SpicyIP Tidbit: India’s Draft Medical Device Policy – Focus on Standards and Innovation

On the blog here, we’ve been huge fans of transparency in standards and innovation. In fact, a while ago we had blogged about how the Indian standards system is fairly opaque and how there are some major access problems (see here and Swaraj’s post here). The thrust of these posts was that the Bureau of Indian Standards, the standard setting organisation has locked these standards up behind fairly expensive payment systems when they are critical to the everyday lives of most people. In Swaraj’s post he specifically notes how this problem of access affects the medical industry, where the lack of a regulator has compounded the problem.

Fortunately, in an encouraging step, the Government of India, recently released a draft policy to encourage standardisation in the medical industry. The draft policy lays emphasis on the increased need for standardisation owing to the lack of a regulator and the sheer size of the Indian market for medical devices. It endeavours to set up an environment in India that would foster innovation and to promote domestic content in the industry by the use of procurement preferences. The most important contribution however would be the setting up of a body called the National Medical Device Authority to serve as a sort of umbrella organisation to oversee efforts in this field.

The document lays down some interesting suggestions to specifically help foster innovation like concessional power tariffs, interest subsidies, funding options and tax incentives. However, what is also particularly striking is a clause that states that a system should be created in which companies may make available their IP in “non-core” areas to an “exchange” for the betterment of the industry itself. It would be really interesting to observe the form that this clause takes in the final policy document.

While the document itself is quite promising and satisfies many of the demands in this area, one prominent way in which this could have been improved is with an explicit mention in the policy document of free accessibility of these standards. In its present form all the policy document seeks to achieve is to “promote general awareness as to medical device safety and medical device standards”. A more explicit reference to freely accessible standards would perhaps have served this purpose better. In any case, this would be an interesting policy to keep track of considering its implications for innovation in this sector.


Thomas J. Vallianeth

Thomas is a final year law student at the National Law University, Jodhpur pursuing a B.Sc. LL.B. (IP Hons.) course. His first exposure to IP law was at a workshop that he attended in High School and ever since then, he has pursued a keen interest in the field. However, his real interests lie in the interfaces between Technology Law and IP, with an active interest in the Open Source movement.

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