India’s pharmaceutical industry is set for significant transformation under the Modi 3.0 government. The sector’s spectacular growth over the past two decades has positioned India as a global leader, often referred to as the “Pharmacy of the World.” Prime Minister Narendra Modi has launched several groundbreaking programs in healthcare, such as Pradhan Mantri Jan Arogya Yojana, Pradhan Mantri Bhartiya Janaushadhi Pariyojana, and the successful COVID-19 vaccination drive. These initiatives have reshaped the pharma landscape, promoting preventive healthcare, robust infrastructure, and innovative technologies.
With the government entering its third term, there is an optimistic outlook for further enhancements in quality healthcare through continued reforms and policies aimed at fostering innovation and streamlining regulatory processes.
Fostering innovation through Intellectual Property and R&D
As India builds on its fundamental strengths, focusing on innovation is crucial to propel growth, and increase access to life-saving treatments. To strengthen innovation and research, India needs to improve regulatory policies, particularly around patent and price control, to capitalise on growth opportunities. A strong IPR ecosystem will be critical as pharma companies enhance their efforts to transform the healthcare landscape in India.
Global pharma companies with a strong presence in India have partnered with Indian companies, while others are actively collaborating to foster innovations in various therapy areas. A robust IPR framework is essential for these collaborations and future partnerships to thrive. This includes implementing IP training programs, providing access to legal resources, and partnering with educational institutions to enhance IP knowledge.
The government has a significant opportunity to incentivise R&D investments through fiscal measures such as deductions on R&D expenses, research-linked incentives for MNCs, and corporate tax concessions. Protecting IP rights is crucial to encourage and recognise innovation and innovators.
Addressing Rare Diseases
Rare diseases pose a significant health challenge, affecting a minority of individuals but collectively impacting millions worldwide. Due to the lack of epidemiological data in the country, it has been difficult to estimate the number of persons suffering from these diseases in India. Despite the existence of the National Program for Rare Diseases (NPRD), there is a valuable opportunity for increased involvement and ownership, particularly from state governments. Strengthening infrastructure and ensuring timely patient support, particularly through the establishment of specialised Centers of Excellence (COEs) within state hospitals, is important. These COEs should have multidisciplinary teams to provide comprehensive care for individuals with rare diseases.
Incentives for developing treatments for rare diseases are also crucial. By introducing new sections granting additional incentives for R&D expenditures on rare disease medications, the government can attract substantial investment in this vital area. Furthermore, enhancing the management of rare diseases through more COEs, increased budget allocations, and import duty waivers is essential. Expanding the list of life-saving drugs eligible for GST/import duty exemptions, including all oncology medications, will further improve patient affordability.
Developing an OTC medicines policy
The need for a comprehensive Over-the-Counter (OTC) policy framework is paramount to creating a regulatory environment that facilitates the availability of safe and effective OTC medications. Such a framework ensures that consumers have access to reliable medications without prescription while protecting them from misleading claims and ensuring proper usage.
The country’s pharmaceutical market has long been waiting for a robust regulatory framework for OTC medicines. Such a framework would have enabled and facilitated the creation of a positive list of OTC medicines and ensured their widespread availability across the country, including in remote areas. To achieve this, integrating OTC products into the Drugs, Medical Devices, and Cosmetics Bill (DMDC) and Schedule K of the Drugs and Cosmetics Rules is crucial. This integration will enhance public health by ensuring that all OTC products are properly regulated for safety and efficacy. Additionally, it will mandate accurate labelling of medications, providing patients and consumers with essential information about the products they use, thereby ensuring they make informed choices and use the medications correctly.
A bright future for India’s pharma sector
Strengthening intellectual property regulations and providing robust support for R&D in the pharmaceutical sector are crucial for India’s continued growth and innovation in healthcare. By fostering a more innovation-friendly environment and offering fiscal incentives, India can attract substantial investment, drive technological advancements, and ensure the development of new and effective treatments. The Modi 3.0 government has a unique opportunity to further transform the healthcare landscape, ensuring better health outcomes for all Indians and positioning the country as a global leader in the pharmaceutical industry.
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