Bills & Policies That Shaped the Pharma-MedTech Industry in 2023

The Pharma-MedTech industry went through a series of transformative changes, thanks to the introduction, resubmission and revisions in the bills and policies. These legislative initiatives, aimed at fostering innovation, enhancing accessibility, and ensuring regulatory clarity, have played a pivotal role in shaping the course of Indian healthcare.

Let's delve into the key bills and policies that have left an indelible mark on the Pharma-MedTech ecosystem in the year 2023.

1. National Medical Devices Policy, 2023: Accelerating Growth and Innovation

Let's start with India's Union Cabinet approval of the National Medical Devices (NMD) Policy, 2023. This comprehensive policy marked a strategic commitment to propel the growth of the medical devices sector.

Focused on accessibility, affordability, quality, and innovation, the NMD Policy outlined a roadmap to streamline regulations, boost infrastructure, foster research and development (R&D), attract investments, and create awareness about the Indian medical devices sector.

With a 1.5% share of the global medical devices market valued at $11 billion, India established itself as a significant player in the Asia Pacific region. The policy aimed to position India as a global hub for medical devices by aligning with key missions such as patient-centred care, preventive health, and skilled workforce development.

Under the NMD Policy, the Production Linked Incentive (PLI) scheme was introduced to incentivise local production, complementing the government's initiatives to establish medical device parks in Himachal Pradesh, Madhya Pradesh, Tamil Nadu, and Uttar Pradesh.

Focusing on research, innovation, and quality, the policy set the stage for India to harness its strengths in the medical devices sector.

2. Pharmaceutical and Medical Devices Industry Policy 2023: Fostering Growth in Uttar Pradesh

Uttar Pradesh took a decisive step by passing the Pharmaceutical and Medical Devices Industry Policy 2023. Under the leadership of the Chief Minister's office, this policy implemented a single window clearance process to streamline business activities.

The goal was to revitalise the state's pharmaceutical and medical device sector by fostering domestic manufacturing, stimulating R&D, and expanding access to high-quality, affordable medications.

The policy attracted significant investment, with 217 businesses proposing to invest approximately INR 28,500 Cr. The focus on time-bound clearances, subsidies, and land allocation aimed to create a robust ecosystem for research and development.

The establishment of the Uttar Pradesh Pharmaceutical Development Cell (UPPDC) and the appointment of a nodal officer by the Food and Drug Administration (FSDA) streamlined processes and ensured prompt services.

An empowered committee chaired by the Chief Secretary was instituted to oversee policy implementation, providing a governance structure to approve large-scale projects.

This policy not only showcased Uttar Pradesh as a favourable destination for pharmaceutical investments but also set a precedent for other states to adopt similar approaches.

3. National Policy on Research and Development & Innovation in Pharma-MedTech Sector: A Vision for Excellence

Union Health Minister Dr Mansukh Mandaviya unveiled the National Policy on Research and Development and Innovation in the Pharma-MedTech Sector.

This policy, accompanied by the Scheme for the Promotion of Research and Innovation in the Pharma-MedTech Sector (PRIP), aimed to transition the industry from a cost-based to a value-based and innovation-based paradigm.

The PRIP scheme aspired to position India as a global pharmaceutical leader by emphasising high-volume, high-value production while ensuring quality, accessibility, and affordability.

The policy sought to nurture an ecosystem conducive to innovation by fostering collaboration between academia and the private sector and encouraging youth entrepreneurship through startups.

Mass production of pharmaceuticals and medical devices emerged as a priority, leading to the establishment of bulk drug parks and medical device parks across different states.

The policy's transformative nature involved close cooperation between government institutions and agencies, signalling a strategic move toward advancing India's pharmaceutical and medical technology sectors.

4. Draft National Pharmaceuticals Policy 2023: Empowering Health for All

The Department of Pharmaceuticals (DoP) released the draft National Pharmaceuticals Policy (NPP) 2023 to comprehensively address challenges faced by the Indian pharmaceutical industry.

With a vision of "Empowering Health for All: Pioneering Excellence in Pharmaceuticals," the NPP aimed to establish India as a global pharmaceutical leader with top-notch infrastructure, research, and affordable healthcare solutions.

