A Study on Quality Evaluation and Rational Use of Medicine with Regulatory Perspectives

Abstract

Quality of medicine proper diagnostic good counseling and rational use of medicine are the foremost attributes in quality healthcare outcomes. Evidently every country is the victim of substandard or spurious drugs, which result in life threatening issues, loss in trust on healthcare system and financial loss of consumer and manufacturer as well. Such poor quality drugs tend to cause unsuccessful treatment. Therefore, the expanding issues over the extent of substandard or spurious medicines remain a challenge, mainly when the large sample sizes in market are not fully monitored. Not only poor qualities of medicines are responsible for the treatment failure but irrational use of medicine by medical practitioners and patients also have a role to play especially patients behavior towards treatment adherence and instructions compliance. These are some of the critical issues which call for stringent and predominant regulations in making and following the rules, policies and schemes for better healthcare system by the regulatory bodies. Thus in order to cover these issues though a holistic approach we worked on quality evaluation of medicine available in the market, medical practitioners perception towards various market medicines, patients behavior towards treatment adherence, and in developing fast and reliable quality evaluation model for large number of market product. newlineFor quality evaluation 46 amoxicillin trihydrate 250 mg label claim and 32 diclofenac sodium 50 mg label claim generic products were collected from open market of North India. Out of 46 amoxicillin products, 28.26percent were found to be out of Indian Pharmacopoeia specifications, including 13.04percent products which were of substandard quality. Out of 32 diclofenac productspercent 34.37percent were found to be out of Indian Pharmacopoeia specification including 15.62percent substandard. Such an extent might cause further morbidity and even resistance. And the circumstances may become worst if the prices are high and quality could not be controll