New Delhi: Calling for a complete overhaul of the existing regulatory and licensing framework in India, industry representative 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.
