Rajiv Nath, Founder & Forum Coordinator, Association of Indian Medical Device Industry (AIMED), and Jt. Managing Director, Hindustan Syringes and Medical Devices Ltd.

My moot question is this! Can a nation of 1.2 billion plus citizens afford to be hugely dependent, if not hostage to, on imports in medical devices, which together with healthcare facilities and medicines forms the healthcare security architecture for citizens both in terms of functional criticality as well as healthcare cost?

India overcame its dependency on medicines long time back and even emerged as an exporter of significance because this sector got the right policy push and enabling regulatory architecture. But medical devices on the other hand, despite being an equally if not a bigger mainstay of healthcare citadel, remained the neglected child due to myopic understanding of this sector coupled with legacy issues such as lack of separate legislation and separate specialist regulatory body. Thereby, medical device sector, which basically has bio-medical engineering genes continues to be governed by Drugs & Cosmetics Act, 1940, an act enacted chiefly to govern pharmaceutical sector. If this was a policy tragedy, then the disaster stuck in the form of such policy rollouts, which made imported devices cheaper than domestically manufactured ones. This was done deliberately by making imports of raw materials used in making medical devices costlier than finished imported devices. The net result was devastating - resulting in 70 percent import dependency in general medical devices and over 90 percent import dependency in electronic medical devices. This translates to over 30,000 crore avoidable annual import burden and consequential outgo of valuable foreign exchange.

The other serious impacts of this situation has been: higher price for devices – thereby raising the healthcare cost for average Indians; marketing mal-practices by unscrupulous importers; loss of quality jobs in the country; setback to domestic manufacturing and R&D in medical devices and flight of investment from this sector; and overall compromise of national healthcare security. Thankfully, much is slated to change under the new dispensation which has done commendable job to propel this sector out of this undesirable scenario. Still, much work is needed at various levels to ensure that medical devices get its due and country reduces its undesirable import dependency.

Here are some key enablers:

Buy Indian policy. As is the practice in many other countries such as the US and China which have Buy Domestic Policy, introduce Buy Indian & Preferential Market Access Policy for Made in India medical devices with over 45 percent value addition.

Domestic quality certification: Quality certification is essential but unfortunately due to legacy myopia, quality certification was also used as a tool to subvert the growth of Indian enterprises. Un-thoughtful insistence on USFDA certification gave a massive edge to exporters from other countries. Getting an USFDA certification is not only a time consuming and expensive exercise, it is also an exercise in futility as most Indian manufacturers do not export to USA. Today, we have our own world align certification system i.e. ICMED certification. This certification should be the only criteria in public tenders/procurements.

Scrap 100 percent FDI in brownfield projects. If one is serious about Make in India program, then why allow 100 percent FDI in brownfield projects? Scrap this policy with immediate effect but encourage this for 100 percent greenfield projects.

Provide special packages for upcoming medical device parks. Government needs to nurture upcoming medical device parks in the states of Andhra Pradesh, Maharashtra, Gujrat, and Karnataka. The commercial success and financial viability of these parks will determine the future course of Make in India program. So their success has to be ensured.

Separate set of legislation and regulation for medical device sector. Medical device sector, primarily a medico-engineering sector is ironically still governed by Indian drugs and Cosmetics Act, 1940, which is chiefly to do pharma and chemicals. Time is ripe to put in place a distinct set of legislation and regulations for medical device sector.

There are more desired actionable on our wish list, which will enable India to emerge as a global hub for medical devices and strengthen healthcare security for its citizens.


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