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Anil Jauhri

There was a Chintan Shivir organized by the Export Promotion Council for Medical Devices (EPCMD) with the Department of Commerce (DoC) and Department of Pharmaceuticals (DoP) recently which had excellent representation of the medical device industry and provided a platform for interaction with the government as well as the regulator, CDSCO, which was also present.
Given that the prime mover was EPCMD, the focus was more on export of medical; devices and one of the issues inevitably was relating to standards, and to be more precise, technical regulations, faced in the global market.
The issues raised have equal relevance across other sectors and hence this analysis which should help industry as well as other stakeholders understand the challenges.
One of the issues raised was that the Medical Devices Rules (MDR), 2017 refer primarily to BIS standards and hence undermine global acceptance. A fair argument!
Let us see what MDR, 2017 states:
“7. Product standards for medical device.— (1) The medical device shall conform to the standards laid down by the Bureau of Indian Standards established under section 3 of the Bureau of Indian Standards Act, 1985 (63 of 1985) or as may be notified by the Ministry of Health and Family Welfare in the Central Government, from time to time.
(2) Where no relevant Standard of any medical device has been laid down under sub-rule (1), such device shall conform to the standard laid down by the International Organisation for Standardisation (ISO) or the International Electro Technical Commission (IEC), or by any other pharmacopoeial standards.
(3) In case of the standards which have not been specified under sub-rule (1) and sub-rule (2), the device shall conform to the validated manufacturer’s standards.”
What if we were to switch the provisions related to BIS standards and ISO/IEC standards – that the medical device shall conform to ISO/IEC standards and where no relevant standard is available, they shall conform to BIS standards.
This formulation will immediately change the perception about India – that India relies on international standards for medical devices.
It would also make exports easier and provide an opportunity to engage with overseas regulators to accept licensed devices being on par with their regulations.
Sounds easy, does not it? Why did the CDSCO not think of it or why do we not make this minor change right away?
But wait! Is that so easy?
Before such a formulation is prescribed, we need to ask – is our medical device industry in entirety ready to embrace international standards right away.
We have struggled to adopt international standards in several sectors which include agrifood and pharma – our strengths in exports – because the industry – composed as it is of micro and small industry - finds adoption of international standards a challenge.
Let us look at food – when the licensing regulations were drafted and notified by the newly set up regulator, FSSAI, in 2011, one question was whether we can prescribe HACCP for high risk sectors as is the global norm. We could not and therefore made a mention of IndiaHACCP standards in the preamble with an intent to encourage the food industry to adopt HAACP voluntarily. Where are we now 15 years later? A recent conversation with a senior official in FSSAI indicated far from it.
Therefore, readiness of the industry for international standards is crucial if regulations have to be globally compatible!
In this regard, one can cite the example of the Bureau of Energy Efficiency which has introduced energy labelling first on a voluntary basis and after a few years mandated it as compulsory. There are currently 16 appliances under mandatory list and 23 in the voluntary list.
This phased approach is something which our regulators can, and should adopt!
It can not be anyone’s case that we would perpetually pitch lower standards in our regulations and yet aim to be Viksit Bharat!!!
Until such time India’s regulations become globally compatible, the alternate is to devise a system for certifying exports to global standards – as successfully demonstrated by APEDA’s organic certification and EIC’s marine products certification programmes both of which have acceptance abroad chiefly by EU. In medical devices, QCI had launched ICMED 13485 Plus which is based on global standards and could fill that need – same is true of Ayush Premium Mark for ayush products for acceptance abroad – something that the government and industry need to understand.
Another issue raised was the availability of testing laboratories.
It has to be recognized that when there is little or no manufacturing in India, there is no incentive for anyone to set up labs. We had discovered during covid that even for N95 or PPEs we did not have labs because much of these items were imported.
However, when there is regulation, even if there are few manufacturers, we need independent labs to enforce the regulation. Given the low volumes of most medical devices, there is little likelihood of private sector investment in labs except for those medical devices which are produced in large numbers in India.
There is evidence to show that when a sector was regulated and there was relatively large manufacturing capacity in the country, private sector invested in labs. Toys is one example – PPEs and N95 masks are another.
It therefore requires that government recognize this and invest funds in setting up labs where manufacturing capacity is low but testing is needed – maybe on public-private partnership model where government invest funds to set up labs and invites private sector to manage the lab operations. It may also be desirable to set up such labs in IITs and NIPERs which can also serve dual purpose of research and teaching labs.
This applies to all sectors under regulation or proposed to be regulated. It has to be appreciated that testing infrastructure is fundamental to product regulation.
It may be appropriate to mention that having labs or audit agencies in the country is not enough for global acceptance – they also need to adhere to applicable international standards. India is in a happy situation in this regard here which sometimes is not realised or highlighted enough.
The labs and the audit agencies need to be accredited and India’s accreditation system has consistently been ranked in top 10 globally by a German study (https://www.mesopartner.com/gqii) which annually ranks the quality infrastructure comprising standards bodies (BIS in India), metrology institutions (NPL in India) and accreditation bodies. India’s accreditation system is led by the national accreditation bodies , NABCB and NABL, but there are three private accreditation bodies (QAI, FDAS, IQAS – all in lab accreditation) too which have attained international equivalence.
However, to leverage this strength, we need labs and an industry which is willing to embrace international standards. This applies across sectors.

समृद्धि को रद्दी में फेंकती अर्थव्यवस्था: गाड़ियों की अनिवार्य स्क्रैपिंग नीति पर पुनर्विचार की ज़रूरत

22 Aug 2025

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Anil Jauhri