Regulatory affairs and the health sector


New Member
Sep 22, 2007
The health care sector is the only area that is bound by numerous rules and regulations. A doctor starts his practice with the Hippocrates’ oath. All other professionals working in the medical field like the pharmacist, nurse, biomedical equipment operator and the dentist need to follow the rules and regulations governing their careers.
For a doctor, adhering to the rules governing his profession is so important because it is a life and death issue for him. A minor mistake may be enough to land him behind bars. Coupled with that, the increasingly health conscious public, is now demanding more from the health care professional. The information technology revolution has now brought technological advances in health care taking place anywhere in the world right at our doorstep.
The Regulatory affairs departments normally frame the rules that govern the research, manufacture, storage and marketing of the various drugs. Medical devices need to pass stringent quality tests and also need to be serviced periodically and tested to estimate its accuracy. Similarly cosmetics and beauty care products too come to the market after passing through the web of numerous rules and regulations.
The ministry of health normally allows national registration for a drug developed in the U.S. But when this same drug needs to be marketed in another country, it needs to pass the regulatory rules valid in that country. Sometimes it may entail a complete redesign of the drug to adhere to the standards in those countries. Pricing is another issue. Most multinational drug manufacturers now strive to localize drug production so as to reduce costs in countries like India, China and other third world destinations.