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Health & Wellness
“Many Things in the Pipeline to Regulate Health sector”
Dr R.K Srivastava, Director General of Health Services,
speaks about Regulations in the Indian health system
and other related issues.
Most developed nations and even some developing nations have strict regulations in place for the health industry. Why is this not the case with our country?
However, that does not mean that there is no regulation in place for the health sector in
medical devices, diagnostic labs, hospitals and health human resources. These core components are separately regulated by different regulatory systems.
Pharmaceuticals and medical devices are regulated by the Drugs and Cosmetics Act, hospitals and labs are regulated by the Clinical Establishment Act and the health human resources are regulated by the Indian Medical Council Act, the Dental Council Act, the Pharmacy Council Act and the Nursing Council Act. These Acts have their own rules and regulations and operate through an established mechanism described in the Act.
These Acts are uniformly applicable to the public and private sectors. Health being a state subject, a big part of its regulatory responsibility is vested with the state governments. Enforcement of these regulations is largely under the control of the state government. Besides these core components of health, there are a large number of supportive components that directly assist the health sector.
They include Medical and Paramedical education, research and development, public health, health insurance, quality control and accreditation, health system management, health economics, etc. Some of them are regulated while others are not regulated.
There has been international demand to enforce international regulation in the health sector after GATS (General Agreement on Trade in Services), WTO (World Trade Organisation) and TRIPS (Trade-related aspects of Intellectual Property Rights). Since India has become TRIPS compliant in 1995, there are a series of changes in various regulatory mechanisms that are being worked out in the area of patents, bio-medical research, vaccine and biological products, intellectual property rights, new drug development, concession and taxation policy, import and export policy, GMP (Good Manufacturing Practice), GSP (Good Supply Practice), GLP (Good Laboratory Practice) policies, FDI policy in the pharma sector, etc. where India is working hard, so that the principle of affordability and accessibility is not compromised, the diseases specific to the Indian continent are targeted appropriately in bio-medical research and production of quality drugs by the pharma sector and national and international financial input in R&D is focused towards our own needs without being hijacked by the international priority of a select few pharma giants.
Considering that there has not been any regulation in the health industry and demand is continuously on the rise, a number of health establishments are known to be functioning without following even basic rules/requirements in terms of qualified manpower, equipment and infrastructure. What are the measures from the Government in the pipeline?
As I said, healthcare has yet not been declared as an industry; hence, the specific rules and regulations for an industrial set-up are not applicable to health establishments, but it will be inappropriate to say that the health industry is functioning without basic rules and regulations in terms of qualified manpower, equipment and infrastructure. Drugs, diagnostic aids and medical devices are regulated by the Drugs and Cosmetics Act, which has its huge network in each state and Union Territory in order to enforce these regulations so that only safe and effective drugs, accurate and diagnostic tools and medical devices are allowed in the market for the use of each and every patient of the country. Since it is a new regulatory mechanism, it is in a developmental stage and very soon all clinical establishments in the country will find adequate regulation through this Act. This Act will help in the following manner:
� The Act will provide a reliable database for all types of clinical establishments operating in
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