24 January 2024 | News | By Bhagwati Prasad
From policy frameworks to addressing industry challenges and positioning, the Department of Pharmaceuticals (DoP) forthcoming initiatives to overhaul the pharma industry, are paving the way towards global pharmaceutical dominance. Dr Arunish Chawla, Secretary, Department of Pharmaceuticals, Government of India, in an exclusive interview with BioSpectrum, during the Pharma Live Expo held in Mumbai from January 17 to 19, 2024, delves into the ambitious plans and provides a comprehensive overview of the transformative plans to be outlined in the interest of the pharma industry. Dr Chawla also shares insights into the comprehensive strategy aimed at reshaping India's pharmaceutical landscape, propelling the nation to the forefront in the global arena.
Please provide an overview of the strategic move to reform and redesign the Scheme for Strengthening the Pharmaceutical Industry.
The primary objective is to fortify India's position in the global pharmaceutical sector. We are charting out a comprehensive strategy to reform and redesign the existing Scheme for Strengthening the Pharmaceutical Industry. This initiative is about enhancing our infrastructure facilities and positioning India as a leader in the pharmaceutical domain.
What's the framework of the revamped scheme and its key sub-schemes?
The revamped scheme is an umbrella initiative with three distinct components. The first is the Assistance to Pharmaceutical Industry for Common Facilities (API-CF), focusing on cluster development. The second is the Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS), designed to assist Micro, Small, and Medium Pharma Enterprises (MSMEs) in meeting regulatory standards. The third is the Pharmaceutical and Medical Devices Promotion and Development Scheme (PMPDS), aiming to foster growth in Pharma and Medical Devices Sectors through various initiatives.
How will the newly introduced incentive schemes address the challenges faced by the Indian medical device industry?
While challenges are multifaceted, ranging from high manufacturing costs to import dependency for high-end medical devices, to tackle these issues, we have introduced incentive schemes, including the Medical Device Park scheme. These initiatives aim to level the playing field and support the industry through schematic interventions, such as the Production-Linked Incentive (PLI) scheme for API and medical devices.
How does the policy framework designed by DoP map value chains in the drug and pharma industry and the MedTech industry?
The policy framework is crucial in mapping value chains in both the drug and pharma industry and the MedTech sector. Our goal is to identify key components of finished products and starting materials, ensuring that there is an incentive for value addition within India. The emphasis is on avoiding inversion of duty or tax structure along the value chain to promote industry growth.
Can you elaborate on the initiatives to address the shortage of MedTech professionals and the importance of producing skilled individuals in this sector?
Recognising the shortage of MedTech professionals at the cutting edge, we are taking initiatives to produce high-quality industry professionals. Courses like M Pharm and M Tech in biotech and medical devices have been introduced to bridge the skill gap. It's imperative to have skilled professionals capable of running operation theatres (OTs), critical care units (CCUs), and handling complex medical devices.
Could you elaborate on the country's role and future outlook in the global pharmaceutical landscape?
I firmly believe that "Beyond China plus one, it will be India plus in the future." We are focusing on supplying quality medicines and generics that meet international standards. With nearly half of the $50 billion in exports directed towards supplying quality medicines globally, India is emerging as a global pharmaceutical hub.
How do you see advancements in imaging, cancer therapy, precision medicine, and the use of AI transforming healthcare practices?
The MedTech sector is at the forefront of transformative changes in healthcare practices. Advancements in imaging, cancer therapy, precision medicine, and the use of AI are paving the way for personalised healthcare solutions. The emphasis is on tailor-made solutions for individual health systems, smart medicines, and collaborative efforts to achieve high-quality standards on par with international bodies like the US FDA and WHO.
You mentioned the impending transformation of the quality framework. Could you provide insights into this transformation and its expected impact?
The transformation of the quality framework is imminent, envisioning a high level of performance. We are collaborating with experts to formulate value chains, ensuring consistency with the growth of the industry. This transformation is crucial to elevate the industry and meet international standards.
What non-tariff barriers does the industry face, and how is the DoP addressing these barriers while respecting each country's sovereignty?
Non-tariff barriers are significant challenges, and we respect each country's sovereignty. We are introducing mutual recognition as a mandatory requirement, nudging recognition of the Indian Pharmacopoeia (IP). Our approach is to navigate both local and global considerations, fostering a fair and open global pharmaceutical environment.
What would you like to say about the capabilities of the Indian pharma industry and its global competitiveness?
I want to emphasise that the Indian pharma industry is globally competitive and forward-looking in technology, policy, and industrial strategy. Rooted in science and knowledge, we are evolving to meet the challenges of the future. I encourage belief in the capabilities of the Indian pharma industry as we stride towards becoming a $120 billion-dollar industry.