License overload, inconsistent regulations hurting healthcare businesses: NATHEALTH
NATHEALTH
flagged that the country's 'complex regulatory structure is creating compliance bottlenecks for the healthcare sector and preventing ease of doing business.'
In a meeting with the Niti Aayog members, the lobby group presented a whitepaper highlighting that, healthcare industry is one of the 'top three' regulated sectors in India, where 60 per cent of regulations are decentralized, thereby leading to complexity of compliance due to lack of standardization.
The white ciphered co-authored by EY covers three sectors in healthcare viz hospitals, diagnostics and medtech and underlines that businesses operating under these segments face multiple or numerous licensing requirements and are struggling with a highly dynamic and changing regulatory landscape with little or no transition time.
Speaking to media after their meeting with Niti Aayog, Ameera Shah, President, NATHEALTH, said, 'Under the white paper we have highlighted that regulatory standards vary frequently across different states, and there is often a lack of clarity regarding these regulations.'
'Among the segments, there are variations, with diagnostics being less regulated, while hospitals and medtech face much stricter regulations,' Shah added.
Sharing the MedTech-related concerns raised during the meeting, Himanshu Baid, Vice President, NATHEALTH, said, 'Being classified as drugs, MedTech products are overregulated and at the meet we highlighted the Quality Control Orders (QCOs), which are hampering the manufacturing of medical devices in the country.'
'We also highlighted issues such as the overlap between government departments and labeling challenges, where we are regulated by both the CDSCO and the Ministry of Consumer Affairs, " Baid added.
On Niti Aayog's response, Baid apprised, 'NITI was very receptive to the issues raised, and we will meet again in about eight weeks with concrete solutions and for further discussions.'
Secondly Niti Aayog shares NATHEALTH's view that there should be a separate Act for medical devices, he added.
As per Shah, the whitepaper shared with the government policy think tanks includes a total of 70 regulatory and licensing challenges of which 12 have highlighted as the 'top challenges which require urgent attention.'
For hospitals the whitepaper outlines issues like state registrations for medical practitioners leading to multiple UIN generations and administrative burden, Licensing of blood banks required for central and state licensing authorities, among several others.
Similarly for the other two segments diagnsotics and MedTech it includes Lack of standardization in clinical establishment regulations across states, different licensing authorities based on activity and class of device leading to multiple registrations and delays.
Besides these issues the papers includes two long standing agnostics issues related to the restriction on hospital building heights that is stated to reduce the number of hospitals bed capacity and concerns over stringent penalties imposed in case of failure to obtain or renew consent in a timely manner.
Among its key recommendations, the whitepaper features short, medium and long term suggestions for addressing them including single window clearance, adoption of global standards–ISO and embracing digitization— health records, signatures.
'We seek government support to address these hurdles, which will help the sector grow faster and improve patient access,' Shah noted.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Mint
an hour ago
- Mint
PAN 2.0 tax platform: Digital diligence please
Next Story Mint Editorial Board LMIMindtree won the contract for this taxpayer identity system's digital upgrade. Let's hope lessons were learnt from the rushed GST rollout. PAN 2.0 should be pre-tested well. Various portals for PAN-related services are to be unified, with an emphasis on making them user-friendly and easing digital processes. Gift this article Software company LTIMindtree has reportedly won the Income Tax Department's contract for its PAN 2.0 project, which aims to upgrade India's Permanent Account Number (PAN) system for taxpayer identification. Software company LTIMindtree has reportedly won the Income Tax Department's contract for its PAN 2.0 project, which aims to upgrade India's Permanent Account Number (PAN) system for taxpayer identification. From the design and development of PAN 2.0 as a platform to its operation and upkeep, the Mumbai-based firm will serve tax authorities as a 'managed service provider." Also read: Profiteering worries cast cloud over GST cuts Various portals for PAN-related services are to be unified, with an emphasis on making them user-friendly and easing digital processes, but without asking PAN card holders to get fresh ones issued. While taxpayers can look forward to this platform's rollout, scheduled within 18 months, it's vital to minimize any scope for user dissonance that may arise from a rushed job. Speedy reforms are welcome, but not at the cost of digital diligence. At one time, the hope was that Aadhaar would subsume PAN. Topics You May Be Interested In Catch all the Business News, Market News, Breaking News Events and Latest News Updates on Live Mint. Download The Mint News App to get Daily Market Updates.
