The government will release a consultation paper on the proposed measures within the next two months, aiming to finalise the reforms by the end of the year, a senior official told ET. “A consultation paper will be brought out soon,” the official said. Several rounds of discussions have been held with the stakeholders.
ON CARDS Scrapping dual licences, decriminalising minor violations, simplifying approvals
While the consultations for non-clinical regulations are in the final stage, consultations are continuing on clinical compliance requirements, the official said.
The consultation paper is expected to propose uniform state guidelines, greater transparency in licensing and integration of approvals with the National Single Window System to simplify business operations.
“The idea is to have world-class infrastructure in smaller towns as well. It will help ease the burden on bigger towns and ensure people get the best healthcare facilities in close vicinity,” the official said.
Despite recent efforts to reduce the compliance burden, hospitals and healthcare facilities still have to meet more than 600 legal obligations and around 950 recurring annual compliance requirements across nearly 100 licences and permits issued by central, state and local authorities.
“The healthcare sector faces overlapping compliance burdens with multiple approvals, lengthy timelines and arbitrary requirements that raise costs,” said Rajiv Nath, forum coordinator at AiMeD, the umbrella association of Indian medical device manufacturers. “For medical devices, challenges are sharper: regulation continues under the Drugs Act despite recommendations in the National Health Policy 2017 and parliamentary reports No. 138 and 146 for separate legislation and separate regulator for medical devices, as is also the case in many progressive global jurisdictions.”
“Risk-proportionate regulation is essential to balance safety with ease of business,” he said.
The reforms come as private healthcare providers struggle to expand in tier-2 and tier-3 cities because of a shortage of specialised care, difficulties in retaining talent and limited access to capital.
Hospitals in metropolitan cities have an estimated 2.7-3.0 beds per 1,000 people, compared with 0.8-1.2 beds per 1,000 people in tier-2 and tier-3 towns.
Health is a state subject, requiring hospitals, clinics and diagnostic centres to obtain approvals from state health departments in addition to central clearances.
Regulatory requirements also vary across states, making it difficult for hospital chains to expand nationwide. Healthcare practitioners must register with their respective state medical councils before details are verified and linked through national platforms.