Speed over scrutiny? Karnataka introduces a new 10-day hospital approval rule

Bengaluru:

In a significant overhaul of healthcare regulation, the Karnataka government has amended the Karnataka Private Medical Establishments Act, 2007, introducing a mandatory, time-bound system of temporary registration for hospitals and clinics and providing for deemed approval if authorities fail to act within 10 days.

The amendment, notified this week, marks the first time the law fixes a statutory deadline for processing registration applications, addressing long-standing complaints from private healthcare providers about delays and regulatory uncertainty.

The 10-day deadline with deemed approval fixes a long-standing problem where hospitals waited months — sometimes years — with applications “under process”, making them vulnerable to harassment. A hospital can legally begin operations without any physical inspection, purely because an official missed a deadline. In a system already stretched, this is not a small risk.

Under the new provisions, district-level Registration and Grievance Redressal Authorities are required to issue a temporary registration certificate within 10 days of receiving an application. If no decision is communicated within this period, the establishment will be treated as having been granted registration by default. Such temporary registration will remain valid for six months, during which the establishment must apply for permanent registration or renewal.

Significantly, the amendment also brings existing hospitals and clinics under the temporary registration regime. All establishments that are currently registered will be deemed to be temporarily registered until their present validity expires, after which they must apply afresh under the revised framework. Failure to do so would render them unregistered, exposing them to penal action.

Another key change is the explicit inclusion of mental health establishments within the definition of private medical establishments. This expands the scope of regulation to cover psychiatric hospitals, counselling centres and rehabilitation facilities, many of which have so far operated under overlapping or unclear legal frameworks .

While the amendments aim to speed up approvals, they simultaneously tighten oversight and enforcement. Authorities are empowered to conduct inspections either on receipt of complaints or on their own initiative, direct establishments to rectify deficiencies within a specified time, and suspend or cancel registration in cases of persistent non-compliance. However, hospitals accredited by recognised quality bodies such as NABH, NQAS or QCI will be eligible for registration or renewal without routine inspection, provided accreditation documents are produced.

The law also introduces harsher penalties for violations. Hospitals found employing unqualified or unauthorised medical personnel can now face criminal prosecution, with punishment extending to three years’ imprisonment and a fine of up to ₹1 lakh — a sharp departure from the earlier regime that relied largely on financial penalties.

The amendments further empower the State government to prescribe application formats, fees and additional pre-requisites for both temporary and permanent registration through notifications, giving it greater administrative flexibility in regulating the sector.

The government has said the changes were necessitated as an ordinance had been promulgated earlier this year when the Legislature was not in session, and the law now formalises those provisions. With the rapid expansion of private healthcare facilities, particularly in urban centres such as Bengaluru, officials argue that the revised framework balances ease of doing business with stronger safeguards for patient safety.