Boga Laharee*1, B. Ranganayakulu2
1Department of Drug Regulatory Affairs, Srinivasa Institute of Pharmaceutical Sciences, Sri Chowdeswari Nagar, Peddasetty Palli Proddatur-516361.
2Associate professor, Department of pharmaceutics, Srinivasa Institute of Pharmaceutical Sciences, Sri Chowdeswari Nagar, Peddasetty Palli, Proddatur-516360.
A b s t r a c t
Healthcare sector in India has undergone significant upgrades in the 21st century. Over the years, India has attained a 10% growth rate in this sector and by 2025 it is expected to reach $280 billion. In 2016, percapita spending on healthcare in India was $75 which was negligible in comparison to that of the United States, European Union (EU), China, and the Global average which was $9403, $3613, $420, and $1061, respectively. Today Indian healthcare market size is $128 billion and is expected to grow at 12% for next four years. Indian regulators have made a conscious effort to change their approach to regulating medical devices – from one that is piece meal and need based to one that is systematic and pre-planned. Consequently, an attempt is being made to anticipate developments in this field and to put in place a regulatory framework that is competent enough to test the effectiveness of these developments and can lay down standards to be adopted for their safe deployment. This trend has been welcomed by stakeholders. To further this process, stakeholders need to engage in an effective dialogue with the regulators.
Keywords: Healthcare sector, medical devices, regulatory framework, healthcare market.