Draft Report of the High Level Group on Services Sector

The Ministry of Health is considering substantial strengthening of manpower and infrastructural facilities and capacity building to enable the Central Drugs Control Organization to cope with the challenges ahead.

5.2 Challenges before the Healthcare Sector in India

5.2.1 Regulation

The competitiveness of healthcare services in the country suffers from under-regulation on the whole but over-regulation on the medical education front. Medical professionals are regulated through Central legislation, viz., the Indian Medical Councils Act, the Dentist Act and the Nursing Council Act. These laws provide for the setting up of regulatory councils at the National and State levels. The National Councils prescribe norms and standards of education, while the State Councils deal primarily with registration and enforcement of these standards. The Ministry of Health &Family Welfare has developed Indian Public Health Standards (IPHS) for certain Governmental clinical establishments viz., Community Health Centres (CHC), Primary Health Centres (PHC) and Sub-Centres, which are implemented through administrative means. Standards are also being evolved for the larger hospitals, up to 500 beds. A few States and Union Territories have enacted laws (The Bombay Nursing Homes Act, 1949; Delhi Nursing Homes Act, 1953; and Tamil Nadu Private Clinical Establishments Act, 1997) for registration and regulation of nursing and clinical establishments, but they were not comprehensive in that they did not cover laboratories and diagnostic centers, and there were deficiencies in laying down minimum standards. More importantly their implementation has remained ineffective. There has been resistance from some stakeholders against the introduction of law for the regulation of health care service providers because of the fear of Inspector Raj. Opposition to regulation of health service providers has also been fuelled by the exemption provided in some of the State laws for the public health institutions. On the other hand there is skepticism among policy makers whether publicly funded healthcare institutions will be able to adhere to the standards. The multiplicity in the types of clinical establishments has also daunted policy makers from undertaking the task of formulating minimum standards, which are a prerequisite for effective regulation. At the Central level, some specific aspects of healthcare services have been regulated through legislation, such as management of medical waste, setting up of blood banks, and pre-natal diagnostic tests, but there is absence of an overall statutory framework for the licensing of healthcare establishments such as hospitals, nursing homes and clinics, and laying down the minimum standards that must be met.
We have noted above that some of the private medical establishments rank with quality institutions in the industrialized countries but the lack of regulation of clinical establishments has also resulted in many of them including those in the private sector being of poor standard and lacking in elementary facilities.