Healthcare Compliances in India: A Brief Overview

Neeraj Lal, VP & Cluster Head, Rainbow Children's Hospital Based in Hyderabad, Rainbow Children’s Hospitals is India’s leading child care hospital chain having over 17 years of proven excellence in offering high quality healthcare services in the areas of child care, women care, and fertility

Healthcare market in India is blooming with newer technologies and effective care delivery. Various government initiatives – Smart Cities, Clean India, Digital India and Ayushman Bharat etc. are creating enabling environment giving further push to the services sectors such as communication, healthcare, environment, technology, energy, banking to name a few.

Demand Drivers
• Large ageing population
• Increasing healthcare costs in the western world
• Increase in chronic and communicable diseases
• Increase in disposable income aiding affordability of healthcare services

Presence of world-class hospitals and skilled medical professionals is an added advantage. Treatment for major surgeries in India costs approximately 10 percent of the cost in most of the developed countries.

Healthcare compliance requires healthcare organizations and providers to develop effective processes, policies,and procedures to define appropriate conduct, train the organization's staff,and then monitor the adherence to the processes, policies, and procedures. Focus on quality - The quality of care is increasingly important – as patients begin to exercise their right to choose how and with whom they engage for their healthcare. They demand transparency of data and processes. As a consequence, healthcare organizations will need to focus on how quality outcomes can be published in a meaningful way for patients. Patient safety is the major focus of patient advocacy groups and healthcare leaders. They will enforce deeper investigations of medication errors, hospital acquired infections,wrong site surgery or pressure sores, like never before. NABH(under Quality council of India)is now monitoring clinical and managerial indicators hospital wise,state wise and country.

Healthcare in India features a universal healthcare care system run by the constituent states and territories. Law is an obligation on the part of society imposed by the competent authority, and noncompliance may lead to punishment in the form of
monetary fine or imprisonment or both. The earliest known code of laws called the code of Hammurabi governed the various aspects of health practices including the fees payable to physician for satisfactory services. The modern versionof Hippocratic Oath(called the declaration of Geneva), devised by the WHO after the Second World War and is accepted by international medical fraternity. The first legal recognition and registration for the Indian systems of medicine came when the Bombay Medical Practitioner’ Act was passed in 1938. Laws governing the commissioning of hospital are the laws to ensure that the hospital facilities are created after due process of registration, the facilities created are safe for the public using them, have at least the minimum essential infrastructure for the type and volume of workload anticipated and are subject to periodic inspections to ensure compliance.

Compliance and License Requirements for Healthcare Companies in India
The Ministry of Health and Family Welfare acts as a watchdog for regulating the healthcare industry in India. The Directorate General of Health Services (DGHS)renders technical advice on all Medical and Public Health matters and is involved in the implementation of various Health services. The Pharmaceutical Industry is one of the areas which come under the ambit of healthcare compliances and is extensively regulated by the following:
• Central Drugs Standard Control Organization(CDSCO)
• National Pharmaceutical Pricing Authority(NPPA)
• Indian Council for MedicalResearch(ICMR)
• Drugs Controller General of India(DCGI)

Laws Governing the Commissioning of Hospitals, these are the laws to ensure that the hospital facilities are created after due process of registration, the facilities created are safe for the public using them, have at least the minimum essential infrastructure for the type and volume of workload anticipated,and are subject to periodic inspections to ensure compliance.

Laws governing to the qualification /practice and conduct of professionals

Laws Governing to Sale,Storage of Drugs and Safe-Medication,these are laws to control the usage of drugs, chemicals, blood, blood products, prevent misuse of dangerous drugs, regulate the sale of drugs through licenses, prevent adulteration of drugs and provide for punitive action against the offenders.

Laws Governing Management of Patients, these are the laws for setting standards and norms for conduct of medical professional practice, regulating /prohibiting performance of certain procedure, prevention of unfair practices and control of public health problems /epidemic disease. They deals with the management of emergencies, medico legal cases and all aspects related there to including dying declaration, and conduct of autopsy and the types of Professional negligence.

Laws Governing Environmental Safety,these are the laws aimed at protection of environment through prevention of air, water, surface, noise pollution and punishment of offenders.

A hospital administrator should be aware about the licenses that are essentially required and to renew them as and when required. Periodic Reports and Returns as legal commitment he should be aware about the reports and returns that are essentially required by different agencies with fixed periodicity.

The health legislations are very few as compared to the size and problems in the health care sector. There is a need for having a comprehensive health care act,framed in order to gear the entire health care sector to the objectives laid down in the different policy in India. Most of the common medico legal situations arise out on non-compliance with these rules and regulations. If a hospital or doctor acquaints well with these rules and regulations and follows them sincerely, he/ she would be on the right side of the law.