The National Commission for Macroeconomics and Health (NCMH), co-chaired by the ministers of health and finance, may soon recommend the formation of a standard setting agency for the entire gamut of healthcare activities in the country. Healthcare establishments, right from the Clinical Research Organizations, hospitals and diagnostic centres would be brought under the purview of the proposed agency.

The call for the establishment of National Commission for Excellence in Healthcare (NCEH) is likely to be made in the forthcoming report of NCMH, it is learnt. The NCMH would also propose formation of National Commission for Accreditation (NCA), an agency that can accredit healthcare establishments on the basis of standards set by NCEH.

The observations were made after considering the urgent need for quality standards in healthcare establishments. The new agency may have some overlapping responsibilities of the Medical Council of India.

According to sources, NCEH standards would help the growth of clinical research activities in the country. Once accreditation from NCA becomes compulsory, the international clinical trials conducted in India would have more credibility and acceptance, it is felt. Medical experts have predicted a huge market in clinical research activities for India in the coming years.

The NCMH is expected to come out with specific recommendations for the clinical trial sector. Apart from the plans for accreditation, there would also be call for setting up of a National Registry of clinical trials. The information would be made available to the public thereby bringing in more transparency about the ongoing clinical trials. The status of every approved clinical trial could be known from a single point once the national registry is in place. Claiming that transparency, quality, ethics and dissemination of information are the most urgent requirements to tap the opportunities in clinical research, official sources hope NCMH recommendations to take care of all these aspects.

It should be recalled that accreditation of clinical research establishments was a much debated topic due to the WHO refusal of some of the bioequivalence studies. The health minister is also known to be in favour of having an accreditation system in place to check the growth of ill equipped CR establishments in the country. The National Human Rights Commission (NHRC) had also recently called for an autonomous Health Services Regulatory Authority (HSRA), similar to the Telecom Regulatory Authority of India (TRAI) to define and sanction what constitutes rational and ethical practice in healthcare. NHRC wants the authority to set quality standards for healthcare services and monitor the prices of services. The recommendations came at the end of India's first ever 'national public hearing on right to healthcare' jointly organised by NHRC and Jan Swasthya Abhivan (JSA), a network of about 2000 NGOs working in the health sector at the grass root level, in Delhi in December 2004.