The second draft of the medical devices regulations seems to have got both MNC and domestic medical device manufacturers on the same page. Both groups are protesting against the draft regulations and asking for changes.
For instance, the common grouse is that medical devices are being judged by the same yardstick as medicines. The recently formed Medical Technology Association of India (MTaI), which comprises the likes of Johnson & Johnson, Bausch & Lomb, Smith & Nephew, C R Bard, Terumo, Boston Scientific and Vygon, has pointed out that globally, most orthopaedic implants are granted a shelf life of 10 years, a time period supported by bio-material evidence. But the draft rules dated October 17, have included all medical devices, including orthopaedic implants, under a common five year shelf life. Is this mere oversight on the part of the Drugs Technical Advisory Board (DTAB), or have they decided to play safe?
Another instance where the MTaI says that the Indian regulator is being unreasonable is on the process of putting Unique Device Identifiers (UDIs) on medical devices. While this is being rolled out as per the classification of the device in a stage-wise manner in the US and EU, the two major markets of the world, the draft medical device rules mandate that every medical device should have a UDI from 2017 in India. The association has pointed out that it will not be feasible to do so only for products being exported to India.
A third grouse is that while the initial notifications allowed all medical devices to put the manufacturing date and physical manufacturer’s address on the label prior to distribution in India, the new draft bill now requires that these details have to be added at the time of manufacturing. This is an unprecedented change from global norms, according to the MTaI.
Previous drafts of the medical devices regulations have been branded as protectionist of local manufacturers but in this case, the Association of Indian Medical Device Industry (AIMED) has called it “an assault on the ‘Make in India’ programme as they will “legalise pseudo manufacturing, result in closure of domestic manufacturing and drive jobs out of India.”
While the Ministry of Health & Family Welfare welcomes comments on the draft, it clearly has its own mind. It might relax some rules but both industry lobbies would do well to not take the Ministry for granted.
The Health Ministry’s stance with all segments of the sector has been very tough. For example, more medicines have been brought under price control in the past year. Therefore medical device manufacturers cannot expect a lenient line.
This stance is quite understandable. After all, the Health Ministry faces the tall task of providing quality healthcare, medicines and medical devices to every Indian citizen, on a very tight budget.
Just how tall a task it is was illustrated in a recently released report in The Lancet on the progress of 188 countries on 33 of the 47 health-related SDG indicators. India ranks a low 143, ahead of Pakistan (149th) and Bangladesh (151st). While Iceland topped the ranking, followed by Singapore and Sweden, the US came 28th, an indicator that bigger economies need not necessarily have more efficient health systems. The buzzword is efficiency, doing more with less, measuring progress against health indicators and continuous benchmarking.
Clearly, we in India have a long way to go but we have already taken the first step. An recent study done by researchers at IIM Ahmedabad, titled ‘Development of a Health Index of Indian States’, ranks 21 Indian states on a unique outcome:input matrix which does not just show their relative status, but also indicates which ones are performing better with lesser resources (inputs) as well as those unable to utilise resources optimally. So while Kerala ranks first on outcome variables, followed by Maharashtra, the input variables chart is topped by UP, followed by Bihar. Maharashtra, Tamil Nadu and Andhra Pradesh bag the top three positions on the outcome-input matrix. The authors plan to make this an annual exercise, and include more states next time, hoping that the government will use this matrix to identify focussed policies for further work.
As we start the countdown to the second edition of Healthcare Sabha, due in February 2017, we will take forward our agenda. While the first edition identified India’s public health-related crises areas, our 2017 edition will focus on getting thought leaders to build a ‘Manifesto for a Healthy India’. We will use evidence-based methods to discover excellence models which will achieve equity in health for all citizens of India. Come, help us make this a reality.
Viveka Roychowdhury
Editor
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