India’s model of regulating the private sector is heavily dependent on standardised guidelines. Report may further impact poor uptake of Clinical Establishment Act
India’s complex debate about healthcare regulation just got more complex. A study published in the BMJ has found that most clinical practice guidelines in India do not meet international standards. Clinical practice guidelines otherwise known as standard treatment guidelines are the cornerstone of the way regulation of the private sector is envisaged in India through the clinical establishment act.
The study by Soumyadeep Bhaumik, a former student of international public health at Liverpool School of Tropical Medicine, UK found: “Most clinical practice guidelines in India do not meet international standards in either their scope, the way they were developed, or the independence of their authors, a study has found. Indian guidelines should be better regulated by introducing a central approval system…”
For the study, researchers examined 11 clinical practice guidelines for the four conditions that account for the highest disease burden in India—ischaemic heart disease, lower respiratory infections, chronic obstructive pulmonary disease, and tuberculosis. STGs are supposed to serve as the master document for treatment in order to contain the practice of surfeit diagnostic tests. They are also supposed to act as the shield for a doctor when patients allege apathy or malpractice.
STGs are also important for India’s plans to roll out universal health coverage. A 2014 article in the Journal of Family Medicine and Primary Care said: “Standard Treatment Guidelines (STGs) have been in vogue in India only since recent times and is gaining popularity among practitioners. STGs have many advantages for the patients, healthcare providers, drug manufacturers and marketing agencies, and above all, the policy makers and the legislative system of the country. The drawback in STGs lies in the difficulties in implementation on a large scale. With due efforts to prioritize the health needs, comprehensive coverage of national health programs involving all the stakeholders including professional organizations, undergraduate medical curriculum planners and medical practitioners, STGs can be implemented effectively and thereby we can ensure a quality health care at the primary care level at an affordable cost as part of the now redefined Universal Health Coverage. “
Under the Clinical Establishments Act 2010, STGs were prepared for 21 specialities and disease specific guidelines prepared for common conditions such as osteoarthritis of the knee and neonatal jaundice. STGs have also been drawn up for national programmes such as tuberculosis, kala azar, chikungunya, filariasis etc. The guidelines it examined lack “scope, vigour and quality,” researchers concluded in the study in The BMJ.
