India proposes regulatory streamlining to promote medical device industry

Indian government has published plans to streamline the regulation of medical devices as part of its strategy for promoting the sector. Specific plans outlined in the strategy include changes to licensing that are designed to avoid the duplication of efforts and imposition of unnecessary compliance burdens.

Indian officials have identified the promotion of the medical device industry as a way to help achieve the key objectives of the National Health Policy, 2017. The government has already started several schemes and programs across different departments to support the medical device industry but now sees a need for “a comprehensive framework supported by guiding strategies for ensuring sustained growth and development of the sector in a holistic and coordinated manner.”

The resulting document, which is intended to give India a 10%-12% share of the global market over the next 25 years, features five proposals to change how medical devices are regulated in the country.

“In view of the multiple agencies associated with [the] medical device sector, there is a need to bring further regulatory streamlining that balances patient safety with product innovation, while reducing compliance burden and enhancing the ease of doing research and business,” the government wrote.

The five specific proposals are: the creation of a single window clearance system for licensing of medical devices; the formulation and adoption of Indian Standards for Medical Devices; the development of a framework for a coherent pricing regulation; the design of a guidance framework for researchers, innovators, and entrepreneurs; and steps to ensure the ethical marketing of medical devices.

Officials provided some additional information about the proposals and their objectives. The proposed licensing system will align with the National Single Window System “to avoid duplication of efforts and imposition of any unnecessary compliance burden,” and the work on standards is intended to “enhance the level of standardization, quality and enable the indigenous industry to gain global competitiveness.”

Regulatory streamlining is one of several strategies for promoting the sector; others include creating infrastructure, facilitating R&D and innovation, attracting investments, developing human resources, and raising awareness. The human resources proposals have regulatory implications, with skilled regulators among the types of experts the Indian government aims to foster through its program.

For report click: Gazette Notification -National Medical Devices Policy 2023, Department of Pharmaceuticals. Raps