Additional certification schemes in MedTech sector to impact ease of doing business and investment opportunities: Experts

The government admirably has held multiple consultation sessions recently to reduce the compliance burden for the industry.

Industry experts have voiced concern that additional certification schemes like ICMED Plus will impact ease of doing business and investment opportunities.

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The Quality Council of India has recently launched a local medical device certification scheme called Indian Certification for Medical Devices (ICMED) Plus, re-specifying the requirements for a quality management system for Medical devices in India which were already existing in Medical Device Rules (MDR)- 2017 and ISO 13485.

The QCI and the Association of Indian Manufacturers of Medical Devices (AiMeD) had jointly come up with the ICMED Plus Scheme in June 2021. The scheme is meant to significantly eliminate the use of trading of sub-standard products or devices of doubtful origins.

According to industry experts, the foreign direct investment (FDI) in the MedTech sector has gone down to $21 Million in the first quarter of 2021 (from $248 Million in the same quarter in 2020) in a year where we could have seen the FDI going up due to global shift. Such certification schemes increase unpredictability, thereby decreasing the attractiveness further, as the global interests are unsure of whether or not they will have to comply with new certification schemes as they enter the country besides adding more hurdles and cost burdens on the industry, which will eventually result in higher costs and delays for patients.

Medical Technology Association of India (MTaI), which represents leading research-based medical technology companies with large footprints in manufacturing, R&D and healthcare workers (HCW) training in India, highlighted the issues regarding such additional local certifications that have come up in the recent past.

India, despite being a large market, still ranks 63rd in ease of doing business index. The government admirably has held multiple consultation sessions recently to reduce the compliance burden for the industry. But these additional certifications, which were not required in the first place, will actually place additional hurdles especially for domestic SMEs which constitute the most numerous cohort in the sector.

Pavan Choudary, Chairman, MTaI, said “After numerous industry consultations and the tireless efforts of CDSCO, the government launched the Medical Device Rules in 2017, which aimed to regulate the medical device ecosystem of the country. These rules effectively measure the safety, efficacy and quality of a medical device that enters the Indian market (locally manufactured and imported). Despite having an established regulatory system in place, we are seeing that new quasi- certification schemes such as ICMED Plus are being launched which are not only redundant but confuse the budding entrepreneurs and could burden SMEs, who aim to sell their medical devices globally – to the point of despair.”

Choudary added “Such schemes have a real potential to cause more harm than good in the following few ways:
The industry already takes the required regulatory approvals from Central Drugs Standard Control Organization (CDSCO) and is currently facing the issue of multiplicity of regulatory authorities that cover the gamut of medical devices often encroaching on each other’s jurisdiction.

“Any new policy should be evaluated on the basis of at least three factors – credibility, value and applicability. Redundancy in regulations should be avoided. In the pharma sector, there is only one quality standard i.e. Good Manufacturing Practices (GMP) which every pharma player abides by. A sunrise sector like medical devices is best left with only globally recognised regulatory pathways, to help the industry focus more on actual growth rather than concern itself with these superfluous certifications”, added Sanjay Bhutani, Director, MTaI.