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A parliamentary panel report on health and family welfare, tabled less than a fortnight ago, put the spotlight on certain regulatory procedures governing medical devices, calling for its overhaul to bring in transparency, besides paving the way for the growth of this sector.
Taking a critical view of the Central Drugs Standard Control Organisation’s (CDSCO) licensing process, for instance, the House panel report said that it was “plagued by delays, inconsistent timelines and a lack of transparency, hindering the growth of the medical device industry”. Further, pointing to the “centralisation of authority”, the report said it could create “a situation for arbitrary/ discretionary decision-making” — and called instead for “overhauling the licensing system” and bringing in a transparent process with “minimum room for discretion/human inference.”
Medical device industry insiders, however, are taking a more layered view of the report’s observations aimed at helping grow their sector. While agreeing with comments on delays and too much “centralisation”, industry representatives, speaking off the record, also point to the ever-increasing load at the already short-staffed regulator’s doorstep.
The report’s observations on streamlining processes for industry and the regulator come even as the medical devices sector grapples with ways to grow in the domestic market, besides expanding its international footprint in the face of geo-political pressures and tariff uncertainties.
Predictable environment
The report recommends implementation “of a fully digitised, time-bound and trackable licensing system” that helps bring in a predictable regulatory environment. Further, it recommends replacing the “query process” with a “single query” policy, apart from granting conditional approval in 45 days through a combination of self-declarations, international certifications, documentation and so on.
In fact, industry voices have also suggested recognition for third-party certifications from government institutions like BIS or private reputed institutions — under the CDSCO’s watch.
Anil Jauhri, former Chief Executive Officer of the National Accreditation Board for Certification bodies, explains that “regulations are done for the protection of the common man and, therefore, it is the responsibility of the government; and industry should be consulted on the manner of regulation but not on the need for regulation”.
Against the backdrop of the challenges outlined by the report, of delays and shortage of hands, Jauhri says that an alternative system is possible that will certify devices in line with global regulations. Recommending “risk-based oversight”, he says companies can be encouraged to get their certifications — ISO 13485 (2016), ICMED-Plus, BIS certification, and so on — and the regulator could rely on that documentation to make its decision. The regulator can step in at any point, if anything is amiss, he says, pointing out that international regulatory systems are increasingly taking a similar approach.
“The textile market, agri-food market, aerospace market, telecom market, automotive market is full of private voluntary certifications, which are necessary if you want to be in the global market,” he says. Third-party certifications may have their issues but that too can be fixed, he adds.
Pointing out that private certifications are not a replacement for regulation, he says they allow a regulator to identify a company that could pose less risk — if they were to choose between a company that is not certified and one that has multiple certifications.
Industry representatives further point to delays due to State regulators interpreting regulations differently from the Centre.
Nuanced approach
Medical Technology Association of India, a platform of global medical technology firms with a base in India, called for a “nuanced perspective”. The report is good in certain aspects, says MTAI Chairman Pavan Choudary, referring to the suggestion for a collaborative approach. It has identified opportunities for improvement, such as ongoing training of CDSCO officials, implementation of a fully digitised, time-bound and trackable licensing system, minimising frequent and delayed queries, and lateral entry from the industry. On understaffing, he says it is acutely felt “since all classes of devices have recently come under a mandatory licensing regime”.
The report says its recommendations will foster a transparent and collaborative regulatory environment, besides building trust between CDSCO and the industry, ensuring “that regulations are aligned with the needs of a rapidly evolving sector, moving CDSCO from a perceived roadblock to a true facilitator”. It also creates a channel for industry concerns to be heard and addressed, paving the way for a more dynamic and responsive regulatory approach, it adds.
Not many may argue with that, says an industry observer, provided patient welfare remains the guiding principle behind regulatory decisions.
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