India’s GDP by boosting local manu- care equity, accessibility, affordability, pandemic has brought to the forefront
facturing, enhancing economic com- and quality for all citizens. It facilitates the role of innovation in expanding
petitiveness, and fostering self-reliance. the streamlining of regulatory processes, the scale, access and affordability of
It also underscores the positive impact promotes research and innovation, and healthcare products. It has also empha-
of affordability of drugs in improving ensures ethical practices within the sised the urgency of reinforcing the
the living standards of society, address- industry. current healthcare infrastructure.
ing critical areas such as accessibility,
equity, focus on innovation, streamlining Despite strong fundamentals, Indian The pandemic served as a reflection,
regulatory hurdles. Recognising the pharma industry faces various challen- revealing our shared vulnerabilities in
pivotal role of talent and skills, the ges, including: the inability to implement proactive
policy places emphasis on diversity High degree of import dependence measures for robust pandemic preven-

and inclusion as core tenets of enabling on Active Pharma Ingredients tion, preparedness, and response (PPR)
employment opportunities and deve- (APIs) and Key Starting Materials at an early stage. In order to incentivise
loping a skilled workforce to support (KSMs); the global and domestic players to
the growth of the Indian pharmaceuti- Relatively low pace of development enhance investment and production in
cals ecosystem. of biologics, biosimilars and other diversified product categories, a well-
emerging products/trends; designed and suitably targeted inter-
In essence, NPP 2023 recognises Regulation inefficiencies; vention is required to incentivise pro-

that its true potential lies not in isola- Lack of skilled human resource; and duction of specific high value goods
tion, but in its ability to weave a tapes- Access to funding for innovation. such as biopharmaceuticals, complex
try of collaboration and synergy, creat- generic drugs, etc. R&D in the pharma
ing a stronger, more resilient healthcare At present, low value generic drugs sector is a capital-intensive, high- risk
system that serves the diverse health- account for the major component of activity with heavy burden of regula-
care needs of the nation while creat- Indian exports, while a large proportion tory oversight, high rates of failure,
ing global champions out of India. Its of the domestic demand for patented and long product development cycles.
primary strategy is to inform, clarify, drugs is met through imports due to Furthermore, India’s pharma manufactur-
strengthen, and prioritise India’s key lack in high value production along ing will have to shift from the existing
goals and parameters in shaping the with the necessary pharma R&D. mindset of focussing on “exceptional

178 Chemical Weekly November 21, 2023

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