Abstract

REVIEW AND EVALUATION OF REGULATORY PROCESS IN NOT OF STANDARD QUALITY AND SPURIOUS DRUGS IN INDIA IN COMPARISON WITH EUROPE AND USA

Reddy Bala Durga Prasad* and M. V. Nagabhushanam

ABSTRACT

India has a larger problem with counterfeit and substandard products, leading to life threatening complications, financial loss of consumers and manufacturers, and loss of faith in the health system. The point of this enumerative audit was to test the degree on low quality medications with their results on general wellbeing and the preventive estimates taken by the Indian pharmaceutical administrative framework. To collate the current system to Track and Trace the not of standard Quality and spurious Drugs in India in comparison with USA & EU. A consuming problem is false and unacceptable drugs. In view of the fact that the conversion of credible medication into unsatisfactory medication can cause a number of adverse effects from (disorder, spasms, dermatitis, laziness or seizures) and to severe (cerebral oedema, unconsciousness), it is inadmissible, intracerebral drain, harming) perilous responses. In order to correct this illegal demonstration and broaden shoppers' well-being, knowing the vast number of methods for misleading and substituting is critical. India is the largest producer of non-exclusive drugs, and potentially 12-25 percent of all prescriptions are contaminated, unsatisfactory and fake. Be that as it may, by the Focal Drug Quality Control Association or the Directorate General of Health Administrations, Ministry of Health and Family Welfare, Legislature of India, the countrywide analysis is currently leading to misleading drugs. India has made some preventive measures in the nation to fight against the poor quality of drugs from administrative organisations to ensure and encourage general well-being, late inspections of fake drugs, Guidelines for making a move on drug tests pronounced misleading or not of usual quality in the light of increased penalties under the act of medicines and embellishing agents (revision) and potential investigation plan. C In perspective on above perceptions and information acquired compared with US and Europe, we may conclude that it might be inferred that, the degree of misleading medications in retail drug store is much underneath the projections made by CDSCO.

Keywords: Spurious drugs, NSQ drugs, D&C act, Indian regulatory system, Policies.