Indian healthcare sector is a fast-growing industry which is expected to reach $280 billion by 2025. Medical devices market in India is one of the top 20 medical device markets in the world. It is currently valued at $5.2 billion and is expected to reach $50 billion by 2025. However, India does not manufacture many devices indigenously and still imports approximately 70% of its medical devices. Manufacturing and monitoring of medical devices are highly regulated activities. In India, there were no specific medical device regulations and devices were regulated under the Drugs and Cosmetics Act, 1940. To fulfill this gap, Central Drug Standard Control Organization released Indian Medical Device Rules, 2017, which are the new regulations for medical devices in India. Keeping pace with the requirements, these were amended as Medical Devices (Amendment) Rules, 2020, which has come into force in April 2020. These rules cover various aspects of device related regulations, including classification, registration, manufacturing and import, labeling, sales, and postmarket requirements, etc. The rules are a positive step and encompass most of the European Union (EU) approval process, which mandates that the devices are safe and performs its intended function. However, with rapid advancements in medical device technology, much is desired in clarity and revamping of the current regulatory system to harmonize standards to be in-line with advanced regulations like EU.

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Publications in peer-reviewed journals as well as oral and poster presentations for scientific conferences comes under the purview of GPP3 guideline. The GPP3 has kept pace with the changes in publication practices and focusses on every burning aspect of publications. The present paper evaluates the purview of GPP3 guideline in context with the evolving role of medical writer (MW) in the present times. A MW plays an important role to in producing high quality authentic documents. The role of professional MW have previously been emphasised upon in previous versions of GPP guidelines, and have been instrumental in acknowledging role of MWs in medical publications and cementing their existence rather than them being termed as ‘ghostwriters’. Additionally the paper focuses on evolving publication and research presentation standards with reference to other guidelines. The paper also focusses on clarity on reimbursements which is in contrast to other Acts (Sunshine Act). Most importantly, the expectations from subsequent guidelines are also discussed which may form basis of subsequent GPP guidelines.

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