The government of Kerala has brought out a Kerala Clinical Establishments (Registration, Accreditation and Regulation) bill 2009 to regulate the healthcare institutions in the state.

The bill, prepared with a view to prescribe basic standards of facilities and services provided by the clinical establishments, envisages to monitor and control the entire spectrum of healthcare service providers both in public and private sectors in the state. The new regulation will bring hospitals, nursing homes, dispensaries, clinics, sanatorium and laboratories conducting pathological, bacteriological, genetic, radiological, chemical, biological investigations under its purview.

Under the new bill, the government has provisions to set up a state council with the power to fix the criterion for establishment of clinical establishments, to grant and withdraw recognition and to fix the fees for registration and renewal of such establishment. The secretary of health department will be nominated as the chairperson of the council, in which heads of all the related departments and representatives from various medical relevant councils and hospitals associations join as members.

The council will have the authority to determine the standards for ensuring proper health care by the clinical establishments, to classify them into different categories and establish a dynamic system of accreditation, to develop minimum standards and to review them periodically and to compile, maintain and update a state register of clinical establishments.

The council should also collect the statistics in respect of clinical establishments, according to the bill. The government, through a notification, will designate an official as the registrar of clinical establishment who have the onus to issue registration which will be mandatory to the healthcare institutions. The council will classify different standards for each category of establishments prior to certification.

A provisional registration for one year will be issued to the applicant institutions within a period of fifteen days of application without prior inspections even as a certificate of permanent registration will be provided after inspections.

The regulation also specifies penalties for contravention against the rules. "Whoever contravenes any provision of this Act shall, if no penalty is provided elsewhere; be punishable for the first offence with fine which may extend to ten thousand rupees, for any second offence with fine which may extend to fifty thousand rupees and for any subsequent offence with fine which may extend to five lakh rupees," explains the bill.

A penalty for non registration will be a fine extends from Rs 50000 to Rs 5 lakh considering the number of offences by the establishments. Whoever knowingly serves in a clinical establishment which is not duly registered under the new act shall be punishable with fine which may extend to twenty five thousand rupees.

Once the government gets nod for the bill from the state assembly, subsequent rules for carrying out the provisions of the Act will be notified through gazette. However, the government, which has introduced the bill in January 2009, has not revealed a timeline to put the bill in the assembly.

Meanwhile, the private healthcare institutions and the local chapter of Indian Medical Association has been protesting against such a regulation right from the conception of the bill.