The policy prioritised regulatory efficiency, research, innovation, equitable access to medicines, healthcare self-sufficiency, and enhancing India's global reputation in the pharmaceutical sector.

It outlined a coherent framework to help Indian pharmaceutical companies adapt swiftly to changes, maintain international compliance, and consistently deliver high-quality, safe, and efficacious medicines.

With a focus on fostering global pharmaceutical leadership, promoting self-reliance, advancing health equity and accessibility, enhancing regulatory efficiency, and attracting investments, the NPP set ambitious goals aligned with the government's vision of Amrit Kaal Vision@2047.

The policy aspired to promote a paradigm shift in the Indian pharmaceutical industry, encouraging disruptive innovation and the introduction of novel drugs, devices, and technologies.

5. Karnataka's Revamped Biotechnology Policy: Genomic Leadership and Global Hub for Clinical Trials

Karnataka, known as the Silicon Valley of India, revamped its biotechnology policy to position the state as a global hub for clinical trials and a leader in genomics.

The policy introduced incentives, including subsidies for bio-manufacturing units, reimbursement of R&D expenses, and support for startups and MSMEs.

The strategic goal outlined in the draft note was to achieve a $150 billion bioeconomy by 2025, with projections soaring to $300 billion by 2030.

The policy identified key biotechnology areas, including bio-agriculture, marine biotechnology, synthetic biology, medical devices, AI & ML, and space biotechnology.

Karnataka's commitment to continuous support for research and development in these domains showcased its strategic move to foster innovation and economic growth.

The state's focus on 'Transformation through impactful Implementation' positioned Karnataka at the forefront of innovation and economic growth in the biotech sector.

6. Comprehensive Bio-manufacturing Policy: Fostering a Robust Ecosystem

The Union government of India geared up to launch a comprehensive bio-manufacturing policy, aiming to catalyse the establishment of bio-foundries across the country.

With a clear focus on fostering a robust domestic bio-manufacturing ecosystem, the policy aligned with India's vision of becoming a $5 trillion economy by promoting biotechnology and synthetic biology advancements.

The Bio-manufacturing Policy intended to attract investments by providing funding and subsidies to biotech companies, emphasising the importance of sustainable growth and the role of biotechnology in achieving economic targets.

The policy acknowledged the pivotal role of biomanufacturing in the pharmaceutical, agriculture, and industrial sectors, highlighting its potential to contribute significantly to India's economic growth.

The proposed policy sought to create a conducive business environment for the biotech industry by addressing regulatory challenges, promoting innovation, and encouraging collaboration between the government, academia, and the private sector.

The policy aimed to position India as a global leader in the biotechnology sector by emphasising bio-manufacturing capabilities.

7. Drugs, Medical Devices, and Cosmetics Bill, 2023: Ensuring Quality and Safety

The Drugs, Medical Devices, and Cosmetics Bill of 2023 emerged as a significant legislative move, set to replace the archaic Drugs and Cosmetics Act of 1940.

The bill aimed to regulate the import, manufacture, distribution, and sale of drugs, medical devices, and cosmetics, focusing on ensuring their quality, safety, efficacy, and performance.

While the bill was welcomed for addressing gaps in the existing regulatory framework, stakeholders expressed concerns about potential complexities and their impact on innovation.

Striking the right balance between stringent regulations and fostering innovation in the pharmaceutical and medical devices industry became a central point of discussion.

The bill reflected the evolving healthcare landscape, acknowledging the need for a modernised regulatory framework to keep pace with technological advancements and emerging healthcare challenges.

As the government aimed to strengthen the regulatory landscape, industry stakeholders engaged in dialogues to ensure that the new legislation would facilitate growth, innovation, and the delivery of safe and effective healthcare products.

Summing Up

The year 2023 witnessed a tapestry of legislative measures, each weaving a distinct thread into the intricate fabric of the healthcare landscape in India.

From policies fostering innovation to bills reshaping regulatory frameworks, these enactments collectively paved the way for a future where technology, healthcare, and innovation seamlessly converge.

The collective impact of these legislative measures positions India as a global player in healthcare innovation, research, and manufacturing. As stakeholders collaborate to navigate the evolving healthcare landscape, the synergy between policy, technology, and healthcare delivery promises a healthier and more technologically advanced future for India.