Thrust on research, AI, blockchain and patent laws — the draft of the National Pharmaceutical Policy aligns with the Amrit Kaal Vision@2047, envisaging a change in India’s pharma story from a volume-based industry to value-based.
The draft policy has been rolled out for inputs from stakeholders. Once approved, a high-level task force will be set up in the Department of Pharmaceuticals under the Minister for Chemicals and Fertilizers, Mansukh Mandaviya, to guide and review the implementation of the policy.
According to the 21-page policy document, the task force will draw upon resource persons from departments and organisations related to the implementation.
The document also states that the policy will be supported by a 10-year strategy and action plans that will spell out the policy.
From bringing a single-window clearance system, simplifying the licensing system, creating ease of doing research and enhancing the role of Indian Standards like BIS, the policy aims to make businesses easy in India.
In an important move, the policy also seeks to establish mechanisms that prevent price manipulation and arbitrary increases — saving consumers from harsh spends on medical purchases.
“This approach not only assures citizens of affordable healthcare options but also boosts investor confidence as it brings stability to the market,” the policy document said.
In crux, the policy says it cultivates an environment where Indian pharmaceutical companies can thrive on the global platform, excelling not only in terms of cost-efficiency but also in quality, innovation, and ethical standards.
How does policy align with Amrit Kaal Vision@2047?
The draft policy, released by the Department of Pharmaceuticals on October 31, carries a vision titled “Enhance Health Access for Everyone: Leading the Way in Pharmaceutical Excellence.”
The document says it “aspires to establish India as a global leader in pharmaceuticals”.
Supported by world-class infrastructure and advanced research and development to invent cost-effective healthcare solutions, the policy aims at promoting a healthier and prosperous nation contributing to “global health equality” aligning with the Amrit Kaal Vision@2047.
With a powerful combination of cost-efficiency, quality, and scalability in the pharmaceutical sector, the Centre, through the policy, aims to intensify its commitment to enhance the industry’s image as the provider of high-quality generic medications at a significant production scale and affordable rates.
Additionally, the focus is on expanding India’s capacities beyond volume to value, “primarily relying on our capacity to stand out through innovation in the coming 25 years”.
According to the document, the top five focus areas described as “pillars” are fostering global pharmaceutical leadership, promoting self-reliance, advancing health equity and accessibility, enhancing regulatory efficiency in the Indian pharmaceutical sector and attracting investments.
Use of digital tech in pharma
According to the document, the policy recognises that digital technologies like telemedicine, electronic health records, and data analytics can transform healthcare and drug innovation. It plans to use artificial intelligence, machine learning, and blockchain to enhance drug safety, supply chain management, and regulations.
It said in the knowledge economy, the existing mindset has to change from a “siloed approach towards health data” to a new vision of “convergence of drugs, devices, and data”.
The policy foresees a future in which digital platforms make it easy to access healthcare services, provide real-time tracking of drug quality and availability, and empower consumers with the information they need to make informed choices.
The policy also aims to strengthen Intellectual Property laws. It says the policy is committed to strengthening the Indian Patent Office and facilitating patent applications by “fast-tracking the examination of evidence and building a tracking mechanism for the grant of patents”.
“By reinforcing IP safeguards, we not only incentivise pharmaceutical companies to invest in ground-breaking research but also create an environment conducive to attracting foreign investments and collaborations,” it said.
Greater focus on R&D & FDI
Aligning with Prime Minister Narendra Modi’s “Atma Nirbhar Bharat”, the policy recognises the importance of promoting research and innovation in new developments, streamlining regulatory approvals, and enhancing manufacturing capabilities to support self-reliant India and maintain a competitive global supply chain.
The National Pharmaceuticals Policy aims to make “substantial contributions to India’s GDP” by boosting local manufacturing, enhancing economic competitiveness, and fostering self-reliance.
Also, the policy says that “it strives to position India as a global leader in the manufacturing of innovative and cost-effective medications, guided by the principle of ‘Vasudhaiva Kutumbakam’.”
Moreover, understanding the importance of foreign direct investments (FDI), the policy provides well-defined rules and transparent processes for foreign investors interested in setting up or growing their presence in India’s pharmaceutical industry. This encourages the transfer of technology, sharing of knowledge, and infusion of capital.
“Aim to offer a welcoming and conducive climate for foreign investors, enabling them to contribute to the growth and global prominence of India’s pharmaceutical industry,” said the document.
Fair pricing & aligning international drug standards
The policy encourages private sector investment through risk-based financing and venture capital support along with various other models.
It also suggests an important and critical point of implementing a rational and transparent drug pricing mechanism to ensure fair pricing of medicines, balancing industry sustainability with affordability for patients.
“While ensuring that essential medicines remain affordable to all, the policy seeks to strike a balance that encourages fair pricing without stifling innovation,” it said.
“By monitoring and regulating drug prices, it aims to reduce the financial burden on patients while maintaining a conducive environment for pharmaceutical companies to thrive.”
With an objective of protecting India’s image in the global arena, the policy aims to align India’s regulatory standards with international best practices that balance innovation with safety, reducing compliance burdens, and ensuring that pharmaceutical companies can seamlessly adhere to global standards.
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