Time of India
2 hours ago
- Time of India
NITI Aayog launches India Electric Mobility Index to assess state-level EV readiness
New Delhi: NITI Aayog on Monday launched the India Electric Mobility Index (IEMI), a first-of-its-kind tool to comprehensively track and benchmark the progress of states and union territories in achieving their electric mobility IEMI scores all Indian states and UTs out of 100 across 16 indicators grouped under three core themes—Transport Electrification Progress, Charging Infrastructure Readiness, and EV Research and Innovation index was launched by NITI Aayog Member Rajiv Gauba in the presence of B V R Subrahmanyam, CEO of NITI Aayog, Kamran Rizvi, Secretary, Ministry of Heavy Industries, O P Agarwal, Distinguished Fellow, NITI Aayog and Sudhendu Sinha, Programme Director – E-Mobility, NITI Aayog. 'The IEMI provides a transparent, comparative framework to assess progress across key themes such as electrification, infrastructure, and innovation. It enables states to benchmark their efforts, identify gaps, and learn from each other's successes,' Gauba said. According to the government think tank, the index enables evaluation across states and UTs by identifying key drivers of success and areas requiring targeted interventions. It aims to inform decision-making, promote healthy competition among states, and encourage sharing of best practices. CEO B V R Subrahmanyam said, 'NITI Aayog has already been at the forefront of enabling the ongoing EV revolution. This index is yet another effort by NITI Aayog to propel India towards its vision of a decarbonized and energy-secure future.' The tool underscores the importance of state-level coordination, integrated planning, and cross-sectoral collaboration in achieving India's electric mobility vision. The index covers both demand-side and supply-side aspects of electric mobility, tracking adoption, infrastructure growth, and ecosystem R&D. The report and dashboard launched alongside the index will help policy makers, industry, and researchers in monitoring EV transition outcomes and aligning with India's net-zero commitment by 2070.
Time of India
2 hours ago
- Time of India
Niti Aayog urges shift from incentives to mandates for EV push
Niti Aayog on Monday called for a strategic pivot in India's electric vehicle (EV) policy, urging a transition from reliance on incentives to a regime of mandates and disincentives, alongside a regulatory framework to accelerate adoption in high-potential segments and geographies. In its new report titled 'Unlocking a $200 Billion Opportunity: Electric Vehicles in India' , the policy think tank said the country must adopt a more aggressive and targeted approach to achieve its goal of 30 per cent EV penetration by 2030, Economic Times reports. In 2024, EVs accounted for just 7.6 per cent of total vehicle sales — about 18.78 million units — necessitating a compounded growth of over 22 per cent annually over the next five years. Call for National EV Policy and Urban Electrification To unlock this opportunity, the Aayog has recommended the establishment of a national EV policy with clear targets, timelines, and phased EV mandates. It also advocated pilot programmes to electrify 100 per cent of buses, paratransit, and freight vehicles in five urban areas as demonstration models. The report highlights the need for prioritising service delivery models over asset-heavy procurement, with a shift in expenditure patterns from capital costs to operating costs. This would enable faster fleet transitions while easing the financial burden on public and private sector operators. Financing, R&D and Infrastructure Critical The Aayog has also proposed the operationalisation of a blended finance facility to lower capital costs for commercial EVs, particularly for electric buses and trucks — two segments that currently face challenges in financing and adoption. Further, it called for scaling domestic R&D to reduce dependence on imported rare earth materials, improve battery technology, and enhance energy density. Expanding the Corporate Average Fuel Efficiency (CAFE) norms to cover more vehicle segments was also recommended as a regulatory enabler. 'Strategic scaling of charging infrastructure and enhancing public awareness and information systems are critical enablers,' the report stated. The proposals come amid growing concerns over India's slow EV penetration in certain categories, particularly electric trucks and four-wheelers, even as electric two-wheelers and buses gain traction.
